PREZISTA 100 mg/ml oral suspension - Ireland[爱尔兰药品]

TOP

PREZISTA 100 mg/ml oral suspension

2015-06-03 09:59:07 来源: 作者: 【大中小】浏览:505次评论:0条

1. Name of the medicinal product

PREZISTA 100 mg/ml oral suspension

2. Qualitative and quantitative composition

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

Excipient with known effect: sodium methyl parahydroxybenzoate (E219) 3.43 mg/ml.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Oral suspension

White to off-white opaque suspension

4. Clinical particulars

4.1 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 and paediatric patients from the age of 3 years and at least 15 kg body weight (see section 4.2).

PREZISTA, co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients (see section 4.2).

In deciding to initiate treatment with PREZISTA co-administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.

4.2 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, dose form or discontinue therapy without discussing with their health care provider.

The interaction profile of darunavir depends on whether ritonavir or cobicistat is used as pharmacokinetic enhancer. Darunavir may therefore have different contraindications and recommendations for concomitant medications depending on whether the compound is boosted with ritonavir or cobicistat (see sections 4.3, 4.4 and 4.5).

Posology

PREZISTA must always be given orally with cobicistat or low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products. The Summary of Product Characteristics of cobicistat or ritonavir as appropriate, must therefore be consulted prior to initiation of therapy with PREZISTA. Cobicistat is not indicated for use in twice daily regimens or for use in the pediatric population.

ART-naïve adult patients

The recommended dose regimen is 800 mg once daily with cobicistat 150 mg once daily or ritonavir 100 mg once daily taken with food.

ART-experienced adult patients

The recommended dose regimen is 600 mg twice daily taken with ritonavir 100 mg twice daily taken with food.

A dose regimen of 800 mg once daily with cobicistat 150 mg once daily or ritonavir 100 mg once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,00