Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Merial Animal Health Limited
QV07AB
.
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens
Solvents and diluting agents, incl. irrigating solutions
Immunological - Diluent
Authorised
2005-11-18
Health Products Regulatory Authority 21 February 2018 CRN000VWJ Page 1 of 4 1 NAME OF THE VETERINARY MEDICINAL PRODUCT DILUMAREX 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Aqueous diluent q.s. 1 ml 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In chickens: For the suspension preparation of MERIAL frozen vaccines against Marek’s disease. 4.3 CONTRAINDICATIONS Do not use alone. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Read special precautions for use of MERIAL frozen vaccines against Marek’s disease. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Health Products Regulatory Authority 21 February 2018 CRN000VWJ Page 2 of 4 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Read corresponding information of MERIAL frozen vaccines against Marek’s disease. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE Refer to posology and method of administration of MERIAL frozen vaccines against Marek’s disease. 4.10 OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF NECESSARY None. 4.11 WITHDRAWAL PERIOD(S) Zero days. 5 PHARMACOLOGICAL OR IMMUNOLOGICAL PROPERTIES Not applicable. ATCvet code: QV07AB. Solvents and diluting agents, incl. irrigating solutions. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sucrose Casein hydrolysate Dipotassium phosphate Potassium dihydrogen phosphate Phenol red (1% solution) Hydrochloric acid concentrated Sodium hydroxide Water for injections Health Products Regulatory Authority 21 February 2018 CRN000VWJ Page 3 of 4 6.2 MAJOR INCOMPATIBILITIES Do not mix with any other medi Read the complete document