[vc_row][vc_column width="1/3"][vc_single_image image="2041" img_size="300x510" alignment="center"][/vc_column][vc_column width="2/3"][vc_column_text]
20 mg/ml Dorzolamide
5 ml Ophthalmic Solution
S3 Reg. No. 45/15.4/1035
[/vc_column_text][vc_tta_accordion][vc_tta_section title="COMPOSITION" tab_id="1504694888460-f282d4a8-c0c3"][vc_column_text]Each ml of GLAUCOPRESS Ophthalmic Solution contains: dorzolamide hydrochloride equivalent to 20 mg dorzolamide base and 0,0075 % m/v benzalkonium chloride as preservative.
Other ingredients are: sodium citrate, hydroxyethyl-cellulose, mannitol, sodium
hydroxide and purified water.[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL CLASSIFICATION" tab_id="1504696653492-dead5ed4-53ea"][vc_column_text]A.15.4 Ophthalmic Preparations, other.[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL ACTION" tab_id="1504696784236-399cdfd2-f45c"][vc_column_text][/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacodynamics:" tab_id="1504696941473-15b39f01-f80e"][vc_column_text]Dorzolamide hydrochloride is a carbonic anhydrase inhibitor formulated for topical ophthalmic use.
Carbonic anhydrase (CA) is an enzyme found in many tissues of the body including the eye. It catalyses the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In humans, carbonic anhydrase exists as a number of isoenzymes, the most active being carbonic anhydrase II (CA-II) found primarily in red blood cells (RBCs) but also in other tissues. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction i n sodium and fluid transport. The result is a reduction in intraocular pressure (IOP).
Topically applied beta-adrenergic blocking agents also reduce IOP by decreasing aqueous humor secretion but by a different mechanism of action. When dorzolamide is added to a topical beta-blocker, there is an additional reduction in IOP. This is consistent with the reported additive effects of beta-blockers and oral carbonic anhydrase inhibitors.
When topically applied, dorzolamide reaches the systemic circulation. Dorzolamide accumulates in red blood cells (RBCs) during chronic dosing as a result of selective binding to CA-II while low concentrations of free dorzolamide in the plasma is maintained. Dorzolamide forms a single N-desethyl metabolite that inhibits CA-II less potently than dorzolamide but also inhibits a less active isoenzyme (CA-I). The m etabolite also accumulates in red blood cells (RBCs) where it binds primarily to CA-I.[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacokinetics:" tab_id="1504696941330-da539579-c4e1"][vc_column_text]Dorzolamide binds moderately to plasma proteins (approximately 33 %).
Dorzolamide is primarily excreted unchanged in the urine, the metabolite is also excreted in urine. After dosing ends, dorzolamide washes out of red blood cells (RBCs) nonlinearly, resulting in a rapid decline of agent concentration initially, followed by a slower elimination phase with a half life of about 4 months.
When dorzolamide was given orally to simulate the maximum systemic exposure after long term topical ocular administration, steady state was reached within 13 weeks. At steady state, there is virtually no free dorzolamide or metabolite in plasma.
CA inhibition in red blood cells (RBCs) is less than that anticipated to be necessary for a pharmacological effect on renal function or respiration. Similar pharmacokinetic results were observed after chronic topical administration of dorzolamide. However, some elderly patients with mild to moderate renal impairment (estimated CrCl 30 – 60 ml/min) had higher metabolite concentrations in red blood cells (RBCs), but no meaningful differences in carbonic anhydrase inhibition and no clinically significant systemic side effects were directly attributable to this finding.[/vc_column_text][/vc_tta_section][vc_tta_section title="INDICATIONS" tab_id="1504696941138-eb436d2c-d9d2"][vc_column_text]GLAUCOPRESS is indicated in the treatment of elevated intra-ocular pressure in
patients with:
• ocular hypertension
• open angle glaucoma
• pseudoexfoliative glaucoma and other secondary open-angle glaucomas[/vc_column_text][/vc_tta_section][vc_tta_section title="CONTRAINDICATIONS" tab_id="1504696940964-6db7aa2a-ce57"][vc_column_text]•Hypersensitivity to dorzolamide or any of the ingredients contained in GLAUCOPRESS.
• GLAUCOPRESS has not been evaluated in patients with moderate to severe
renal impairment (i.e. creatinine clearance less than 30 ml/minute). Due to
renal excretion of dorzolamide and N-desethyldorzolamide, topical ocular use of
GLAUCOPRESS in patients with severe renal impairment is not recommended.
• GLAUCOPRESS has not been evaluated in patients with hepatic impairment, and
GLAUCOPRESS should be used with caution in such patients.
• GLAUCOPRESS has not been evaluated in patients wearing contact lenses. The
preservative in GLAUCOPRESS, benzalkonium chloride, may be absorbed by soft
contact lenses.[/vc_column_text][/vc_tta_section][vc_tta_section title="WARNINGS AND SPECIAL PRECAUTIONS" tab_id="1504696940792-b2502b16-79d9"][vc_column_text]GLAUCOPRESS is a sulphonamide and topical administration can result in systemic
absorption. Thus side-effects pertaining to sulphonamides may be experienced.
These include Stevens-Johnson Syndrome, toxic epidermal necrolysis, fulminant
hepatic necrosis, agranulocytosis, aplastic anaemia and other blood dyscrasis.
Sensitisation may recur when a sulphonamide is re-administered irrespective of
the route of administration.
If signs of serious reactions or hypersensitivity occur, discontinue the use of
GLAUCOPRESS and consult your doctor.
There is a potential for an additive effect on the systemic effects of the inhibition
of carbonic anhydrase in patients taking an oral carbonic anhydrase inhibitor and
GLAUCOPRESS concurrently. Thus concurrent administration of the GLAUCOPRESS
and oral carbonic anhydrase inhibitors is not recommended (See ‘’INTERACTIONS’’).
