מדינה: אוסטרליה
שפה: אנגלית
מקור: APVMA (Australian Pesticides and Veterinary Medicines Authority)
GONADORELIN AS GONADORELIN ACETATE
ELANCO AUSTRALASIA PTY LTD
gonadorelin as acetate(100ug/mL)
PARENTERAL LIQUID/SOLUTION/SUSPENSION
GONADORELIN AS GONADORELIN ACETATE HORMONE-GONADOTROPHIN Active 100.0 ug/ml
100 mL; 20 mL
VM - Veterinary Medicine
BAYER AUSTRALIA
CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER
ENDOCRINE SYSTEM
CYSTIC OVARIES | DELAYED OVULATION | IMPROVEMENT OF POSTPARTUM FERTILITY | SYNCHRONISATION OF OESTRUS & OVULATION | POST-PARTUM FERTILITY
Poison schedule: 4; Withholding period: MEAT: WITHHOLDING PERIODS: NIL MILK: WI THHOLDING PERIODS: NIL ESI: An ESI ha s not been established for this product. Note – observing the meat withholding period may not be sufficient to mitigate potential risks to export trade. Trade advice should be sought from Elanco Aust ralasia Pty Ltd on 1800 995 709 before u sing this product.; Host/pest details: CATTLE: [CYSTIC OVARIES, DELAYED OVULATION, IMPROVEMENT OF POSTPARTUM FERTILITY, SYNCHRONISATION OF OESTRUS & OVULATION]; Poison schedule: 4; Withholding period: MEAT: WITHHOLDING PERIODS: NIL MILK: WI THHOLDING PERIODS: NIL EXPORT SLAUGHT ER INTERVAL (ESI): The product does not have an ESI established. For advice on t he ESI, contact the manufacturer on 1800 995 709 before using this product.; Host/pest details: CATTLE: [CYSTIC OVARIES, DELAYED OVULATION, IMPROVEMENT OF POSTPARTUM FERTILITY, SYNCHRONISATION OF OESTRUS & OVULATION]; Poison schedule: 4; Withholding period: WHP: NIL ESI: THIS PRODUCT DOES NOT HA VE AN ESI ESTABLISHED. FOR ADVICE ON TH E ESI, CONTACT THE MANUFACTURER ON 02 9 987 4922 BEFORE USING THIS PRODUCT.; Host/pest details: CATTLE: [CYSTIC OVARIES, DELAYED OVULATION, IMPROVEMENT OF POSTPARTUM FERTILITY, SYNCHRONISATION OF OESTRUS & OVULATION]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [CYSTIC OVARIES, DELAYED OVULATION, IMPROVEMENT OF POSTPARTUM FERTILITY, SYNCHRONISATION OF OESTRUS & OVULATION]; For use in oestrus synchronisation programs in combination with PGF2a. For the treatment of cystic ovaries, prevention of delayed ovulation and improvement of postpartum fertility in cattle.
Registered
2023-07-01
Product Name: APVMA Approval No: OVURELIN INJECTION 63035/138414 Label Name: OVURELIN INJECTION Signal Headings: PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Constituent Statements: 100 μg/mL GONADORELIN AS ACETATE Claims: For use in oestrus synchronisation programs in combination with PGF2α. For the treatment of cystic ovaries, prevention of delayed ovulation and improvement of postpartum fertility in cattle. Net Contents: 20 mL 100 mL Directions for Use: Restraints: Contraindications: Precautions: Side Effects: Dosage and Administration: Discard all open vials 28 days after broaching. Cattle: Injection to be given into the anterior half of the neck. Cystic ovaries: 5 mL (500 µg gonadorelin) by intramuscular injection. Prevention of delayed ovulation: 2.5 mL (250 µg gonadorelin) by intramuscular injection. Improvement of postpartum fertility: 2.5 mL (250 µg gonadorelin) by intramuscular injection. RLP APPROVED Oestrus synchronisation: 1 mL (100 µg gonadorelin) by intramuscular injection, for example: Day 0 1 mL (100 µg gonadorelin) Day 7 2 mL PGF2α Day 9 1 mL (100 µg gonadorelin) Insemination 8-24 hours after 2nd OVURELIN INJECTION. General Directions: DESCRIPTION: OVURELIN INJECTION is a clear, colourless, sterile solution containing 100 µg/mL of gonadorelin (as acetate). Gonadorelin is a synthetic decapeptide, identical to the endogenous Gonadotropin Releasing Hormone (GnRH), which controls the production, and secretion of Luteinising Hormone (LH) and Follicle Stimulating Hormone (FSH) by the pituitary gland. Both LH and FSH have a direct effect on the ovary: FSH stimulates follicle development, while LH induces ovulation and luteinisation. Injection of gonadorelin acetate induces the simultaneous release of FSH and LH thereby stimulating the maturation of ovarian follicles, ovulation and development of the corpus luteum. INDICATIONS: 1. OESTRUS SYNCHRONISATION Oestrus synchronisation protocols involving the use of Prostaglandin F2α (PGF2α) and Gonadotropin Rel קרא את המסמך השלם
