BRUFEN

País: Indonèsia

Idioma: indonesi

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

ingredients actius:

IBUPROFEN

Disponible des:

ABBOTT INDONESIA - Indonesia

Designació comuna internacional (DCI):

IBUPROFEN

Dosis:

100 MG

formulario farmacéutico:

SUSPENSI

Unidades en paquete:

DUS, 1 BOTOL @ 60 ML

Fabricat per:

ABBOTT INDONESIA - Indonesia

Data d'autorització:

2019-08-29

Fitxa tècnica

1
BRUFEN®
IBUPROFEN 100 MG/5 ML
NAME OF THE MEDICINAL PRODUCT
Ibuprofen 100 mg/5 mL oral suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 100 mg/5 mL oral suspension
The suspension contains 100 mg/5 mL ibuprofen.
Excipients with known effect: Sucrose, sorbitol, sunset yellow, methyl
parahydroxybenzoate, propyl
parahydroxybenzoate.
PHARMACEUTICAL FORM
Ibuprofen 100 mg/5 mL oral suspension
Oral suspension
Yellow with orange flavor
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
•
To reduce fever in children.
•
To relief mild to moderate pain, such as dental pain or dental
extraction pain, headache,
postoperative pain, pain in rheumatic conditions of bones and joints,
pain in association with
sprains.
POSOLOGY AND METHOD OF ADMINISTRATION
Recommended dose for:
ADULT
To relief pain: 3 to 4 times of 10 ml a day._ _
_ _
CHILDREN
To relief fever and pain:
AGE
DOSE
FREQUENCY
1 to 2 years
2.5 ml
3 to 4 times a day
3 to 7 years
5 ml
3 to 4 times a day
8 to 12 years
10 ml
3 to 4 times a day
CONTRAINDICATIONS
-
Patients with severe and active ulcus pepticum (gastric and duodenal
ulceration).
-
Patients with history of hypersensitivity to ibuprofen and other
non-steroidal anti-inflammatory
drugs.
-
Patients with polyps in the nose, angioedema and patients who develop
asthma symptoms, rhinitis or
urticaria when taking acetylsalicylic acid or other non-steroidal
anti-inflammatory drugs.
-
Last trimester in pregnancy.
Disetujui oleh BPOM: 18/02/2021
ID REG: EREG100346VR12000182
2
-
Severe dehydration (caused by vomiting, diarrhea or insufficient fluid
intake)
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
General
Undesirable effects may be minimized by using the lowest effective
dose for the shortest duration
necessary to control symptoms (_see section Posology and method of
administration_, _and gastrointestinal _
_and cardiovascular effects below_). As with other NSAIDs, ibuprofen
may mask the signs of infection.
On prolonged use of any painkillers, headache may occur that must not
be treated with increased doses
of t