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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: Prezista 75 mg, 150 mg, 400 mg, 600 mg film-coated tablets and Oral suspension 100mg/ml (2012)

Εκδότης

Εκδότης Janssen-Cilag Ltd
Διεύθυνση 50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
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

PREZISTA 100mg/ml oral suspension. PREZISTA 75 mg film-coated tablets. PREZISTA 150 mg film-coated tablets. ...

Qualitative and quantitative composition

100mg/ml oral suspension Each ml of oral suspension contains 100 mg of darunavir (as ethanolate). Excipient ...

Pharmaceutical form

Oral suspension: White to off-white opaque suspension. Film-coated tablet: White caplet shaped tablet ...

Therapeutic indications

PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral ...

Posology and method of administration

Therapy should be initiated by a health care provider 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 does not cure HIV and has not been proven ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. Darunavir and ritonavir are both inhibitors of ...

Fertility, pregnancy and lactation

Pregnancy As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection ...

Effects on ability to drive and use machines

PREZISTA in combination with ritonavir has no or negligible influence on the ability to drive and use ...

Undesirable effects

Summary of the safety profile During the clinical development program (N=1,968 treatment-experienced ...

Overdose

Human experience of acute overdose with PREZISTA co-administered with low dose ritonavir is limited. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitors ATC code: J05AE10 Mechanism ...

Pharmacokinetic properties

The pharmacokinetic properties of darunavir, co-administered with ritonavir, have been evaluated in healthy ...

Preclinical safety data

Animal toxicology studies have been conducted at exposures up to clinical exposure levels with darunavir ...

List of excipients

Oral suspension Hydroxypropylcellulose Microcrystalline cellulose Carmellose sodium Citric acid monohydrate ...

Incompatibilities

Not applicable.

Shelf life

Oral suspension: 2 years. Tablets: 3 years.

Special precautions for storage

Oral suspension: Do not store above 30°C. Do not refrigerate or freeze. Avoid exposure to excessive heat. ...

Nature and contents of container

Oral suspension Amber-coloured multiple-dose glass bottle for 200 ml suspension with a polypropylene ...

Special precautions for disposal and other handling

No special requirements for disposal. Oral suspension: Shake the bottle vigorously prior to each dose. ...

Marketing authorization holder

Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium

Marketing authorization number(s)

EU/1/06/380/006 EU/1/06/380/005 EU/1/06/380/004 EU/1/06/380/003 EU/1/06/380/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 12 February 2007 Date of latest renewal: 12 February 2009

Date of revision of the text

24 October 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.