TRANDATE INJECTION

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

LABETALOL HYDROCHLORIDE

Tersedia dari:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

Kode ATC:

C07AG01

Bentuk farmasi:

SOLUTION FOR INJECTION

Komposisi:

LABETALOL HYDROCHLORIDE 5 MG/ML

Rute administrasi :

I.V

Jenis Resep:

Required

Diproduksi oleh:

CENEXI SAS, FRANCE

Kelompok Terapi:

LABETALOL

Area terapi:

LABETALOL

Indikasi Terapi:

Treatment of hypertension when rapid control of blood pressure is essential.

Tanggal Otorisasi:

2014-08-31

Karakteristik produk

1
SUMMARY
OF
PRODUCT
CHARACTERISTICS
1.
NAME
OF
THE
MEDICINAL
PRODUCT
Trandate Injection
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
1 ml contains 5 mg labetalol hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Solution for injection.
Trandate is a clear, colourless or almost colourless solution and is
supplied in a clear glass
ampoule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension when rapid control of blood pressure is
essential.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Labetalol for injection is intended for intravenous use in
hospitalised patients.
It is desirable to monitor the blood pressure and heart rate after
injection and during infusion.
In most patients, there is a small decrease in the heart rate; severe
bradycardia is unusual but
may be controlled by injecting atropine 1 to 2 mg intravenously.
Respiratory function should
be observed particularly in patients with any known impairment.
Once the blood pressure has been adequately reduced by bolus injection
or infusion,
maintenance therapy with labetalol Tablets should be substituted with
a starting dose of 100
mg twice daily.
Labetalol Injection has been administered to patients with
uncontrolled hypertension already
receiving other hypotensive agents, including beta-blocking drugs,
without adverse effects.
2
POPULATIONS
•
ADULTS:
SEVERE HYPERTENSION
_ _
_BOLUS INJECTION: _
If it is essential to reduce the blood pressure quickly a dose of 50
mg should be given by
intravenous injection (over a period of at least one minute) and, if
necessary, repeated at five
minute intervals until a satisfactory response occurs. The total dose
should not exceed 200 mg.
The maximum effect usually occurs within 5 minutes and the duration of
action is usually about
6 hours but may be as long as 18 hours.
_INTRAVENOUS INFUSION: _
A 1 mg/ml solution of labetalol should be used, i.e. the contents of
two ampoules (200mg)
diluted to 200 ml with Sodium Chloride and Dextrose Injection BP or 5%
Dex