Λογότυπο www.galinos.gr Beta
 

Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

Ακολουθήστε μας Λογότυπο Facebook Λογότυπο Twitter

Αναζήτηση σε 63811 καταχωρήσεις
Εικονίδιο αναζήτησης

Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Sustiva 50 mg, 100 mg and 200 mg Hard Capsules (2012)

Εκδότης

Εκδότης Bristol-Myers Squibb Pharmaceutical Limited
Διεύθυνση Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
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

SUSTIVA 50 mg hard capsules. SUSTIVA 100 mg hard capsules. SUSTIVA 200 mg hard capsules.

Qualitative and quantitative composition

Each hard capsule contains 50 mg, 100 mg or 200 mg of efavirenz. Excipient, with known effect: Each 50 ...

Pharmaceutical form

Hard capsule. 50 mg: Dark yellow and white, printed with "SUSTIVA" on the dark yellow cap and 50 mg on ...

Therapeutic indications

SUSTIVA is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected ...

Posology and method of administration

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

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Efavirenz ...

Special warnings and precautions for use

Efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen. ...

Interaction with other medicinal products and other forms of interaction

Efavirenz is an in vivo inducer of CYP3A4, CYP2B6 and UGT1A1.Compounds that are substrates of these enzymes ...

Fertility, pregnancy and breast-feeding

Women of childbearing potential: see below and section 5.3. Efavirenz should not be used during pregnancy, ...

Effects on ability to drive and use machines

Efavirenz may cause dizziness, impaired concentration, and/or somnolence. Patients should be instructed ...

Undesirable effects

a. Summary of the safety profile Efavirenz has been studied in over 9,000 patients. In a subset of 1,008 ...

Overdose

Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Non-nucleoside reverse transcriptase inhibitors ATC code: J05AG03 Mechanism ...

Pharmacokinetic properties

Absorption: peak efavirenz plasma concentrations of 1.6 9.1 μM were attained by 5 hours following single ...

Preclinical safety data

Efavirenz was not mutagenic or clastogenic in conventional genotoxicity assays. Efavirenz induced foetal ...

List of excipients

Capsule core: Sodium laurilsulfate Lactose monohydrate Magnesium stearate Sodium starch glycolate Capsule ...

Incompatibilities

Not applicable.

Shelf life

50 mg & 100 mg: 3 years. 200 mg: For bottles: 3 years. For blisters: 2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

50 mg & 200 mg: HDPE bottles with a child-resistant polypropylene closure. Each carton contains 1 bottle ...

Special precautions for disposal and other handling

No special requirements for disposal. Use in the paediatric population: for children at least 3 years ...

Marketing authorization holder

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH United Kingdom ...

Marketing authorization number(s)

50 mg: EU/1/99/110/001 bottle 100 mg: EU/1/99/110/002 bottle 200 mg: EU/1/99/110/003 bottle EU/1/99/110/004 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 28 May 1999 Date of latest renewal: 28 May 2009

Date of revision of the text

June 2012
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.