FORCERIS (Canada)

Company: Ceva Animal Health

Toltrazuril and Iron Dextran Complex Injection

Veterinary Use Only

DIN 02487179

30 mg/mL toltrazuril and 133.4 mg/mL iron (as gleptoferron)

Sterile suspension for injection in piglets

Description

Dark brown sterile suspension for injection.

Active Ingredients

Each mL contains 30 mg of toltrazuril and 133.4 mg of iron (as gleptoferron, an iron dextran complex).

PRESERVATIVE:

6.4 mg/mL phenol

NON-MEDICINAL INGREDIENTS:

Water for injection, povidone, silica, sodium docusate, sodium chloride, simethicone emulsion

FORCERIS Indications

In piglets:

- 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.

Note: 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.

Dosage and Administration

Swirl the vial gently to disperse the contents prior to administration.

Administer 1.5 mL FORCERIS^® suspension per animal (45 mg of toltrazuril and 200 mg of iron) as a single intramuscular injection behind the ear of newborn piglets (between 1 and 3 days of age). Normal aseptic injection techniques should be practiced.

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

Contraindications

Do not administer to piglets suspected to suffer from deficiency of vitamin E and/or selenium.

CAUTIONS:

● As with any antiparasiticide, frequent and repeated use of antiprotozoals may lead to the development of resistance.

● It is recommended to treat all piglets in a litter prior to the occurrence of clinical signs to reduce the likelihood of damage to the small intestine and environmental contamination.

● Use with caution in piglets smaller than 0.9 kg at the time of administration, as it may result in an overdose of iron.

Warnings

● Treated swine must not be slaughtered for use as food for at least 70 days after the latest treatment with this drug.

● Do not use in piglets intended to be used as sucking or barbecue pigs since they may be marketed before 70 days after administration of this drug.

● Care should be taken to avoid self-injection or direct contact with skin or eyes, especially for people with known hypersensitivity to iron dextran or gleptoferron. Wash hands after use.

● In case of accidental self-injection, seek medical advice, and show the product label to the physician.

● The product is slightly irritating to the eye. In the event of accidental contact with the eyes, rinse with plenty of water and seek medical attention if irritation persists.

● Keep out of reach of children.

Adverse Reactions

Very rarely deaths have occurred in piglets following the administration of injectable iron products. These deaths have been associated with genetic factors or deficiency of vitamin E and/or selenium.

Bacterial disease, arthritis or abscess formation and occasional piglet deaths have been reported which have been attributed to an increased susceptibility to infection due to temporary blocking of the reticuloendothelial system from high levels of iron.

Hypersensitivity reactions can occur.

Clinical Pharmacology

PHARMACODYNAMICS:

Toltrazuril acts against all intracellular development stages of coccidia including schizonts and gamonts. It is believed to interfere with the division of the protozoal nucleus, the activity of the mitochondria and the wall forming bodies in the microgametes resulting in death of the organism.

Iron is an essential micronutrient. It plays a major role in the oxygen transport of haemoglobin and myoglobin, as well as it has a key role in enzymes, such as cytochromes, catalases, and peroxidases. Injectable iron-carbohydrate complexes are established haematinic agents in veterinary medicine and are effective in significantly increasing the haemoglobin levels in piglets under intensive conditions in which an all milk diet does not provide an adequate source of iron. Following intramuscular injection, the complex is absorbed and metabolised to release the iron for utilisation and/or storage in accordance with the nutritional status of the animal. Excess iron is stored principally in the liver.

PHARMACOKINETICS:

The main metabolite of toltrazuril is toltrazuril sulfone. After intramuscular administration of toltrazuril maximal concentration is reached at 6 days and 13 days for toltrazuril sulfone. Both parent and metabolite are eliminated slowly with a half life of 3 days. The principal route of excretion is faecal.

After intramuscular injection, iron is absorbed rapidly from the injection site into the capillaries and the lymphatic system. It is stored primarily in the liver. Since iron is recycled in the body little of the absorbed iron is excreted. Very small losses occur in faeces, sweat and urine.

EFFICACY:

Field study data provided indicated that when 1.5 mL of FORCERIS^® was administered intramuscularly to piglets ranging in weight from 0.9 to 3.0 kg on either day 1, 2 or 3 of age, clinical signs of diarrhea associated with coccidiosis infection and shedding of oocysts was significantly reduced in treated animals compared to non-treated controls.

Study data demonstrated that the iron contained in FORCERIS^® is as effective as other injectable iron products at preventing anaemia in piglets when administered at day 1, 2 or 3 of age.

SAFETY:

Safety studies demonstrated that FORCERIS^®, when administered at 1.5 mL intramuscularly to piglets ranging from 0.9 to 3 kg body weight is safe at the label dose.

Signs of iron overdose including increased susceptibility to infection (abscess, arthritis, bacterial infection) and hemosiderosis were seen in some animals receiving more than 200 mg/kg of iron.

Storage

Store at room temperature (15°C to 30°C).

FORCERIS^® has a shelf-life of 28 days after broaching.

How Supplied

FORCERIS^® is supplied in translucent multi-layered plastic vials. FORCERIS^® is available in vials of 100 mL, 250 mL or 500 mL.

Not all pack sizes may be marketed.

For technical assistance, or to report suspected adverse reactions, call 1-800-510-8864.

Ceva Animal Health Inc., 150 Research Lane, Suite 225 Guelph ON N1G 4T2

FORCERIS^® is a registered trademark of Ceva Santé Animale, France

C6295-3120201

A2384-02

CPN: 1221139.1