Parofor 140 mg/ml solution for use in drinking water, milk or milk replacer for pre-ruminant cattle and pigs

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Paromomycin

Disponible depuis:

Huvepharma NV

Code ATC:

QA07AA06

DCI (Dénomination commune internationale):

Paromomycin

Dosage:

140 milligram(s)/millilitre

forme pharmaceutique:

Oral solution

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Cattle, Pigs

Domaine thérapeutique:

paromomycin

indications thérapeutiques:

Antibiotics

Statut de autorisation:

Authorised

Date de l'autorisation:

2017-08-04

Résumé des caractéristiques du produit

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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Parofor 140 mg/ml solution for use in drinking water, milk or milk
replacer for pre-ruminant cattle
and pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 1 ml:
ACTIVE SUBSTANCE:
Paromomycin sulfate 200 mg, equivalent to paromomycin base 140 mg or
140.000 IU of paromomycin activity
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
1.0 mg
Propyl parahydroxybenzoate
0.1 mg
Sodium metabisulphite (E223)
4.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for use in drinking water, milk or milk replacer.
A clear yellow to amber solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (pre-ruminant calves), pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of gastro-intestinal infections caused by
_Escherichia coli_
.
4.3
CONTRAINDICATIONS
Do not use in animals with 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
Cross-resistance has been shown between paromomycin and some
antimicrobials in the
aminoglycosides class in Enterobacterales. Use of the product should
be carefully considered when
susceptibility testing has shown resistance to aminoglycosides because
its effectiveness may be
reduced.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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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.
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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 nephro