COPAXONE Solution for injection (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Copaxone 20 mg/ml solution for injection in pre-filled syringe.
Qualitative and quantitative composition
1 pre-filled syringe (1 ml) of solution for injection contains 20 mg glatiramer acetate*, equivalent to 18 mg of glatiramer. * Glatiramer acetate is the acetate salt of synthetic polypeptides, containing ...
Pharmaceutical form
Solution for injection Clear solution free of visible particles. The solution for injection has a pH of 5.5 7.0 and an osmolarity of about 265 mOsmol/L.
Therapeutic indications
Copaxone is indicated for the treatment of relapsing forms of multiple sclerosis (MS) (see section 5.1 for important information on the population for which efficacy has been established). Copaxone is ...
Posology and method of administration
The initiation of Copaxone treatment should be supervised by a neurologist or a physician experienced in the treatment of MS. Posology The recommended dosage in adults is 20 mg of glatiramer acetate (one ...
Contraindications
Copaxone is contraindicated under the following conditions: Hypersensitivity to the active substance (glatiramer acetate) or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Copaxone should only be administered subcutaneously. Copaxone should not be administered by intravenous or intramuscular routes. The treating physician should explain to the patient that a reaction associated ...
Interaction with other medicinal products and other forms of interaction
Interaction between Copaxone and other medicinal products have not been formally evaluated. Observations from existing clinical trials and post-marketing experience do not suggest any significant interactions ...
Fertility, pregnancy and lactation
Pregnancy Studies in animals have not shown reproductive toxicity (see section 5.3). Current data on pregnant women indicate no malformative or feto/neonatal toxicity of Copaxone. To date, no relevant ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
In all clinical trials, injection-site reactions were seen to be the most frequent adverse reactions and were reported by the majority of patients receiving Copaxone. In controlled studies, the proportion ...
Overdose
Symptoms A few cases of overdose with Copaxone (up to 300 mg glatiramer acetate) have been reported. These cases were not associated with any adverse reactions other than those mentioned in section 4.8. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other immunostimulants ATC code: L03AX13 Mechanism of action The mechanism by which glatiramer acetate exerts therapeutic effects ...
Pharmacokinetic properties
Pharmacokinetic studies in patients have not been performed. In vitro data and limited data from healthy volunteers indicate that with subcutaneous administration of glatiramer acetate, the active substance ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction, beyond ...
List of excipients
Mannitol Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years.
Special precautions for storage
Keep the pre-filled syringes in the outer carton, in order to protect from light. Store in a refrigerator (2°C-8°C). Do not freeze. If the pre-filled syringes cannot be stored in a refrigerator, they can ...
Nature and contents of container
A pre-filled syringe containing Copaxone solution for injection consists of a 1 ml colourless type I glass syringe barrel with staked needle, a polypropylene (optional polystyrene) plunger rod, a rubber ...
Special precautions for disposal and other handling
For single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Teva Pharmaceuticals Ltd., Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX United Kingdom
Marketing authorization number(s)
PL 10921/0023
Date of first authorization / renewal of the authorization
Date of first authorisation: 7 April 2003 Date of latest renewal: 11 September 2007
Date of revision of the text
24/07/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
