Imrestor (Pegbovigrastim) – Summary of product characteristics - QL03AA90
Updated on site: 09-Feb-2018
|Výrobca:||Eli Lilly and Company Limited|
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 3. PHARMACEUTICAL FORM
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.3 Contraindications
- 4.4 Special warnings for each target species
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
- 4.11 Withdrawal period(s)
- 5. PHARMACOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
- 10. DATE OF REVISION OF THE TEXT
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
Imrestor 15 mg solution for injection for cattle
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.7 ml
Pegbovigrastim (Pegylated bovine Granulocyte Colony
Stimulating Factor [PEG
For the full list of excipients, see section 6.1.
Solution for injection
Clear, colourless to pale yellow solution
Cattle (dairy cows and heifers).
4.2Indications for use, specifying the target species
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.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
4.4Special warnings for each target species
In a European field trial, the incidence of clinical mastitis observed in the treated group was 9.1 % (113/1235) and in the control group 12.4 % (152/1230), showing a relative reduction in mastitis incidence of 26.0 % (p=0.0094). The efficacy was tested together with normal management practice. Clinical mastitis is investigated as a change in the appearance of the milk or of the quarter or of both milk and quarter.
Based on all field studies, the proportion of mastitis prevented due to herd treatment with Imrestor (Prevented Fraction) is 0.25 (with 95% confidence interval 0.14 – 0.35).
The product should only be used on the basis of a positive benefit: risk assessment performed at the herd level by the responsible veterinarian.
4.5Special precautions for use
Special precautions for use in animals
Only for subcutaneous administration.
In one safety study in Jersey cows the margin of safety of this product was 1.5x the highest recommended dose (an overdose of 60µg/kg was administered on three occasions) (see also section 4.10). 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the case of accidental
People with known hypersensitivity to pegbovigrastim should avoid contact with the veterinary medicinal product.
Personal protective equipment consisting of gloves should be worn when handling broken or damaged syringes. Remove gloves and wash hands and exposed skin after use.
4.6Adverse reactions (frequency and seriousness)
In the clinical studies,
Subcutaneous administration of the product may induce transient local swelling at the injection site as well as inflammatory reactions which resolve within 14 days post treatment.
The frequency of adverse reactions is defined using the following convention:
-very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
-common (more than 1 but less than 10 animals in 100 animals)
-uncommon (more than 1 but less than 10 animals in 1,000 animals )
-rare (more than 1 but less than 10 animals in 10,000 animals)
-very rare (less than 1 animal in 10,000 animals, including isolated reports)
4.7Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
4.8Interaction with other medicinal products and other forms of interaction
Concurrent administration of substances which alter immune function (e.g. corticosteroids or non steroidal
No information is available on the safety and efficacy of the concurrent use of this product with vaccines.
4.9Amounts to be administered and administration route
The treatment regimen consists of two syringes. The content of a single
A single syringe delivers a dose of
Excessive shaking of the 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Evidence from similar active substances in humans suggests that accidental administration of more than the authorised 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 µg/kg, administered on three occasions (1.5x the highest recommended dose), abomasal ulcers were observed.
4.11 Withdrawal period(s)
Meat and offal: zero days.
Milk: zero days.
Pharmacotherapeutic group: Colony stimulating factors.
ATCvet code: QL03AA90
Pegbovigrastim is a modified form of the naturally occurring immunoregulatory cytokine, bovine granulocyte colony stimulating factor
No information is available with regard to a possible immune reaction towards the product or towards the endogenous molecule
There is no information available about the pharmacokinetics of pegbovigrastim in cattle.
6.1List of excipients
Citric acid monohydrate.
Water for injections.
Do not mix with any other veterinary medicinal products.
6.4Special precautions for storage
Store in a refrigerator (2 C – 8 C).
Do not freeze.
Sensitive to light. Store in original packaging.
The product may be stored at 25 °C for 24 hours maximum.
6.5Nature and composition of immediate packaging
2.7 ml of solution for injection in a
The syringes are packed into cardboard boxes as follows;
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7.MARKETING AUTHORISATION HOLDER
Eli Lilly and Company Limited
Elanco Animal Health
Hampshire RG24 9NL
8.MARKETING AUTHORISATION NUMBER(S)
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 09/12/2015
10.DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).