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Annex Iii Labelling and Package Leaflet ANNEX III LABELLING AND PACKAGE LEAFLET version 2020/11 page 1 of 12 A. LABELLING version 2020/11 page 2 of 12 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Butorgesic 10 mg/ml solution for injection butorphanol 2. STATEMENT OF ACTIVE SUBSTANCES Active substance: butorphanol 10.00 mg/ml (as butorphanol tartrate 14.58 mg/ml) Excipients: benzethonium chloride 0.10 mg/ml 3. PHARMACEUTICAL FORM Solution for injection 4. PACKAGE SIZE 10 ml 20 ml 5. TARGET SPECIES Horse, dog and cat 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. Horse: IV Dog, Cat: IV, SC, IM 8. WITHDRAWAL PERIOD(S) Withdrawal period(s): Horse (meat, offal, milk): zero days 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE EXP {month/year} version 2020/11 page 3 of 12 Once opened use within 28 days. 11. SPECIAL STORAGE CONDITIONS Keep the vial in the outer carton in order to protect from light. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Disposal: read package leaflet. 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only. To be supplied only on veterinary prescription. 14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER ADOH B.V. Godfried Bomansstraat 31 6543 JA Nijmegen The Netherlands 16. MARKETING AUTHORISATION NUMBER(S) 17. MANUFACTURER’S BATCH NUMBER Lot {number} version 2020/11 page 4 of 12 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 10 ml, 20 ml vials 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Butorgesic 10 mg/ml solution for injection butorphanol 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) butorphanol 10.00 mg/ml (as butorphanol tartrate 14.58 mg/ml) Excipients: benzethonium chloride 0.10 mg/ml 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 ml 20 ml 4. ROUTE(S) OF ADMINISTRATION Horse: IV Dog, Cat: IV, SC, IM 5. WITHDRAWAL PERIOD Withdrawal period(s): Horse (meat, offal, milk): zero days 6. BATCH NUMBER Lot {number} 7. EXPIRY DATE EXP {month/year} Once opened use within 28 days. 8. THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only version 2020/11 page 5 of 12 B. PACKAGE LEAFLET version 2020/11 page 6 of 12 PACKAGE LEAFLET FOR: Butorgesic 10 mg/ml solution for injection I1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: ADOH B.V. Godfried Bomansstraat 31 6543 JA Nijmegen The Netherlands Manufacturer responsible for batch release: CP-Pharma Handelsgesellschaft mbH Ostlandring 13 31303 Burgdorf Germany I2. NAME OF THE VETERINARY MEDICINAL PRODUCT Butorgesic 10 mg/ml solution for injection butorphanol I3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS 1 ml of solution for injection contains: Active substance: butorphanol 10.00 mg (as butorphanol tartrate 14.58 mg) Excipients: benzethonium chloride 0.10 mg Clear, colourless solution. I4. INDICATION(S) Horse: As an analgesic Relief of abdominal pain caused by colic of gastrointestinal origin. As a sedative (in combination) For therapeutic and diagnostic measures such as minor surgical procedures on the standing horse. For sedation in combination with certain α2-adrenoceptor-agonists (detomidine, romifidine). Dog: As an analgesic Relief of mild to moderate visceral pain and mild to moderate pain after soft tissue surgery. As a sedative (in combination) For deep sedation in combination with medetomidine. version 2020/11 page 7 of 12 As a pre-anaesthetic Pre-anaesthetic use of the product has resulted in a dose related reduction in the dose of induction anaesthetic agents. As an anaesthetic (in combination) As part of anaesthesia in combination with medetomidine and ketamine. Cat: As an analgesic To alleviate moderate postoperative pain after soft tissue surgery and minor surgical procedures. As a sedative (in combination) For deep sedation in combination with medetomidine. As an anaesthetic (in combination) As part of anaesthesia in combination with medetomidine and ketamine. I5. CONTRAINDICATIONS All target species Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in cases of severe dysfunctions of liver or/and kidney. Do not use in cases of head trauma or organic brain lesions as well in animals with obstructive respiratory disease, heart failure or spastic conditions. Horse: Butorphanol/detomidine hydrochloride combination: Do not use in horses with a pre-existing cardiac arrhythmia or bradycardia. The combination causes impaired movement of the gastrointestinal system and should therefore not be used