Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
bovine herpesvirus lyophylisated 2 ml
Pfizer Limited
QI02A
Powder and solvent for solution for injection
IMMUNOLOGICALS
Cattle
2012-01-24
Paul-Ehrlich-Institut DE/V/0022/001/II/023/G Page 1 PACKAGE LEAFLET Rispoval IBR-Marker Vivum Lyophilisate and diluent for suspension 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:Manufacturer for the batch release: Pfizer Animal Health s.a. Rue Laid Burniat, 1 B-1348 Louvain-la-Neuve Belgium 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Rispoval IBR-Marker Vivum Lyophilisate and diluent for suspension for injection for cattle. 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose (2 ml) contains: ACTIVE SUBSTANCE: _Freeze-dried pellet _ Bovine Herpes Virus type 1 (BHV-1), strain Difivac (gE-negative), modified live (attenuated) virus min. 10 5.0 CCID 50 * max. 10 7.0 CCID 50 * EXCIPIENT(S): _Diluent _ Water for injections 2 ml * CCID50 = Cell culture infective dose 50% _ _ 4. INDICATION(S) For active immunisation of cattle against Infectious Bovine Rhinotracheitis (IBR), to reduce virus shedding and clinical signs including, in female cattle, abortions associated with BHV-1 infection. A reduction of abortion associated with BHV-1 infections has been demonstrated during the second trimester of gestation upon challenge 28 days after vaccination. Paul-Ehrlich-Institut DE/V/0022/001/II/023/G Page 2 Onset of immunity: 7 days after a single dose via intranasal administration or 21 days after a single dose via intramuscular administration as demonstrated in seronegat Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Rispoval IBR-Marker Vivum, Lyophilisate and diluent for suspension for injection for cattle Rispoval IBR-Marker Live _(for UK and Ireland only_) Rispoval Marker Vivo Attenuato (_for Italy only_) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition for 2 ml dose: ACTIVE SUBSTANCE: _Freeze-dried pellet _ Bovine Herpes Virus type 1 (BoHV-1), strain Difivac (gE-negative), modified live (attenuated) virus min. 10 5.0 CCID 50 * max. 10 7.0 CCID 50 * EXCIPIENT(S): _Diluent _ Water for injections 2 ml * CCID50 = Cell culture infective dose 50% _ _ For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and diluent for suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of cattle against Infectious Bovine Rhinotracheitis (IBR), to reduce virus shedding and clinical signs including, in female cattle, abortions associated with BoHV- 1 infection. A reduction of abortion associated with BoHV-1 infections has been demonstrated during the second trimester of gestation upon challenge 28 days after vaccination. Vaccinated cattle can be differentiated from field virus infected animals due to the marker deletion, unless the cattle were previously vaccinated with a conventional vaccine or infected with field virus. _Onset of immunity_: 7 days after a single dose via intranasal administration or 21 days after a single dose via intramuscu Read the complete document