Tylovet 20% w/v Solution for injection for cattle and pigs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Tylosin

Dostopno od:

Eurovet Animal Health B.V.

Koda artikla:

QJ01FA90

INN (mednarodno ime):

Tylosin

Odmerek:

20 percent weight/volume

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Cattle, Pigs

Terapevtsko območje:

tylosin

Terapevtske indikacije:

Antibacterial

Status dovoljenje:

Authorised

Datum dovoljenje:

1988-10-01

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tylovet 20% w/v Solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injections contains:
Active substance:
Tylosin (as tylosin tartrate)
200 mg
Excipients:
Benzyl alcohol
40 mg
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by microorganisms susceptible
to tylosin. The spectrum of antimicrobial activity
of tylosin includes:_ Staphylococcus_ spp.;_ Streptococcus_ spp.;_
Corynebacterium_ spp.:_ Neisseria_ spp.;_ Flavobacterium_
spp.;_ Campylobacter_ spp.;_ Bacillus anthracis; Moraxella bovis;
Clostridium_ spp.;_ Haemophilus_ spp.;_ Bordetella_
_bronchiseptica; Spirochaetes_;_ Bacteroides_ spp.;_ Mycoplasma_ spp.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
any other macrolide antibiotics or to any of the
excipients.
Do not use in new-born animals.
Do not use in equine species.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_3_
_/_
_1_
_2_
_/_
_2_
_0_
_1_
_6_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_5_
_4_
_3_
_7_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
This prod