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Bimectin Plus Injection Value Pack
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Bimectin Plus Injection Value Pack


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Bimectin Plus Injection 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. The Bimectin Plus Injection value pack includes 2 X 500ml bottle 1 X 250ml bottle and a 10ml automatic syringe.

Active Ingredient: Ivermectin, Clorsulan

Target Species: Cattle

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

Administration Method: Subcutaneous injection (under the skin)

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

Body WeightDose VolumeNumber of full doses per pack:
250ml500mlValue Pack 1250ml
50kg1 ml2505001250
100kg2 ml125250625
150kg3 ml83166416
200kg4 ml62125312
250kg5 ml50100250
300kg6 ml4183208
350kg7 ml3571178
400kg8 ml3162156
450kg9 ml2755138
500kg10 ml2550125
550kg11 ml2245113
600kg12 ml2041104

Always read the label and all enclosed information for Bimectin Plus Injection before administering to animals!

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

 

Summary of Product Characteristics


1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bimectin Plus 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.
Health Products Regulatory Authority
Date Printed 18/09/2015 CRN 7021973 page number: 1

 

4.2 Indications for use, specifying the target species
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
EyeWorms (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 viviparus 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.
Do not use in animals with known hypersensitivity to the active substance or to any of the excipients.
Health Products Regulatory Authority
Date Printed 18/09/2015 CRN 7021973 page number: 2

 

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 body weight, 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.

 

4.5 Special precautions for use
Special precautions for use in animals
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.
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.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the
physician.

 

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.
Health Products Regulatory Authority
Date Printed 18/09/2015 CRN 7021973 page number: 3

 

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
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.
The product should be given only by subcutaneous injection 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) 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 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 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.
Health Products Regulatory Authority
Date Printed 18/09/2015 CRN 7021973 page number: 4

 

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 7
at 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
Ethanolamine
Health Products Regulatory Authority
Date Printed 18/09/2015 CRN 7021973 page number: 5

 

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 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
Cross Vetpharm Group Ltd.
Broomhill Road
Tallaght
Dublin 24


8 MARKETING AUTHORISATION NUMBER(S)
VPA 10960/070/001


9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16th July 2010
Date of last renewal: 15th July 2015


10 DATE OF REVISION OF THE TEXT
Health Products Regulatory Authority
Date Printed 18/09/2015 CRN 7021973 page number: 6

At Agridirect we have joined forces with Fastway & DPD, to ensure your products are delivered to your door within 2-4 working days from time of order.

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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.
 

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

The cost of the return, including all packaging and freight, lies solely with the consumer.
 

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.

 

Packaging

All returns must be the complete product which includes boxes, manuals and accessories that may have been include 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.
 

Address: Please ship the product to the following address: Agridirect, Drumrahan Retail, Church Street, Ballyconnell, Co Cavan
 

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.

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