Quốc gia: Hungari
Ngôn ngữ: Tiếng Anh
Nguồn: HMA (Heads of Medicines Agencies)
Mareks Disease Virus 0 -, Mareks disease virus - Rispens strain Cvi 988 0 -
Pfizer Animal Health BV
QJ57GA0
Lyophilisate and Solvent
mareks disease
Chicken Food
2011-08-26
1 ANNEX II A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE D. STATEMENT OF THE MRLS E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER 2 A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) of the biological active substance(s) Pfizer Global Manufacturing Weesp C.J. van Houtenlaan 36 1381 CP Weesp The Netherlands or Pfizer Animal Health 2000 Rockford Road Charles City Iowa 50616 USA Name and address of the manufacturer(s) responsible for batch release Pfizer Global Manufacturing Weesp C.J. van Houtenlaan 36 1381 CP Weesp The Netherlands or Pfizer Olot, S.L.U. Carretera Camprodon s/n - La Riba 17813 - Vall de Bianya Girona Spain B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE To be supplied only on veterinary prescription. C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT Not applicable. D. STATEMENT OF THE MRLS Not applicable. E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER 3 Not applicable. 4 ANNEX III LABELLING AND PACKAGE LEAFLET 5 Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac Marek CVI + HVT 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose of 0.2 ml contains: Active substances: Live Marek’s disease virus, strain CVI 988, cell associated: not less than 10 2.9 CCID 50 , not more than 10 3.5 CCID 50 *. Live Marek HVT strain F#126, cell associated: not less than 1000 PFU, not more than 6000 PFU** *CCID 50 = cell culture 50% infective dose **PFU = plaque forming units Excipient(s): For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Frozen virus-infected cell suspension, after thawing to be diluted in Poulvac Marek Diluent. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chicken. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of healthy day-old chicks against Marek’s Disease to reduce mortality, clinical signs and lesions of the disease. Onset of immunity: 9 days post vaccination. 4.3 CONTRAINDICATIONS Do not use in unhealthy chickens. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The vaccine viruses have the potential to spread. After 10 passages, the vaccine showed an increase in virulence in the highly susceptible pure bred Rhode Island Red bird. Maternal antibodies may have some negative influence on vaccination. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals 3 Exposure to heat and direct sunlight must be avoided. Contact with disinfectants makes the vaccine ineffective. Use clean materials for vaccination. Avoid v Đọc toàn bộ tài liệu