ANIMAL USE ONLY

IMIDOX^® INJECTION

Reg.No. G3257 Act 36/1947

INDICATIONS

lmidox^® cures redwater (Babesiosis) and tick-borne gallsickness (Anaplasmosis) in cattle. It can be used in cattle for the prevention of Asiatic redwater for up to 4 weeks and Afr ican redwater for up to 8 weeks.  lmidox^® is also indicated for the treatment of equine and canine Babesiosis. 

CAUTION

COMPOSITION

Each 1 mℓ contains 120 mg Imidocarb dipropionate equivalent  to Imidocarb 85 mg per mℓ.

STORAGE  INSTRUCTIONS

Can be stored at temperatures higher than 8 °C but below 25 °C.   Do not freeze. Protect from light. Use the contents of  the vial within 28 days of initial broaching and discard any unused portion.

WARNINGS

Do not slaughter for human consumption within 213 days of last treatment (As per instruction from The Registrar, Act 36/1947).

Do not use in lactating cows where milk or milk products may be used for human consumption. Keep out of reach of children, uninformed persons and animals.

Do not exceed recommended dosage.

Do not use the product after expiry date as it may be ineffective or harmful to the animal.

A swelling may occur at the injection site in some animals which would disappear without forming abscesses.

Salivation may be seen after treatment. Protect from light.

Treatment of over dosage is symptomatic and supportive.

If poisoning occurs, contact a doctor or healthcare professional.

Although this product has been tested extensively under a large variety of conditions failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS

Avoid  intravenous administration.

The injection site should be swabbed clean with antiseptic prior to dosing. Dispose of empty containers by wrapping with paper and putting in garbage.

Discarded needles should immediately be placed in a designated and appropriately labelled sharps container.

DOSAGE

CATTLE

Therapy of Babesiosis: 1 mℓ per 100 kg bodyweight by subcutaneous or intramuscular injection. Very severe cases may require a second dose 24 hours following the first injection.

Chemoprophylaxis of bovine Babesiosis: 2,5 mℓ per 100 kg body mass. The prophylactic period for Babesiabovisis up to 4 weeks and for Babesiabigeminaup to 8 weeks.  In the field it is possible under certain circumstances e.g. high challenge, that outbreaks of B. bovis could occur as early as 18 days after prophylactic administration of lmidox^®.  Immunity develops if treated animals are subjected to challenge during the prophylactic period. Do not repeat the dose within 4 weeks.

Therapy of Anaplasmosis: 2,5 mℓ per 100 kg body mass by subcutaneous or intramuscular injection.

HORSES

Equine Babesiosis: B. caballi: 2 mℓ per 100 kg body mass by intramuscular injection. B. equi:2 mℓ per 100 kg body mass by intramuscular injection. Two treatments at 24 hours may be required.

DOGS

Canine Babesiosis: 0,5 mℓ per 10 kg body mass by subcutaneous injection.

DIRECTIONSFORUSE:Useonlyasdirected

Sterilise all injection apparatus by boiling (or equivalent) before use. Avoid use of strong disinfectants on apparatus.

Maintain cleanliness at all times.

Keep needles sharp and clean. Replace frequently.

Use shortest needle possible, certainly not exceeding 15 mm.

As far as possible avoid injection of animals during wet weather or under dusty conditions.

This product should be injected only under the skin, preferably high on the neck behind the ear.

PHARMACOLOGICAL ACTION

lmidocarb dipropionate is a derivative of the carbanilide antiprotozoals. Although the exact mode of action of the drug is not known, a possible mechanism is interference with cellular repair and replication through binding with DNA.   lmidocarb is highly effective against infections caused by Babesia and Anaplasma spp.

Babesiosis, also known as tick fever or redwater, is caused by tick-borne protozoal parasites of the genus Babesia. Babesiosis is characterised by fever, anaemia, icterus and haemoglobinuria. It is a widespread disease most common in tropical regions where the cattle tick Rhipicephalus(Boophilus) decoloratus and Rhipicepha/us (Boophilus) microplus is abundant. The most significant parasites causing Babesiosis in cattle are Babesia bovis and Babesia bigemina.

In endemic areas infection with Babesia is acquired by calves at a young age but infection does not manifest as clinical disease due to natural resistance. Animals infected early act as carriers of infection, remaining immune to clinical disease as long as infection persists.   Re-infection constantly occurs in endemic areas. Without re-infection, immunity is lost within several  months and clinical disease results.

Clinical disease most commonly occurs when:

• susceptible cattle are transported from a non-endemic to an endemic region
• contact occurs between infected and non-infected cattle
• epidemics occur following introduction of infection to non-endemic areas or sudden increases in tick populations where environmental conditions are favourable
• the tick vector population drops due to altered weather patterns or tick control measures reducing re-infection rate and therefore immunity

Treatment of clinical cases of Babesiosis with lmidox^® is most effective when cattle are treated early in the course of the disease and in combination with supportive therapy such as provision of shade.

Where disease is severe, repeat treatment with lmidox^® may be required after 24 hours.

Sterilization of infection with lmidox^® results in complete elimination of Babesial parasites from carrier animals. Elimination of carriers is necessary where movement of cattle from an endemic to a non-endemic area would otherwise result in infection of susceptible cattle.

Prevention of Babesia infection may be achieved by treatment of susceptible animals with lmidox^® prior to introduction into an endemic area.  Over time the level of imidocarb in the animal's body diminishes, allowing a small number of parasites to establish infection while the animal is still protected by the drug.  The result is the development of immunity to disease without the occurrence of clinical signs. However if there is no exposure to infection during the period of weaning imidocarb levels, the animal will become susceptible to clinical disease. One dose of lmidox^® will provide protection from infection for up to 4 weeks.  lmidox^® is useful for the protection against Babesiosis where a short passage through an endemic area is planned for a herd of susceptible cattle.  Outbreaks of Babesiosis may be controlled by administration of preventative doses of lmidox^® to all animals exposed to infection, however vaccination will still be necessary at a later time.

Anaplasmosis is a tick-borne disease caused by the rickettsial organism Anaplasma marginalewhich parasitisises red blood cells. The course of the disease may be prolonged over months. The severity of disease resulting from infection tends to increase with age, reaching up to 50 % mortality in susceptible adult cattle.

The clinical signs of Anaplasmosis relate to the acute anaemia that results and include fever, jaundice and emaciation. Decreased milk production and abortion are common. The clinical signs of Anaplasmosis and Babesiosis are very similar, however the dose rate for their treatment differs. It is therefore important to prepare blood smears from suspect cases for laboratory examination in order to distinguish between them.

lmidox^® is an effective treatment for Anaplasmosis at the recommended dose rate. Supportive therapy should be instituted including provision of shade and plenty of feed and water. In severe cases blood transfusion may be required. Recovered animals should be monitored for approximately 4 weeks following treatment, as re- treatment may be necessary if relapse occurs.

To reduce risk of transmission of the disease the herd should be dipped several times for tick control.

PRESENTATION

lmidox^® Injection is available in 100 mℓ amber polyethylene multidose vials in cartons.

REGISTRATION  HOLDER:

Ceva Animal Health (Pty) Ltd Reg. No. 1973/016009/07

P O Box 7707

Halfway House 1685

011 312 4088