Fortemec 1 % w/v Pour On Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Abamectin

Available from:

Ancare Ireland Ltd.

ATC code:

QP54AA02

INN (International Name):

Abamectin

Dosage:

1 percent weight/volume

Pharmaceutical form:

Pour-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

abamectin

Authorization status:

Authorised

Authorization date:

2001-01-26

Summary of Product characteristics

Health Products Regulatory Authority
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fortemec 1 % w/v Pour On Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
QUANTITY:
Abamectin
1% w/v
EXCIPIENTS:
Benzyl alcohol
25% w/v
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pour-on solution.
4
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (Beef and non-lactating dairy cattle).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
A broad-spectrum endectocide of the avermectin family, effective
against internal and external parasites sensitive to this family.
For the treatment and control of the following mature and immature
roundworms and lungworms in cattle:
_Haemonchus _spp.,
_Ostertagia _spp.,
_Cooperia _spp.,
_Trichostrongylus _spp.,
_Oesophagostomum _spp.,
_Nematodirus _spp.,
_Trichuris _spp. (adults only),
_Dictyocaulus _spp.
Also for the treatment and control of sucking and biting lice
(_Linognathus vituli _and _Damalinia bovis _respectively).
4.3 CONTRAINDICATIONS
Do not concurrently treat animals with drugs which can increase GABA
activity such as barbital.
Do not treat animals with a known hypersensitivity to the active
ingredient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
Assess body weight as accurately as possible before calculating
dosage. Intensive use or misuse of anthelmintics may give rise
to drug resistance. To reduce this risk, dosing programs should be
discussed with your veterinary surgeon.
Health Products Regulatory Authority
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS:
Avoid contact with the skin.
Do not smoke or eat while handling the product.
The use of plastic gloves is advised.
Wash hands after use.
Do not use in other species.
If the drug is taken by mistake immediately seek medical treatment.
Emetine or ephedrine may be useful.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)