Safety and efficacy of dorzolamide ophthalmic solution in children younger than 16
years of age has not been established.
In patients 65 years of age or older compared with younger patients, safety and
efficacy of dorzolamide were similar however the possibility of greater sensitivity of
some older patients cannot be ruled out.
In clinical studies, local ocular adverse effects, primarily conjunctivitis and lid reactions,
were reported with chronic administration of GLAUCOPRESS ophthalmic solution.
Some of these reactions had the clinical appearance and course of an allergictype
reaction that resolved upon discontinuation of GLAUCOPRESS therapy. If such
reactions occur, treatment with GLAUCOPRESS should be discontinued, and the
patient evaluated before restarting GLAUCOPRESS is considered.
As the possibility of adverse effects on the corneal permeability, and the danger
of disruption of the corneal epithelium with prolonged or repeated usage of
benzalkonium chloride preserved ophthalmological preparations, cannot be
excluded, regular ophthalmological examination is required. Caution should
be exercised in the use of benzalkonium chloride preserved topical medication,
such as GLAUCOPRESS, over an extended period in patients with extensive ocular
surface disease.
The management of patients with acute angle-closure glaucoma requires
therapeutic intervention in addition to ocular hypotensive agents.
Incorrect handling of ophthalmic solutions can result in bacterial contamination of
the solution and subsequent ocular infections. Thus avoid allowing the tip of the
dispensing container to come in contact with the eye or surrounding areas.
Serious damage to the eye and subsequent loss of vision may result from using
contaminated ophthalmic solutions.
GLAUCOPRESS contains mannitol, which may have a mild laxative effect.[/vc_column_text][/vc_tta_section][vc_tta_section title="Effects on ability to drive and use machines" tab_id="1504696940622-1618a33d-4c35"][vc_column_text]Administration of eye drops may cause transient blurring of vision.[/vc_column_text][/vc_tta_section][vc_tta_section title="INTERACTIONS" tab_id="1504696940447-93197fdb-e240"][vc_column_text]Specific interaction studies with GLAUCOPRESS have not been performed however,
in clinical studies dorzolamide was used concomitantly with the following medicines
without evidence of adverse interactions: timolol ophthalmic solution, betaxolol
ophthalmic solution and systemic medication including ACE-Inhibitors, calcium
channel blockers, diuretics, non-steroidal anti-inflammatory drugs (NSAIDs) and
hormones (e.g. oestrogen, insulin, thyroxine).
GLAUCOPRESS is a carbonic anhydrase inhibitor and although administered
topically, is absorbed systemically.
Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors
and have in some cases resulted in interactions (e.g. toxicity associated with highdose
salicylate therapy). Thus the potential for such interactions in patients using
GLAUCOPRESS should be considered.
When GLAUCOPRESS is used in conjunction with beta adrenergic blocking agents,
the intraocular pressure lowering effect may be additive.
Concomitant administration with oral carbonic anhydrase inhibitors is not
recommended due to the potential for an additive effect on the known systemic
effects of carbonic anhydrase inhibition.[/vc_column_text][/vc_tta_section][vc_tta_section title="PREGNANCY AND LACTATION" tab_id="1504696940262-98475ac1-fe09"][vc_column_text]Pregnancy:
There are no adequate and controlled studies in pregnant women, and
GLAUCOPRESS is not recommended during pregnancy.
In rabbits given maternotoxic doses associated with metabolic acidosis greater than
or equal to 2,5 mg/kg/day, malformation of the vertebral bodies were observed.
Lactation:
It is unknown whether dorzolamide is excreted into human milk. Due to the potential
for serious adverse reactions to dorzolamide in breastfed infants, a decision should
be made whether to discontinue breastfeeding the infant or the medicine, taking
into account the importance of GLAUCOPRESS to the women.[/vc_column_text][/vc_tta_section][vc_tta_section title="DOSAGE AND DIRECTIONS FOR USE" tab_id="1504696939902-865da232-1a1b"][vc_column_text]Benzalkonium chloride may be absorbed by soft contact lenses. Patients wearing
soft contact lenses should be instructed to wait at least 15 minutes after
instilling GLAUCOPRESS to insert soft contact lenses (See “WARNINGS AND
SPECIAL PRECAUTIONS”).[/vc_column_text][/vc_tta_section][vc_tta_section title="Recommended dosage for adults (including the elderly)" tab_id="1504698296730-b0688eef-6335"][vc_column_text]If more than one topical ophthalmic medication is
being used, the medicines should be administered at least ten minutes apart.
When used as monotherapy, the dose is one drop of GLAUCOPRESS in the affected
eye(s) three times a day.
When used as adjunctive therapy with an ophthalmic ß-adrenergic blocker, the
dose is one drop of GLAUCOPRESS in the affected eye(s) twice daily.
When substituting GLAUCOPRESS for another ophthalmic antiglaucoma agent,
discontinue the other agent after completing the proper dosing on one day, and
start the GLAUCOPRESS the next day.[/vc_column_text][/vc_tta_section][vc_tta_section title="SIDE-EFFECTS" tab_id="1504696939701-d619dd3e-19b6"][vc_column_text]Eye disorders:
Frequent:
Burning and stinging, blurred vision, eye itching, tearing, conjunctivitis, eyelid
inflammation, eyelid irritation.
Less frequent:
Iridocyclitis, photophobia.
Frequency unknown:
Transient myopia, superficial punctuate keratitis, eye pain and redness.
General disorders and administrative site conditions:
Frequent:
Asthenia/fatigue.
Nervous system disorders:
Frequent:
Headache.
Frequency unknown:
Dizziness, paraesthesia.
Respiratory, thoracic and mediastinal disorders:
Less frequent:
Epistaxis.
Frequency unknown:
Bronchospasm.
Gastro-intestinal disorders:
Frequent:
Bitter taste, nausea.
Hepato-biliary disorders:
Less frequent:
Fulminant hepatic necrosis.
