AQUATET 100 %W/W ORAL POWDER
Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
03-06-2024
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Virkt innihaldsefni:
OXYTETRACYCLINE HYDROCHLORIDE
Fáanlegur frá:
Pharmaq Ltd.
ATC númer:
QJ01AA06
INN (Alþjóðlegt nafn):
OXYTETRACYCLINE HYDROCHLORIDE
Skammtar:
100 %w/w
Lyfjaform:
Oral Powder
Gerð lyfseðils:
POM
Meðferðarhópur:
Fish - (Atlantic) Salmon
Lækningarsvæði:
Oxytetracycline
Ábendingar:
Antibacterial
Leyfisstaða:
Authorised
Leyfisdagur:
1996-03-22
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Aquatet 100%w/w Oral Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Oxytetracycline hydrochloride 100 %w/w
3 PHARMACEUTICAL FORM
Oral powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Salmon.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and control of furunculosis due to _Aeromonas salmonicida _in Atlantic salmon.
4.3 CONTRAINDICATIONS
Fish must not be slaughtered for human consumption during treatment.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Medicated feed should be used for the treatment period only.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS:
Avoid inhaling dust, wear rubber gloves and a dust mask which at least complies with European Standard EN149, FFP2 to
avoid inhalation of any
dust particles.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
No adverse effects are observed when the product is administered at normal dose.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 16/07/2014_
_CRN 7015201_
_page number: 1_
4.7 USE DURING PREGNANCY, LACTATION OR LAY
This product may be used on broodstock.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Do not administer together with Growth Promoters or other antibiotics.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
FOR ORAL ADMINISTRATION.
Administer orally via the food at a dose rate of 75mg/kg bodyweight daily, initially for 4 days. After the initial
treatment mortalities should be assessed and a further 4 days course of treatment should be adm
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