DBL™ PENTAMIDINE ISETHIONATE FOR INJECTION BP 300mg

Land: Malaysia

Språk: engelska

Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiva substanser:

PENTAMIDINE ISETHIONATE

Tillgänglig från:

HOSPIRA MALAYSIA SDN BHD

INN (International namn):

PENTAMIDINE ISETHIONATE

Enheter i paketet:

1Units Units

Tillverkad av:

Hospira Australia Pty Ltd

Bipacksedel

This information is currently not available, we apologize for the
inconvenience caused.

Produktens egenskaper

1
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.
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:
-
As an alternative first line treatment for _Pneumocystis carinii_
infection in AIDS patients;
-
As second line treatment for _Pneumocystis carinii_ infection in
non-AIDS patients;
-
As second line treatment of Leishmaniasis (visceral and cutaneous),
except _Leishmania aethiopica_
where it may be used as first line therapy;
-
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.
2
-
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 information on the
kinetics or the adverse effects