Septrin 80 mg/400 mg per ampoule, concentrate for solution for infusion

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Sulfamethoxazole; Trimethoprim

Inapatikana kutoka:

Aspen Pharma Trading Limited

ATC kanuni:

J01EE01

INN (Jina la Kimataifa):

Sulfamethoxazole; Trimethoprim

Kipimo:

80 mg/400 mg/5ml

Dawa fomu:

Concentrate for solution for infusion

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Eneo la matibabu:

sulfamethoxazole and trimethoprim

Idhini hali ya:

Not marketed

Idhini ya tarehe:

1975-11-14

Taarifa za kipeperushi

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SEPTRIN 80 MG/400 MG PER AMPOULE, CONCENTRATE FOR SOLUTION FOR
INFUSION
TRIMETHOPRIM AND SULFAMETHOXAZOLE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 Septrin is and what it is used for
2.
What you need to know before you are given Septrin
3.
How Septrin is given
4.
Possible side effects
5.
How to store Septrin
6.
Contents of the pack and other information
1.
WHAT SEPTRIN IS AND WHAT IT IS USED FOR
Septrin 80 mg/400 mg per ampoule, concentrate for solution for
infusion (called ‘Septrin’ in this leaflet) is a
combination of two different antibiotics called sulfamethoxazole and
trimethoprim, which is used to treat
infections caused by bacteria. This medicine combination is also named
as co-trimoxazole. Like all
antibiotics, Septrin only works against some types of bacteria. This
means that it is only suitable for treating
some types of infections.
Septrin can be used to treat or prevent:
•
lung infections (pneumonia) caused by the micro-organism,
_Pneumocystis_
_jiroveci_
(previously known
as
_Pneumocystis carinii_
) (some people call this ‘PJP’).
Septrin can be used to treat:
•
urinary bladder or urinary tract infections (water infections).
•
respiratory tract infections such as bronchitis.
•
ear infections such as otitis media.
•
an infection called nocardiosis which can affect the lungs, skin and
brain.
•
an infection caused by a bacteria called toxoplasma (toxoplasmosis).
•
an infection called brucellosis, i

Tabia za bidhaa

Health Products Regulatory Authority
09 February 2023
CRN00D55P
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Septrin 80 mg/400 mg per ampoule, concentrate for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml ampoule contains 80 mg trimethoprim and 400 mg
sulfamethoxazole.
Excipients with known effect:
Contains 38.25 mg of sodium per 5 ml ampoule (inclusive of sodium
metabisulphite E 223), 0.5 mg ethanol (alcohol) per 5 ml
ampoule and 2.25 g of propylene glycol (E 1520) per 5ml ampoule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for Solution for Infusion
Clear faintly yellow to brown solution.
The pH of the solution is in the range 9.6 to 10.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In general, the indications for the use of Septrin for Infusion are
the same as those for oral presentations. Septrin for Infusion is
for use when oral dosage is not possible.
Septrin 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) andadults (>18 years old) for the treatment of
the following infections when owing to sensitive
organisms (see section 5.1):
_ _
_ - Urinary tract infections: _For simple urinary tract infections,
trimethoprim alone or another single anti-microbial agent is the
preferred treatment. Since trimethoprim is also as efficacious as
Septrin for Infusion for the prophylaxis of recurrent urinary
tract infections, Septrin for Infusion is not indicated for
prophylactic use.
_ - Respiratory tract infections:_ Septrin for Infusion may be used as
second line therapy in chronic obstructive airways disease or
other respiratory tract infections, including acute otitis media where
sensitivity has been demonstrated or is highly probable.
(Septrin is not indicated for prophylactic or prolonged administration
in otitis media).
- Treatment and prevention of _Pneumocystis _jirovecii pneumonitis or
'PJP.'
- Septrin for Infusion