国家: 匈牙利
语言: 英文
来源: HMA (Heads of Medicines Agencies)
cloprostenol sodium salt 0.25 mg/ml
Alfasan Nederland B.V.
QG02AD90
Solution for injection
cloprostenol
Cattle Food
2010-03-24
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ALFAGLANDIN C 0.250 mg/ml solution for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PER ML : ACTIVE SUBSTANCE: Each ml solution contains 0.250 mg cloprostenol (as cloprostenol sodium) EXCIPIENT(S): Chlorocresol 1 mg / ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pyometra Suboestrus Oestrus synchronisation Termination of abnormal pregnancy in cattle up to day 150 of the pregnancy (for abnormal pregnancy) Ovarian luteal cysts Induction of parturition 4.3 CONTRAINDICATIONS Do not administer to pregnant animals unless the objective is to terminate gestation or to induce parturition. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES A refractory period of 4 to 5 days after ovulating has to be taken into account during which cattle will not be sensitive to the luteolytic effects of prostaglandins. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Administer by intramuscular injection observing the usual aseptic precautions. Care should be taken to avoid injection through wet or dirty areas of skin. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS - Prostaglandins of the F 2α type can be absorbed through the skin and may cause bronchospasm or miscarriage. - Direct contact 阅读完整的文件
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ALFAGLANDIN C 0.250 mg/ml solution for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PER ML: ACTIVE SUBSTANCE: Cloprostenol 0.250 mg (as cloprostenol sodium) EXCIPIENT(S): Chlorocresol 1 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pyometra Suboestrus Oestrus synchronisation Termination of abnormal pregnancy up to day 150 of the pregnancy Ovarian luteal cysts Induction of parturition 4.3 CONTRAINDICATIONS Do not use in pregnant animals where the induction of abortion or parturition is not intended. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES A refractory period of 4 to 5 days after ovulating has to be taken into account during which cattle will not be sensitive to the luteolytic effects of prostaglandins. 4.5 SPECIAL PRE CAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Administer by intramuscular injection observing the usual aseptic precautions. Care should be taken to avoid injection through wet or dirty areas of skin. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS - Prostaglandins of the F 2α type can be absorbed through the skin and may cause bronchospasm or miscarriage. - Direct contact with the skin or eyes may cause irritation and allergic reactions. - The product should 阅读完整的文件