Septrin for Infusion 80mg/400mg/5ml solution for infusion ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulfamethoxazole; Trimethoprim

Available from:

Aspen Pharma Trading Ltd

ATC code:

J01EE01

INN (International Name):

Sulfamethoxazole; Trimethoprim

Dosage:

80mg/1ml ; 16mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010800; GTIN: 5010706002760

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CO-TRIMOXAZOLE 16 MG/80 MG PER ML FOR INFUSION
Co-trimoxazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Co-Trimoxazole is and what it is used for
2.
What you need to know before you are given Co-Trimoxazole
3.
How Co-Trimoxazole is given
4.
Possible side effects
5.
How to store Co-Trimoxazole
6.
Contents of the pack and other information
1.
WHAT CO-TRIMOXAZOLE IS AND WHAT IT IS USED FOR
Co-Trimoxazole 16 mg/80 mg per ml for Infusion (called
‘Co-Trimoxazole’ in this leaflet) is a
combination of two different antibiotics called sulfamethoxazole and
trimethoprim, which is used to
treat infections caused by certain bacteria. Like all antibiotics,
Co-Trimoxazole only works against
some types of bacteria. This means that it is only suitable for
treating some types of infections.
Co-Trimoxazole can be used to treat or prevent:
•
lung infections (pneumonia or PJP) caused by a bacteria called
_Pneumocystis jirovecii._
•
infections caused by a bacteria called Toxoplasma (toxoplasmosis).
Co-Trimoxazole can be used to treat:
•
urinary bladder or urinary tract infections (water infections).
•
an infection called nocardiosis which can affect the lungs, skin and
brain.
Co-Trimoxazole 16 mg/80 mg per ml for infusion will usually only be
given to you if you are unable
to take medicines by mouth.
Consideration should be given to the official guidance in the
appropriate use of antibacterial agents.
Co-Trimoxazole for Infusion is indicated in children

Summary of Product characteristics

OBJECT 1
CO-TRIMOXAZOLE FOR INFUSION 16 MG/ 80MG PER ML
FOR INFUSION
Summary of Product Characteristics Updated 04-Apr-2018 | Aspen
1. Name of the medicinal product
Co-Trimoxazole 16 mg/ 80 mg per ml for Infusion.
2. Qualitative and quantitative composition
Each 5 ml of Co-Trimoxazole 16 mg/80 mg per ml for Infusion contains
80 mg Trimethoprim and 400
mg Sulfamethoxazole.
Excipient(s) with known effect:
This product contains 1.7 mmoles of sodium, 13.2 vol % ethanol
(alcohol) per 5 ml and sodium
metabisulphite.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Infusion. A clear liquid.
4. Clinical particulars
4.1 Therapeutic indications
Co-Trimoxazole for Infusion is indicated in children aged 12 years and
under (>6 weeks to <12 years
old); children over 12 years old (>12 to < 18 years old) and adults
(>18 years old) for the treatment of the
following infections when owing to sensitive organisms (see section
5.1):
• Acute uncomplicated urinary tract infection: It is recommended
that initial episodes of uncomplicated
urinary tract infections be treated with a single effective
antibacterial agent rather than a combination
such as Co-Trimoxazole for Infusion.
• Treatment and prevention of _Pneumocystis jirovecii_ pneumonitis
or “PJP”.
• Treatment and prophylaxis of toxoplasmosis.
• Treatment of nocardiosis.
• In general, the indications for the use of Co-Trimoxazole for
Infusion are the same as those for oral
presentations.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Posology:
Standard dosage recommendations for acute infections
_Adults (>18 years old):_
STANDARD DOSAGE
AGE
SOLUTION FOR INFUSION
>18 years old
2 ampoules (10 ml) every 12 hours
The standard dosage for children is equivalent to approximately 6 mg
trimethoprim and 30 mg
sulfamethoxazole per kg body weight per day, given in two equally
divided doses. The schedules for
children are according to the child's age a