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

Active Ingredient: Ivermectin, Clorsulan

Target Species: Cattle

Administration Method: Subcutaneous injection (under the skin)

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.

Dosage: 1 ml per 50 kg of bodyweight

Always read the label and all enclosed information for Topimec Super before administering to animals!

Key Features of Topimec Super

• A  broad spectrum anti parasitic for cattle.
• Helps treat and control of gastro-intestinal roundworms, lungworms, adult liver fluke, eyeworms, warbles, mites      and lice
• Can be used in beef and non lactating dairy cattle. 
• Withdrawal period of 66 days for animals intended for meat and offal

Identifying infected cattle:

It can sometimes be hard to see the signs of  fluke in infected cattle and a slight decline in the performance of the herd can be hard to associate to a single factor. Yet liver fluke affects at least 50% of all Irish herds. The following list will show some of the common signs that your herd has been infected by liver fluke.

In Young Stock

• Weakened calves
• Reduced weight at the time of weaning caused by both the poor quality and quantity of the milk being produced
• Poor feed conversion
• On occasion, anaemia, loss of weight and even death in animals younger than 2 years old.

In Breeding Stock

• Weakened or incapacitated cows, especially in later stages of pregnancy.
• Lower fertility rates which leads to an increase in culls
• Sale weight of cull cows reduced
• Production of milk is greatly reduced
• Reduction in the nutritional value of the milk
• Lower conception rates
• Slower growth in heifers
• Delay in the onset of first oestrus in the herd
• Poor reproductive performance from bulls

​Datasheet

​This product is only licensed for sale within the Republic of Ireland

Click here to Download Data Sheet

Health Products Regulatory Authority 

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Topimec Super Solution for Injection

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance(s):

Ivermectin 10 mg
Clorsulon 100 mg

Excipients:

For the 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.

4.2 Indications for use, specifying the target species In beef and non-lactating dairy cattle:

For the treatment of mixed infestations of the following parasite species:

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 up to 14 days after treatment,
Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 days after treatment and
Dictyocalus vivparus acquired up to 28 days after treatment.

4.3 Contraindications

Do not use 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 (especially Collies, Old English Sheepdogs and related breeds and crosses). 
Do not use in animals with known hypersensitivity to the active substance or to any of the excipients.

 4.4 Special warnings for each target species

Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:
 Too frequent and repeated use of anthelmintics from the same class, over an extended period of time
 Underdosing, which may be due to underestimation of bodyweight, misadministration of the product, or lack of calibration of the dosing device (if any).

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). 
Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.
Resistance to Ivermectin has been reported in Ostertagia ostertagi and Cooperia species in cattle within the EU. 

Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of these helminth species and recommendations on how to limit further selection for resistance to anthelmintics.

4.5 Special precautions for use

Special precautions for use in animals

None

This product does not contain any antimicrobial preservative. 
Swab septum before removing each dose
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.
Direct contact with the skin should be avoided.  T
ake care to avoid self-administration; the product may cause local irritation and/or pain at the site of injection.
In case of accidental self injection, seek medical advice and show the label to the physician. 
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.

Other precautions

The product is very toxic to aquatic organisms and dung insects.
Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment.
Long term effects on dung insects caused by continuous or repeated use cannot be excluded.
Therefore repeated treatment of animals on a pasture with an ivermectin-containing product within a season should only be given in the absence of alternative treatments or approaches to maintain animal/flock health, as advised by a veterinarian

4.6 Adverse reactions (frequency and seriousness)

The frequency of adverse reactions is defined using the following convention:
- Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment).
- Common (more than 1 but less than 10 animals in 100 animals).
- Uncommon (more than 1 but less than 10 animals in 1,000 animals).
- Rare (more than 1 but less than 10 animals in 10,000 animals).
- Very rare (less than 1 animal in 10,000 animals, including isolated reports).

In very rare cases transitory discomfort has been observed in some cattle following subcutaneous administration. In very rare cases 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 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.

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

Dosage and duration of treatment

The product should be given at the recommended dosage level of 1 ml/50 kg bodyweight (based on a dosage level of 200 mcg ivermectin plus 2 mg clorsulon per kg bodyweight).

Method of administration

The product should be administered only be subcutaneous injection 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 using the 500 ml pack size use only automatic syringe equipment.   
For the 50 ml pack size, use of a multidose syringe 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.
The timing of treatment should be based on epidemiological factors and should be customised for each individual farm.

A dosing program should be established by a qualified professional person.
To ensure a correct dosage, body weight should be determined as accurately as possible;
accuracy of the dosing device should be checked.
If animals are to be treated collectively rather than individually, to avoid under- or over-dosing, they should be grouped according to their bodyweight and dosed accordingly.

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

The administration of 5 ml per 50 kg 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 

Not authorised for use in animals producing milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

ATC Vet Code: QP54AA51

Pharmacotherapeutic Group:
Endectocides,
macrocyclic lactones,
avermectins,
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 gamma-aminobutyric 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 a sulfonamide. Clorsulonis 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 particulars

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.
The terminal half life for the two active ingredients were determined as follows: Ivermectin approximately 3.79 days and Clorsulon approximately 3.58 days.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glycerol Formal
Propylene                                                                                                                                                               Glycol Disodium                                                                                                                                                                  EDTA N-propyl                                                                                                                                                                  Gallate Thipdipropionic                                                                                                                                                          Acid Monoethanolamine (for pH adjustment)

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.

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 derived from the use of such products

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE

Do not contaminate surface water or ditches with product or used container.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Limited
Loughrea
Co. Galway
Ireland

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10987/099/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 21st December 2010
Renewal of the last authorisation: 20th December 2015

10 DATE OF REVISION OF THE TEXT

July 2018

 Cattle Injectables
Injectables should be given according to the manufacturer’s instructions at the recommended injection site.
• Always use a clean, sterile syringe and needle. If using a multiple injection gun, ensure the needle is disinfected between injections, e.g. with an automatic sterilisation system.
• If the site to be injected is dirty, clean the skin and swab with an alcohol-impregnated wipe or cotton wool.
• Before injecting, check the expiry date and read the instructions of the product to be used. Some products need to be shaken before use.
• Use the correct-sized needle according to the size of the animal and site of injection.
• Ensure the animal is adequately restrained before attempting the injection.
• Take care to ensure it is given subcutaneously and not intramuscularly. Raise a fold of skin at the injection site (mainly neck but some are ear) recommended by the product manufacturer and inject carefully into the space created.
• If a large dose is to be delivered, it may be advisable to split the dose between two injection sites. After the injection, briefly massage the site to improve the dispersal of the injected material.
• Dispose of the needle and syringe in appropriate clinical waste and sharps containers.

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).

Delivery Information

Delivery Service

Here at Agridirect we have joined forces with DPD to ensure all packages are delivered promptly and safely to you. We ship to all mainland countries within the EU. Deliveries take place Monday to Friday excluding bank holidays. Once your order has been dispatched from our warehouse you will be notified by email. If there is a delay with your order for any reason you will be contacted immediately. 

Due to Brexit we are temporarily unable to ship to the UK. Shipping to Northern Ireland will remain in place.

Delivery Times

Some products have an extended delivery time, this is noted on the products.

Delivery Rates

A selection of the products we sell are only licensed for sale within the Republic Of Ireland and can not be shipped outside of the country. These products are noted as only being available within the Republic of Ireland on the individual product pages.

There may be an addition charge on certain bulky items. This charge will be clearly marked on an applicable products and will be explained on the checkout page before payment has been made.

Agridirect 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 loss of value of 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 which occur 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 here.

2) To print off your return label click here 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 here.

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.