Hypersol 500 mg/g Powder for use in Drinking water

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxytetracycline

Available from:

HUVEPHARMA SA

ATC code:

QJ01AA06

INN (International Name):

Oxytetracycline

Dosage:

500 milligram(s)/gram

Pharmaceutical form:

Oral powder

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens, Pigs

Therapeutic area:

oxytetracycline

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-05-31

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HYPERSOL 500 mg/g Powder for use in Drinking water
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g of product contains:
ACTIVE SUBSTANCE :
Oxytetracycline (as hydrochloride)
500 mg
EXCIPIENT :
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Citric acid, anhydrous
Yellow powder for use in drinking water
3.
CLINICAL INFORMATION
3.1. TARGET SPECIES
Chickens (broilers, breeding hens) and pigs.
3.2. INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment and metaphylaxis at the group level of septicaemia,
respiratory and gastrointestinal infections
caused by bacteria sensitive to oxytetracycline.
The presence of disease in the group should be established before the
veterinary medicinal product is
used.
3.3. CONTRAINDICATIONS
Do not use in cases of hypersensitivity to oxytetracycline or any
other substance from tetracyclines
group.
Do not use in cases of known tetracycline resistance.
3.4. SPECIAL WARNINGS
None.
3.5. SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
This powder should be dissolved in water before use.
Use of the veterinary medicinal product should be based on
identification and susceptibility testing of
the target pathogen(s). If not possible, therapy should be based on
local epidemiological information
and knowledge of susceptibility of the target pathogens at farm level,
or at local/regional level.
Use of the veterinary medicinal product should be in accordance with
official, national and regional
antimicrobial policies. Use of the veterinary medicinal product
deviating from the instructions given in
the SPC may increase the prevalence of bacteria resistant to the
oxytetracycline and may decrease the
effectiveness of treatment with tetracyclines, due to the potential
for cross-resistance.
Prolonged or repeated use should be avoided as these practises can
enforce development and spread
of the bacterial resistance. This is particularly likely in
enterobacteria and _ Salmonella spp._, many of
which are already re