Blood and the lymphatic system disorders:
Less frequent:
Agranulocytosis, aplastic anaemia
Skin and subcutaneous tissue disorders:
Less frequent:
Rash, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Frequency unknown:
Urticaria, pruritus.
Immune system disorder:
Frequency unknown:
Angioedema.
Renal and urinary disorders:
Less frequent:
Urolithiasis.[/vc_column_text][/vc_tta_section][vc_tta_section title="KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS" tab_id="1504697656865-f242e147-a927"][vc_column_text]Limited data is available in regard to overdosage in humans. Overdosage of
GLAUCOPRESS can be expected to result in electrolyte imbalances, systemic
acidosis and possible central nervous system effects.
Serum electrolyte levels (particularly potassium) and blood pH levels should be
monitored.
Treatment is supportive and symptomatic.[/vc_column_text][/vc_tta_section][vc_tta_section title="IDENTIFICATION" tab_id="1504697656470-fa82922f-13cc"][vc_column_text]Sterile clear colourless or slightly yellowish, slightly viscous solution.[/vc_column_text][/vc_tta_section][vc_tta_section title="PRESENTATION" tab_id="1504697656056-d141d0d1-b24c"][vc_column_text]Sterile Opaque, white, low density polyethylene, 5 ml dropper bottle, with white low density polyethylene capillary plugs and blue polypropylene cap in cardboard carton.[/vc_column_text][/vc_tta_section][vc_tta_section title="STORAGE INSTRUCTIONS" tab_id="1504697655670-4d98e465-bd16"][vc_column_text]Store at or below 30 °C. Protect from light. Discard the product after 30 days of
being opened.
Keep well closed. For external use only.
KEEP OUT OF REACH OF CHILDREN.[/vc_column_text][/vc_tta_section][vc_tta_section title="REGISTRATION NUMBER" tab_id="1504697655304-2efb71f5-a8e6"][vc_column_text]45/15.4/1035[/vc_column_text][/vc_tta_section][vc_tta_section title="NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION" tab_id="1504697653976-4fb20b42-ff45"][vc_column_text]Actor Pharma (Pty) Ltd
Unit 7, Royal Palm Business Estate
646 Washington Street, Halfway House, Midrand, 1685
Gauteng[/vc_column_text][/vc_tta_section][vc_tta_section title="DATE OF PUBLICATION OF THIS PACKAGE INSERT" tab_id="1504697953640-4b9e076c-b7e5"][vc_column_text]27 November 2014[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row]
[vc_row][vc_column width="1/3"][vc_single_image image="2016" img_size="303x500" alignment="center"][/vc_column][vc_column width="2/3"][vc_column_text]
2 mg/ml Brimonidine Tartrate
5 ml Ophthalmic Solution
S3 Reg. No. 45/15.4/0688
[/vc_column_text][vc_tta_accordion][vc_tta_section title="COMPOSITION" tab_id="1504694888460-f282d4a8-c0c3"][vc_column_text]Each ml of BRIMOCT Ophthalmic Solution contains Brimonidine Tartrate 2,0 mg
Other ingredients are: Citric Acid Monohydrate
Polyvinyl Alcohol
Purified Water
Sodium Chloride
Sodium Citrate Dihydrate
Sodium Hydroxide
Preservative: Benzalkonium Chloride 0,005 % m/v
[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL CLASSIFICATION" tab_id="1504696653492-dead5ed4-53ea"][vc_column_text]A.15.4 Ophthalmic Preparations. Other[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL ACTION" tab_id="1504696784236-399cdfd2-f45c"][vc_column_text]Brimonidine a selective alpha-2-adrenergic receptor agonist.[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacodynamics:" tab_id="1504696941473-15b39f01-f80e"][vc_column_text]Following topical administration to the eye, brimonidine tartrate, a selective alpha-2-adrenergic receptor agonist, reduces intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Peak ocular hypotensive effect occurs at two hours post-dosing. Due to its selectivity brimonidine tartrate has minimal effect on cardiovascular and pulmonary parameters.
Brimonidine has a dual mechanism of action as suggested by fluorophotometric studies done in animals and humans. It lowers intraocular pressure by reducing aqueous humour production and by increasing uveoscleral outflow.
[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacokinetics:" tab_id="1504696941330-da539579-c4e1"][vc_column_text]Following topical ocular administration of 0,2 % brimonidine solution, plasma concentrations peaked within 0,5 to 2,5 hours and declined with a systemic half life of approximately 2 hours. Systemic metabolism of brimonidine in humans is extensive and occurs primarily by the liver. The major route of elimination of the medicine and its metabolites is by urinary excretion.[/vc_column_text][/vc_tta_section][vc_tta_section title="INDICATIONS" tab_id="1504696941138-eb436d2c-d9d2"][vc_column_text]BRIMOCT ophthalmic solution is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
[/vc_column_text][/vc_tta_section][vc_tta_section title="CONTRAINDICATIONS" tab_id="1504696940964-6db7aa2a-ce57"][vc_column_text]BRIMOCT is contraindicated in patients with hypersensitivity to brimonidine tartrate, benzalkonium chloride or any other ingredient in BRIMOCT. BRIMOCT is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.
Safety and efficacy of BRIMOCT in children younger than 2 years of age have not been established. However due to potentially serious adverse central nervous system effects, including apnoea and lethargy, reported in infants treated with topical brimonidine tartrate, the use of BRIMOCT is not recommended for use in paediatric patients under the age of two.
[/vc_column_text][/vc_tta_section][vc_tta_section title="WARNINGS AND SPECIAL PRECAUTIONS" tab_id="1504696940792-b2502b16-79d9"][vc_column_text]As the possibility of adverse effects on the corneal permeability, and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations, cannot be excluded, regular ophthalmological examination is required.
Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.
The use of BRIMOCT may result in dry eyes and therefore should be used with caution in patients with dry eye syndrome.