PAGE 1 OF 6 SAFETY DATA SHEET A18318/02/AUS OVURELIN INJECTION SECTION 1 – IDENTIFICATION, CONTACTS Bayer Australia Ltd 875 Pacific Highway Pymble NSW 2073 EMERGENCY TELEPHONE NUMBER 1800 033 111 24 hour Emergency Service Australia Wide, Toll Free CONTACT POINT (FOR NON-EMERGENCY CALLS) Animal Health Division (02) 9391 6000 Full Product Name OVURELIN INJECTION Other Names None allocated Product Use FOR ANIMAL TREATMENT ONLY For use in oestrus synchronisation programs in combination with PGF2 α, prevention of delayed ovulation and improvement of postpartum fertility and for the treatment of cystic ovaries in cattle. Creation Date April 2013 Revision Date 2 October 2013 SECTION 2 – HAZARDS IDENTIFICATION Hazard Classification NON- HAZARDOUS SUBSTANCE NON- DANGEROUS GOODS According to the Criteria of NOHSC, and the ADG Code. Poisons Schedule S4 Risk Phrases Nil Safety Phrases Nil SECTION 3 – COMPOSITION INGREDIENTS CAS NO PROPORTION Gonadorelin diacetate tetrahydrate 52699-48-6 0.01% This is a commercial product whose exact ratio of components may vary slightly. Minor quantities of other non hazardous ingredients are also present. A18318/02/AUS: OVURELIN INJECTION PAGE 2 OF 6 SECTION 4 – FIRST AID MEASURES Label Regulated First Aid Statement If poisoning occurs contact a doctor or the Poisons Information Centre. Phone Australia 13 11 26. Scheduled Poisons S4 Inhalation Unlikely to occur. Move individual to fresh air. If breathing ceases, give artificial respiration. Seek medical attention if irritation occurs. Skin contact If skin contact occurs, wash thoroughly with soap and water. Remove any contaminated clothing. If sprayed in mouth rinse mo קרא את המסמך השלם
100 ML PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY _ACTIVE CONSTITUENT: _ _Gonadorelin (as acetate) _ _100µg/mL_ For use in oestrus synchronisation programs in combination with PGF2 α . For the treatment of cystic ovaries, prevention of delayed ovulation and improvement of postpartum fertility in cattle. Ovurelin Injection ™ 100 ML 100 ML PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY _ACTIVE CONSTITUENT: _ _Gonadorelin (as acetate) _ _100µg/mL_ For use in oestrus synchronisation programs in combination with PGF2 α . For the treatment of cystic ovaries, prevention of delayed ovulation and improvement of postpartum fertility in cattle. Ovurelin Injection ™ _ACTIVE CONSTITUENT: Gonadorelin (as acetate) 100µg/mL_ For use in oestrus synchronisation programs in combination with PGF2 α . For the treatment of cystic ovaries, prevention of delayed ovulation and improvement of postpartum fertility in cattle. Ovurelin Injection ™ READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT DIRECTIONS FOR USE: Discard all open vials 28 days after broaching. CATTLE: Injection to be given into the anterior half of the neck. CYSTIC OVARIES: 5mL (500µg gonadorelin) by intramuscular injection . PREVENTION OF DELAYED OVULATION: 2.5mL (250µg gonadorelin) by intramuscular injection. IMPROVEMENT OF POSTPARTUM FERTILITY: 2.5mL (250µg gonadorelin) by intramuscular injection. OESTRUS SYNCHRONIZATION: 1mL (100µg gonadorelin) per dose by intramuscular injection (see enclosed leaflet). WITHHOLDING PERIODS: MEAT, MILK: ZERO (0) DAYS TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (ESI): THIS PRODUCT DOES NOT HAVE AN ESI ESTABLISHED. FOR ADVICE ON THE ESI, CONTACT THE MANUFACTURER ON 1800 678 368 BEFORE USING THIS PRODUCT. FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre, Australia 131126 DISPOSAL: Dispose of empty container by wrapping with paper and putting in garbage. STORAGE: Store below 25°C (air conditioning). Protect from light. L קרא את המסמך השלם