Imrestor - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET

Imrestor 15 mg 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:

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven

Germany

Manufacturer for the batch release:

Elanco UK AH Limited

Elanco Speke Operations

Fleming Road

Liverpool

L24 9LN

United Kingdom

Or

Elanco France S.A.S.

26 Rue de la Chapelle

68330 Huningue

France

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Imrestor 15 mg solution for injection for cattle pegbovigrastim

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

The veterinary medicinal product is a clear, colourless to pale yellow solution for injection containing 15 mg pegbovigrastim (pegylated bovine colony stimulating factor) in a pre-filled syringe.

• 4. INDICATION(S)

As an aid in a herd management programme, to reduce the risk of clinical mastitis in periparturient dairy cows and heifers during the 30 days following calving.

• 5. CONTRAINDI­CATIONS

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

• 6. ADVERSE REACTIONS

Non typical anaphylactoid type reactions were uncommonlyobserved during the clinical field studies. The cows presented with swelling of mucous membranes (notably vulva and eyelid), skin reactions, increased respiration rate and salivation. The animal may collapse in rare cases. These clinical signs typically appear between 30 minutes and 2 hours after the first dose and resolve within 2 hours. Symptomatic treatment may be required.

Transient local swelling at the injection site as well as inflammatory reactions which resolve within 14 days post treatment may be induced through the subcutaneous administration of the veterinary medicinal product.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s) during the course of one treatment)

• – 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 serious effects or other effects not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Cattle (dairy cows and heifers).

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

Subcutaneous use.

The treatment regimen consists of two syringes. The content of a single pre-filled syringe is to be injected subcutaneously to a dairy cow/heifer 7 days before the anticipated date of calving. The content of a second pre-filled syringe is to be injected subcutaneously within 24 hours after calving. The intervals between the two administrations should not be less than 3 days or more than 17 days.

A single pre-filled syringe delivers a dose of 20–40 ^g/kg pegbovigrastim for most cows depending on bodyweight: e.g. a dose of 21 ^g/kg bodyweight for a 700 kg cow or 33 ^g/kg bodyweight for a 450 kg heifer.

• 9. ADVICE ON CORRECT ADMINISTRATION

Only for subcutaneous injection.

Excessive shaking of the pre-filled syringe may aggregate pegbovigrastim reducing its biological activity: The solution should be visually inspected prior to use. Only clear solutions without particles should be used.

No information is available with regards to a possible immune reaction towards the veterinary medicinal product or towards the endogenous molecule (bG-CSF) after repeated use of the veterinary medicincal product in cows.

In one safety study in Jersey cows the margin of safety of this veterinary medicinal product was 1.5× the highest recommended dose (an overdose of 60^g/kg was administered on three occasions). Do not exceed the stated dose.

As expected from the mode of action of the active substance, safety data shows that a mild and transient rise in somatic cell counts in individual cows may be seen.

• 10. WITHDRAWAL PERIOD(S)

Meat and offal: zero days.

Milk: zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of sight and reach of children.

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Sensitive to light. Store in the original packaging in order to protect from light.

The veterinary medicinal product may be stored at 25 °C for 24 hours maximum.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and on the pre-filled syringe.

• 12. SPECIAL WARNING(S)

In animals, which have pharmaceutically altered immune function e.g. those which have recently received systemically administered corticosteroids or non-steroidal anti-inflammatory drugs the product may not be effective. Concurrent use of such products should be avoided.

The veterinary medicinal product should only be used on the basis of a positive benefit: risk assessment performed at the herd level by the responsible veterinarian.

Evidence from similar active substances in humans suggests that accidental administration to cattle of more than the recommended dose could result in adverse reactions, which are related to the activity of pegbovigrastim. Treatment should be symptomatic. There is no known antidote.

In one safety study in Jersey cows, at overdose of 60 ^g/kg, administered on three occasions (1.5× the highest recommended dose), abomasal ulcers were observed.

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

In the case of accidental self -injection, headache, bone and muscle pain may occur. There may also be other effects including nausea and a skin rash, hypersensitivity reactions (breathing difficulties, hypotension, urticarial and angioedema). Seek medical advice immediately and show the package leaflet to the physician.

People with known hypersensitivity to pegbovigrastim should avoid contact with the veterinary medicinal product.

Personal protective equipment consisting of gloves when handling broken or damaged syringes. Remove gloves and wash hands and exposed skin and after use.

Pregnancy and lactation:

Can be used in pregnancy and lactation

Incompatibili­ties:

Do not mix with other veterinary medicinal products.

Concurrent administration of substances which alter immune function (e.g. corticosteroids or non steroidal anti-inflammatory drugs) may reduce the efficacy of the veterinary medicinal product. Concurrent use of such products should be avoided.

No information is available on the safety and efficacy of the concurrent use of this veterinary medicinal product with vaccines.

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

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon or pharmacist 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