Patients that use intraocular lowering medication should be routinely monitored for intraocular pressure.
Brimonidine had minimal effects on the blood pressure of patients in clinical studies however caution should be exercised in treating patients with severe cardiovascular disease.
BRIMOCT should be used with caution in patients with Raynaud’s phenomenon, cerebral or coronary insufficiency, depression, orthostatic hypotension, or thromboangiitis obliterans.
BRIMOCT ophthalmic solution has not been studied in patients with renal or hepatic impairment and therefore caution should be exercised in treating such patients.
Benzalkonium chloride may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling BRIMOCT ophthalmic solution to insert soft contact lenses. The overall difference in safety and efficacy between the elderly and other adult patients has not been observed.
BRIMOCT may cause fatigue and/or drowsiness in some patients. Patients who engage in hazardous activities should therefore be cautioned of the potential for a decrease in mental alertness.[/vc_column_text][/vc_tta_section][vc_tta_section title="Effects on ability to drive and use machines" tab_id="1504696940622-1618a33d-4c35"][vc_column_text]BRIMOCT may sting, burn or cause itchiness and blurred vision just after instillation. Patients should be advised to not drive, use machinery or do any activity that requires clear vision, until they are sure that they can perform such activities safely.
[/vc_column_text][/vc_tta_section][vc_tta_section title="INTERACTIONS" tab_id="1504696940447-93197fdb-e240"][vc_column_text]BRIMOCT has the possibility of an additive or potentiating effect when used with CNS depressants (alcohol, sedatives, barbiturates, opiates or anaesthetics).
Caution in using concomitant medicines such as beta blockers (ophthalmic and systemic), antihypertensive and/or cardiac glycosides is advised, since alpha agonists as a class, may reduce pulse and blood pressure.
The hypotensive effects of systemic clonidine have been reported to be blunted by tricyclic antidepressants. It is not known whether the concurrent use of these agents with BRIMOCT ophthalmic solution can lead to an interference with the IOP lowering effect.
There is no information available regarding the level of circulating catecholamines after BRIMOCT administration. However, since tricyclic antidepressants may affect the metabolism and uptake of circulating amines, caution is advised in patients using these antidepressants.
[/vc_column_text][/vc_tta_section][vc_tta_section title="PREGNANCY AND LACTATION" tab_id="1504696940262-98475ac1-fe09"][vc_column_text]Pregnancy:
The safety and efficacy of BRIMOCT in pregnant women have not been established.
Lactation:
It has not been established whether BRIMOCT is excreted in human milk. A decision should be made on whether to discontinue BRIMOCT or discontinue breastfeeding, taking into account the importance of the medicine to the mother.[/vc_column_text][/vc_tta_section][vc_tta_section title="DOSAGE AND DIRECTIONS FOR USE" tab_id="1504696939902-865da232-1a1b"][vc_column_text]
Benzalkonium chloride may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling BRIMOCT ophthalmic solution to insert soft contact lenses [See “Warnings and Special precautions”].
The recommended dose is one drop of BRIMOCT in the affected eye(s) twice daily, approximately 12 hours apart.
BRIMOCT may be used concomitantly with other topical ophthalmic medicinal products to lower ocular pressure. The topical ophthalmic products should be administered at least 5 minutes apart if more than one product is being used.[/vc_column_text][/vc_tta_section][vc_tta_section title="SIDE-EFFECTS" tab_id="1504696939701-d619dd3e-19b6"][vc_column_text]The most undesirable side-effects relate to the ocular system and may include
Conjunctival hyperaemia, eye pruritus. Allergic conjunctivitis.
Frequent:
Burning sensation, stinging, foreign body sensation, follicular conjunctivitis, photophobia, eye pain, eye dryness, conjunctival oedema, blepharitis, eye irritation, eye discharge, conjunctival haemorrhage.
Conjunctival folliculosis, conjunctivitis, epiphora, visual field defects, visual disturbances, worsened visual acuity, superficial punctate keratopathy, vitreous floaters.
Less frequent:
Corneal erosion.
Frequency unknown:
Iritis, miosis.
Nervous system disorders:
Frequent:
Headache, dizziness.
Less Frequent:
Taste perversion, somnolence in adults and infants.
Psychiatric disorders:
Less frequent:
Insomnia, depression, anxiety, syncope.
Vascular disorders:
Frequent:
Hypertension.
Frequency unknown:
Hypotension in adults and infants.
Musculoskeletal disorders:
Frequency unknown:
Hypotonia in infants.
Cardiac disorders:
Less frequent:
Palpitations.
Frequency unknown:
Bradycardia in adults and infants, tachycardia.
Immune system disorders:
Frequent:
Allergic reactions.
Skin and subcutaneous tissue disorders:
Frequent:
Rash. Eyelid erythema, eyelid oedema.
Frequency unknown:
Eye pruritus, vasodilation.
Respiratory, thoracic and mediastinal disorders:
Frequent:
Cough, dyspnoea.
Less frequent:
Nasal dryness.
Frequency unknown:
Apnoea in infants.
Gastrointestinal disorders:
Frequent:
Oral dryness, dyspepsia.
Infections and infestations:
Frequent:
Sinusitis, sinus infection, flu syndrome, bronchitis, rhinitis, pharyngitis.
General disorders and administration site condition:
Frequent:
Asthenia.
Frequency unknown:
Hypothermia in infants.[/vc_column_text][/vc_tta_section][vc_tta_section title="KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS" tab_id="1504697656865-f242e147-a927"][vc_column_text]Treatment, in the event of an oral overdose, includes supportive and symptomatic therapy. A patent airway should be maintained.[/vc_column_text][/vc_tta_section][vc_tta_section title="IDENTIFICATION" tab_id="1504697656470-fa82922f-13cc"][vc_column_text]Clear, transparent, yellowish solution without suspending particles.[/vc_column_text][/vc_tta_section][vc_tta_section title="PRESENTATION" tab_id="1504697656056-d141d0d1-b24c"][vc_column_text]BRIMOCT® ophthalmic solution is supplied in an opaque white sterile dropper bottle with a white sterile capillary plug and a purple sterile cap, containing 5 ml solution. The dropper bottle is contained in an outer cardboard carton.[/vc_column_text][/vc_tta_section][vc_tta_section title="STORAGE INSTRUCTIONS" tab_id="1504697655670-4d98e465-bd16"][vc_column_text]Store at or below 25 oC. Keep well closed. Protect from light. Do not refrigerate.
