Imrestor

Country: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

Pegbovigrastim

Fáanlegur frá:

Elanco GmbH

ATC númer:

QL03AA90

INN (Alþjóðlegt nafn):

Pegbovigrastim

Meðferðarhópur:

Cattle (cows and heifers); Cattle

Lækningarsvæði:

Colony stimulating factors, Immunostimulants, Antineoplastic agents

Ábendingar:

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.

Vörulýsing:

Revision: 3

Leyfisstaða:

Authorised

Leyfisdagur:

2015-12-09

Upplýsingar fylgiseðill

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

Vara einkenni

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