EMADINE Eye drops, solution (2018)
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Περιεχόμενα
Name of the medicinal product
EMADINE 0.5 mg/ml, eye drops, solution.
Qualitative and quantitative composition
1 ml of solution contains emedastine 0.5 mg (as difumarate). Excipient with known effect: Benzalkonium chloride 0.1 mg/ml. For the full list of excipients, see section 6.1.
Pharmaceutical form
Eye drops, solution. Clear, colourless solution.
Therapeutic indications
Symptomatic treatment of seasonal allergic conjunctivitis.
Posology and method of administration
EMADINE has not been studied in clinical trials beyond six weeks. Posology The dose is one drop of EMADINE to be applied to the affected eye(s) twice daily. When used with other ophthalmic medicines, an ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Ocular corneal infiltrates Ocular corneal infiltrates were reported in conjunction with the use of EMADINE. In case of corneal infiltrates, the product should be discontinued and appropriate management ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of emedastine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Nevertheless, ...
Effects on ability to drive and use machines
EMADINE has no or negligible influence on the ability to drive and use machines, however as with any ocular medication, if transient blurred vision or other visual disturbance occurs at instillation, the ...
Undesirable effects
Summary of safety profile In 13 clinical studies involving 696 patients, Emadine was administered one to four times daily in both eyes for up to 42 days. In clinical trials, approximately 7% of patients ...
Overdose
No specific reactions are to be expected with an ocular overdose of the product. No data are available in humans regarding overdose by accidental or deliberate ingestion. In case of accidental ingestion ...
Pharmacodynamic properties
Pharmacotherapeutic group: decongestants and antiallergics; other antiallergics ATC code: S01GX06 Emedastine is a potent selective and topically effective histamine H<sub>1</sub> antagonist (Ki = 1.3 nM). ...
Pharmacokinetic properties
Absorption Emedastine is absorbed systemically, as are other topically administered drug substances. In a study involving ten normal volunteers dosed bilaterally twice daily for 15 days with EMADINE 0.5 ...
Preclinical safety data
Emedastine difumarate demonstrated low acute toxicity in a number of species by various routes of administration. No clinically significant local or systemic effects were observed in long-term topical ...
List of excipients
Benzalkonium chloride 0.1 mg/ml Trometamol Sodium chloride Hypromellose Hydrochloric acid/sodium hydroxide (to adjust pH) Purified water
Incompatibilities
Not applicable.
Shelf life
Shelf life: 30 months. EMADINE should not be used for longer than 4 weeks after first opening.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
EMADINE is supplied in 5 ml and 10 ml opaque plastic DROP-TAINER bottles. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/98/095/001-2
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 January 1999 Date of latest renewal: 13 January 2009
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