Fuzeon 90 mg/ml powder and solvent for solution for injection (2010)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Roche Products Limited |
|---|---|
| Διεύθυνση | Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW |
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Name of the medicinal product
Fuzeon 90 mg/ml powder and solvent for solution for injection.
Qualitative and quantitative composition
Each vial contains 108 mg enfuvirtide. Each ml of reconstituted solution contains 90 mg enfuvirtide. For a full list of excipients, see section 6.1.
Pharmaceutical form
Powder and solvent for solution for injection. White to off-white lyophilised powder.
Therapeutic indications
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least ...
Posology and method of administration
Fuzeon should be prescribed by physicians who are experienced in the treatment of HIV infection. Fuzeon is only to be administered by subcutaneous injection. Adults and adolescents ≥ 16 years: The recommended ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use
Fuzeon must be taken as part of a combination regimen. Please also refer to the respective summary of product characteristics of the other antiretroviral medicinal products used in the combination. As ...
Interaction with other medicinal products and other forms of interaction
Interactions studies have only been performed in adults. No clinically significant pharmacokinetic interactions are expected between enfuvirtide and concomitantly given medicinal products metabolised by ...
Fertility, pregnancy and lactation
There are no adequate and well-controlled studies in pregnant women. Animal studies do not indicate harmful effects with respect to foetal development. Enfuvirtide should be used during pregnancy only ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. There is no evidence that enfuvirtide may alter the patients ability to drive and use machines, however, the adverse ...
Undesirable effects
Safety data mainly refer to 48-week data from studies TORO 1 and TORO 2 combined (see section 5.1). Safety results are expressed as the number of patients with an adverse reaction per 100 patient-years ...
Overdose
No case of overdose has been reported. The highest dose administered to 12 patients in a clinical trial was 180 mg as a single dose subcutaneously. These patients did not experience any adverse reactions ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antivirals ATC code: J05AX07 Mechanism of Action: Enfuvirtide is a member of the therapeutic class called fusion inhibitors. It is an inhibitor of the structural rearrangement ...
Pharmacokinetic properties
The pharmacokinetic properties of enfuvirtide have been evaluated in HIV-1-infected adult and paediatric patients. Absorption: The absolute bioavailability after subcutaneous administration of enfuvirtide ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and late embryonal development. Long-term animal carcinogenicity ...
List of excipients
Powder: Sodium carbonate Mannitol Sodium hydroxide Hydrochloric Acid Solvent: Water for Injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Powder: 4 years. Solvent: 4 years. Shelf life after reconstitution After reconstitution: Store in a refrigerator (2°C – 8°C). Chemical and physical in-use stability has been demonstrated for 48 hours at ...
Special precautions for storage
Powder: Keep the vial in the outer carton in order to protect from light. For storage conditions of the reconstituted medicinal product, see section 6.3. Solvent: This medicinal product does not require ...
Nature and contents of container
Powder Vial: 3 ml vial, colourless glass type 1 Closure: lyophilisate stopper, rubber (latex free) Seal: aluminum seal with flip-off cap Solvent Vial: 2 ml vial, colourless glass type 1 Closure: rubber ...
Special precautions for disposal and other handling
Any unused product should be disposed of in accordance with local requirements. Patients should be instructed on the use and administration of Fuzeon by a healthcare professional before using for the first ...
Marketing authorization holder
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Marketing authorization number(s)
EU/1/03/252/001-002
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 May 2003 Date of last renewal: 27 May 2008
Date of revision of the text
27 April 2010