Furosemide-hameln 10mgml Injection

מדינה: מלזיה

שפה: אנגלית

מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

מרכיב פעיל:

FRUSEMIDE/FUROSEMIDE

זמין מ:

IMEKS PHARMA SDN. BHD.

INN (שם בינלאומי):

FRUSEMIDE/FUROSEMIDE

יחידות באריזה:

2ml10Units mL

תוצרת:

Mefar Ilac Sanayii A.S.

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
FUROSEMIDE-HAMELN 10 MG/ML SOLUTION FOR INJECTION
HAMELN
1.
NAME OF THE MEDICINAL PRODUCT
Furosemide-hameln 10 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml of solution contains 20 mg furosemide (10 mg/ml).
Excipient(s) with know effect:
This medicinal product contains a maximum 4 mg sodium per
1 ml of solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Furosemide-hameln is clear colourless solution, free from vis-
ible particles.
pH 8.0-9.3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Furosemide-hameln is a diuretic indicated for use when a
prompt and effective diuresis is required. The intravenous for-
mulation is appropriate for use in emergencies or when oral
therapy is precluded. Indications include cardiac, pulmonary,
hepatic and renal oedema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Doses of 20 to 50 mg intramuscularly or intravenously may be
given initially. If larger doses are required, they should be given
increasing by 20 mg increments and not given more often than
every two hours. If doses greater than 50 mg are required it is
recommended that they be given by slow intravenous infusion.
The recommended maximum daily dose of furosemide admin-
istration is 1,500 mg.
_Elderly_
The dosage recommendations for adults apply, but in the el-
derly furosemide is generally eliminated more slowly. Dosage
should be titrated until the required response is achieved.
_Paediatric population_
Parenteral doses for children range from 0.5 to 1.5 mg/kg body
weight daily up to a maximum total daily dose of 20 mg.
Method of administration
Furosemide-hameln is administered intravenously or intramus-
cularly.
Intravenous furosemide must be injected or infused slowly; a
rate of 4 mg per minute must not be exceeded. In patients with
severe impairment of renal function (serum creatinine>5 mg/
dl), it is recommended that an infusion rate of 2.5 mg per min-
ute is not exceeded.
In