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Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Animec Super Solution for Injection.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
:
Active substance(s):
Ivermectin 10 mg
Clorsulon 100 mg

Excipients:
For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless to pale yellow coloured non-aqueous solution.

4 CLINICAL PARTICULARS

4.1 Target Species
Cattle.

For the treatment and control of the following parasites:

Gastrointestinal Roundworms (adult and fourth-stage larvae):
Ostertagia spp. (including inhibited O. ostertagi)
Haemonchus placei
Trichostrongylus axei
Trichostrongylus colubriformis
Cooperia spp.
Bunostomum phlebotomum
Oesophagostomum radiatum
Strongyloides papillosus (adult only)
Nematodirus helvetianus (adult only)
Nematodirus spathiger (adult only)
Toxocara vitulorum
Trichuris spp. (adult only)

Lungworm (adult and fourth-stage larvae):
Dictyocaulus viviparus

Liver Fluke (adult):
Fasciola hepatica

Eye Worms (adult):
Thelazia spp.

Warbles (parasitic stages):
Hypoderma bovis
H. lineatum

Mange mites:
Psoroptes bovis
Sarcoptes scabiei var. bovis

Sucking Lice:
Linognathus vituli
Haematopinus eursternus
Solenopotes capillatus `

The veterinary medicinal product may also be used as an aid in the control of biting lice (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 at the recommended dose rate can control re-infection with Haemonchus placei and Cooperia spp., acquired upto 14 days after treatment, Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 days after treatment and Dictyocalus viviparus acquired up to 28 days after treatment.

4.3 Contraindications
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.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
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.


Special precautions to be taken by the person administering the medicinal product to animals

Do not eat, drink or smoke while handling the product.
Wash hands after use.
Take care to avoid self-administration; the product may cause local irritation and/or pain at the site of 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.

4.6 Adverse reactions (frequency and seriousness)

Transitory discomfort has been observed in some cattle following subcutaneous administration.
Soft tissue swellings may occur at the site of injection.
These reactions resolve over time without treatment.

4.7 Use during pregnancy, lactation or lay

The product is safe for use at any stage of pregnancy or lactation.
However, the product is not permitted for use in animals producing milk for human consumption, including pregnant animals intended to produce milk 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.

4.8 Interaction with other medicinal products and other forms of interaction

No interactions have been identified with other products.

4.9 Amounts to be administered and administration route

The product should be given only by subcutaneous injection at the recommended dosage level of 1ml/50 kg
bodyweight (based on a dosage level of 200 mcg ivermectin plus 2 mg clorsulon per kg bodyweight) under the loose
skin in front of, or behind, the shoulder.
Divide doses greater than 10 ml between two injection sites.
A sterile 17 gauge ½-inch (15-20 mm) needle is recommended.
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 products.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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.

4.11 Withdrawal Period(s)

Meat and offal: 66 days after the last treatment.
Not permitted for use in animals producing milk for human consumption, including pregnant animals intended to
produce milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

ATC Vet Code:
QP54AA51

Pharmacotherapeutic Group:
Endectocides, ivermectin combinations.

5.1 Pharmacodynamic properties

Ivermectin
Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action.
Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gammaaminobutyric acid (GABA)

The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated
chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand gated chloride channels
and they do not readily cross the blood-brain barrier.

Clorsulon
Clorsulon is rapidly absorbed into the circulating blood. Erythrocytes with bound drug as well as plasma are ingested
by Fasciola spp. Adult Fasciola spp. are killed by clorsulon because of inhibition of enzymes in the glycolytic
pathway, which is their primary source of energy.

5.2 Pharmacokinetic properties

Maximum plasma concentration

After subcutaneous administration of 2 mg clorsulon and 0.2 mg ivermectin per kg bodyweight, maximum plasma
concentrations of ivermectin (Cmax: 65.80 ng/ml) were achieved 1-2 days after treatment and maximum plasma
concentrations of clorsulon (Cmax: 2.58 μg/ml) were achieved approximately 8 hours after treatment

Excretion: length of time and route

A dose rate of 2 mg clorsulon and 0.2 mg ivermectin per kg bodyweight was administered by subcutaneous injection.
For ivermectin, liver had the highest average residues, peaking on day 7 post dose at an average of 220 ppb.

Depletion
followed so that by days 28 and 35 the liver residues were 11 and 6 ppb respectively.
Fat residues also peaked on day 7at an average of 160 ppb.
They decreased to 6 and 4 ppb by days 28 and 35 respectively. Muscle and kidney residues were negligible at 1 and 2 ppb respectively by day 28.
For clorsulon, kidney had the highest average residues of 0.54 ppm (540ppb) on day 3 post dose.
At the same time, liver averaged 0.20 ppm, muscle averaged 0.06 ppm and fat averaged 0.02 ppm.
Rapid depletion followed, resulting in average residues at or below the detection limit of 0.01 ppm by day 21 for all tissues.

