Taneven LC 3 g intramammary suspension for cattle

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Benzylpenicillin procaine monohydrate

Dostopno od:

WDT - Wirtschaftsgenossenschaft deutscher Tierarzte eG,

Koda artikla:

QJ51CE09

INN (mednarodno ime):

Benzylpenicillin procaine monohydrate

Odmerek:

3 gram(s)

Farmacevtska oblika:

Intramammary suspension

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtsko območje:

procaine benzylpenicillin

Status dovoljenje:

Authorised

Datum dovoljenje:

2020-07-24

Lastnosti izdelka

Health Products Regulatory Authority
20 January 2022
CRN00CMNT
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Taneven LC 3 g intramammary suspension for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 intramammary syringe (20 g) contains:
​
ACTIVE SUBSTANCE: ​
​
Benzylpenicillin (procaine) monohydrate
​
3 g
​
(equivalent to 1.7 g benzylpenicillin) ​
​
​
EXCIPIENTS:​ ​
​
Procaine hydrochloride
​
0.20 g
​
Sodium metabisulfite
​
0.02 g
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary suspension
White to off-white homogenous suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (lactating cows)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of clinical mastitis caused by benzylpenicillin-susceptible
streptococci and staphylococci in lactating cows.
4.3 CONTRAINDICATIONS
Do not use in cases of
- infections with ß-lactamase producing pathogens
- hypersensitivity to penicillins, other beta-lactam antibiotics or to
any of the excipients.
- severe renal dysfunction with anuria or oliguria
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
In case of mastitis with systemic clinical signs, additionally an
appropriate parenteral antimicrobial should be administered.
Particular attention should be paid to _Staphylococcus aureus _udder
infections, which require to distinguish between acute and
chronic udder infections prior treatment. Culling of animals which
have been identified to suffer from chronic _Staphylococcus _
_aureus _udder infections might be preferred over treatment.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the 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, national and regional antimicrobial policies should be taken
into account when the produ