NEVANAC Eye drops, suspension (2018)
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Περιεχόμενα
Name of the medicinal product
NEVANAC 1 mg/ml eye drops, suspension.
Qualitative and quantitative composition
1 ml of suspension contains 1 mg nepafenac. Excipient with known effect: Each ml of suspension contains 0.05 mg of benzalkonium chloride. For the full list of excipients, see section 6.1.
Pharmaceutical form
Eye drops, suspension. Light yellow to light orange uniform suspension, pH 7.4 (approximately).
Therapeutic indications
NEVANAC 1 mg/ml is indicated in adults for: Prevention and treatment of postoperative pain and inflammation associated with cataract surgery. Reduction in the risk of postoperative macular oedema associated ...
Posology and method of administration
Posology Adults, including the elderly For the prevention and treatment of pain and inflammation, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to other nonsteroidal anti-inflammatory drugs (NSAIDs). Patients in whom attacks of asthma, ...
Special warnings and precautions for use
The product should not be injected. Patients should be instructed not to swallow NEVANAC. Patients should be instructed to avoid sunlight during treatment with NEVANAC. Ocular effects Use of topical NSAIDs ...
Interaction with other medicinal products and other forms of interaction
In vitro studies have demonstrated a very low potential for interaction with other medicinal products and protein binding interactions (see section 5.2). Prostaglandin analogues There are very limited ...
Pregnancy and lactation
Women of childbearing potential NEVANAC should not be used by women of child bearing potential not using contraception. Pregnancy There are no adequate data regarding the use of nepafenac in pregnant women. ...
Effects on ability to drive and use machines
NEVANAC has no or negligible influence on the ability to drive and use machines. Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision ...
Undesirable effects
Summary of the safety profile In clinical studies involving 2314 patients receiving NEVANAC 1 mg/ml the most common adverse reactions were punctate keratitis, foreign body sensation and eyelid margin crusting ...
Overdose
No toxic effects are likely to occur in case of overdose with ocular use, nor in the event of accidental oral ingestion.
Pharmacodynamic properties
Pharmacotherapeutic group: Opthalmologicals, Anti-inflammatory agents, non-steroids ATC code: S01BC10 Mechanism of action Nepafenac is a non-steroidal anti-inflammatory and analgesic prodrug. After topical ...
Pharmacokinetic properties
Absorption Following 3 times daily dosing of NEVANAC eye drops in both eyes, low but quantifiable plasma concentrations of nepafenac and amfenac were observed in the majority of subjects 2 and 3 hours ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Nepafenac has not been evaluated in long-term carcinogenicity ...
List of excipients
Mannitol (E421) Carbomer Sodium chloride Tyloxapol Disodium edetate Benzalkonium chloride Sodium hydroxide and/or hydrochloric acid (for pH adjustment) Purified water
Incompatibilities
Not applicable.
Shelf life
2 years. Discard 4 weeks after first opening.
Special precautions for storage
Do not store above 30°C. For storage conditions after first opening of the medicinal product, see section 6.3.
Nature and contents of container
5 ml round low density polyethylene bottle with a dispensing plug and white polypropylene screw cap containing 5 ml suspension. Carton containing 1 bottle.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/07/433/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 December 2007 Date of latest renewal: 24 September 2012
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