TRANDATE INJECTION 25MG5ML AMP

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

LABETALOL HYDROCHLORIDE

Disponible depuis:

Aspen Medical Products Malaysia Sdn Bhd

DCI (Dénomination commune internationale):

LABETALOL HYDROCHLORIDE

Unités en paquet:

5Units Units

Fabriqué par:

UBI Pharma Inc.

Notice patient

Not Applicable

Résumé des caractéristiques du produit

1
TRANDATE
LABETALOL HYDROCHLORIDE
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRANDATE Injection is a clear, colourless solution, practically free
from visible particles,
containing 5mg of Labetalol Hydrochloride per ml and supplied in 5ml
ampoule.
TRANDATE Tablets are orange, round, biconvex film-coated tablets,
engraved TT01 on one
face. Each tablet contains 100mg of Labetalol Hydrochloride.
PHARMACEUTICAL FORM
Solution for injection.
Film-coated tablets.
CLINICAL INFORMATION
INDICATIONS
_INJECTION IS INDICATED FOR: _
•
Severe hypertension, including severe hypertension of pregnancy, when
rapid control
of blood pressure is essential.
•
May be used to achieve controlled hypotension during anaesthesia.
_ _
_TABLET IS INDICATED FOR: _
•
Mild, moderate or severe hypertension.
•
Hypertensions in pregnancy.
•
Angina pectoris with coexisting hypertension.
DOSAGE AND ADMINISTRATION
_INJECTION: _
POSOLOGY
Labetalol injection is intended for i.v. use in hospitalised patients.
POPULATIONS
•
ADULTS
INDICATION
DOSE
SEVERE
HYPERTENSION
Bolus Injection:
If it is essential to reduce the blood pressure quickly a dose of 50
mg
should be given by I.V. injection (over a period of at least 1 min)
and, if
necessary, repeated at 5 min intervals until a satisfactory response
occurs. The total dose should not exceed 200 mg.
2
The maximum effect usually occurs within 5 min and the duration of
action
is usually about 6 h but may be as long as 18 h.
Intravenous Infusion:
_ _
A 1 mg/ml solution of labetalol should be used, i.e. the contents of
eight 5
ml ampoules (200 mg) diluted to 200 ml with Sodium Chloride and
Dextrose Injection BP or 5% Dextrose Intravenous Infusion BP.
The infusion rate should normally be about 160 mg/h but may be
adjusted
according to the response at the discretion of the physician. The
effective
dose is usually 50 to 200 mg but infusion should be continued
until a
satisfactory response is obtained and larger doses may be needed,
especially in patients with phaeochromocytoma.
In case of severe hypertension