DBL PENTAMIDINE ISETHIONATE FOR INJECTION BP 300 mgvial

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

PENTAMIDINE ISETHIONATE

Tillgänglig från:

PFIZER PRIVATE LIMITED

ATC-kod:

P01CX01

Dos:

300 mg/vial

Läkemedelsform:

INJECTION, POWDER, FOR SOLUTION

Sammansättning:

PENTAMIDINE ISETHIONATE 300 mg/vial

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

Prescription Only

Tillverkad av:

HOSPIRA AUSTRALIA PTY LTD

Bemyndigande status:

ACTIVE

Tillstånd datum:

1992-01-13

Produktens egenskaper

DBL™ PENTAMIDINE ISETHIONATE FOR INJECTION
1.
NAME OF THE MEDICINE
Pentamidine isethionate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of DBL™ Pentamidine Isethionate for Injection contains 300
mg pentamidine
isethionate as a freeze dried powder or plug.
Each 4 mg of pentamidine isethionate is equivalent to 2.3 mg
pentamidine base.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Powder for injection.
DBL™ Pentamidine Isethionate for Injection is a white or almost
white, odourless or almost
odourless hygroscopic powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pentamidine isethionate is indicated for intravenous administration in
the treatment of the
following conditions:
1.
As an alternative first line treatment for
_Pneumocystis carinii_
infection in AIDS
patients;
2.
As second line treatment for
_Pneumocystis carinii_
infection in non-AIDS patients;
3.
As
second
line
treatment
of
Leishmaniasis
(visceral
and
cutaneous),
except
_Leishmania aethiopica_
where it may be used as first line therapy;
4.
As
second
line
treatment
for
Trypanosomiasis
(except
for
the
_Trypanosomiasis rhodesiense_
strain due to lack of efficacy).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The following dosage regimens are recommended.
_P. CARINII PNEUMONIA_
4 mg/kg bodyweight Pentamidine Isethionate once daily for 14 days,
preferably by slow
intravenous infusion.
_LEISHMANIASIS_
On the basis of current knowledge the following dosage are suggested
however the optimal
treatment regimen has yet to be established.
- Visceral (Kala-azar): 3 to 4 mg/kg bodyweight Pentamidine
Isethionate on alternate days (3
times a week) to a maximum of 10 injections.
- Cutaneous: 3 to 4 mg/kg bodyweight Pentamidine Isethionate once or
twice weekly, until the
condition resolves.
_TRYPANOSOMIASIS_
Haemolymphete stage only.
4 mg/kg bodyweight Pentamidine Isethionate daily or on alternate days
to a total of 7 to 10
injections.
DOSAGE ADJUSTMENT
_RENAL IMPAIRMENT_
Creatinine clearance <35 mL/min: There is little i