Glucantime 1,5g/5ml solution for injection

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

meglumine antimoniate

Disponible des:

Famar Health Care Services Madrid

Codi ATC:

P01CB01

Designació comuna internacional (DCI):

meglumine antimoniate

Dosis:

300mg/ml

formulario farmacéutico:

solution for injection

Unidades en paquete:

(5) ampoules 5ml

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2019-06-05

Informació per a l'usuari

GLUCANTIME® 1.5 G/5 ML
_meglumine antimoniate _
SOLUTION FOR INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
If you have any further questions or are unsure of anything, ask your
doctor or pharmacist for more
information.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve.

If you notice any side effects not listed in this leaflet, or if you
feel that one of the side effects listed
is serious, please inform your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1. What GLUCANTIME 1.5 g/5 ml solution for injection is and what it is
used for
2. What you need to know before you use GLUCANTIME 1.5 g/5 ml solution
for injection
3. How to use GLUCANTIME 1.5 g/5 ml solution for injection
4. Possible side effects
5. How to store GLUCANTIME 1.5 g/5 ml solution for injection
6. Contents of the pack and other information
1. WHAT GLUCANTIME 1.5 G/5 ML SOLUTION FOR INJECTION IS AND WHAT IT IS
USED FOR
ANTILEISHMANIAL AGENT
This medicine is an antiparasitic agent used to treat cutaneous and
visceral leishmaniasis.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLUCANTIME 1.5 G/5 ML SOLUTION
FOR
INJECTION
DO NOT USE GLUCANTIME 1.5 G/5 ML SOLUTION FOR INJECTION IF YOU HAVE:

a history of allergy to one of the ingredients of this medicine,

liver, kidney or heart disease.
IF YOU ARE UNSURE OF ANYTHING, IT IS ESSENTIAL THAT YOU ASK YOUR
DOCTOR
OR PHARMACIST FOR ADVICE.
TAKE SPECIAL CARE WITH GLUCANTIME 1.5 G/5 ML SOLUTION FOR INJECTION:
SPECIAL WARNINGS
This medicine contains sulfites and can cause severe allergic
reactions and difficulty breathing.
Meglumine antimoniate may cause prolongation of the QT interval and
severe arrhythmia. It is
advisable to monitor the ECG pattern and caution should be exercised
when using meglumine
antimoniate in patients with known risk factors to cause QT
prolongation such that e

Fitxa tècnica

______________________________________________________________________________________________
Translated from the French by Sanofi Regulatory Translation Services
under Tracking No. SA-PH-RTS12495 on March 01, 2018
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
GLUCANTIME® 1.5 G/5 ML SOLUTION FOR INJECTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Meglumine antimonate
............................................................1.5000 g
Equivalent to 0.4050 g of antimony per 5 ml vial.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment
of
visceral
leishmaniasis
(_Kala-azar_)
and
cutaneous
leishmaniasis
(except
resistant
_Leishmania aethiopica_).
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
VISCERAL LEISHMANIASIS:
Intramuscular injection of 20 mg/kg/day of antimony (i.e. 75 mg/kg/day
of meglumine antimonate),
without exceeding 850 mg of antimony, for at least 20 consecutive
days. Treatment should be
continued until no parasites are detected in splenic aspirates
obtained at 14-day intervals.
In case of recurrence, another treatment course must immediately be
administered using the same
daily doses.
CUTANEOUS LEISHMANIASIS:
For forms other than those due to _Leishmaniasis braziliensis _and
_Leishmaniasis amazonensis_:
Intralesional injections should only be considered in the early stage
of the disease. Infiltration must be
thorough until complete blanching is obtained at the base of the
lesion.
Systemic treatment is required when lesions are too numerous,
inflamed, ulcerated or located in areas
where scarring could cause disfigurement or disability, particularly
if there is obstruction of the
lymphatic system or cartilage involvement.

Local treatment:
Injection of 1 to 3 ml at the base of the lesion, repeated once (or
twice if there is no visible
improvement), at intervals of 1 to 2 days.
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