B. BRAUN IBUPROFEN SOLUTION FOR INFUSION 4MGML

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

Ibuprofen

제공처:

B. BRAUN SINGAPORE PTE LTD

약제 형태:

INFUSION, SOLUTION

구성:

Ibuprofen 4mg/ml

관리 경로:

INTRAVENOUS

처방전 유형:

Prescription Only

Manufactured by:

B. Braun Medical S.A

승인 상태:

ACTIVE

승인 날짜:

2022-04-04

제품 특성 요약

626/12628808/0322
1. NAME OF THE MEDICINAL PRODUCT
Ibuprofen B. Braun 4 mg/ml solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 4 mg of ibuprofen.
Each 50 ml bottle contains 200 mg of ibuprofen.
Each 100 ml bottle contains 400 mg of ibuprofen.
Excipient with known effect:
Each ml of solution contains 9.10 mg of sodium chloride (3.58 mg of
sodi-
um).
Each 50 ml bottle contains 455 mg of sodium chloride (179 mg of sodi-
um).
Each 100 ml bottle contains 910 mg of sodium chloride (358 mg of sodi-
um).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion.
Clear and colourless to pale yellow solution for infusion, without any
par-
ticulate matter.
pH: 6.8–7.8
Osmolarity: 310–360 mOsm/L
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ibuprofen B. Braun is indicated in children (≥ 5 kg body weight),
adoles-
cents and adults for the short-term symptomatic treatment of acute
mod-
erate pain, and for the short-term symptomatic treatment of fever,
when
administration by intravenous route is clinically justified, when
other
routes of administration are not possible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest effective dose should be used for the shortest duration
neces-
sary to relieve symptoms (see section 4.4.). This may minimise
undesirable
effects.
Use should be limited to situations where oral administration is
inappro-
priate. Patients must switch to oral treatment as soon as this is
possible.
Adequate hydration of the patient should be maintained to minimize the
risk of possible adverse reactions at renal level.
_Adults_
The recommended dose is 400 mg of ibuprofen, every 6–8 hours as nec-
essary. The recommended maximum daily dose of 2400 mg and should not
be exceeded.
_Paediatric patients_
The recommended ibuprofen dose in children and adolescents is based on
the body weight or age. As a general rule, the recommended daily dose
is
20–30 mg/kg of body weight divided into three to four single doses
(5