Do not use more than 30 days after opening.
KEEP OUT OF REACH OF CHILDREN.[/vc_column_text][/vc_tta_section][vc_tta_section title="REGISTRATION NUMBER" tab_id="1504697655304-2efb71f5-a8e6"][vc_column_text]45/15.4/0688[/vc_column_text][/vc_tta_section][vc_tta_section title="NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION" tab_id="1504697653976-4fb20b42-ff45"][vc_column_text]Actor Pharma (Pty) Ltd
Unit 7, Royal Palm Business Estate
646 Washington Street, Halfway House, Midrand, 1685
Gauteng
[/vc_column_text][/vc_tta_section][vc_tta_section title="DATE OF PUBLICATION OF THIS PACKAGE INSERT" tab_id="1504697953640-4b9e076c-b7e5"][vc_column_text]11 December 2014[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row]
[vc_row][vc_column width="1/3"][vc_single_image image="2023" img_size="300x520" alignment="center"][/vc_column][vc_column width="2/3"][vc_column_text]
5 mg/ml (0,5 % m/v) Betaxolol
5 ml Ophthalmic Solution
S3 Reg. No. 47/15.4/0526
[/vc_column_text][vc_tta_accordion][vc_tta_section title="COMPOSITION" tab_id="1504694888460-f282d4a8-c0c3"][vc_column_text]Each ml contains betaxolol hydrochloride equivalent to 5 mg (0,5 % m/v) betaxolol and 0,01% m/v benzalkonium chloride as the preservative.
The other ingredients are disodium edetate, sodium chloride and water for injection.[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL CLASSIFICATION" tab_id="1504696653492-dead5ed4-53ea"][vc_column_text]A.15. 4 Ophthalmic Preparations, other[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL ACTION" tab_id="1504696784236-399cdfd2-f45c"][/vc_tta_section][vc_tta_section title="Pharmacodynamics:" tab_id="1504696941473-15b39f01-f80e"][vc_column_text]Pharmacodynamic properties:
Betaxolol hydrochloride is a cardio-selective (beta-1-adrenergic) receptor blocking agent.
When administered to the eye, betaxolol reduces elevated and normal intraocular pressure.
The mechanism of ocular hypotensive action appears to be a reduction of aqueous production.[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacokinetics:" tab_id="1504696941330-da539579-c4e1"][vc_column_text]
| Pharmacokinetic properties:
The onset of action of betaxolol is observed within 30 minutes with a duration of 12 to 24 hours. The maximal effect is usually detected 2 hours after topical administration to the eye. A single dose results in a 12 hour reduction in intraocular pressure. No negative effect on the blood supply to the optic nerve has been observed while on treatment with betaxolol ophthalmic solution. Betaxolol ophthalmic solution does not produce miosis and accommodative spasm. |
[/vc_column_text][/vc_tta_section][vc_tta_section title="INDICATIONS" tab_id="1504696941138-eb436d2c-d9d2"][vc_column_text]LOXOPTIC has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of:
[/vc_column_text][/vc_tta_section][vc_tta_section title="CONTRAINDICATIONS" tab_id="1504696940964-6db7aa2a-ce57"][vc_column_text]
[/vc_column_text][/vc_tta_section][vc_tta_section title="WARNINGS AND SPECIAL PRECAUTIONS" tab_id="1504696940792-b2502b16-79d9"][vc_column_text]
[/vc_column_text][/vc_tta_section][vc_tta_section title="Effects on ability to drive and use machines" tab_id="1504696940622-1618a33d-4c35"][vc_column_text]LOXOPTIC may cause dizziness, fatigue, transient ocular irritation, blurred vision and lacrimation.
Patients should be advised to exercise caution until they know how LOXOPTIC affects them.[/vc_column_text][/vc_tta_section][vc_tta_section title="INTERACTIONS" tab_id="1504696940447-93197fdb-e240"][vc_column_text]
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INTERACTIONS · LOXOPTIC used alone has little or no effect on pupil size; however concurrent therapy of LOXOPTIC and epinephrine (adrenaline) has resulted in mydriasis. · There is a potential for additive effects resulting in hypotension and/or marked bradycardia when LOXOPTIC is administered concomitantly with oral calcium channel blockers, beta adrenergic blocking agents, anti-dysrhythmics (including amiodarone, digoxin), parasympathomimetics and catecholamine-depleting agents such as reserpines (see WARNINGS AND SPECIAL PRECAUTIONS). · Caution should be exercised in patients using LOXOPTIC, hypoglycaemic agents and phenothiazines concurrently. · Caution should be exercised in patients using concomitant adrenergic psychotropic medicines. |
[/vc_column_text][/vc_tta_section][vc_tta_section title="PREGNANCY AND LACTATION" tab_id="1504696940262-98475ac1-fe09"][vc_column_text]Pregnancy:
Safety in pregnancy has not yet been established. Infants of mothers administered beta-blockers shortly before giving birth, or during labour may be born hypotonic, collapsed and hypoglycaemic.
Lactation:
LOXOPTIC is secreted in human milk therefore caution should be exercised when administering LOXOPTIC to mothers breastfeeding their babies.[/vc_column_text][/vc_tta_section][vc_tta_section title="DOSAGE AND DIRECTIONS FOR USE" tab_id="1504696939902-865da232-1a1b"][vc_column_text]The usual dose is one drop of LOXOPTIC in the affected eye(s) twice daily.
