Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
Escherichia coli J5 inactivated, Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime-associated antigenic complex
Laboratorios Hipra S.A.
QI02AB
adjuvanted inactivated vaccine for cattle against Staphylococcus aureus, coliforms and coagulase-negative staphylococci
Cattle (cows and heifers)
Immunologicals for bovidae
For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci.The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection (equivalent to 130 days post-parturition).
Revision: 3
Authorised
2009-02-11
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET FOR: STARTVAC EMULSION 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: Laboratorios Hipra S.A. Avda. la Selva, 135 17170 Amer (Girona) SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT STARTVAC emulsion for injection for cattle 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) _ _ One dose (2 ml) contains: _Escherichia coli _ (J5) inactivated .......................................................................... > 50 RED 60 * _Staphylococcus aureus_ (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC)........................................................................ ........................................ > 50 RED 80 ** * RED 60 : Rabbit effective dose in 60% of the animals (serology). ** RED 80 : Rabbit effective dose in 80% of the animals (serology). Liquid paraffin: 18.2 mg Benzyl alcohol: 21 mg. STARTVAC is an ivory-coloured homogeneous emulsion for injection. 4. INDICATION(S) For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by _Staphylococcus aureus_ , coliforms and coagulase-negative staphylococci. The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection. 5. CONTRAINDICATIONS None. 17 6. ADVERSE REACTIONS Very rare adverse reactions: - Slight to moderate transient local reactions may occur after the administration of one dose of vaccine based on post-authorisation pharmacovigilance reporting. They would mainly be: swelling (up to 5 cm 2 on average), which disappears within 1 or 2 weeks at most. In some cases, there may also be pa Belgenin tamamını okuyun
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT STARTVAC emulsion for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (2 ml) contains: ACTIVE SUBSTANCES: _Escherichia coli _ J5 inactivated ............................................................................. > 50 RED 60 * _Staphylococcus aureus_ (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) ............. …………………………………………… > 50 RED 80 ** * RED 60 : Rabbit effective dose in 60% of the animals (serology). ** RED 80 : Rabbit effective dose in 80% of the animals (serology). ADJUVANT: Liquid paraffin.............................................................................. 18.2 mg EXCIPIENT: Benzyl alcohol…………….......................................................... 21 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. Ivory-coloured homogeneous emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (cows and heifers). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by _Staphylococcus aureus_ , coliforms and coagulase-negative staphylococci. The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection. 4.3 CONTRAINDICATIONS None. 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The whole herd should be immunised. Immunisation has to be considered as one component in a complex mastitis control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality, health monitoring) and other management pra Belgenin tamamını okuyun