Naxcel

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ceftiofur

Available from:

Zoetis Belgium SA

ATC code:

QJ01DD90

INN (International Name):

ceftiofur

Therapeutic group:

Pigs; Cattle

Therapeutic area:

Antibacterials for systemic use

Therapeutic indications:

PigsTreatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.CattleTreatment of acute interdigital necrobacillosis in cattle also known as Panaritium or foot rot.Treatment of acute post-partum (puerperal) metritis in cattle, in cases where treatment with another antimicrobial has failed.

Product summary:

Revision: 15

Authorization status:

Authorised

Authorization date:

2005-05-19

Patient Information leaflet

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET:
NAXCEL 100 MG/ML SUSPENSION FOR INJECTION FOR PIGS
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:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Naxcel 100 mg/ml suspension for injection for pigs
ceftiofur
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
One ml contains:
ACTIVE SUBSTANCE:
Ceftiofur (as crystalline free acid)
100 mg.
4.
INDICATION(S)
Treatment of bacterial respiratory disease associated with
_Actinobacillus pleuropneumoniae_
,
_Pasteurella multocida_
,
_Haemophilus parasuis_
and
_Streptococcus suis_
.
Treatment of septicaemia, polyarthritis or polyserositis associated
with
_Streptococcus suis _
infection.
5.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to ceftiofur or other
beta-lactam antibiotics, or to any of the
excipients.
6.
ADVERSE REACTIONS
Occasionally, transient local swelling may occur following
intramuscular injection.
Mild tissue reactions at the injection site, such as small areas (less
than 6 cm²) of discolouration and
small cysts have been observed for up to 42 days after injection.
Resolution has been observed at 56
days post-injection.
In very rare cases anaphylactic type reactions may occur following
administration of the 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))
- 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)
27
- very rare (less than 1 animal in 10,000 animals treated, including
isolated reports).
If you notice any side effects, even those not already listed in this
package leafle

Summary of Product characteristics

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Naxcel 100 mg/ml suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Ceftiofur (as crystalline free acid)
100 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Opaque white to light brown suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of bacterial respiratory disease associated with
_Actinobacillus pleuropneumoniae_
,
_Pasteurella multocida_
,
_Haemophilus parasuis_
and
_Streptococcus suis_
.
Treatment of septicaemia, polyarthritis or polyserositis associated
with
_Streptococcus suis _
infection.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to ceftiofur or other
beta-lactam antibiotics, 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
For systemically administered broad spectrum cephalosporins (3
rd
and 4
th
generation, such as
ceftiofur), it should be reflected that these are to be reserved for
the treatment of clinical conditions
which have responded poorly, or are expected to respond poorly, to
less critical antimicrobials.
Increased use, including use of the product deviating from the
instructions given in the SPC, may
increase the prevalence of bacteria resistant to ceftiofur. Official,
national and regional antimicrobial
policies should be taken into account when the product is used.
Whenever possible, cephalosporins should only be used based on
susceptibility testing. When
considering the treatment strategy, it is appropriate to consider
improvement of the herd management
practice and use supporting treatment with suitable local products
(e.g. disinfectants).
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Penicillins and cephalosporins such as cefti