ANIMEC SUPER SOLUTION FOR INJECTION Presentation Animec

ANIMEC SUPER SOLUTION FOR INJECTION
Presentation
Animec Super Solution for Injection contains Ivermectin 10mg/ml and Clorsulon 100mg/ml.
Uses
The veterinary medicinal product is an injectable parasiticide.
The veterinary medicinal product contains ivermectin and the flukicide, clorsulon.
Animec Super is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, liver fluke, eyeworms, warbles, mites and lice.
PARASITE
Gastrointestinal Roundworms:
Ostertagia lyrata
Ostertagia ostertagi
Cooperia oncophora
Cooperia pectinata
Cooperia punctata
Haemonchus placei
Trichostrongylus axei
Trichostrongylus colubriformis
Bunostomum phlebotomum
Oesophagostomum radiatum
Strongyloides papillosus
Nematodirus helvetianus
Nematodirus spathiger
Toxocara vitulorum
Trichuris spp.
Lungworm:
Dictyocaulus viviparus
Liver Fluke
Fasciola hepatica
Eye Worms
Thelazia spp.
Warbles
Hypoderma bovis
H. lineatum
Mange mites
Psoroptes bovis
Sarcoptes scabiei var. bovis
Sucking Lice
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Adult
L4
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Inhibited L4
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Adult
Immatures
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The veterinary medicinal product may also be used as an aid in the control of biting louse Damalinia bovis
and the mange mite Chorioptes bovis, but complete elimination may not occur.
PERSISTENT ACTIVITY
When cattle have to graze on pasture contaminated with infective larvae of cattle nematodes, treatment with
the product given at the recommended dosage of 1 ml per 50 kg bodyweight, controls re-infection with the
following nematodes up to the duration shown:
PARASITE
Barbers pole worm – Haemonchus placei
Small intestinal worm – Cooperia spp.
Brown Stomach worm – Ostertagia ostertagi
Nodular worm – Oesophagostomum radiatum
Lungworm – Dictyocaulus viviparus
NO. OF DAYS AFTER TREATMENT
14
14
21
21
28
Dosage and administration
The veterinary medicinal product should only be given by subcutaneous injection at the recommended
dosage level of 200 mcg ivermectin and 2 mg clorsulon per kg of bodyweight.
Each ml contains 10 mg of ivermectin and 100 mg of clorsulon, sufficient to treat 50 kg of bodyweight. Use
the following dosage schedule:
Bodyweight
(kg)
Up to 50
51-100
101-150
151-200
201-250
251-300
Dose Volume
(ml)
1
2
3
4
5
6
Bodyweight
(kg)
301-350
351-400
401-450
451-500
501-550
551-600
Dose Volume
(ml)
7
8
9
10
11
12
Administration
The veterinary medicinal product is to be given SUBCUTANEOUSLY ONLY. Inject under the loose skin
behind the shoulder. Use of a 17 gauge ½-inch (15-20 mm) needle is suggested. Injection of animals with
wet or dirty hides is not recommended. If using a hypodermic syringe, use a draw-off needle to withdraw the
product from the pack. When the temperature of the product is below 5ºC, difficulty in administration may be
encountered due to increased viscosity. Warming the product and injection equipment to about 15ºC will
greatly increase the ease with which the product can be injected. Different injection sites should be used for
other parenteral (injectable) products.
This product is not for intravenous or intra-muscular use.
Advice on correct administration
Instructions for use with automatic injection equipment
• Disinfect all needles and syringes before using by boiling in clean water for 15-20 minutes.
• Boiled needles should be stored in an antiseptic solution before use and changed frequently when injecting
cattle.
• The use of a sterile draw-off assembly is recommended with the product. Handle carefully to avoid
contamination.
• Connect the plastic tube firmly to the dosing syringe. Use a stepped adaptor if needed.
• Remove cap from bottle and disinfect rubber stopper with alcohol or other suitable chemical disinfectant.
