Land: Armenien
Sprog: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
oxytetracycline (oxytetracycline hydrochloride)
Interchemie werken De Adelaar Eesti AS
QD06AA03
oxytetracycline (oxytetracycline hydrochloride)
25mg/ml
spray
200ml spray can
Prescription
Registered
2018-10-03
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT: Marketing authorisation holder: Manufacturer and batch releaser: Interchemie werken “De Adelaar” B.V. Interchemie werken “De Adelaar” Eesti AS Metaalweg 8 Vanapere tee 14 5804 CG Venray Viimsi, Harju county The Netherlands Estonia NAME PRODUCT: Limoxin-25 spray. PHARMACEUTICAL FORM: A blue solution for external administration; antiseptic spray for external (topical) administration. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S): Each ml contains: - ACTIVE SUBSTANCE: oxytetracycline hydrochloride 25.0 mg. INDICATIONS: External skin, teat, hoof and paw infections caused by oxytetracycline sensitive micro-organisms, like _Bordetella_, _Campylobacter_, _Chlamydia_, _E_. _coli_, _Haemophilus_, _Mycoplasma_, _Pasteurella_, _Rickettsia_, _Salmonella_, _Staphylococcus_ and _Streptococcus_ spp. CONTRA-INDICATIONS: Hypersensitivity to tetracyclines. Administration to animals with a seriously impaired renal and/or hepatic function. Concurrent administration of penicillins, cephalosporins, quinolones and cycloserine. TARGET SPECIES: Calves, cattle, goats, sheep and swine. ADVERSE REACTIONS: Hypersensitivity reactions. DOSAGE AND ADMINISTRATION: Spray one or two times a day from a distance of 15 - 20 cm. SPECIAL WARNINGS Pressurized container. Protect from direct sunlight and do not expose to temperatures exceeding 50 ºC. do not spray towards or close to the eyes. Do not pierce or burn before or after use. WITHDRAWAL TIMES: None. PACKAGING: Spraycan of 200 ml. SHELF LIFE AND STORAGE INSTRUCTIONS: Limoxin-25 spray has a 3-year shelf life when stored dark at 15 - 25 C. KEEP OUT OF REACH AND SIGHT OF CHILDREN! LEGAL STATUS FOR SUPPLY: Prescription only medicine (POM-V). Læs hele dokumentet
PART I: SUMMARY OF DOSSIER I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Limoxin-25 spray 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Oxytetracycline hydrochloride 25 mg/ml 3. PHARMACEUTICAL FORM Limoxin-25 spray is an antiseptic spray for external administration. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Calves, cattle, goats, sheep and swine. 4.2 INDICATIONS External skin, teat, hoof and paw infections caused by oxytetracycline sensitive micro- organisms, like _Bordetella_, _Campylobacter_, _Chlamydia_, _E. _ _coli_, _Haemophilus_, _Mycoplasma_, _ Pasteurella_, _ Rickettsia_, _ Salmonella_, _ Staphylococcus_ and _ Streptococcus_ spp. 4.3 CONTRA-INDICATIONS Hypersensitivity to tetracyclines. Administration to animals with a seriously impaired renal and/or hepatic function. Concurrent administration of penicillins, cephalosporins, quinolones and cycloserine. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special pecautions for use in animals Do not spray in or around the eyes. Special precautions to be taken by the person administering the veterinary medicinal product to animals Because of possible sensitisation and contact dermatitis, direct skin contact has to be avoided during administration. Do not incinerate or puncture the spraycan. Do not expose to temperatures above 50 °C. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Hypersensitivity reactions may occur. 4.7 USE DURING PREGNANCY AND LACTATION No restrictions. 4.8 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Do not combine Limoxin-25 Spray with other external formulations. 4.9 AMOUNT(S) TO BE ADMINISTERED AND ADMINISTRATION ROUTE Spray one or two times a day from a distance of 15 - 20 cm. 4.10 OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF NECESSARY Not relevant for this external formulation. 4.11 WITHDRAWAL PERIODS None. 5. PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Oxytetracycline belongs Læs hele dokumentet