IVERVETo-1

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ivermectin

Available from:

Laboratoires Biove

INN (International Name):

ivermectin

Dosage:

10mg/ml

Pharmaceutical form:

solution for injection

Prescription type:

Prescription

Patient Information leaflet

IVERVETo-1
INJECTABLE SOLUTION
COMPOSITION
ACTIVE INGREDIENT PER ML SOLUTION
10 mg ivermectin
EXCIPIENTS
0.40 ml Glycerol formal
1.00 ml Propylene glycol
PHARMACEUTICAL FORM
Injectable solution
DOSAGE AND ADMINISTRATION
IVERVETo-1 should be given by subcutaneous injection only.
* Cattle:
1 ml per 50 kg body weight (= 200 µg ivermectin per kg)
(inject under the loose skin in front or behind the shoulder)
* Sheep:
0.5 ml per 25 kg body weight (= 200 µg ivermectin per kg)
(inject under the loose skin in front or behind the shoulder or the
inside
of the thigh)
* Pigs:
1 ml per 33 kg body weight (= 300 µg ivermection per kg)
(inject under the loose skin in front or behind the shoulder or the
inside
of the thigh)
WARNINGS
Do not slaughter cattle or sheep for human consumption within 21 days
of last
treatment, and pigs within 28 days of last treatment.
Do not use in lactating cattle when the milk or milk derived products
are used for
human consumption.
Do not use in dairy cattle within 28 days of calving.
Do not use intramuscularly or intravenously.
PRECAUTIONS
Do not eat, drink or smoke when handling the product.
Temporary discomfort has been observed in animals following
subcutaneous
injection. The pain reaction is sometimes intense, but usually
transient. A low
incidence of soft tissue swelling at the injection site has been
observed. Those
reactions have disappeared without treatment.
MARKETING AUTHORIZATION HOLDER
VMD Animal Health Hungary Ltd. H-1093, Budapest, Közraktár u. 22/B.
MANUFACTURER
Laboratoires Biové, Rue de Lorraine 3, 62510 Arques, France
SHELF LIFE
48 months is recommended.
Following withdrawal of the first dose, use the product within 28
days. Sign on the
label.
STORAGE
Store dry below 25°C and protect from light.
PRESENTATION AND PACKING
Vials of 50 and 100 ml multi-dose vials
LEGAL STATUS
Prescription Only Medicine (POM)
VMD - Hoge Mauw 900 - 2370 Arnedonk - Belgium

Summary of Product characteristics

IVERVETo-1
INJECTABLE SOLUTION
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
IVERVETo-1
ATC VET Code QP54AA01 ivermectin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
IVERVETo-1 is a broad spectrum anthelmintic that is effective against
immature and adult stages of the
most common GI nematodes and lungworms of cattle and sheep and as well
of pigs. It is indicated for the
treatment of mange mites and lice infestations.
IVERVETo-1 contains the following ingredients:
NAME OF INGREDIENTS
QQUANTITIES
QQUALITY
FUNCTION
Ivermectin
1.00 g
Eur. Ph. 4th ed./2002
Active ingredient
Glycerol formal
40.00 ml
VMDAH-QS-21-0896
Excipient
Propylene glycol
ad to 100.00 ml
VMDAH-QS-10-0896
Excipient
_Eur. Ph.=European Pharmacopeia 4th edition revised in 2002 _
_VMDAH= VMD Animal Health Quality Standard_
Active ingredient:
IVERVETo-1 contains the active ingredient of ivermectin.
ACTIVE INGREDIENT PER ML SOLUTION:
10 mg ivermectin
EXCIPIENTS:
0.40 ml Glycerol formal
1.00 ml Propylene glycol
3. PHARMACEUTICAL FORM
Injectable solution.
4. PHARMACEUTICAL PROPERTIES
IVERVETo-1 contains the active ingredient ivermectin.
Ivermectin is a derivative of broad-spectrum antiparasitic agents
called avermectins, derived from the
fermentation of the soil organism _Streptomyces avermitilis._ It
controls a broad spectrum of both internal
and external parasites in cattle, sheep, goat, swine and camel.
Ivermectin acts on nematodes by stimulating the release of inhibitory
neurotrasmitter gamma-
aminobutyric acid (GABA) from presynaptic nerve terminals and
reinforcing its binding to the special
receptors of the nerve junction. In consequence of that the nematodes
become immobilized and die.
In arthropods ivermectin inhibits signal transmission at the
neuromuscular junctions via the same
mechanism. Amplification of GABA action results in paralysis of
arthropods.
Pharmacokinetics of ivermection in the target species can be
characterized with slow absorption, fast
distribution and prolonged elimination phases. In the recommended dose
ivermectin can't cross the