Parofor 140 mg/ml Solution for Use in Drinking Water, Milk or Milk Replacer for Pre-ruminant Cattle and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Paromomycin

Available from:

Huvepharma NV

ATC code:

QA07AA06

INN (International Name):

Paromomycin

Pharmaceutical form:

Solution for use in drinking water/milk

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2017-07-25

Summary of Product characteristics

Unlimited renewal: August 2022
AN: 01734/2021 & 01735/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Revised: August 2022
AN: 01734/2021 & 01735/2021
Page 2 of 6
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
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