Zestaval tablets film-coated

Land: Armenien

Språk: engelska

Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiva substanser:

albendazole

Tillgänglig från:

Remedica Ltd

ATC-kod:

P02CA03 վերարտադրված դեղ, պարզ ընթացակարգով

INN (International namn):

albendazole

Dos:

200mg (2/1x2/) in blister

Läkemedelsform:

tablets film-coated

Enheter i paketet:

200mg (2/1x2/) in blister

Receptbelagda typ:

Prescription

Bemyndigande status:

Registered

Tillstånd datum:

2018-06-19

Bipacksedel

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZESTAVAL 200 MG FILM-COATED TABLETS
Albendazole
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illnessare the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zestaval is and what it is used for
2.
What you need to know before you take Zestaval
3.
How to take Zestaval
4.
Possible side effects
5.
How to store Zestaval
6.
Contents of the pack and other information
1.
WHAT IS ZESTAVAL AND WHAT IT IS USED FOR
Albendazole, the active ingredient of Zestaval, belongs to the group
of medicines known as
anthelmintics. Anthelmintics are medicines used in the treatment of
worm infections.
Albendazoleis thought to exert its anthelmintic effect by inhibiting
tubulin polymerisation. This
causes the distribution of the helminth metabolism, including energy
depletion, which immobilises
and then kills the susceptible helminth.
Zestaval is indicated in the treatment of hydatid cysts caused by
_E.granulosus_or _E. multilocularis. _
Zestaval may be used as first-line medical therapy in patients with
hydatid disease where surgery is
not possible or as an adjunct to surgery, either pre- or
post-operatively.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZESTAVAL
DO NOT TAKE ZESTAVAL
-
if you are allergic to albendazole or to any of the other ingredients
of this medicine (listed in
section 6).
-
if you are pregnant, or you intend to become pregnant or if you are
breast-feeding.
-
if you have liver problems.
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zestaval.
Alben

Produktens egenskaper

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SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Zestaval 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet containsalbendazole200 mg.
Excipient with known effect:
This product contains 150 mg lactose.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, film-coated tablets with star embossed on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zestaval is indicated in the treatment of hydatid cysts caused by _
Echinococcusgranulosus_ or
_Echinococcusmultilocularis_. Zestaval may be used as first-line
medical therapy in patients with
hydatid disease where surgery is not possible or as an adjunct to
surgery, either pre- or post-
operatively.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly _
_Echinococcusgranulosus_: Zestaval is normally given at a dose of 800
mg/day in divided doses for
28 days. This 28-day treatment period may be repeated after a 14-day
period without treatment, for
a total of 3 cycles. Zestaval shows greatest efficacy in the treatment
of liver, lung and peritoneal
cysts. More prolonged treatment may be required for sites such as
bones and brain.
Pre-surgery: Dosage is 800 mg/day in divided doses for 28 days
followed by a period of 14 drug-
free days. Two 28-day cycles should be given where possible prior to
surgery. Where surgical
intervention is necessary before completion of two cycles of
treatment, Zestaval should be given for
as long as possible before surgery, but for not more than 28 days at a
time.
Pre- and post-surgery: Where only a short pre-operative course of
Zestaval has been given, and in
cases where emergency surgery is required, Zestaval should be given
post-surgically for two 28-day
cycles separated by 14 days drug free. In addition, where cysts are
found to be viable after pre-
surgical treatment or where spillage has occurred, a full two-cycle
course should be given.
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