Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Pegbovigrastim
Elanco GmbH
QL03AA90
Pegbovigrastim
Cattle (cows and heifers); Cattle
Colony stimulating factors, Immunostimulants, Antineoplastic agents
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.
Revision: 3
Authorised
2015-12-09
14 B. PACKAGE LEAFLET 15 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 uncommonly observed 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 16 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 Read the complete document
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Imrestor 15 mg solution for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.7 ml pre-filled syringe contains: ACTIVE SUBSTANCE: Pegbovigrastim (Pegylated bovine Granulocyte Colony Stimulating Factor [PEG bG-CSF]) 15 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless to pale yellow solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (dairy cows and heifers). 4.2 INDICATIONS 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. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL 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 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. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Only for subcutaneous administration. 3 In one safety study in Jersey cows the margin of safety of this veterinary medicinal 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. A Read the complete document