In some patients, the intraocular pressure lowering response to LOXOPTIC may require a few weeks to stabilise.
A clinical follow up should include a determination of the intraocular pressure during the first month of treatment with LOXOPTIC. Thereafter, intraocular pressure readings should be determined on an individual basis at the judgement of the medical practitioner.
When substituting LOXOPTIC for another ophthalmic anti-glaucoma agent, continue the agent already used and add one drop of LOXOPTIC in the affected eye(s) twice a day. On the following day, discontinue the previous anti-glaucoma agent completely and continue with LOXOPTIC.
Due to diurnal variations of intraocular pressure in individual patients, a satisfactory response to twice a day therapy is best determined by measuring intraocular pressure at different times during the day.
Therapy with LOXOPTIC should be individualised. If the intraocular pressure of the patient is poorly controlled on this regimen, concurrent therapy with pilocarpine, other miotics, epinephrine (adrenaline) or systemically administered carbonic anhydrase inhibitors can be initiated.
If more than one eye drop is being used, the eye drops should be administered at least 10 minutes apart.
When a patient is transferred from several concomitantly administered anti-glaucoma agents individualisation is needed. The adjustment should involve one agent at a time made at intervals of not less than one week. A recommended approach is to continue the agents being used and add one drop of LOXOPTIC in the affected eye(s) twice a day. On the following day, discontinue one of the other anti-glaucoma agents. The remaining anti-glaucoma agents may be decreased or discontinued according to the patient’s response to treatment.[/vc_column_text][/vc_tta_section][vc_tta_section title="Recommended dosage for adults (including the elderly)" tab_id="1504698296730-b0688eef-6335"][vc_column_text][/vc_column_text][/vc_tta_section][vc_tta_section title="SIDE-EFFECTS" tab_id="1504696939701-d619dd3e-19b6"][vc_column_text]LOXOPTIC is absorbed into the systemic circulation and may cause similar undesirable effects as seen with systemic beta-blockers.
Immune system disorders:
Frequency unknown: Systemic allergic reactions including angioedema, urticaria, localised and generalised rash, pruritus.
Eye disorders:
Frequent: Discomfort on instillation.
Less frequent: Tearing, instances of decreased corneal sensitivity, itching sensation, corneal punctuate staining, keratitis, anisocoria, photophobia, erythema.
Frequency unknown: Blepharitis, decreased tear production and dry eyes, blurred vision, conjunctivitis, soreness, ocular irritation (burning, stinging, redness), diplopia, ptosis, corneal erosion.
Psychiatric disorders:
Frequency unknown: Depressive neurosis, malaise, vivid dreams and nightmares, overt psychosis, hallucinations.
Nervous system disorders:
Frequent: Headache.
Less frequent: Depression.
Frequency unknown: Insomnia, confusion, memory loss, syncope, cerebrovascular accident, cerebral ischaemia, increase in signs and symptoms of myasthenia gravis, dizziness, paraesthesia.
Metabolism and nutrition disorders:
Frequency unknown: Hypoglycaemia.
Cardiac disorders:
Less frequent: Marked bradycardia.
Frequency unknown: Congestive cardiac failure, chest pain, palpitations, dysrhythmia, cardiac failure, atrioventricular block, cardiac arrest, a slowed AV-conduction or increase of an existing AV-block.
Vascular disorders:
Frequency unknown: Exacerbation of peripheral vascular disease, Raynaud’s phenomenon (due to unopposed arteriolar sympathetic activation), severe peripheral vascular disease, peripheral gangrene, hypotension, cold and cyanotic hands and feet, oedema, exacerbation of intermittent claudication.
Respiratory, thoracic and mediastinal disorders:
Less frequent: Dyspnoea, asthma.
Frequency unknown: Bronchospasm, cough.
Gastro-intestinal disorders:
Frequency unknown: Nausea, vomiting, diarrhoea, constipation, abdominal cramping, dysgeusia, dyspepsia, dry mouth.
Skin and subcutaneous tissue disorders:
Less frequent: Alopecia.
Frequency unknown: Erythema, psoriasiform rash or exacerbation of psoriasis.
Musculoskeletal, connective tissue and bone disorders:
Frequency unknown: Skeletal muscle weakness, myalgia.
Reproductive system and breast disorders:
Frequency unknown: Sexual dysfunction, impotence, decreased libido.
Side-effects are frequent in patients with renal decomposition.[/vc_column_text][/vc_tta_section][vc_tta_section title="KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS" tab_id="1504697656865-f242e147-a927"][vc_column_text]KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
(see SIDE EFFECTS and WARNINGS AND SPECIAL PRECAUTIONS)
The symptoms which might be expected in an overdosage of a systemically administered beta-1-adrenergic receptor blocking agent are hypotension, bradycardia, and acute cardiac failure.
A topical overdose of LOXOPTIC may be flushed from the eye(s) with warm tap water.[/vc_column_text][/vc_tta_section][vc_tta_section title="IDENTIFICATION" tab_id="1504697656470-fa82922f-13cc"][vc_column_text]LOXOPTIC ophthalmic solution is a clear, colourless solution free from visible particulate matter.[/vc_column_text][/vc_tta_section][vc_tta_section title="PRESENTATION" tab_id="1504697656056-d141d0d1-b24c"][vc_column_text]Carton containing a colourless, translucent, LDPE bottle with a white to off-white polystyrene cap.
Each bottle contains 5 ml of LOXOPTIC ophthalmic solution.[/vc_column_text][/vc_tta_section][vc_tta_section title="STORAGE INSTRUCTIONS" tab_id="1504697655670-4d98e465-bd16"][vc_column_text]
STORAGE INSTRUCTIONS
Store at or below 30 °C. Protect from light.
Do not use more than 28 days after opening.