in the case of colic associated with constipation. Do not use in horses with lung emphysema due to a possible breathing depressive effect. See also section 12. I6. ADVERSE REACTIONS There may be some pain on intramuscular injection. Horse: The most commonly observed side effect is slight ataxia (lack of voluntary coordination of muscle movements) which may persist for 3-10 minutes. Mild to severe ataxia may be encountered in combination with detomidine, but clinical studies have shown that horses are unlikely to collapse. Normal precautions should be observed to prevent patient self-injury. Mild sedation may occur in approximately 15% of horses following the administration of butorphanol as a sole agent. Intravenous bolus injection with the highest permissible dose may cause excitatory locomotor effects (e.g. walking around). Restlessness, tremors and sedation with subsequent restlessness has been observed in some horses. Butorphanol can lower the intestinal motility in horses (impaired movement of the gastrointestinal system), although the gastrointestinal passage time does not decrease. This effect is dose-dependent and usually minor and temporary. Butorphanol can stimulate motor activity (walking movements). When used in combination with α2-adrenoceptor-agonists (e.g. detomidine, romifidine), cardiopulmonary depression may occur, which in rare cases can be fatal. version 2020/11 page 8 of 12 Dog: Respiratory and cardiac depression (evidenced by the decrease in respiratory rate, the development of bradycardia and the decrease of the diastolic blood pressure) may occur, with the degree of depression being dose-dependent. A slight sedation can also occur. Transient ataxia, anorexia, and diarrhoea have been reported as occurring rarely. Gastrointestinal motility may be reduced. Cat: Respiratory depression may occur. Butorphanol can cause arousal, anxiety, confusion, dysphoria and mydriasis. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports) If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. Alternatively, you can report via your national reporting system {national system details}. I7. TARGET SPECIES Horse, dog and cat. I8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Horse: intravenously (IV). Dog and Cat: intravenous (IV), subcutaneous (SC) and intramuscular (IM). When administering as an intravenous injection, do no inject as a bolus. If repeat SC or IM administrations are required, use different injection sites. The rubber stopper should not be pierced more than 20 times. HORSE As an analgesic Monotherapy: 0.1 mg of butorphanol /kg (1 ml of product /100 kg) IV. The dose may be repeated as required. Analgesic effects are seen within 15 minutes of injection. As a sedative With detomidine: Detomidine hydrochloride: 0.012 mg/kg IV, followed within 5 minutes by Butorphanol: 0.25 ml/100 kg IV. With romifidine: Romifidine: 0.04 - 0.12 mg/kg IV, followed within 5 minutes by Butorphanol: 0.2 ml/100 kg IV. DOG version 2020/11 page 9 of 12 As an analgesic Monotherapy: 0.2-0.3 mg butorphanol /kg (0.02-0.03 ml of product /kg) IV, IM or SC injection. Administer 15 minutes before terminating anaesthesia to provide analgesia in the recovery phase. Repeat dose as required. As a sedative With medetomidine: Butorphanol: 0.01 ml/kg IV or IM Medetomidine: 0.01-0.025 mg/kg IV or IM. Allow 20 minutes for sedation to develop before commencing the procedure. As a pre-anaesthetic Monotherapy for canine analgesia: 0.1-0.2 mg butorphanol /kg (0.01-0.02 ml of product /kg) IV, IM or SC given 15 minutes prior to induction. As an anaesthetic In combination with medetomidine and ketamine: Butorphanol: 0.01 ml/kg IM Medetomidine: 0.025 mg/kg IM, followed after 15 minutes by Ketamine: 5 mg/kg IM. It is not advisable to reverse this combination in the dog with atipamezole. CAT As an analgesic Pre-operative: 0.4 mg butorphanol /kg (0.04 ml of product/ kg) IM or SC Administer 15-30 minutes prior to the administration of IV induction anaesthetic agents. Administer 5 minutes before induction with IM induction anaesthetic agents such as combinations of IM acepromazine/ketamine or xylazine/ketamine. See also section 5.1. for duration of analgesia. Post-operative: Administer 15 minutes before terminating anaesthesia to provide analgesia in the recovery phase: either 0.4 mg butorphanol /kg (0.04 ml of product /kg) SC or IM or: 0.1 mg butorphanol /kg (0.01 ml of product /kg) IV.
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