In cattle receiving a single dose of tritium-labelled ivermectin (0.2-0.3 mg/kg bodyweight), analyses showed that
composites of faeces collected during the first 7 days after dosing contained almost all the dosed radioactivity, only
about 1-2% being excreted in the urine.
Analyses of the faeces showed that about 40-50% of the excreted radioactivity was present as unaltered drug. The remaining 50-60% was present as metabolites or degradation products.
During the first 7 days following intra-ruminal administration of 7 mg/kg clorsulon to a 270 kg steer, about 90% of the
radiolabel in the administered dose was found in the urine (25%) and the faeces (65%).

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Glycerol Formal
Propylene Glycol

6.2 Incompatibilities
None known.

6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening the immediate packaging: 28 days

6.4 Special precautions for storage
Keep the container in the outer carton in order to protect from light.

6.5 Nature and composition of immediate packaging
Container material: High density polyethylene
Container closure: Siliconised grey bromobutyl rubber stopper
Container volume: 50, 250 or 500 ml
Not all pack sizes may be marketed

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE.
Do not contaminate surface waters or ditches with product or used container. Any unused product or waste material
should be disposed of in accordance with national requirements.

7 MARKETING AUTHORISATION HOLDER
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea,
Co. Galway,
Ireland.


8 MARKETING AUTHORISATION NUMBER(S)
VPA 10987/068/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25th June 2010

10 DATE OF REVISION OF THE TEXT
 

Ivermectin is a semi-synthetic antiparasitic medication derived from avermectins, a class of highly active broad-spectrum antiparasitic agents isolated from the fermentation products of Streptomyces avermitilis. 
Ivermectin itself is a mixture of two avermectins, comprising roughly 90% 5-O-demethyl-22,23-dihydroavermectin A1a (22,23-dihydroavermectin B1a) and 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro­-25-(1-methylethyl) avermectin A1a (22,23-dihydroavermectin B1b).

Animec Super Injection (Ivermectin, Clorsulan)

Animec Super Injection is a broad spectrum anti parasitic for cattle. It is used for the treatment and control of gastro-intestinal nematodes, lungworms, adult liver fluke, eyeworms, warbles, mites and lice in beef and non lactating dairy cattle.

​Active Ingredient: Ivermectin, Clorsulan

Target Species: Cattle

Treats and Controls: Gastro-intestinal roundworms, lungworms, adult liver fluke, eyeworms, warbles, mites and lice

Withdrawal Time: 66 days for animals intended for meat and offal. Not permitted for use on animals producing milk for human consumption.

Legal Status: POM

Returns Policy

We’re sorry your purchase didn’t work out. But don’t worry; we have a great returns policy to help you out.

All purchases can be returned to us within 14 days of delivery, and returned goods must be received within 14 days from the date you informed us of the return.

Purchases may be opened for inspection but must not be used and must be repackaged securely in the original packaging if you wish to return it.

If we discover goods have been used or there has been a loss in value of the goods due to damage to the goods while in your care or whilst being returned to us, we will reduce the amount refunded, which may amount to the full cost of the product, to cover the loss of value of the goods.

All returns should be complete, which includes boxes, manuals, and accessories that may have been included with the order.

All returns must be packaged appropriately for shipping; we will not accept responsibility for damages or loss that occurs during shipping of a return product.

We accept no responsibility for goods damaged or lost while in transit to us. 

How do I return a product?

We have partnered with DPD to make your returns process easy and secure. Simply follow the steps below and bring your package to an official DPD pickup point.

1) All returns must be accompanied with a fully filled out returns form which can be downloaded returns form PDF.

2) To print off your return label click DPD Returns page or visit www.dpd.ie/returns and follow the on-screen instructions. Make sure and use your order number as your reference.

• Select “Continue as Guest”
• Select “Agridirect” from the drop-down menu
• Select your reason for returning
• Select the size of the package you wish to return
• Accept DPD’s terms and conditions
• Fill in your payment details
• Fill in your own details
• Follow the instructions to print off your label

3) Bring your package to a DPD pickup point. To find your nearest drop off point DPD pickup shops.

Once the returned product has been received into our warehouse and been fully inspected a refund will be issued.

If you choose not to use the DPD returns service we recommend that you use a method that can be tracked.

For the return of bulk products please contact us at sales@agridirect.ie

I have received a damaged product from you, what should I do?

First off, if you have received a damaged electrical product from us, do not plug it in. Any electrical products that are plugged in are deemed ‘as used and accepted’ and are not accepted as returns. All damages must be reported to us via phone or email within 24hours of receipt of goods. Please ensure you check your items upon delivery.

How do I begin the returns process?

If you wish to begin the return process, please email us at sales@agridirect.ie and ensure the following information is included in your email. Your name, phone number, Order id, the item you wish to return, reason for return and if the product is damaged we require photos of the product.

Once you have sent us all required information a member of our team will assess your claim and will contact you as soon as possible. Please hold off on returning products until a member of our team has called you to confirm.

Refunds

Once the returned product has been returned to us and fully inspected a refund will be issued.

Please Note: A typical timeline for a refund to show in your account is up to 10 working days from the date processed, depending on your bank.