Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
oxytetracycline (oxytetracycline dihydrate)
Interchemie werken 'De Adelaar' B.V.
oxytetracycline (oxytetracycline dihydrate)
200mg/ml
solution for injection
Prescription
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-200 LA. PHARMACEUTICAL FORM: Solution for parenteral administration. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S): Each ml contains: - ACTIVE SUBSTANCE: oxytetracycline (as dihydrate) 200.0 mg. - EXCIPIENTS: benzyl alcohol 10.5 mg. INDICATIONS: Oxytetracycline belongs to the group of tetracyclines and acts bacteriostatic against many Gram-positive and Gram-negative bacteria like Bordetella, Campylobacter, Chlamydia, E. coli, Haemophilus, Mycoplasma, Pasteurella, Rickettsia, Salmonella, Staphylococcus and Streptococcus spp. The action of oxytetracycline is based on inhibition of bacterial protein synthesis. Oxytetracycline is mainly excreted in urine, for a small part in bile and in lactating animals in milk. One injection acts for two days. Limoxin-200 LA solution for parenteral administration is indicated for arthritis, gastrointestinal and respiratory infections caused by oxytetracycline sensitive micro-organisms like Bordetella, Campylobacter, Chlamydia, E. coli, Haemophilus, Mycoplasma, Pasteurella, Rickettsia, Salmonella, Staphylococcus and Streptococcus spp. in calves, cattle, goats, sheep and swine. 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: After intramuscular administration local reactions can occur, which disappear in a few days. Discoloration of teeth in young animals and hypersensitivity reactions may happen. Overdoses may result in re Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME LIMOXIN-200 LA 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT CONTENT SPECIFICATION Oxytetracycline base (as dihydrate) 200.0 mg/ml Ph. Eur. OTHER INGREDIENTS CONTENT SPECIFICATION Magnesium chloride hexahydrate 88.8 mg/ml Ph. Eur. Polyvidone 50.0 mg/ml Manufacturer’s specifications N-Methyl-2-pyrrolidone 0.36 ml/ml Manufacturer’s specifications Benzyl alcohol 0.01 ml/ml Ph. Eur. Monoethanolamine ad pH = 9.2 BP Water for injections ad 1 ml Ph. Eur. 3. PHARMACEUTICAL FORM Solution for parenteral administration. 4. PHARMACOLOGICAL PROPERTIES OXYTETRACYCLINE belongs to the group of tetracyclines and acts bacteriostatically against many Gram-positive and Gram-negative bacteria like Bordetella, Campylobacter, Chlamydia, E. coli, Haemophilus, Mycoplasma, Pasteurella, Rickettsia, Salmonella, Staphylococcus and Streptococcus spp. The action of oxytetracycline is based on inhibition of bacterial protein synthesis. Oxytetracycline is mainly excreted in urine, for a small part in bile and in lactating animals in milk. 5. CLINICAL PARTICULARS 5.0 Target species: Calves, cattle, goats, sheep and swine. 5.1 Indications. Arthritis, gastrointestinal and respiratory infections and arthritis caused by oxytetracycline sensitive micro-organisms, like Bordetella, Campylobacter, Chlamydia, E. coli, Haemophilus, Mycoplasma, Pasteurella, Rickettsia, Salmonella, Staphylococcus and Streptococcus spp. 5.2 Contra-indications. • Hypersensitivity to tetracyclines. • Administration to animals with a seriously impaired renal and/or hepatic function. • Concurrent administration of penicillins, cephalosporines, quinolones and cycloserine. 5.3 Undesirable effects. • After intramuscular administration local reactions can occur, which disappear in a few days. • Discoloration of teeth in young animals. • Hypersensitivity reactions. 5.4 Special precautions for use. None. 5.5 Use during pregnancy and lactation. No restrictions. 5.6 Interactions. Do not combine LIMOXIN-200 LA with Read the complete document