TRANDATE INJECTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharmacare Limited û Woodmead

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH 1 ml SOLUTION CONTAINS LABETALOL HYDROCHLORIDE 5 mg

Authorization status:

Registered

Authorization date:

1977-07-10

Patient Information leaflet

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_Page 1 of 10 _
1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S3
TRANDATE INJECTION 5 MG/1 ML
LABETALOL HYDROCHLORIDE
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE TRANDATE INJECTION IS
ADMINISTERED

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor pharmacist nurse
or other healthcare
provider.

TRANDATE INJECTION has been prescribed for you personally and you
should not share
your medicine with other people. It may harm them, even if their
symptoms are the same
as yours.
WHAT IS IN THIS LEAFLET
1.
What TRANDATE INJECTION is and what it is used for
2.
What you need to know before you receive TRANDATE INJECTION
3.
How to receive TRANDATE INJECTION
4.
Possible side effects
5.
How to store TRANDATE INJECTION
6.
Contents of the pack and other information
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_Page 2 of 10 _
1.
WHAT TRANDATE INJECTION IS AND WHAT IT IS USED FOR
TRANDATE INJECTION belongs to a group of medicines called beta
blockers.
TRANDATE INJECTION decreases high blood pressure by reducing the rate
and force of the
heartbeat and by widening arteries and helping blood flow.
TRANDATE INJECTION is given in hospital.
TRANDATE INJECTION is used when a person’s blood pressure needs to
be reduced very quickly. It
can be used to lower very high blood pressure in pregnant women.
TRANDATE INJECTION is sometimes used by anaesthetists to keep your
blood pressure down
during operations.
If you are not sure why you have been given this injection, ask your
doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE TRANDATE INJECTION
TRANDATE INJECTION SHOULD NOT BE ADMINISTERED TO YOU IF:

you are hypersensitive (allergic) to labetalol or any of the other
ingredients of TRANDATE
INJECTION (listed in section 6).

you have second or third degree heart block, or a condition where your
heart suddenly cant
pump enough blood (cardiogenic shock), chest pain caused by reduced
blood flow to t

Summary of Product characteristics

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_ Page 1 of 21 _
1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S3
1. NAME OF THE MEDICINE
TRANDATE INJECTION 5 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of TRANDATE INJECTION contains 5 mg of labetalol
hydrochloride.
Sugar free
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Injection
TRANDATE INJECTION is a clear, colourless solution.
4.
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
TRANDATE 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.
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_ Page 2 of 21 _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults _
TRANDATE INJECTION is intended for intravenous use in hospitalised
patients.
The plasma concentrations achieved after intravenous doses of TRANDATE
INJECTION in
severe hypertension are substantially greater than those following
oral administration of the
medicine.
Patients should therefore always receive TRANDATE INJECTION whilst in
the supine position.
Raising the patient into the upright position within three hours of
intravenous TRANDATE
INJECTION administration should be avoided since excessive postural
hypotension may occur.
The blood pressure and heart rate should be monitored after injection
and during infusion.
It is desirable to monitor the BP 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 IV. Respiratory function
should be observed
particularly in patients with any known impairment.
Once the BP has been adequately reduced by bolus injection or
infusion, maintenance therapy
with TRANDATE tablets should be substituted with a starting dose of
100 mg twice daily.
TRANDATE INJECTION has been administered to patients with uncontrolled
hypertension
already receiving other hypotensive medicines, in