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

Страна: Великобритания

Език: английски

Източник: VMD (Veterinary Medicines Directorate)

Активна съставка:

Paromomycin Sulfate

Предлага се от:

Ceva Animal Health Ltd

АТС код:

QA07AA06

INN (Международно Name):

Paromomycin Sulfate

Лекарствена форма:

Solution for use in drinking water/milk

Вид предписание :

POM-V - Prescription Only Medicine – Veterinarian

Терапевтична група:

Cattle, Pigs

Терапевтична област:

Antimicrobial

Статус Оторизация:

Authorized

Дата Оторизация:

2018-04-10

Данни за продукта

Unlimited Renewal : May 2023
AN : 00012/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gabbrovet 140 mg/ml solution for use in drinking water, milk or milk
replacer for
pre-ruminant cattle and pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Paromomycin (as sulfate)
140 mg
(equivalent to 140 000 IU of paromomycin activity)
(equivalent to approximately 200 mg of paromomycin sulfate)
EXCIPIENTS:
Benzyl alcohol
(E1519)
7.5 mg
Sodium metabisulfite
(E223)
3.0 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for use in drinking water, milk or milk replacer
Pale yellow to yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (pre-ruminant cattle), pigs
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 animals with known 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.
Unlimited Renewal : May 2023
AN : 00012/2023
Page 2 of 6
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