SIMBRINZA Eye drops, suspension (eye drops) (2022)
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Περιεχόμενα
1. Name of the medicinal product
SIMBRINZA 10 mg/mL + 2 mg/mL eye drops, suspension.
2. Qualitative and quantitative composition
1 mL of suspension contains 10 mg of brinzolamide and 2 mg of brimonidine tartrate equivalent to 1.3 mg of brimonidine. <u>Excipient with known effect:</u> Each mL of suspension contains 0.03 mg of benzalkonium ...
3. Pharmaceutical form
Eye drops, suspension (eye drops). White-to-off-white uniform suspension, pH 6.5 (approximately).
4.1. Therapeutic indications
Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction(see section 5.1).
4.2. Posology and method of administration
Posology Use in adults, including the elderly The recommended dose is one drop of SIMBRINZA in the affected eye(s) two times daily. Missed dose If a dose is missed, treatment should be continued with the ...
4.3. Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Hypersensitivity to sulphonamides (see section 4.4). Patients receiving monoamine oxidase (MAO) inhibitor ...
4.4. Special warnings and precautions for use
The medicinal product should not be injected. Patients should be instructed not to swallow SIMBRINZA. Ocular effects SIMBRINZA has not been studied in patients with narrow-angle glaucoma and its use is ...
4.5. Interaction with other medicinal products and other forms of interaction
No specific drug interaction studies have been performed with SIMBRINZA. SIMBRINZA is contraindicated in patients receiving monoamine oxidase inhibitors and in patients on antidepressants which affect ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of SIMBRINZA in pregnant women. Brinzolamide was not teratogenic in rats and rabbits, following systemic administration (oral gavage). Animal ...
4.7. Effects on ability to drive and use machines
SIMBRINZA has a moderate influence on the ability to drive and use machines. SIMBRINZA may cause dizziness, fatigue and/or drowsiness, which may impair the ability to drive or use machines. Temporary blurred ...
4.8. Undesirable effects
Summary of the safety profile In clinical trials involving SIMBRINZA dosed twice daily the most common adverse reactions were ocular hyperaemia and ocular allergic type reactions occurring in approximately ...
4.9. Overdose
If overdose with SIMBRINZA occurs treatment should be symptomatic and supportive. The patients airway should be maintained. Due to the brinzolamide component of SIMBRINZA, electrolyte imbalance, development ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Ophthalmologicals, Antiglaucoma preparations and miotics <b>ATC code:</b> S01EC54 Mechanism of action SIMBRINZA contains two active substances: brinzolamide and brimonidine ...
5.2. Pharmacokinetic properties
Absorption Brinzolamide is absorbed through the cornea following topical ocular administration. The substance is also absorbed into the systemic circulation, where it binds strongly to carbonic anhydrase ...
5.3. Preclinical safety data
Brinzolamide Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity, repeated dose toxicity, genotoxicity and carcinogenic potential. ...
6.1. List of excipients
Benzalkonium chloride Propylene glycol Carbomer 974P Boric acid Mannitol Sodium chloride Tyloxapol Hydrochloric acid and/or sodium hydroxide (to adjust pH) Purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years. 4 weeks after first opening.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
8 mL round, opaque, low density polyethylene (LDPE) bottles with a LDPE dropper tip and white polypropylene screw cap containing 5 mL suspension. Carton containing 1 or 3 bottles. Not all pack sizes may ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
8. Marketing authorization number(s)
EU/1/14/933/001-002
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 18 July 2014 Date of last renewal: 20 February 2019
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