NIMOTOP INFUSION SOLUTION 0.02% 50ML

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

NIMODIPINE

Dostupné s:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (Mezinárodní Name):

NIMODIPINE

Jednotky v balení:

1 Units; 50 ml Vials

Výrobce:

SOLUPHARM PHARMA ERZEUGNISSE GMBH &CO KG

Charakteristika produktu

Reference: Nimotop / solution for infusion / CCDS / Version 05
RESTRICTED
NIMOTOP® (ASAH)
1.
NAME OF THE MEDICINAL PRODUCT
Nimotop solution for infusion 10 mg (50 mL)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 bottle of Nimotop solution for infusion 10 mg (50 mL) contains 10 mg
nimodipine in
50 mL alcoholic solvent.
3.
PHARMACEUTICAL FORM
Clear slightly yellowish solution
4.
CLINICAL PARTICULARS
4.1
INDICATION(S)
Prophylaxis and treatment of ischemic neurological deficits caused by
cerebral
vasospasms following subarachnoid hemorrhage of aneurysmal origin.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
4.2.1
METHOD OF ADMINISTRATION
Nimotop solution for infusion is administered as a continuous i.v.
infusion via a central
catheter using an infusion pump. It should be given via a three-way
stopcock together
with either glucose 5%, sodium chloride 0.9%, lactated Ringer's
solution, lactated
Ringer's solution with magnesium, dextran 40 solution or HAES®
(poly(O-2-
hydroxyethyl) starch 6% in a ratio of about 1:4 (nimodipine:
co-infusion). Also mannitol,
human albumin or blood are suitable for co-infusion.
The three-way stopcock should be used to connect the nimodipine
polyethylene tube with
the co infusion line and the central catheter.
Nimotop solution for infusion must not be added to an infusion bag or
bottle and must not
be mixed with other drugs.
Administration of Nimotop solution for infusion should be continued
during anesthesia,
surgery and angiography.
4.2.2
DOSAGE REGIMEN
Intravenous infusion:
At the beginning of treatment 1 mg/h nimodipine (= 5 mL Nimotop
solution for infusion
/h) for 2 h (about 15 µg/kg body weight/h).
If this is well tolerated, and particularly if there is no marked
reduction in blood pressure,
the dose is increased after 2 h to 2 mg/h nimodipine (= 10 mL Nimotop
solution for
infusion /h) (about 30 µg/kg body weight/h).
Reference: Nimotop / solution for infusion / CCDS / Version 05
RESTRICTED
Patients whose body weight is appreciably below 70 kg or who have
labile blood pressure
should be