Revozyn RTU 400 mg/ml Suspension for Injection for Cattle

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Penethamate Hydriodide, micronised

Fáanlegur frá:

Eurovet Animal Health B.V.

ATC númer:

QJ01CE90

INN (Alþjóðlegt nafn):

Penethamate Hydriodide, micronised

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cattle

Lækningarsvæði:

Antimicrobial

Leyfisstaða:

Authorized

Leyfisdagur:

2017-07-10

Vara einkenni

Revised: April 2022
AN: 02009/2021 & 02011/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Revozyn RTU 400 mg/ml suspension for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml suspension contains:
ACTIVE SUBSTANCE:
Penethamate hydriodide
400 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
A white to yellowish white oily suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (lactating cows).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of clinical and subclinical mastitis in lactating cows
caused by
staphylococci and streptococci, sensitive to penicillin.
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance,
or to any of
the excipients.
Do not administer by intravenous injection.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the veterinary medicinal product should be based on
susceptibility testing of
the bacteria isolated from the animal.
If this is not possible, therapy should be based on local (regional,
farm level)
epidemiological information about susceptibility of the target
bacteria.
Official and local antimicrobial policies should be taken into account
when the
veterinary medicinal product is used.
Revised: April 2022
AN: 02009/2021 & 02011/2021
Page 2 of 5
Use of the veterinary medicinal product deviating from the
instructions given in the
SPC may increase the prevalence of bacteria resistant to
benzylpenicillin and may
decrease the effectiveness of treatment with other beta-lactams due to
the potential
for cross-resistance.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
This veterinary medicinal product can cause sensitisation and contact
dermatitis.
Hypersensitivity to penicillins may lead to cross reactions to
cephalosporins, and _vice _
_versa_.
Allergic reactions to these sub