Zeleris

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

florfenicol, meloxicam

MAH:

CEVA Santé Animale

ATC_code:

QJ01BA99

INN:

florfenicol, meloxicam

therapeutic_group:

Cattle

therapeutic_area:

Amphenicols, combinations, Antibacterials for systemic use

therapeutic_indication:

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

authorization_status:

Authorised

authorization_date:

2017-05-15

PIL

16
B. PACKAGE LEAFLET
17
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.
6.
ADVERSE REACTIONS
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 a

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zeleris 400 mg/ml + 5 mg/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Florfenicol
400 mg
Meloxicam
5 mg.
EXCIPIENTS:
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For therapeutic treatment of bovine respiratory disease (BRD)
associated with pyrexia due to
_Mannheimia haemolytica_
,
_Pasteurella multocida _
and
_Histophilus somni_
susceptible to florfenicol.
4.3
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
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.
3
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 th