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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Fuzeon 90 mg/ml powder and solvent for solution for injection (2010)

Εκδότης

Εκδότης Roche Products Limited
Διεύθυνση Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

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. ...

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 ...

Posology and method of administration

Fuzeon should be prescribed by physicians who are experienced in the treatment of HIV infection. Fuzeon ...

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 ...

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 ...

Undesirable effects

Safety data mainly refer to 48-week data from studies TORO 1 and TORO 2 combined (see section 5.1). Safety ...

Overdose

No case of overdose has been reported. The highest dose administered to 12 patients in a clinical trial ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other antivirals ATC code: J05AX07 Mechanism of Action: Enfuvirtide is a member ...

Pharmacokinetic properties

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

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section ...

Shelf life

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)

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
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.