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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

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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Reyataz 150 mg, 200 mg and 300mg 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

REYATAZ 150 mg hard capsules* REYATAZ 200 mg hard capsules* REYATAZ 300 mg hard capsules* * Intensive ...

Qualitative and quantitative composition

Each capsule contains 150 mg, 200 mg or 300 mg of atazanavir (as sulphate) Excipient: 82.18 mg of lactose ...

Pharmaceutical form

Hard capsule. REYATAZ 150 mg capsules are blue and powder blue capsule printed with white and blue inks, ...

Therapeutic indications

REYATAZ capsules, co-administered with low dose ritonavir, are indicated for the treatment of 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. Patients ...

Special warnings and precautions for use

Patients should be advised that current antiretroviral therapy has not been proven to prevent the risk ...

Interaction with other medicinal products and other forms of interaction

When REYATAZ and ritonavir are co-administered, the metabolic drug interaction profile for ritonavir ...

Fertility, pregnancy and lactation

Pregnancy A moderate amount of data in pregnant women (between 300-1000) pregnancy outcomes) indicate ...

Undesirable effects

a. Summary of the safety profile REYATAZ has been evaluated for safety in combination therapy with other ...

Effects on ability to drive and use machines

Patients should be informed that dizziness has been reported during treatment with regimens containing ...

Overdose

Human experience of acute overdose with REYATAZ is limited. Single doses up to 1,200 mg have been taken ...

Pharmacodynamic properties

Pharmacotherapeutic group: protease inhibitor ATC code: J05AE08 Mechanism of action: atazanavir is an ...

Pharmacokinetic properties

The pharmacokinetics of atazanavir were evaluated in healthy adult volunteers and in HIV-infected patients; ...

Preclinical safety data

In repeat-dose toxicity studies, conducted in mice, rats, and dogs, atazanavir-related findings were ...

List of excipients

Capsule content: Crospovidone Lactose monohydrate Magnesium stearate Capsule shells: Gelatine Indigocarmin ...

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Each carton contains one high-density polyethylene (HDPE) bottle closed with child-resistant polypropylene ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. ...

Marketing authorization holder

BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom ...

Marketing authorization number(s)

REYATAZ 150 mg Hard Capsules Bottle: EU/1/03/267/003 REYATAZ 200 mg Hard Capsules Bottle: EU/1/03/267/005 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 02 March 2004 Date of latest renewal: 02 March 2009

Date of revision of the text

08/2012
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.