ATRACURIUM-HAMELN 10MGML INJECTION5.0ML

Country: Malaysia

Language: English

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

Active ingredient:

ATRACURIUM BESYLATE

Available from:

IDAMAN PHARMA SDN. BHD.

INN (International Name):

ATRACURIUM BESYLATE

Units in package:

5Units Units; 10Units Units

Manufactured by:

Siegfried Hameln GmBH

Summary of Product characteristics

Atracurium-hameln 10 mg/ml Injection
Active ingredient: atracurium besilate
DESCRIPTION
Colourless, clear solution.
COMPOSITION
One ampoule with 2.5 ml injection solution contains
Active ingredient: 25 mg atracurium besilate
Other ingredients:
Benzenesulfonic acid, water for injections
One ampoule with 5 ml injection solution contains
Active ingredient: 50 mg atracurium besilate
Other ingredients:
Benzenesulfonic acid, water for injections
PHARMACEUTICAL FORM AND CONTENT
-
5 ampoules with 2.5 ml solution for intravenous injec-
tion and infusion
-
10 ampoules with 2.5 ml solution for intravenous injec-
tion and infusion
-
5 ampoules with 5 ml solution for intravenous injection
and infusion
-
10 ampoules with 5 ml solution for intravenous injec-
tion and infusion
Not all pack sizes will be marketed.
NON-DEPOLARISING MUSCLE RELAXANT
MANUFACTURER
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
THERAPEUTIC INDICATIONS
Intravenous use during surgical and other procedures and
in intensive care.
Atracurium besilate is used as an adjunct to general an-
aesthesia, to facilitate tracheal intubation and controlled
ventilation.
CONTRAINDICATIONS
Atracurium besilate should not be administered to patients
known to have an allergic hypersensitivity to the drug or to
benzenesulphonic acid.
PREGNANCY AND LACTATION
There are no adequate data on the use of atracurium besil-
ate during pregnancy. Animal studies of effects on pregnan-
cy, embryo/foetal development, parturition and post natal
development are incomplete (See section Toxicology prop-
erties). Atracurium besilate should only be administered
during pregnancy after careful risk-benefit assessment.
Placental transfer is low. Applications within the recom-
mended dose range in caesarean section patients showed
no detrimental effects on the new born. Therefore, atracu-
rium besilate is also suitable for maintenance of muscle
relaxation during caesarean section.
It is not known whether the atracurium besilate passes into
breast milk. Due to short half-life, an influen