Parofor 70 000 IU/g Powder for Use in Drinking Water, Milk or Milk Replacer for Pre-Ruminant Cattle and Pigs

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Paromomycin

זמין מ:

Huvepharma N.V.

קוד ATC:

QA07AA06

INN (שם בינלאומי):

Paromomycin

טופס פרצבטיות:

Powder for use in drinking water

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Cattle, Pigs

איזור תרפויטי:

Antimicrobial

מצב אישור:

Authorized

תאריך אישור:

2014-09-17

מאפייני מוצר

Revised: September 2019
AN: 01429/2018
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Parofor 70 000 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
Revised: September 2019
AN: 01429/2018
Page 2 of 6
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 neona