Երկիր: Իսրայել
Լեզու: անգլերեն
Աղբյուրը: Ministry of Health
FLORFENICOL
COMEX LTD., ISRAEL
SOLUTION FOR INJECTION
FLORFENICOL 300 MG/ML
I.M
Required
NORBROOK LABORATORIES LIMITED, NORTHERN IRELAND
Treatment of bovine respiratory disease (BRD) associated with pasteurella haemolytica, pasteurella multocida and haemophilus somnus.
2021-05-31
An authorized leaflet approved by The Ministry of Health: June 2016 Consumer leaflet of veterinary product Veterinarian prescription only medicine Animal use only 1. NAME OF VETERINARY PRODUCT, ROUTE & STRENGTH Norfenicol 300 mg/ml Injection Veterinary Solution for I.M. injection 2. ACTIVE INGREDIENTS Florfenicol 300 mg/ml Full excepients list is provided under section 13 3. WHAT IS THE MEDICINE INDICATED FOR Therapeutic classification: Antibiotics The medicine is indicated for the treatment of bovine respiratory disease (BRD) associated with pasteurella haemolytica, pasteurella multocida and haemophilus somnus. 4. CONTRA-INDICATIONS • Do not use in adult bulls or boars intended for breeding purposes. • Do not use in cases of hypersensitivity to the active substance or to any of the excipients. • Do not use in cases of known resistance. • Not permitted for use in lactating animals producing milk for human consumption. 5. SIDE EFFECTS: - The medicine may cause inflammatory lesions (swelling and hardness) at the injection site which may persist for 31 days. - A decrease in food consumption and transient softening of the feces may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment. - In very rare cases, anaphylactic shock has been reported. Any suspected adverse events should be reported to the Ministry of Health by clicking on the link below and using an online form http://forms.gov.il/globaldata/getsequence/getsequence.aspx?form Type=AdversEffectMedic@moh. gov.il The form can be found on the Ministry of Health website ( www.health.gov.il) 6. TARGET SPECIES Cattle 7. ROUTE AND DOSE FOR EACH TARGET SPECIES Intramuscular Injection: 20 mg/kg body weight (1 ml/15 kg) to be administered twice 48 hours apart. The dose volume given at any one injection site should not exceed 10 ml. 8. ADMINISTRATION METHOD It is recommended to use a 16-gauge needle. The injection should only be given in the neck. It is recommended to treat animals in the early stages Կարդացեք ամբողջական փաստաթուղթը
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NORFENICOL 300 MG/ML INJECTION VETERINARY 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Florfenicol 300 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. A light yellow to straw coloured solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of bovine respiratory disease (BRD) associated with _Pasteurella _ _haemolytica_, _Pasteurella multocida _and _Haemophilus somnus_. 4.3 CONTRAINDICATIONS Do not use in adult bulls intended for breeding purposes. Do not use in the case of known hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Page 2 of 5 Special precautions for use in animals The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies. Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to Florfenicol or any of the excipients should avoid contact with the veterinary medicinal product. In case of accidental contact with skin or eyes, rinse immediately with plenty of water. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A decrease in food consumption and transient softening of the faeces may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment. Intramuscular administration may cause inflammatory lesions at the injection site which may persist for 14 days. In very rare cases, anaphylactic shock has been reported. Reporting suspected adverse reactions: Reporting suspected adverse reactio Կարդացեք ամբողջական փաստաթուղթը