Parofor 70000 IU/g powder for use in drinking water, milk or milk replacer for pre-ruminant cattle and pigs

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Paromomycin

Fáanlegur frá:

Huvepharma NV

ATC númer:

QA07AA06

INN (Alþjóðlegt nafn):

Paromomycin

Skammtar:

70000 international unit(s)/gram

Lyfjaform:

Powder for use in drinking water

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Cattle, Pigs

Lækningarsvæði:

paromomycin

Ábendingar:

Antibiotics

Leyfisstaða:

Authorised

Leyfisdagur:

2014-09-12

Vara einkenni

Health Products Regulatory Authority
06 September 2019
CRN008V67
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Parofor 70000 IU/g powder for use in drinking water, milk or milk
replacer for pre-ruminant cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 1 gram:
ACTIVE SUBSTANCE:
70,000 IU of paromomycin activity (as paromomycin sulfate)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water, milk or milk replacer
A white to almost white powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (pre-ruminant calves), pig.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of gastro-intestinal infections caused by _Escherichia coli_
susceptible to paromomycin.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to paromomycin, other
aminoglycosides or any of the excipients.
Do not use in cases with impaired function of the kidneys or liver.
Do not use in ruminating animals.
Do not use in turkeys due to the risk of selection for antimicrobial
resistance in intestinal bacteria.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The uptake of medication by animals can be altered as a consequence of
illness. In case of insufficient uptake of water/milk
animals should be treated parenterally using a suitable injectable
product following the advice of the veterinarian.
The use of the product should be combined with good management
practices e.g. good hygiene, proper ventilation, no
overstocking.
Since the product is potentially ototoxic and nephrotoxic, it is
recommended to assess kidney function.
Special care should be taken when considering administration of the
product to newborn animals due to the known higher
gastrointestinal absorption of paromomycin in neonates. This higher
absorption could lead to an increased risk of oto-and
nephrotoxicity. The use of the product in neonates should be based on
benefit-ri