BACTRIM INJECTION

Land: Sydafrika

Språk: engelska

Källa: South African Health Products Regulatory Authority (SAHPRA)

Tillgänglig från:

LeBasi Pharmaceuticals (Pty) Ltd

Dos:

See ingredients

Läkemedelsform:

INJECTION

Sammansättning:

EACH 5 ml SOLUTION CONTAINS SULFAMETHOXAZOLE 400 mg TRIMETHOPRIM 80 mg

Bemyndigande status:

Registered

Tillstånd datum:

1975-09-03

Bipacksedel

LeBasi Pharmaceuticals (Pty) Ltd_ _
Bactrim
Solution for infusion_ _
_ _
80 mg trimethoprim and 400 mg sulfamethoxazole per 5 mL
Date of revision of text: 20 February 2024
Page 1 of 9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
BACTRIM, 80 MG/400 MG PER 5 ML, SOLUTION FOR INFUSION
TRIMETHOPRIM AND SULFAMETHOXAZOLE
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE BACTRIM IS ADMINISTERED.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
WHAT IS IN THIS LEAFLET
1.
What BACTRIM is and what it is used for
2.
What you need to know before BACTRIM is administered
3.
How BACTRIM will be administered
4.
Possible side effects
5.
How to store BACTRIM
6.
Contents of the pack and other information.
1.
WHAT BACTRIM IS AND WHAT IT IS USED FOR
BACTRIM treats and prevents a type of lung infection (_Pneumocystis
jirovecii_ pneumonia) in adults
and children, particularly in patients with a severely low immune
system.
BACTRIM is also used to treat a disease called toxoplasmosis; the
parasite is often found in cat
faeces (soil) and undercooked meat.
2.
WHAT YOU NEED TO KNOW BEFORE BACTRIM IS ADMINISTERED
BACTRIM SHOULD NOT BE ADMINISTERED
LeBasi Pharmaceuticals (Pty) Ltd_ _
Bactrim
Solution for infusion_ _
_ _
80 mg trimethoprim and 400 mg sulfamethoxazole per 5 mL
Date of revision of text: 20 February 2024
Page 2 of 9
•
If you are hypersensitive (allergic) to BACTRIM, sulfamethoxazole,
trimethoprim, any other
sulfonamide, or any of the other ingredients of BACTRIM (listed in
section 6).
•
If you have severe liver or kidney disease, any blood disorder or
megaloblastic anaemia.
•
If it is for a child who is prematurely or newly born or in the first
6 weeks of life.
•
If you have vitamin B
12
or folic acid deficiencies.
•
If you are pregnant and breastfeeding.
•
If you have porphyria (a group of disorders that result from a
build-up of natural chemicals that
produce porphyrin in your body).
•
If yo

Produktens egenskaper

LeBasi Pharmaceuticals (Pty) Ltd_ _
Bactrim
Solution for infusion_ _
_ _
80 mg trimethoprim and 400 mg
sulfamethoxazole per 5 mL
Date of revision of text: 20 February 2024
Page 1 of 22
PROFESSIONAL INFORMATION FOR BACTRIM
SCHEDULING STATUS: S4
1.
NAME OF THE MEDICINE
BACTRIM 80 mg/400 mg per 5 mL, solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BACTRIM contains as active ingredient trimethoprim (TMP) and
sulfamethoxazole (SMZ)
(trimethoprim + sulfamethoxazole = cotrimoxazole).
Each 5 mL solution contains 80 mg TMP and 400 mg SMZ.
Sugar free.
Excipients with known effect:
Contains 10 % _m/v_ ethanol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear liquid not more than faintly yellow in a 5 mL glass ampoule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis (primary and secondary) of _Pneumocystis _
_jirovecii_ pneumonia in adults and children, particularly in the
severely immunocompromised host.
Treatment of toxoplasmosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
LeBasi Pharmaceuticals (Pty) Ltd_ _
Bactrim
Solution for infusion_ _
_ _
80 mg trimethoprim and 400 mg
sulfamethoxazole per 5 mL
Date of revision of text: 20 February 2024
Page 2 of 22
_INTRAVENOUS INFUSION _
If oral administration is impossible, or not indicated, the ampoule
for IV infusion can only be used
following dilution with the appropriate infusion solutions.
_Standard dosage for adults and children over 12 years of age: _
2 x 5 mL ampoules twice a day (10 mL_ _twice a day), after appropriate
dilution, in the morning and in
the evening.
_High dosage (for particularly severe cases):_
3 x 5 mL ampoules twice daily (15 mL twice a day), after appropriate
dilution, in the morning and in
the evening.
_ _
_Duration of treatment:_
As a general rule, the BACTRIM parenteral formulation should be given
only during the period that
oral treatment is not possible; the standard dosage for not longer
than 5 consecutive days, and the
high dose for not more