Hold bottle upright and fully insert draw-off needle into centre of rubber stopper. Secure firmly with screw-on
cap attached to tube.
• Hang bottle comfortably in inverted position from neck, shoulder or belt.
• Gently prime injector. Equipment is now ready for use.
• After use, remove draw off assembly and flush out entire apparatus with clean water before storing.
• Store partly-used bottle in carton to protect from light. Do not re-use empty bottles.
• If the connecting tube is used a second time, it should also be boiled for 15-20 minutes before use along
with the injecting syringe and needles.
Contra-indications, warnings, etc
This product is not to be used intramuscularly or intravenously. This product is registered for use in cattle
only. Do not use in other species as severe adverse reactions, including fatalities in dogs, may occur.
Do not use in animals with known hypersensitivity to the active ingredient or any of the excipients.
Adverse reactions
Transitory pain has been observed in some cattle following subcutaneous administration. Soft-tissue
swelling may occur at the site of injection. These reactions resolve over time without treatment.
Divide doses greater than 10 ml between two injection sites to reduce occasional discomfort or site reaction.
Special warning(s)
Following withdrawal of the first dose, use the product within 28 days. Discard unused material. The product
does not contain an anti-microbial preservative. Should any apparent growth or discoloration occur, the
product should be discarded.
User safety warnings
Do not eat, drink or smoke while handling the product. Wash hands after use. Take care to avoid selfadministration: the product may cause local irritation and/or pain at the site of the injection. In the event of
accidental skin contact, wash the affected area immediately with soap and water. If accidental eye exposure
occurs flush the eyes immediately with water.
The timing for treatment should be based on epidemiological factors and should be customised for each
individual farm. A dosing programme should be established by the veterinary surgeon.
Veterinary advice should be sought on appropriate dosing programmes and stock management to achieve
adequate parasite control, and to reduce the likelihood of anthelmintic resistance developing.
Veterinary advice should also be sought if the product does not achieve the desired clinical effect, as other
diseases, nutritional disturbances or anthelmintic resistance might be involved. Frequent and repeated use
may lead to the development of resistance. It is important that the correct dose is given in order to minimize
the risk of resistance. To ensure administration of a correct dose, bodyweight should be determined as
accurately as possible. The accuracy of the dosing device should be checked. If animals are to be treated
collectively rather than individually they should be grouped according to their bodyweight and dosed
accordingly, in order to avoid under- or overdosing.
Avermectins may not be well tolerated in non-target species. Cases of intolerance resulting in fatalities have
been reported in dogs, especially Collies, Old English Sheep Dogs and related breeds or crosses, and also
in turtles/tortoises.
Divide doses in excess of 10 ml between different injection sites and use different sites to those used for
other parenteral medications.
Swab septum before removing each dose. Avoid the introduction of contamination during use.
When using the 250 ml and 500 ml pack sizes, use only automatic syringe equipment. For the 50 ml pack
size, the use of a multidose syringe is recommended.
The product can be administered to beef cows at any stage of pregnancy or lactation provided that the milk
is not intended for human consumption. The product will not affect the fertility of cows and bulls and can be
given to all ages of animals including young calves.
No interactions have been identified with other products.
The administration of 5 ml per 50kg bodyweight (5 x the recommended dose rate) resulted in injection site
lesions (including swelling, sensitivity, oedema and inflammation). No other drug-related adverse reactions
are expected. Do not dilute or mix with other compounds.
Special precautions for the disposal of unused product or waste material, if any
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE.
Do not contaminate surface waters or ditches with product or used container. Unused product or waste
material should be disposed of in accordance with current practice for pharmaceutical waste under national
waste disposal regulations.
Withdrawal periods
Meat and offal: 66 days
Not permitted for use in animals producing milk for human consumption, including pregnant animals
intended to produce milk for human consumption.
Pharmaceutical precautions
Protect from light.
For animal treatment only.
Keep out of the reach and sight of children.
Legal Category
Package Quantities
50ml, 250ml and 500ml
VPA
10987/68/1
LM