For the treatment and prevention of bovine babesiosis (redwater) and the treatment of tick borne gallsickness (anaplasmosis), canine and equine babesiosis.

FOR ANIMAL USE ONLY

65 Injection

Reg. No. G1442 (Act 36/1947)

Namibia Reg. No. V03/17.4.2/757 [NS0]

INDICATIONS

Forray^® 65kills redwater (babesiosis) and tick-borne gallsickness (anaplasmosis) organisms in cattle. It also prevents Asiatic redwater for up to 4 weeks and African redwater for up to 8 weeks in cattle. Forray^® 65 is also indicated for treatment of canine and equine babesiosis.

COMPOSITION

Contains: lmidocarb dipropionate 12 % m/v

POISONOUS

STORAGE INSTRUCTIONS

Store between 2 °C and 25 °C.
Protect from light.

WARNINGS

Withdrawal period: Animals should not be slaughtered for human consumption within 213 days of therapy. Do not use milk from treated cows for human consumption for 6 days after treatment.
Not to be used prophylactically in cattle where milk is intended for human consumption.
Forray^® 65 is not recommended for use after expiry date as it may be ineffective and may even be harmful to the animal.
A swelling may occur at the site of injection in some animals. These disappear without forming abscesses. There might be slight salivation after treatment.
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 Forray^® 65.
The dose of 2 mℓ/100 kg (2,4 mg/kg) live weight may not be exceeded in donkeys and mules.
Dispose of any empty containers and injection equipment according to local waste disposal regulations.
KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
Although this remedy has been extensively tested 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.

VACCINE WARNING

After treatment with Forray^® 65 (2,5 mℓ/100 kg live weight) cattle cannot be effectively vaccinated against Asiatic redwater for 8 weeks and against African redwater for 16 weeks.

NOTE TO DOCTOR

This product in animal studies has been shown to be nephrotoxic and this should be borne in mind in the treatment of humans following accidental injection.

PRECAUTIONS

Sterilise all injection apparatus and use a separate clean sharp needle for each animal.
Swab the rubber seal of the bottle with methylated spirits immediately before puncturing with a needle.
The dose must be administered strictly according to body mass and must not be exceeded.
Take care to avoid accidental injection of operators.

KNOWN SYMPTOMS OF OVERDOSAGE

Overdose may cause salivation, restlessness, tachycardia, or muscular tremors. No specific antidote exists. Atropine sulphate has proved of value as well as intravenous administration of calcium borogluconate to cattle. Atropine and 5 % dextrose have proved of value to horses. Antihistamines, corticosteroids, and vitamin B complex may be considered.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Route Cattle: Subcutaneous or intramuscular injection (neck region or area

of least value).

Horses: Intramuscular injection.

Dogs: Subcutaneous injection.

Dosage

Therapy of babesiosis and anaplasmosis: One treatment is normally sufficient.

Bovine babesiosis: 1 mℓ/100 kg (1,2 mg/kg) live weight.

Anaplasmosis: 2,5 mℓ/100 kg (3,0 mg/kg) live weight.

Equine babesiosis:

B. caballi: 2 mℓ/100 kg (2,4 mg/kg) live weight.

B. equi: 2 mℓ/100 kg (2,4 mg/kg) live weight. Two treatments at an interval of 24 hours may be required.

Canine babesiosis: 0,5 mℓ/10 kg (6,0 mg/kg) live weight.

Chemoprophylaxis of bovine babesiosis: 2,5 mℓ/100 kg (3,0 mg/kg) live weight.

The prophylactic period for B. bovis is up to 4 weeks and for B. bigemina, up to 2 months. 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 Forray^® 65. Immunity develops if treated animals are subjected to a challenge during the prophylactic period.

DO NOT REPEAT THE DOSE WITHIN 4 WEEKS.

EXAMPLES OF THE USE OF FORRAY^® 65 FOR THE PREVENTION OF REDWATER.

N.B. Only on the advice and recommendation of a veterinarian for each set of circumstances.

Outbreak of redwater in a herd:

Treat all the cattle with Forray^® 65 at 2,5 mℓ/100 kg live weight.

Movement of susceptible cattle into blue tick areas:

Treat with Forray^® 65 at 2,5 mℓ/100 kg live weight before moving cattle or on arrival at property. Vaccinate as advised under “VACCINE WARNING”.

Protection of heavily pregnant females from redwater where there is a risk that redwater vaccination may cause abortion:

Treat with Forray^® 65 at 2,5mℓ/100 kg live weight, followed by regular weekly treatment for tick control.

Movement of susceptible animals through a redwater area:

Dip animals and treat with Forray^® 65 at 2,5 mℓ/100 kg.

To protect uninfected, susceptible cattle in tick-free areas of redwater after tick infested cattle have been moved to the area:

Dip all cattle.

Purchase of cattle of unknown origin, i.e., susceptible or carrier cattle from the market:

Treat all cattle with Forray^® 65 at 2,5 mℓ/100 kg live weight to ensure prophylaxis or elimination of redwater followed by prophylaxis.

The protection of clean susceptible cattle sold at yards and transported to areas of redwater challenge:

Treat with Forray^® 65 at 2,5 mℓ/100 kg live weight before transporting. Vaccinate as advised under “VACCINE WARNINGS”.

Animals taken to shows or sales where there is risk of redwater:

Treat with Forray^® 65 at 2,5 mℓ/100kg live weight. The injection of Forray^® 65 can be delayed providing it is administered within 7 days of first exposure to risk. Advise the auctioneer that the animal is protected from redwater by Forray^® 65.

To reduce the losses from redwater following the introduction of cattle into feedlots:

Treat with Forray^® 65 at 2,5 mℓ/100 kg live weight. Dip all cattle.

PRESENTATION

40 mℓ and 100 mℓ glass bottles.

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd.

20 Spartan Road, Spartan

1619, RSA

Tel: +27 (0) 11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

30 May 2016