Zeleris - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET

Zeleris 400 mg/ml + 5 mg/ml solution for injection for cattle

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release :

Ceva Santé Animale

10 av. de La Ballastière

33500 Libourne

FRANCE

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Zeleris 400 mg/ml + 5 mg/ml solution for injection for cattle florfenicol / meloxicam

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

1 ml contains 400 mg of florfenicol and 5 mg of meloxicam.

Clear yellow solution.

• 4. INDICATION

For therapeutic treatment and of bovine respiratory disease (BRD) associated with pyrexia due to Mannheimia haemolytica , Pasteurella multocida and Histophilus somni susceptible to florfenicol.

• 5. CONTRAINDI­CATIONS

Do not use in adult bulls intended for breeding.

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or when there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in case of hypersensitivity to the active substances or to any of the excipients.

Injection site reactions (mostly swelling, induration, heat and pain) were very commonly observed after subcutaneous administration of the product. These effects were transitory and usually resolved without any treatment within 5 to 15 days, but could persist up to 49 days.

During injection of this product animals may exhibit signs of moderate pain, manifested as movement of the head or neck.

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.

Cattle.

• 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Subcutaneous use.

A single subcutaneous injection at a dosage of 40 mg florfenicol/kg bodyweight and 0.5 mg meloxicam / kg bodyweight (i.e. 1 ml/10 kg bodyweight).

The single dose volume should not exceed 15 ml per injection site. The injection should only be given in the neck area.

For the 250 ml vials, the rubber stopper may safely be punctured up to 20 times. Otherwise, the use of a multiple-dose syringe is recommended.

• 9. ADVICE ON CORRECT ADMINISTRATION

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

Meat and offal : 56 days.

Milk : Not authorised for use in lactating animals producing milk for human consumption. Do not use in pregnant cows, which are intended to produce milk for human consumption, within 2 months of expected parturition.

SPECIAL STORAGE CONDITIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage condition.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton after „EXP“. The expiry date refers to the last day of that month.

Shelf life after first opening the immediate packaging: 28 days.

Special precautions for use in animals

Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing. Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.

Avoid use in severely dehydrated, hypovolaemic or hypotensive animals, as there may be a potential risk of renal toxicity. In the absence of safety data it is not recommended to use the product in calves less than 4 weeks old.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

The product is slightly irritant to the eye. Rinse any splashes from eyes immediately with plenty of water.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

People with known hypersensitivity to florfenicol, meloxicam or to any of the excipients should avoid contact with the veterinary medicinal product.

Dose dependent maternotoxic and foetotoxic effects have been observed after oral administration of meloxicam to pregnant rats. Therefore, the veterinary medicinal product should not be administered by pregnant women.

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established in breeding, pregnant and lactating animals.

Use only according to the benefit-risk assessment by the responsible veterinarian.

Fertility

Do not use in adult bulls intended for breeding (see section “Contraindica­tions”).

Interactions with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In pre-ruminant calves, repeated administration of the recommended dose once per week for three weeks was well tolerated as well as a single administration of 3 times (3x) the recommended dose. Repeated weekly administration of overdoses (3× and 5× the recommended dose) in calves was associated with decreased milk consumption, decreased weight gain, loose faeces or diarrhoea. Repeated weekly administration of a 3× dose was fatal in 1 out of 8 calves after the third administration. Repeated weekly administration of a 5× dose was fatal in 7 out of 8 calves after the third administration.

The extent of these adverse effects was dose-dependent. Macroscopic intestinal lesions were observed post-mortem (presence of fibrin, abomasal ulcers, haemorrhagic dots and thickening of the abomasal wall).

Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ().

• 15. OTHER INFORMATION