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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

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

Προτάσεις

SPC, UK: Emtriva 10 mg/ml oral solution (2011)

Εκδότης

Εκδότης Gilead Sciences Ltd
Διεύθυνση Flowers Building, Granta Park, Abington, Cambridge, Cambridge, CB21 6GT, UK
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Περιεχόμενα

Name of the medicinal product

Emtriva 10 mg/ml oral solution.

Qualitative and quantitative composition

Each ml of Emtriva oral solution contains 10 mg of emtricitabine. Excipient(s): Each dose (24 ml) contains ...

Pharmaceutical form

Oral solution. The clear solution is orange to dark orange in colour.

Therapeutic indications

Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of ...

Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection. Posology ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

General: Emtricitabine is not recommended as monotherapy for the treatment of HIV infection. It must ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. In vitro, emtricitabine did not inhibit metabolism ...

Fertility, pregnancy and lactation

Pregnancy A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, patients ...

Undesirable effects

a. Summary of the safety profile In clinical trials of HIV infected adults, the most frequently occurring ...

Overdose

Administration of up to 1,200 mg emtricitabine has been associated with the adverse reactions listed ...

Pharmacodynamic properties

Pharmacotherapeutic group: Nucleoside and nucleotide reverse transcriptase inhibitors ATC code: J05AF09 ...

Pharmacokinetic properties

Absorption: Emtricitabine is rapidly and extensively absorbed following oral administration with peak ...

Preclinical safety data

Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies ...

List of excipients

Cotton candy flavouring Disodium edetate Hydrochloric acid Methyl parahydroxybenzoate (E218) Propylene ...

Incompatibilities

Not applicable.

Shelf life

3 years. After first opening: 45 days.

Special precautions for storage

Store in a refrigerator (2°C – 8°C). After opening: Do not store above 25°C.

Nature and contents of container

Amber-coloured polyethylene terephthalate (PET) bottle with a child-resistant closure. The pack also ...

Special precautions for disposal and other handling

Patients should be instructed that any solution left in the bottle 45 days after opening should be disposed ...

Marketing authorization holder

Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom

Marketing authorization number(s)

EU/1/03/261/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 24 October 2003 Date of latest renewal: 22 September 2008

Date of revision of the text

07/2011
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.