MARBOSOL 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

MARBOFLOXACIN

Mevcut itibaren:

CP-Pharma Handelsgesellschaft mbH

ATC kodu:

QJ01MA93

INN (International Adı):

MARBOFLOXACIN

Doz:

100 Mg/Ml

Farmasötik formu:

Solution for Injection

Reçete türü:

POM

Terapötik grubu:

Bovine, Porcine

Terapötik alanı:

Marbofloxacin

Terapötik endikasyonlar:

Antibacterial

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2013-01-11

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbosol 100 mg/ml solution for injection for cattle and pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
Active substance:
Marbofloxacin
100 mg
Excipients:
Metacresol
2 mg
Monothioglycerol
1 mg
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
Treatment of respiratory infections caused by susceptible strains of _Pasteurella multocida_, _Mannheimia haemolytica_
and _Histophilus somni_.
Treatment of acute mastitis caused by _Echerichia coli _strains susceptible to marbofloxacin during the lactation period.
Pigs:
Treatment of Metritis Mastitis Agalactia Syndrome (MMA syndrome, postpartum dysgalactia syndrome, PDS) caused
by bacterial strains susceptible to marbofloxacin.
4.3 CONTRAINDICATIONS
Do not use in case of bacterial infections with resistance to other fluoroquinolones (cross resistance).
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Efficacy data have shown an insufficient efficacy of the product for the treatment of acute mastitis caused by Gram
positive strains.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 01/06/2016_
_CRN 7021352_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones
should be reserved for the treatment of clinical conditions which have respond