KEEP OUT OF REACH OF CHILDREN.[/vc_column_text][/vc_tta_section][vc_tta_section title="REGISTRATION NUMBER" tab_id="1504697655304-2efb71f5-a8e6"][vc_column_text]47/15.4/0526[/vc_column_text][/vc_tta_section][vc_tta_section title="NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION" tab_id="1504697653976-4fb20b42-ff45"][vc_column_text]Actor Pharma (Pty) Ltd
Unit 7, Royal Palm Business Estate
646 Washington Street, Halfway House, Midrand, 1685
Gauteng[/vc_column_text][/vc_tta_section][vc_tta_section title="DATE OF PUBLICATION OF THIS PACKAGE INSERT" tab_id="1504697953640-4b9e076c-b7e5"][vc_column_text]26 November 2015[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row]
[vc_row][vc_column width="1/3"][vc_single_image image="2381" img_size="full"][/vc_column][vc_column width="2/3"][vc_column_text]
Ketorolac Tromethamine 5,0 mg/ml.
5 ml Ophthalmic Solution
S3 Reg. No. 45/15.4/1033
[/vc_column_text][vc_tta_accordion][vc_tta_section title="COMPOSITION" tab_id="1504694888460-f282d4a8-c0c3"][vc_column_text]KELOPT Ophthalmic Solution contains: Ketorolac Tromethamine
5,0 mg/ml.
Other ingredients are:
Disodium Phosphate Anhydrous
Monosodium Phosphate Dihydrate
Sodium Chloride
Purified Water
Preservatives: Benzalkonium Chloride 0,01 % m/v
Disodium Edetate Dihydrate 0,05 % m/v
[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL CLASSIFICATION" tab_id="1504696653492-dead5ed4-53ea"][vc_column_text]A 15.4 Ophthalmic preparations, others.[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL ACTION" tab_id="1504696784236-399cdfd2-f45c"][/vc_tta_section][vc_tta_section title="Pharmacodynamic Properties" tab_id="1504696941473-15b39f01-f80e"][vc_column_text]Pharmacodynamic properties:
Ketorolac tromethamine is a non-steroidal anti-inflammatory agent, demonstrating both anti-inflammatory and analgesic activity.
The mechanism of action of ketorolac tromethamine is believed to
be due to its ability to inhibit the cyclo-oxygenase enzymes, which
are essential for the biosynthesis of certain prostaglandins in the
arachidonic acid pathway.
Ketorolac tromethamine has been shown to reduce aqueous
humour concentrations of these prostaglandins (PGE2) following
topical application to the eye. Ketorolac tromethamine has no
significant effect on intraocular pressure.
Systemic administration of ketorolac tromethamine does not cause
pupil constriction.[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacokinetic Properties:" tab_id="1504696941330-da539579-c4e1"][vc_column_text]Following topical administration of one drop (0,05 ml) of 0,5 %
ketorolac tromethamine ophthalmic solution into one eye and
one drop of vehicle into the other eye, 3 times a day in 26 normal
individuals, it was noted that only some of the individuals had
a detectable amount of ketorolac in their plasma (range: 10,7 to
22,5 ng/ml) at day 10. Steady state plasma levels of about
960 ng/ml is achieved when 10 mg of ketorolac tromethamine is
administered systemically every 6 hours.[/vc_column_text][/vc_tta_section][vc_tta_section title="INDICATION" tab_id="1504696941138-eb436d2c-d9d2"][vc_column_text]KELOPT is indicated for the relief of inflammation following ocular surgery.[/vc_column_text][/vc_tta_section][vc_tta_section title="CONTRAINDICATIONS" tab_id="1504696940964-6db7aa2a-ce57"][vc_column_text]KELOPT is contraindicated in patients who are hypersensitive to
ketorolac tromethamine, benzalkonium chloride or any ingredient in the formulation.
There is a potential for cross-sensitivity to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). KELOPT is contraindicated in individuals who have previously exhibited sensitivities to these components (See WARNINGS AND SPECIAL PRECAUTIONS).
Pregnancy and lactation.
Safety and effectiveness of KELOPT in children have not been established.
KELOPT should not be administered while wearing soft (hydrophilic)
contact lenses.[/vc_column_text][/vc_tta_section][vc_tta_section title="WARNINGS AND SPECIAL PRECAUTIONS" tab_id="1504696940792-b2502b16-79d9"][vc_column_text]Since there is potential for cross-sensitivity between KELOPT and other NSAIDs [including aspirin (acetylsalicylic acid)], KELOPT should be used with caution in patients in whom asthma, rhinitis or urticaria is precipitated by aspirin or other NSAIDs.
KELOPT may mask the usual signs of infection.
KELOPT has the potential to increase bleeding time due to interference with thrombocyte aggregation and may cause increased bleeding of ocular tissue (including hyphemas) in conjunction with ocular surgery.
KELOPT should be used with caution in patients with a known history of peptic ulceration, in patients who have bleeding tendencies or who are receiving other medication which may prolong the bleeding time.
Keratitis may result from the use of KELOPT. Continued use of KELOPT may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or cornea perforation in some susceptible patients. These events may threaten vision.
KELOPT should be immediately discontinued in patients with evidence of
corneal epithelial breakdown and these patients should be closely monitored for corneal health.
Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time, may be at increased risk for corneal adverse events which may become sight threatening.
It is therefore recommended that KELOPT be used with caution in these patients.
The use of KELOPT for more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.
KELOPT may slow or delay the healing process.
Benzalkonium chloride is known to cause eye irritation and discolour soft contact lenses. Patients that wear soft contact lenses should be instructed to remove their lenses prior to using KELOPT and to wait at least 15 minutes before reinserting them (See DOSAGE AND DIRECTIONS FOR USE).
In view of KELOPT’s inherent potential to cause fluid retention, heart
failure may be precipitated in some compromised patients.
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required.
