Pentostam 10g/100ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium stibogluconate

Available from:

GlaxoSmithKline UK Ltd

ATC code:

P01CB02

INN (International Name):

Sodium stibogluconate

Dosage:

100mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05040500; GTIN: 5010706008243

Patient Information leaflet

[GlaxoSmithKline Logo]
PACKAGE LEAFLET: INFORMATION FOR THE USER
PENTOSTAM
®
SODIUM STIBOGLUCONATE INJECTION
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, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Pentostam is and what it is used for
2. What you need to know before you have Pentostam
3. How Pentostam is given
4. Possible side effects
5. How to store Pentostam
6. Contents of the pack and other information
1
WHAT PENTOSTAM IS AND WHAT IT IS USED FOR
The name of your injection is Pentostam. It contains a medicine called
sodium stibogluconate.
Pentostam kills parasites, which cause a disease called leishmaniasis.
These parasites are spread by
bites from sand flies.
There are 3 main ways in which leishmaniasis can show itself:
•
by sores on your skin (cutaneous)
•
by sores in your nose, mouth and throat (mucocutaneous)
•
by affecting your internal organs like the liver (visceral).
2
WHAT YOU NEED TO KNOW BEFORE YOU HAVE PENTOSTAM
YOU SHOULD NOT HAVE PENTOSTAM IF YOU:
•
are allergic to sodium stibogluconate or any of the other ingredients
of this medicine (listed in
section 6)
•
have serious kidney disease.
Do not have Pentostam if any of the above apply to you. If you are not
sure, talk to your doctor,
pharmacist or nurse before having Pentostam.
WARNINGS AND PRECAUTIONS
Take special care with Pentostam if you have:
•
liver problems
•
heart problems, an unusual heart rhythm or beat
•
been treated for leishmaniasis disease before
•
sores in your nose, mouth or throat.
If you are not sure if any of the above apply to you, talk to your
doctor, pharmacist or nurse before you
have Pentostam.
Your doctor or nurse will normally check your heart rhythm and be

Summary of Product characteristics

OBJECT 1
PENTOSTAM INJECTION
Summary of Product Characteristics Updated 19-Mar-2014 |
GlaxoSmithKline UK
1. Name of the medicinal product
Pentostam
®
Injection.
2. Qualitative and quantitative composition
Sodium Stibogluconate equivalent to 100 mg pentavalent antimony in
each ml.
3. Pharmaceutical form
Injection
4. Clinical particulars
4.1 Therapeutic indications
Pentostam should be used in accordance with international and local
treatment guidelines. Consideration
should be given to visceral leishmaniasis resistance patterns prior to
administration.
Pentostam is indicated for the following diseases:
Visceral leishmaniasis (kala azar).
Cutaneous leishmaniasis.
South American mucocutaneous leishmaniasis.
Pentostam may also be of value in the treatment of leishmaniasis
recidivans and diffuse cutaneous
leishmaniasis in the New World.
NOTE:-
• There is limited data available on the effectiveness of sodium
stibogluconate to treat cutaneous and
diffuse cutaneous leishmaniasis caused by Leishmania infantum and
Leishmania aethiopica.
4.2 Posology and method of administration
Route of administration
Due to the presence of particulates (size range 20 to 300 microns)
Pentostam solution should be drawn up
through a filter immediately prior to administration. These
particulates are insoluble complexes formed
by an interaction between product preservative and the antioxidant in
the rubber stopper. Filters of pore
size 5 micron or less and membrane types polyvinylidene difluoride,
polyethersulfone, polysulfone,
nylon, surfactant-free cellulose acetate and mixed cellulose esters
have been shown to be suitable. Where
sterile filters are not available the risks and benefits of
administering unfiltered Pentostam therapy should
be assessed by the clinician on an individual basis.
All dosage recommendations are based on the findings of the WHO Expert
Committee on leishmaniasis
which met in 2010. There are no special recommendations for different
age groups.
_Visceral leishmaniasis:_ 20 mg pentavalent antimony (0.2 ml
Pentostam) pe