SEPTRIN FOR INFUSION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SULPHAMETHOXAZOLE; TRIMETHOPRIM

Available from:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC code:

J01EE01

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

SULPHAMETHOXAZOLE 400 MG / 5 ML; TRIMETHOPRIM 80 MG / 5 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

JUBILANT HOLLISTERSTIER GENERAL PARTNERSHIP (JHSGP), CANADA

Therapeutic group:

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Therapeutic area:

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Therapeutic indications:

Bacterial infections of respiratory tract, gastrointestinal tracts and skin, susceptible to the drug.

Authorization date:

2018-02-28

Patient Information leaflet

העדוה
לע
הרמחה
(
עדימ
ןולעב )תוחיטב
ל
אפור :ךיראת
21.5.2013
םש
רישכת
תילגנאב
רפסמו
םושירה
SEPTRIN FOR INFUSION
126-27-30623-00
םש
לעב
םושירה
מ"עב תויונכוס לארשי וגירפ
! דבלב תורמחהה טורפל דעוימ הז ספוט
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
4.2 POSOLOGY AND METHOD
OF ADMINISTRATION
.
New
Creatinine Clearance (ml/min)
15 to 30, recommended dosage
Half the standard dosage
Creatinine Clearance (ml/min)
less than 15, recommended
dosage Not recommended
Paediatric dosage may be increased by
50% for severe infections.
Creatinine Clearance (ml/min) 15-25,
dosage standard dosage for a maximum
of three days followed by half the
standard dosage
.
Creatinine Clearance (ml/min) below 15,
dosage Not to be administered unless
haemodialysis facilities are available.
Under this condition half the standard
dosage may be given.
Use in the elderly: The elderly are more
likely to suffer from adverse reactions.
Therefore, the drug should be used only
where specifically indicated and for as
short a time as possible and only with
particular caution in elderly patients
.
4.3 CONTRAINDICATIONS
Trimethoprim-
sulfamethoxazole for Infusion
should not be given to patients
with a history of
hypersensitivity to
sulphonamides, trimethoprim,
Trimethoprim-
sulfamethoxazole or any
excipients of excipients of the
presentations.
Trimethoprim-
sulfamethoxazole for Infusion is
Trimethoprim-
sulfamethoxazole
for
Infusion Septrin presentations should not
be given to patients with a history of
hypersensitivity
to
sulphonamides,
trimethoprim,
co-trimoxazole
-
Trimethoprim- sulfamethoxazole
or any
excipients
of
excipients
of
the
presentations
Trimethoprim-
sulfamethoxazole
for
Infusion is Ccontra-indicated in patients
with
severe renal
insufficiency where
repeated measurements monitoring of the
plasma drug concentration cannot be
contra-indicated in patients
showing marked liver
parenchymal d

Summary of Product characteristics

CODE 128: 410510
SEPTRIN
™ FOR INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
SEPTRIN
™
FOR INFUSION, Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml ampoule contains 80mg trimethoprim and 400mg sulfametoxazole.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear faintly yellow to brown solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bacterial infections of respiratory tract, gastrointestinal tracts and
skin,
susceptible to the drug
4.2
DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION
Trimethoprim- sulfamethoxazole for Infusion is for administration ONLY
by
the intravenous route and must be diluted before administration (See
Use and
Handling).
The duration of the infusion should be approximately 1 to 1.5 hours,
but this
needs to be balanced against the fluid requirements of the patient.
When fluid restriction is necessary, Trimethoprim- sulfamethoxazole
for
Infusion may be administered at a higher concentration, 5 ml diluted
with 75
ml of glucose 5% w/v in water. The resultant solution, whilst being
clear to
the naked eye, may on occasion exceed the BP limits set for
particulate matter
in large volume parenterals. The solution should be infused over a
period not
exceeding an hour.
ACUTE INFECTIONS
Treatment should be continued until the patient has been symptom free
for
two days; the majority will require treatment for at least 5 days.
For severe infections in all age groups dosage may be increased by
50%.
POPULATIONS
•
ADULTS AND CHILDREN OVER 12 YEARS
Standard dosage: 2 ampoules (10 ml) every 12 hours.
•
CHILDREN AGED 12 YEARS AND UNDER
The recommended dosage is approximately 6mg trimethoprim and 30mg
sulphamethoxazole per kilogram bodyweight per 24 hours, given in two
equally divided doses.
As a guide, the following schedules may be used diluted as described
above:
AGE
DOSAGE
6 weeks to 5 months
1.25 ml every 12 hours.
6 months to 5 years
2.5 ml every 12 hours
6 to 12 years
5.0 ml every 12 hours.
•
ELDERLY
See Warnings and Preca