Caution should be exercised in the use of benzalkonium chloride
preserved topical medication over an extended period in patients with extensive ocular surface disease.[/vc_column_text][/vc_tta_section][vc_tta_section title="Effects on ability to drive and use machines" tab_id="1504696940622-1618a33d-4c35"][vc_column_text]KELOPT may cause transient burning on instillation. Patients should
be advised not to drive or use machines unless vision is clear.[/vc_column_text][/vc_tta_section][vc_tta_section title="INTERACTIONS" tab_id="1504696940447-93197fdb-e240"][vc_column_text]Concomitant use with medication containing anticoagulants, coumarin- or indandione-derivatives, heparin or platelet aggregation inhibitors may increase the risk of post-operative bleeding.
Since KELOPT and topical corticosteroids slow or delay healing, concomitant use of these agents may increase the potential for healing problems.
KELOPT has been safely administered with systemic and ophthalmic medication such as carbonic anhydrase inhibitors, cycloplegics, betablockers, antibiotics, miotics and mydriatrics.
[/vc_column_text][/vc_tta_section][vc_tta_section title="PREGNANCY AND LACTATION" tab_id="1504696940262-98475ac1-fe09"][vc_column_text]Concomitant use with medication containing anticoagulants, coumarin- or indandione-derivatives, heparin or platelet aggregation inhibitors may increase the risk of post-operative bleeding.
Since KELOPT and topical corticosteroids slow or delay healing, concomitant use of these agents may increase the potential for healing problems.
KELOPT has been safely administered with systemic and ophthalmic medication such as carbonic anhydrase inhibitors, cycloplegics, betablockers, antibiotics, miotics and mydriatrics.[/vc_column_text][/vc_tta_section][vc_tta_section title="DOSAGE AND DIRECTIONS FOR USE" tab_id="1504696939902-865da232-1a1b"][vc_column_text]Benzalkonium chloride is known to cause eye irritation and discolour soft contact lenses. Patients that wear soft contact lenses should be instructed to remove their lenses prior to using KELOPT and to wait at least 15 minutes before reinserting them (See WARNINGS AND SPECIAL PRECAUTIONS).
The recommended dose is one drop of KELOPT into the affected eye(s) four times daily starting 24 hours before surgery and continuing post-operatively.
Post marketing experience with topical NSAIDs such as KELOPT suggest that use of these medications for more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase the risk for the occurrence and severity of corneal adverse events (See WARNINGS AND SPECIAL PRECAUTIONS).[/vc_column_text][/vc_tta_section][vc_tta_section title="SIDE-EFFECTS" tab_id="1504696939701-d619dd3e-19b6"][vc_column_text]Eye disorders:
Frequent:
Stinging or burning upon instillation. Minor symptoms of ocular irritation.
Superficial ocular infections, corneal infiltrates, superficial keratitis, ocular irritation, conjunctival hyperaemia, ocular inflammation, ocular pain, ocular oedema, iritis, corneal oedema.
Less frequent:
Dry eyes, corneal ulceration.
Frequency unknown:
Blurring/visual disturbances.
Corneal perforation, corneal erosion, corneal thinning and epithelial breakdown.
Immune system disorders:
Frequent:
Allergic reactions such as rash, itching, redness or swelling of the skin.
Nervous system disorders:
Frequent:
Headache.[/vc_column_text][/vc_tta_section][vc_tta_section title="KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS" tab_id="1504697656865-f242e147-a927"][vc_column_text](See SIDE EFFECTS, WARNINGS AND SPECIAL PRECAUTIONS).
In the event of topical overdosage, flush the eye with water.
Treatment is symptomatic and supportive.[/vc_column_text][/vc_tta_section][vc_tta_section title="IDENTIFICATION" tab_id="1504697656470-fa82922f-13cc"][vc_column_text]Clear, transparent, yellowish solution without suspending particles.[/vc_column_text][/vc_tta_section][vc_tta_section title="PRESENTATION" tab_id="1504697656056-d141d0d1-b24c"][vc_column_text]KELOPT ophthalmic solution is supplied in an opaque white sterile dropper bottle with a white sterile capillary plug and white sterile cap, containing 5 ml solution.[/vc_column_text][/vc_tta_section][vc_tta_section title="STORAGE INSTRUCTIONS" tab_id="1504697655670-4d98e465-bd16"][vc_column_text]Store at or below 30 °C. Do not use more than 28 days after opening.
Discard any unused portion. Protect from light. Keep the container in the outer carton.
Do not refrigerate or freeze.
KEEP OUT OF REACH OF CHILDREN.[/vc_column_text][/vc_tta_section][vc_tta_section title="REGISTRATION NUMBER" tab_id="1504697655304-2efb71f5-a8e6"][vc_column_text]45/15.4/1033[/vc_column_text][/vc_tta_section][vc_tta_section title="NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION" tab_id="1504697653976-4fb20b42-ff45"][vc_column_text]Actor Pharma (Pty) Ltd
Unit 7, Royal Palm Business Estate
646 Washington Street, Halfway House, Midrand, 1685
Gauteng
[/vc_column_text][/vc_tta_section][vc_tta_section title="DATE OF PUBLICATION OF THIS PACKAGE INSERT" tab_id="1504697953640-4b9e076c-b7e5"][vc_column_text]25 August 2015
® - KELOPT is a registered trademark of Actor Pharma (Pty) Ltd
1 Company Registration number: 2008/008787/07[/vc_column_text][/vc_tta_section][vc_tta_section title="Section" tab_id="1523000451982-f9eed3dd-c529"][/vc_tta_section][/vc_tta_accordion][plethora_button button_text="Patient Info Leaflet" button_link="url:http%3A%2F%2Fgen-eye.webtestsite.co.za%2Fwp-content%2Fuploads%2F2016%2F12%2FBRIMOCT-Patient-leaflet-glaucoma-gen-eye-vision-care-medication-south-africa.pdf||target:%20_blank|" button_style="btn-secondary" button_with_icon="0"][/vc_column][/vc_row]
