Hypersol 500 mg/g Powder for Use in Drinking Water

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Oxytetracycline

Available from:

Huvepharma SA

ATC code:

QJ01AA06

INN (International Name):

Oxytetracycline

Pharmaceutical form:

Powder for use in drinking water

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2013-05-10

Summary of Product characteristics

Revised: March 2020
AN: 01520/2019
Page 1 of 7
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
1 g of product contains:
ACTIVE SUBSTANCE
Oxytetracycline (as hydrochloride)
500 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
-
Powder for use in drinking water
-
Yellow powder
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers, breeding hens) and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In chickens (broilers, breeding hens) and pigs:
-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 herd/group should be established before
the product
is used.
4.3 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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: March 2020
AN: 01520/2019
Page 2 of 7
4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
This powder should be dissolved in water, before use.
Use of the product should be based on susceptibility testing of
bacteria isolates from
the animal. If not possible, therapy should be based on local
(regional, farm level)
epidemiological information about susceptibility of the target
bacteria.
Official, national and regional antimicrobial policies should be taken
into account
when the product is used.
Use of the 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
enter