PRIFTIN

Država: Indonezija

Jezik: indonezijščina

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktivna sestavina:

RIFAPENTINE

Dostopno od:

AVENTIS PHARMA - Indonesia

INN (mednarodno ime):

RIFAPENTINE

Odmerek:

150 MG

Farmacevtska oblika:

TABLET SALUT SELAPUT

Enote v paketu:

DUS, 3 BLISTER @ 8 TABLET SALUT SELAPUT

Izdeluje:

SANOFI AVENTIS - Italy

Datum dovoljenje:

2018-11-13

Lastnosti izdelka

PRIFTIN 150MG FILM-COATED TABLETS
1. DESCRIPTION
1.1 ACTIVE INGREDIENTS
Rifapentine: 150 mg per Priftin tablet
1.2 THERAPEUTIC OR PHARMACOLOGICAL CLASS
Antibiotic
1.3 PHARMACEUTICAL FORM(S)
Tablet
1.4 COMPOSITION
Active ingredient: Rifapentine
Excipients: calcium stearate, disodium EDTA, FD&C Blue No. 2 aluminum
lake, hydroxypropyl cellulose,
hypromellose USP, microcrystalline cellulose, polyethylene glycol,
pregelatinized starch, propylene glycol,
sodium ascorbate, sodium lauryl sulfate, sodium starch glycolate,
synthetic red iron oxide, and titanium
dioxide.
2. INDICATIONS
2.1 LATENT TUBERCULOSIS INFECTION
Priftin is indicated for the treatment of latent tuberculosis
infection caused by Mycobacterium tuberculosis
in adults and children 2 years and older who are at high risk of
progression to tuberculosis disease
(including those in close contact with active tuberculosis patients
with culture-confirmed TB disease
and who have a positive TST, recent conversion to a positive
tuberculin skin test, HIV-infected patients,
or those with pulmonary fibrosis on radiograph).
Active tuberculosis disease should be ruled out before initiating
treatment for latent tuberculosis infection.
Priftin must always be used in combination with isoniazid as a 12-week
once-weekly regimen for the
treatment of latent tuberculosis infection.
3. DOSAGE AND ADMINISTRATION
3.1 DOSAGE IN LATENT TUBERCULOSIS INFECTION
Priftin should be administered once-weekly in combination with
isoniazid for 12 weeks as directly observed
therapy.
Adults and children 12 years and older:
The recommended dose of Priftin should be determined based
DISETUJUI OLEH BPOM : 24/12/2021
ID : EREG100022VR12100503
on weight of the patient up to a maximum of 900 mg once-weekly (see
Table 1). The recommended
dose of isoniazid is 15 mg/kg (rounded to the nearest 50 mg or 100 mg)
up to a maximum of
900 mg once-weekly for 12 weeks.
Children 2-11 years:
The recommended dose of Priftin should be determined based on weight
of the
patient up to a maximum of 900 mg once- weekly (se