Intermectin solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ivermectin

Available from:

Interchemie werken "De Adelaar" Eesti AS

ATC code:

QP54AA01 անասնաբուժական դեղի առաջին դեղաձև, դեղաչափ և թողարկման ձև

INN (International Name):

ivermectin

Dosage:

10mg/ml glass bottle 50ml, glass bottle 100ml

Pharmaceutical form:

solution for injection

Units in package:

10mg/ml glass bottle 50ml, glass bottle 100ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-12-30

Patient Information leaflet

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION
HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT:
Marketing authorisation holder:
Manufacturer and batch releaser:
Interchemie werken “De Adelaar” B.V.
Interchemie werken “De Adelaar” Eesti AS
Metaalweg 8
Vanapere tee 14
5804 CG Venray
Viimsi, Harju county
The Netherlands
Estonia
NAME PRODUCT: Intermectin.
PHARMACEUTICAL FORM: Solution for parenteral administration.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S):
Each ml contains:
- ACTIVE SUBSTANCE:
ivermectin
10.0 mg.
INDICATIONS:
Ivermectin belongs to the group of avermectins and acts against
roundworms and parasites.
Intermectin solution for parenteral administration is indicated for
treatment of gastrointestinal roundworm
and lungworm infections, lice, oestriasis and scabies in calves,
cattle, goats, sheep and swine.
CONTRA-INDICATIONS:
Administration to animals producing milk for human consumption,
including pregnant animals intended to
produce milk for human consumption.
TARGET SPECIES:
Calves, cattle, goats, sheep and swine.
ADVERSE REACTIONS:
When ivermectin comes in contact with soil, it readily and tightly
binds to the soil and becomes inactive over
time. Free ivermectin may adversely affect fish and some water born
organisms on which they feed.
PRECAUTIONS:
Do not permit water runoff from feedlots to enter lakes, streams or
ponds.
Do not contaminate water by direct application or the improper
disposal of drug containers.
Dispose of containers in an approved landfill or by incineration.
DOSAGE AND ADMINISTRATION:
For subcutaneous administration.
Calves, cattle, goats and sheep : 1 ml per 50 kg body weight.
Swine
: 1 ml per 33 kg body weight.
WITHDRAWAL TIMES:
- For meat
Calves, cattle, goats and sheep
: 28 days.
Swine
: 21 days.
PACKAGING:
Type II colourless glass bottles of 50 and 100 ml, closed with type I
butylsepta and sealed with aluminium
caps, contained in a cardboard box.
SHELF LIFE AND STORAGE INSTRUCTIONS:
Intermectin has a 3-

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME:
INTERMECTIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
CONTENT
SPECIFICATION
Ivermectin
10.0 mg/ml
Ph. Eur
OTHER INGREDIENTS
CONTENT
SPECIFICATION
Glycerol formal
0.5 ml/ml
Ph. Eur
Propylene glycol
ad 1 ml
Ph. Eur.
3.
PHARMACEUTICAL FORM
Solution for subcutaneous administration.
4.
PHARMACOLOGICAL PROPERTIES
Ivermectin belongs to the group of avermectins and acts against
roundworms and parasites.
5.
CLINICAL PARTICULARS
5.0
Target species:
Calves, cattle, goats, sheep and swine.
5.1
Indications:
Treatment of gastrointestinal roundworm and lungworm infections, lice,
oestriasis and
scabies.
5.2
Contra-indications:
Administration to lactating animals.
5.3
Undesirable effects:
Environmental studies indicate that when ivermectin comes in contact
with the soil, it readily
and tightly binds to the soil and becomes inactive over time.
Free ivermectin may adversely affect fish and some water borne
organisms on which they
feed.
5.4
Special precautions for use:
Do not permit water runoff from feedlots to enter lakes, streams or
ponds.
Do not contaminate water by direct application or the improper
disposal of drug containers.
Dispose of containers in an approved landfill or by incineration.
5.5
Use during pregnancy and lactation:
Do not use in lactating animals producing milk for human consumption.
5.6
Interactions:
No significant interactions are known in open literature.
It is however not advisable to mix INTERMECTIN with other preparations
before injection.
5.7
Dosage recommendations and method(s) of administration:
For subcutaneous administration.
Calves, cattle, goats and sheep : 1.0 ml. per 50 kg body weight.
Swine
: 1.0 ml. per 33 kg body weight.
5.8
Overdose:
Overdoses can result in depression, ataxia, diarrhoea, difficulty in
breathing, tachycardia
and miosis
5.9
Special warnings:
None.
5.10 Withdrawal times:
- For meat
Calves, cattle, goats and sheep : 28 days.
Swine
: 21 days.
5.11 Special precautions to be taken by the person administering the
product