Albendazole tablets chewable

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

albendazole

Available from:

Arpimed LLC

ATC code:

P02CA03

INN (International Name):

albendazole

Dosage:

400mg

Pharmaceutical form:

tablets chewable

Units in package:

(4) in plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-09-02

Summary of Product characteristics

SUMMARY PRODUCT CHARACTERISTIC (SPC)
ALBENDAZOLE
400
, CHEWABLE TABLETS
1. NAME OF THE MEDICAL PRODUCT - ALBENDAZOLE
1.2 INTERNATIONAL NON-PROPERTY NAME –
ALBENDAZOLE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Each chewable tablet contains: _
_ACTIVE INGREDIENT: _
Albendazole – 400.0 mg
_ For a full list of excipients, see section 6.1. _
_ _
_ _ 3. PHARMACEUTICAL FORM
_ _Chewable tablet.
A pink, round,
mottled, tablet with beveled edges and with
raspberry
odor.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Albendazole is a benzimidazole carbamate anthelmintic for use in the
treatment caused by
intestinal
and
tissue
parasites:
Roundworm
(Ascaris
lumbricoides),
pinworm
(Enterobius
vermicularis), hookworm (Necator americanus, Ancylostoma duodenale),
whipworm (Trichuris
trichiura), threadworm (Strongyloides stercoralis), tapeworm (Taenia
spp and Hymenolepis nana
only in the case of associated parasitism), Chlonorchiasis
(Chlonorchis sinensis), Opisthorchiasis
(Opisthorchis
viverrini)
and
cutaneous
larva
migrans;
Giardiasis
(G.lamblia,
G.duodenalis,
G.intestinalis, Lamblia intestinalis) in children, Cystic
Echinococcosis (caused by _Echinococcus _
_granulosus_),
Alveolar
Echinococcosis
(caused
by
_Echinococcus _
_multilocularis_),
Neurocysticercosis (caused by infection with _Taenia solium_, a
tapeworm), Hepatic capillariasis,
caused
by _Capillaria _
_hepatica, _
_Gnathostomiasis _
_(also _
_known _
_as _
_larva _
_migrans _
_profundus _
_caused by the nematode (roundworm) Gnathostoma spinigerum and/or
Gnathostoma hispidum),_
Trichinellosis (caused
by roundworms of
the
genus _Trichinella)_,
Toxocarosis
(caused
by
Toxocara spp).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
Dosage: Dosages are dependent on the parasite involved, the weight of
the patient, and the
severity of the infection:
INTESTINAL PARASITES AND CUTANEOUS LARVA MIGRANS
INDICATIONS
AGE
DOSE
PERIOD
- Roundworm
- Pinworm
- Hookworms
- Whipworm
adults and children over 6
years of age
400 mg
single dose
- Strongyloid