For Animal Health Only
BUTOMIDOR 10 mg/ml
Solution for injection
COMPOSITION: 
It is a colorless and clear solution containing 14.58 g Butorphanol hydrogen tartrate equivalent to 10 mg Butorphanol per ml.Other components:Benzethonium chloride 0.1 mg, Sodium chloride, Water for injections
SPECIFIC CLINICAL INFORMATION AND WARNINGS FOR TARGET SPECIES:
Butorphanol should be used when short-term (horse and canine) and short- to medium-term (feline) analgesia are required. The dose can be repeated as needed. The repetition and timing of treatment varies depending on the clinical response. For information on the duration of analgesia, see the "Pharmacological Properties" section of the package insert.
Rapid intravenous injection should be avoided.
Do not mix the product with other veterinary medicinal products in the same syringe.
Necessary cautionary measures in contact with animals should be followed and stress factors for animals should be avoided. The individual response to butorphanol in cats can vary. In cases where an adequate analgesic response does not occur, an alternative analgesic agent should be used.
Increasing the dose may not affect the severity or duration of analgesia.
Special precautions for use in animals : The safety of the product in puppies, kittens and foals has not been established. The use of the product in these groups should be decided by the responsible veterinarian according to the risk-benefit analysis evaluation.
Due to its antitussive (cough suppressant) property, butorphanol may cause mucous accumulation in the respiratory tract. Therefore, in animals with respiratory diseases associated with increased mucous production, butorphanol should only be used after risk-benefit assessment by the responsible veterinarian. If respiratory depression occurs, naloxone can be used as an antidote.
The sedation effect can be noted in treated animals. The combination of Butorphanol and α2 adrenoceptor agonists should be used with caution in animals with cardiovascular disease. Anticholinergic drugs, eg. Like atropine, concurrent use should be considered.
Concomitant use of butorphanol and romifidine in a syringe should be avoided as increased bradycardia, heart block and ataxia may occur.
HORSE:Use of the product at the recommended dose may cause temporary ataxia and/or excitement.
Therefore, in order to protect patients and people from injury, care should be taken in choosing a place for treatment when treating horses.
CAT:Cats should be weighed to ensure the correct dose has been calculated. An appropriately sized syringe (eg, insulin syringe or 1 ml gauge syringe) should be used to allow accurate administration of the required dose volume. If re-administration is required, different injection sites should be selected.
Use in Racing Horses:Since the legal wash-out period (I.KAS) of butorphanol is in the range of five to seven days, the use should be discontinued at least 7 days before the competition.
Use during pregnancy and lactation:Butorphanol passes through the placenta and into milk. No teratogenic effects on the species were observed in laboratory studies.
The safety of this veterinary medicinal product has not been established in target species during pregnancy and lactation. The use of butorphanol is not recommended during pregnancy and lactation.
WARNINGS ABOUT DRUG RESIDUES IN FOOD:
Not applicable to animals with food value
GENERAL WARNINGS:
Consult your veterinarian in case of an unexpected effect after use and keep the product out of reach of children.
MEASURES TO BE TAKEN BY THE APPLICANT AND FOR THE DOCTORSWARNINGS: Butorphanol has an opioid-like effect. Precautions should be taken by the practitioner to avoid accidental injection/self-injection of this potent drug. Following an unintentional injection in humans; The most common adverse effects of butorphanol are drowsiness, sweating, nausea, drowsiness and dizziness. If the practitioner accidentally injects himself, medical attention should be sought immediately and the package insert or label should be shown to the doctor. Do not use a car. An opioid antagonist (eg, naloxone) can be used as an antidote. Immediately flush skin and eyes with water.
STORAGE CONDITIONS AND SHELF LIFE:
Keep out of reach and sight of children.
This veterinary medicinal product should be stored at temperatures below 25°C.
It should not be stored or frozen in the refrigerator and freezer.
Keep the vial in its outer box to protect it from light.
Do not use after the expiry date stated on the label.
Shelf life:It is 36 months.
Shelf life from first opening of inner container:28 days
WARNINGS FOR END DISPOSAL AND NON-TARGET SPECIES: 
Any unused product or waste material should be disposed of according to national requirements.
METHOD OF COMMERCIAL PRESENTATION:
It is offered for sale in 1 x 10 ml, 5 x 10 ml, 10 x 10 ml, 1 x 50 ml bromobutyl rubber stoppers and clear glass vials with aluminum caps.
PLACE AND CONDITIONS OF SALE: 
It is sold in pharmacies, veterinary clinics, polyclinics and animal hospitals only with a veterinary doctor's prescription.