OXERVATE Eye drops, solution (2022)
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Περιεχόμενα
1. Name of the medicinal product
OXERVATE 20 micrograms/ml eye drops, solution.
2. Qualitative and quantitative composition
One ml of solution contains 20 micrograms of cenegermin*. * Recombinant form of human nerve growth factor produced in <em>Escherichia Coli</em>. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution (eye drops). Clear, colourless solution. pH 7.0-7.4 and osmolarity 280-320 mOsm/kg.
4.1. Therapeutic indications
Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.
4.2. Posology and method of administration
Treatment should be initiated and supervised by an ophthalmologist or a healthcare professional qualified in ophthalmology. Posology Adults The recommended dose is one drop of OXERVATE in the conjunctival ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Risk of corneal melting or impending perforation It is important that the risk of corneal melting or impending perforation, and the need to undergo emergency surgery or another procedure is assessed before ...
4.5. Interaction with other medicinal products and other forms of interaction
Other topical ophthalmic products may be used during treatment with OXERVATE when used 15 minutes apart, with the exception of agents known to inhibit epithelial healing (e.g. corticosteroids or eye drops ...
4.6. Pregnancy and lactation
Pregnancy There are no data from the use of cenegermin in pregnant women. Animal studies with cenegermin do not indicate direct or indirect harmful effects with respect to reproductive toxicity when administered ...
4.7. Effects on ability to drive and use machines
The treatment has minor influence on the ability to drive and use machines, as it may cause temporary blurred vision or other visual disturbances, which is expected to last a few minutes after instillation. ...
4.8. Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions in patients suffering from neurotrophic keratitis and treated with OXERVATE during clinical studies include eye pain (11.1%), ...
4.9. Overdose
A topical overdose is not likely to occur or to be associated with toxicity. A topical overdose of cenegermin may be flushed from the eye(s) with lukewarm water.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Ophthalmologicals, other ophthalmologicals <b>ATC code:</b> S01XA24 Mechanism of action OXERVATE contains cenegermin, a recombinant form of human nerve growth factor. ...
5.2. Pharmacokinetic properties
Absorption Cenegermin is mostly removed from the eye with the tear production and through the naso-lacrimal duct; the minor portion that is absorbed occurs mostly in the conjunctiva and peri-orbital tissue ...
5.3. Preclinical safety data
Nonclinical data reveal no hazard for humans based on conventional studies of safety pharmacology (central nervous system), single-dose toxicity, repeat-dose toxicity and toxicity to reproduction, embryo-foetal ...
6.1. List of excipients
Trehalose dihydrate Mannitol Disodium hydrogen phosphate, anhydrous Sodium dihydrogen phosphate, dihydrate Hydroxypropylmethylcellulose Polyethylene glycol 6000 L-Methionine Water for injections Hydrochloric ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
<u>Unopened vial:</u> 2 years. <u>Opened vial:</u> Once opened, the product must be stored below 25°C and used within 12 hours at 25°C. From a microbiological point of view, the method of opening (i.e. ...
6.4. Special precautions for storage
OXERVATE vials <u>Pharmacy (unopened vial):</u> The weekly carton containing the vials must be stored in a freezer (-20°C ± 5°C). <u>Patient (unopened vial):</u> The patient will receive a weekly carton ...
6.5. Nature and contents of container
1 ml OXERVATE solution in sterile, preservative-free multi-dose Type I glass vials, closed with a rubber stopper and an aluminium overseal with a polypropylene flip-off cap, presented in cardboard cartons. ...
6.6. Special precautions for disposal and other handling
The patient will receive a weekly carton containing 7 multi-dose vials of OXERVATE, which should be stored in a refrigerator until the day of use. The patient will also receive separately vial adapters, ...
7. Marketing authorization holder
Dompé farmaceutici S.p.A., Via Santa Lucia, 6, 20122 Milano Italy, Tel. +39 02 583831, Fax +39 02 58383215, E-mail: info@dompe.com
8. Marketing authorization number(s)
EU/1/17/1197/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 06 July 2017
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