Netvax
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
11-06-2014
Karatteristiċi tal-prodott
(SPC)
11-06-2014
Rapport ta 'Valutazzjoni Pubblika
(PAR)
11-06-2014
Ingredjent attiv:
Clostridium-perfringens-type-A alpha toxoid
Disponibbli minn:
Intervet International BV
Kodiċi ATC:
QI01AB08
INN (Isem Internazzjonali):
adjuvanted vaccine against necrotic enteritis of chickens due to Clostridium perfringens
Grupp terapewtiku:
Chicken
Żona terapewtika:
Immunologicals for aves
Indikazzjonijiet terapewtiċi:
For the active immunisation of chickens to provide passive immunisation against necrotic enteritis to their progeny, during the laying period.To reduce mortality and the incidence and severity of lesions caused by Clostridium-perfringens-type-A-induced necrotic enteritis. Efficacy was demonstrated by challenge of chicks approximately three weeks after hatching.The onset of passive transfer of immunity: 6 weeks following completion of the vaccination procedure.The duration of passive transfer of immunity: 51 weeks following completion of the vaccination procedure.
Sommarju tal-prodott:
Revision: 2
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2009-04-16
Fuljett ta 'informazzjoni
Medicinal product no longer authorised
17
B. PACKAGE LEAFLET
Medicinal product no longer authorised
18
PACKAGE LEAFLET FOR
Netvax emulsion for injection for chickens
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder :
Intervet International B.V.
Wim de Körverstraat 35
5831AN Boxmeer
The Netherlands
Manufacturer for the batch release:
S-P Veterinary Ltd
Breakspear Road South
Harefield
Uxbridge
Middlesex, UB9 6LS
United Kingdom
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Netvax emulsion for injection for chickens
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose (0.5ml) contains:
Active substance:
_Clostridium perfringens_ Type A alpha toxoid
Not less than 6.8 IU *
Adjuvant
Light Mineral Oil
0.31 ml
Excipients
Thiomersal
0.035-0.05 mg
* International units per ml of rabbit serum determined by haemolysis
inhibition assay
4.
INDICATION(S)
For the active immunization of chickens to provide passive
immunisation against necrotic enteritis to
their progeny, during the laying period.
To reduce mortality and the incidence and severity of lesions caused
by _Clostridium perfringens_ Type
A induced necrotic enteritis. Efficacy was demonstrated by challenge
of chicks approximately three
weeks after hatching.
Medicinal product no longer authorised
19
The onset of passive transfer of immunity: 6 weeks following
completion of the vaccination procedure
The duration of passive transfer of immunity: 51 weeks following
completion of the vaccination
procedure
5.
CONTRAINDICATIONS
None
6.
ADVERSE REACTIONS
No systemic reactions to vaccination were seen following intramuscular
vaccination. Vaccination may
result in moderate swelling of the breast tissue which will resolve
within 30 days. Following the
second vaccination swelling may persist for at least 35 days. Swelling
was very common.
After administration of a double dose, local reactions may increase
slightly.
If you notice any seri
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Karatteristiċi tal-prodott
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Netvax emulsion for injection for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5ml) contains:
Active substance:
_Clostridium perfringens_ Type A alpha toxoid
Not less than 6.8 IU *
Adjuvant
Light Mineral Oil
0.31 ml
Excipients
Thiomersal
0.035-0.05 mg
* International units per ml of rabbit serum determined by haemolysis
inhibition assay
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection
Off white oily emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunization of chickens to provide passive
immunisation against necrotic enteritis to
their progeny, during the laying period.
To reduce mortality and the incidence and severity of lesions caused
by _Clostridium perfringens_ Type
A induced necrotic enteritis. Efficacy was demonstrated by challenge
of chicks approximately three
weeks after hatching.
The onset of passive transfer of immunity: 6 weeks following
completion of the vaccination procedure
The duration of passive transfer of immunity: 51 weeks following
completion of the vaccination
procedure
4.3
CONTRAINDICATIONS
None
Medicinal product no longer authorised
3
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
None
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
To the user:
This product contains mineral oil. Accidental injection/self injection
may result in severe pain and
swelling, particularly if injected into a joint or finger, and in rare
cases could result in the loss of the
affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt
medical advice even if only a very
small amount is injected and take the package leaflet with yo
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