Prezista 75 mg, 150 mg, 400 mg, 600 mg film-coated tablets and Oral suspension 100mg/ml (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Janssen-Cilag Ltd |
|---|---|
| Διεύθυνση | 50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG |
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Name of the medicinal product
PREZISTA 100mg/ml oral suspension. PREZISTA 75 mg film-coated tablets. PREZISTA 150 mg film-coated tablets. PREZISTA 400 mg film-coated tablets. PREZISTA 600 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 with known effect: sodium methyl parahydroxybenzoate (E219) 3.43 mg/ml. 75 mg film-coated tablet ...
Pharmaceutical form
Oral suspension: White to off-white opaque suspension. Film-coated tablet: White caplet shaped tablet of 9.2 mm, debossed with 75 on one side and TMC on the other side. White oval shaped tablet of 13.7 ...
Therapeutic indications
PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients ...
Posology and method of administration
Therapy should be initiated by a health care provider experienced in the management of HIV infection. After therapy with PREZISTA has been initiated, patients should be advised not to alter the dosage, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with severe (Child-Pugh Class C) hepatic impairment. Combination of rifampicin with PREZISTA with concomitant ...
Special warnings and precautions for use
Patients should be advised that current antiretroviral therapy does not cure HIV and has not been proven to prevent the transmission of HIV to others through blood or sexual contact. Appropriate precautions ...
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 the CYP3A isoform. Co-administration of darunavir and ritonavir and medicinal products primarily metabolised ...
Fertility, pregnancy and lactation
Pregnancy As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, ...
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 machines. However, dizziness has been reported in some patients during treatment with regimens containing ...
Undesirable effects
Summary of the safety profile During the clinical development program (N=1,968 treatment-experienced subjects who initiated therapy with PREZISTA/rtv 600/100 mg twice daily), 49.5% of subjects experienced ...
Overdose
Human experience of acute overdose with PREZISTA co-administered with low dose ritonavir is limited. Single doses up to 3,200 mg of darunavir as oral solution alone and up to 1,600 mg of the tablet formulation ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitors ATC code: J05AE10 Mechanism of action Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 ...
Pharmacokinetic properties
The pharmacokinetic properties of darunavir, co-administered with ritonavir, have been evaluated in healthy adult volunteers and in HIV-1 infected patients. Exposure to darunavir was higher in HIV-1 infected ...
Preclinical safety data
Animal toxicology studies have been conducted at exposures up to clinical exposure levels with darunavir alone, in mice, rats and dogs and in combination with ritonavir in rats and dogs. In repeated-dose ...
List of excipients
Oral suspension Hydroxypropylcellulose Microcrystalline cellulose Carmellose sodium Citric acid monohydrate Sucralose Strawberry cream flavour Masking flavour: Sodium methyl parahydroxybenzoate (E219) ...
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. Store in the original container. Tablets: This medicinal product does not require any special storage ...
Nature and contents of container
Oral suspension Amber-coloured multiple-dose glass bottle for 200 ml suspension with a polypropylene closure with LDPE liner packaged with a 6 ml oral dosing pipette with 0.2 ml gradations. The bottle ...
Special precautions for disposal and other handling
No special requirements for disposal. Oral suspension: Shake the bottle vigorously prior to each dose. The supplied oral dosing pipette should not be used for any other medicinal products
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