Water Soluble Powders

Oxytetracicline hydrochloride, powder for swine, poultry and fish.

NAME OF THE MANUFACTURING AUTHORISATION HOLDER: SC DELOS IMPEX ’96 SRL, Str. Horia, Cloşca şi Crişan, nr. 81, Otopeni, jud. Ilfov, Tel: 0372.714.433, Fax: 0372.714.460.

NAME OF THE VETERINARY MEDICINAL PRODUCT: OXIDEM 50, 500 mg oxytetracicline hydrochloride /g, powder for swine, poultry and fish.

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS: 1 gram OXIDEM50 contains: Oxytetracicline hydrochloride 500 mg (equivalent to 463 mg oxytetracicline – as base –), Excipient (lactose monohydrate) qs. ad. 1 g

INDICATIONS

In swine: Oxidem 50 is indicated for the treatment of gastrointestinal and respiratory infections caused by susceptible bacteria of the genera: Mycoplasma spp., Pasteurella spp., Actinobacillus spp., Haemophilus spp., Campylobacter spp. (Lawsonia intracellularis), Erysipebatchhrix spp., Leptospira spp., Listeria spp., Streptococcus spp. si Fusobacterium spp.

In poultry: Oxidem 50 is indicated for the treatment of gastrointestinal and respiratory infections caused by susceptible bacteria of the genera: Mycoplasma spp., Pasteurella spp., Streptococcus spp., Haemophilus spp., Borellia spp., Campylobacter spp. and Chlamydia spp.
In fish: for treatment of bacterial disease produced by oxytetracycline-susceptible strains ofAeromonas salmonicida, Aeromonas liquefaciens, Haemophilus piscium, Flavobacterium columnare, Pseudomonas fluorescens, Yersinia ruckeri in many fish species from: fam. Cyprinidae (carp, crucian carp etc), Salmonidae (salmon, trout, rainbow trout etc), atlantic cod (Gadus morhua), Red pacu (Colossoma brachypomum), Acipenseridae (sturgeons), Stiluridae (cat fish), ornamental fish species (Herotilapia multispinosa, Pterophyllum scalare, Brachydanio rerio etc) and many other fish species.

CONTRAINDICATIONS : Do not administer to animals with known hypersensitivity to tetracyclines. Do not administer to animals with renal failure.

 

ADVERSE REACTIONS: Sometimes, at animals with renal failure may develop adverse reaction which may manifest in the following clinical signs: anorexia, vomiting, diarrhea, abdominal cramps, painful defecation; Any toxic phenomena are due to high concentrations of oxytetracycline in blood and tissue that occur after administer excessive doses, repeated at smaller intervals than recommended in the instructions or in case of severe renal insufficiency. Gastrointestinal tract: anorexia, vomiting, diarrhea, abdominal colic, pancreatitis, given a long time can lead to enteritis staphylococcal or candidiasis (mouth, gut, lung). Teeth: dental pigmentation, caries, dental enamel hypoplasia on young, newborn and infants whose mothers received oxytetracycline during pregnancy or after birth.

TARGET SPECIES: Swine, poultry and fish.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

In poultry: therapeutically dosage is 20-40 mg oxytetracycline base / kg body weight / day (21,6 – 43,2 mg oxytetracycline hydrochloride / kg body weight / day, corresponding to 43-86 mg Oxidem 50 / kg body weight / day) administered in drinking water for 3-5 consecutive days .
In swine: therapeutically dosage is 20-40 mg oxytetracycline base / kg body weight / day (21,6 – 43,2 mg oxytetracycline hydrochloride / kg body weight / day, corresponding to 43-86 mg Oxidem 50 / kg body weight / day) administered in drinking water for 3-5 consecutive days.
In fish: the therapeutically dosage is 80 mg/kg body weight. The product is administered via feed, at dosage of 16 g Oxidem 50 /100 kg fish for 4-8 consecutive days. For youngsters, mix together 40 g Oxidem 50 with 50 kg of feed and administer continuously for 4-8 days. As bath (tanks, aquariums etc) administer in dosage of 43 mg Oxidem 50 /1 liter of water. Based on the recommended doses and the number and weight of the animals to be treated, the exact daily amount of Oxidem 50 should be calculated according to the following formula:

In drinking water:

Oxidem 50 apa

In feed:

Oxidem 50 furaj

The uptake of medicated water or feed is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in feed may have to be adjusted.

ADVICE ON CORRECT ADMINISTRATION: During treatment, the animals should drink only medicated water and eat only medicated feed .

WITHDRAWAL PERIOD: For meat and organs (swine, poultry): 28 days after the last treatment. For fish meat: 60 days over 12° and 90 days under 12° C. For eggs: 3 days after the last treatment.

SPECIAL PRECAUTIONS FOR STORAGE: In original packaging, at room temperature (15–25oC), protected from moisture and direct sunlight.

Keep away from reach and sight of children!

SPECIAL WARNINGS

People with known hypersensitivity to any of the product ingredients should avoid contact with the veterinary medicinal product.

To prevent any unpleasant effects, personal protective equipment consisting in gloves, eye-glasses and protective masks, should be worn when handling the product. In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as face swelling, lips or eye lids, accompanied by breath difficulties, need immediate medical attention.

Whenever is possible, the treatments should be done based on susceptibility testing. If that isn’t possible, the treatment should be done as per official and local antimicrobial policies.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

For the environmental protection, the veterinary medicinal product should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

March 2012

OTHER INFORMATION

Presentation: bags of 10 g, 25 g, 100 g, 500 g, 1000 g, 5 kg, 10 kg, sacks of 25 kg, 50 kg. Not all pack size may be marketed

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorization holder.