FOR ANIMAL USE ONLY

FORCERIS

Reg. No. G4385 Act 36/1947

SUSPENSION FOR INJECTION

INDICATIONS

For the reduction in oocyst excretion and the prevention of clinical signs of coccidiosis in farms with a confirmed history of coccidiosis caused by Cystoisospora suis.                            

For the prevention of iron deficiency anaemia.      

CAUTION

STORAGE

Store at or below 25 °C.

COMPOSITION

1 mℓ contains 30 mg Toltrazuril and 133,4 mg iron (as Gleptoferron 20 % Fe).

IDENTIFICATION

Dark brown suspension. White cake like sediment and a brownish supernatent can be formed during standing and can be re-suspended by shaking.

WARNINGS

• Withdrawal period for meat and offal: 70 days.
• Do not administer to piglets suspected to suffer from deficiency of vitamin E and/or selenium.
• Do not mix this product with any other medicinal product.
• As with any antiparasiticide, frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.
• It is recommended to treat all piglets in a litter.
• Hygienic measures may reduce the risk of porcine coccidiosis. It is therefore, recommended to improve concomitantly the hygienic conditions in the concerned facility, particularly dryness and cleanliness.
• To obtain maximum benefit, animals should be treated before the expected onset of clinical signs, i.e. in the prepatent period.
• To alter the course of an established clinical coccidial infection in individual animals already showing signs of diarrhoea, additional supportive therapy may be required.
• Keep out of reach of children, uninformed persons and animals.
• Although this remedy has been 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; notify the registration holder and the Registrar.

PRECAUTIONS

• Very rarely deaths have occurred in piglets following the administration of any form of iron parenteral injection ("very rare" is equivalent to less than 1 animal reacting in 10,000 treated animals). These deaths have been associated with genetic factors or deficiency of vitamin E and/or selenium.
• Occasional piglet deaths have been reported which have been attributed to an increased susceptibility to infection due to temporary blocking of the reticuloendothelial system.
• Hypersensitivity reactions can occur.
• The frequency of adverse reactions is defined using the following convention:
  • very common (more than 1 in 10 animals treated displaying adverse reaction(s))
  • common (more than 1 but less than 10 animals in 100 animals treated)
  • uncommon (more than 1 but less than 10 animals in 1 000 animals treated)
  • rare (more than 1 but less than 10 animals in 10 000 animals treated)
  • very rare (less than 1 animal in 10 000 animals treated, including isolated reports)                          
• If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
• Observe aseptic precautions.  Ensure that all equipment (containers, syringes and needles) are clean and sterile prior to and during use.
• Destroy any unused product and dispose of all the  containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008)
• Care should be taken to avoid accidental self-injection especially people with known hypersensitivity to iron Dextran.
• In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
• The product is slightly irritant to the eye. In the event of accidental contact with the eyes, rinse with plenty of water and seek medical attention if irritation persists.
• Wash hands after use.
• Do not store unused containers for future use.
• Do not contaminate rivers, dams or any water sources with containers or waste.

DIRECTIONS FOR USE: Use only as directed 

Intramuscular route behind the ear.

The suspension for injection must be shaken before use.

The recommended dose is 45 mg of Toltrazuril combined with 200 mg of iron (as Gleptoferron 20 % Fe) per piglet (i.e. 1,5 mℓ/animal) in one single injection to be administered between 1 and 3 days of age  (i.e. 24 to 96 hours after birth).

In order to reduce any possible adverse reactions, a slow administration of the product is recommended.

Depending on animal bodyweight (between 0,9 and 3 kg), the effective dose varies from 15 to 50 mg/kg of Toltrazuril and from 66,7 to 222,2 mg/kg of iron (as Gleptoferron 20 % Fe).

Treatment must not be repeated.

Shelf life after first opening the immediate packaging: 28 days. Once broached, use within 28 days, by __/__/__ (date) 

PRESENTATION

Forceris is packed in translucent multi-layer plastic 100 mℓ / 66 dose and 250 mℓ / 166 dose  vials with grey Bromobutyl stoppers. One vial is packed in a cardboard carton.

REGISTRATION HOLDER

Ceva Animal Health (Pty) Ltd.

(Reg. No. 1973/016009/07)

P O Box 7707

Halfway House

1685

Tel. +27 11 312 4088

MANUFACTURER

Ceva Santé Animale

10 av. de La Ballastière

33500 Libourne

France