SPC, UK: Fuzeon 90 mg/ml powder and solvent for solution for injection
||Roche Products Limited
||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. ...
Powder and solvent for solution for injection. White to off-white lyophilised powder.
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of ...
Posology and method of administration
Fuzeon should be prescribed by physicians who are experienced in the treatment of HIV infection. Fuzeon ...
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 ...
Interaction with other medicinal products and other forms of interaction
Interactions studies have only been performed in adults. No clinically significant pharmacokinetic interactions ...
Fertility, pregnancy and lactation
There are no adequate and well-controlled studies in pregnant women. Animal studies do not indicate harmful ...
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 ...
Safety data mainly refer to 48-week data from studies TORO 1 and TORO 2 combined (see section 5.1). Safety ...
No case of overdose has been reported. The highest dose administered to 12 patients in a clinical trial ...
Pharmacotherapeutic group: Other antivirals ATC code: J05AX07 Mechanism of Action: Enfuvirtide is a member ...
The pharmacokinetic properties of enfuvirtide have been evaluated in HIV-1-infected adult and paediatric ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, ...
List of excipients
Powder: Sodium carbonate Mannitol Sodium hydroxide Hydrochloric Acid Solvent: Water for Injections
This medicinal product must not be mixed with other medicinal products except those mentioned in section ...
Powder: 4 years. Solvent: 4 years. Shelf life after reconstitution After reconstitution: Store in a refrigerator ...
Special precautions for storage
Powder: Keep the vial in the outer carton in order to protect from light. For storage conditions of the ...
Nature and contents of container
Powder Vial: 3 ml vial, colourless glass type 1 Closure: lyophilisate stopper, rubber (latex free) Seal: ...
Special precautions for disposal and other handling
Any unused product should be disposed of in accordance with local requirements. Patients should be instructed ...
Marketing authorization holder
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Marketing authorization number(s)
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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί
πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.