REVATIO

Kraj: Indonezja

Język: indonezyjski

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

Składnik aktywny:

SILDENAFIL CITRATE

Dostępny od:

PFIZER INDONESIA - Indonesia

INN (International Nazwa):

SILDENAFIL CITRATE

Dawkowanie:

14.045 MG

Forma farmaceutyczna:

SIRUP KERING

Sztuk w opakowaniu:

DUS, 1 BOTTLE @ 112 ML

Wyprodukowano przez:

FAREVA AMBOISE - France

Data autoryzacji:

2019-07-31

Charakterystyka produktu

Generic Name: Sildenafil Citrate
Trade Name: Revatio
CDS Effective Date: May 23, 2017
Supersedes: NA
2018-0037193
Page 1 of 26
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Sildenafil Citrate
Trade Name: Revatio
CDS Effective Date: May 23, 2017
Supersedes: NA
1. NAME OF THE MEDICINAL PRODUCT
1.1. PRODUCT NAME
Revatio
1.2. STRENGTH
10 mg/mL
1.3. PHARMACEUTICAL DOSAGE FORM
White to off-white powder for oral suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1. QUALITATIVE DECLARATION
After reconstitution, each mL of the oral suspension contains 10 mg of
sildenafil (as citrate).
Following reconstitution, the volume of suspension is 112 mL
containing 1.12 g of sildenafil
(as citrate), providing a usable volume of 90 mL of suspension at a
sildenafil concentration of
10 mg/mL, adequate to provide a 30 day supply of a 10 mg dose, or a 15
day supply of a
20 mg dose.
2.2. QUANTITATIVE DECLARATION
Each mL of oral suspension contains 250 mg sorbitol. For excipients,
see section 6.1.
3. PHARMACEUTICAL FORM
White to off-white powder. Once reconstituted, white to off-white
opaque fluid containing
undissolved solids.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Pediatric Population
Treatment of paediatric patients aged 1 year to 17 years old with
pulmonary arterial
hypertension. Efficacy in terms of improvement of exercise capacity or
pulmonary
haemodynamics has been shown in primary pulmonary hypertension and
pulmonary
hypertension associated with congenital heart disease.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Pediatric population (1 year to 17 years)_
DISETUJUI BPOM: 18/07/2019
ID: EREG10024111900019
Generic Name: Sildenafil Citrate
Trade Name: Revatio
CDS Effective Date: May 23, 2017
Supersedes: NA
2018-0037193
Page 2 of 26
For pediatric patients aged 1 year to 17 years old, the recommended
dose in patients ≤20 kg
is 10 mg (1 mL of compounded suspension) three times a day and for
patients >20 kg is
20 mg (2 mL of compounded suspension) three times a day. Higher than
recommended dos