국가: 이스라엘
언어: 영어
출처: Ministry of Health
FLUNIXIN AS MEGLUMINE; OXYTETRACYCLINE AS DIHYDRATE
COMEX LTD
SOLUTION FOR INJECTION
OXYTETRACYCLINE AS DIHYDRATE 30 %W/V; FLUNIXIN AS MEGLUMINE 2 %W/V
I.M
Required
NORBROOK LABORATORIES LIMITED, NORTHERN IRELAND
Hexasol veterinary may be of use in the treatment of disease caused by microorgamisms sensitive to oxytetracycline where anti-inflammatory, anti-pyretic, and anti bacterial effect is required.
2022-03-31
VETERINARY MEDICINE USER LEAFLET Veterinarian Prescription Only Medicine For Animal Use Only 1. NAME AND FORM OF THE VETERINARY MEDICINE: _HEXASOL VETERINARY, SOLUTION FOR INJECTION _ 2. ACTIVE INGREDIENTS: Each 1 ml of the medicine contains: _Oxytetracycline (as dihydrate) _ _300 mg _ _ _ _Flunixin (as flunixin meglumine) _ _ 20 mg _ The medicine also contains the excipient: Sodium Formaldehyde Sulphoxylate 0.4% w/v For a full list of excipients, see section 13 “Further Information”. 3. INDICATIONS FOR USE: Hexasol Veterinary is used in the treatment of disease caused by microorganisms sensitive to oxytetracycline where anti-inflammatory, anti- pyretic and anti-bacterial effect is required. THERAPEUTIC GROUP: Antibacterial, anti-inflammatory non-steroidal drug. 4. CONTRAINDICATIONS: Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding or where there is hypersensitivity to the product. Avoid use in dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity. Do not administer other NSAIDs concurrently, or within 24 hours of each other. Concurrent use of potentially nephrotoxic drugs should be avoided. Do not exceed the stated dose or duration of treatment. 5. ADVERSE REACTIONS: The use of tetracyclines during the period of tooth and bone development, including late pregnancy, may lead to discolouration. Although the product is well tolerated, occasionally a local reaction of a transient nature may be observed. Hypersensitivity reactions (collapse) may occur very rarely. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening. Side effects can be reported to the Ministry of Health by clicking on the link “Reporting adverse events due to drug treatment” found on the home page of the Ministry of Health website (www.health.gov.il), which refers to the online form for reporting adverse events, or by entering the link: https 전체 문서 읽기
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Hexasol Veterinary 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ACTIVE SUBSTANCE _ Oxytetracycline (as dihydrate) 30% w/v [300 mg/ml] Flunixin (as flunixin meglumine) 2.0% w/v [20 mg/ml] _EXCIPIENTS _ Sodium Formaldehyde Sulphoxylate 0.4 % w/v For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. A clear dark amber solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES: Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES: Hexasol Veterinary is used in the treatment of disease caused by microorganisms sensitive to oxytetracycline where anti-inflammatory, anti- pyretic and anti bacterial effect is required. 4.3 CONTRAINDICATIONS: Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding or where there is hypersensitivity to the product. Page 2 of 6 Avoid use in dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity. Do not administer other NSAIDs concurrently, or within 24 hours of each other. Concurrent use of potentially nephrotoxic drugs should be avoided. Do not exceed the stated dose or duration of treatment. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES: None known. 4.5 SPECIAL PRECAUTIONS FOR USE: SPECIAL PRECAUTIONS FOR USE IN ANIMALS: Avoid intra-arterial injection. Use in any animals less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided, animals may require a reduced dosage and careful clinical management. It is preferable that prostaglandin inhibiting drugs are not administered to animals undergoing general anaesthesia until fully recovered. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT TO THE ANIMALS: Avoid eye contact and direct contact with skin. To avoid possible sensitisation reactions, avoid contact with skin. Gloves should be worn during appl 전체 문서 읽기