Pharmasin 100% w/w Granules for Use in Drinking Water for Pigs, Chickens, Turkeys and Calves

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Tylosin

Available from:

Huvepharma N.V.

ATC code:

QJ01FA90

INN (International Name):

Tylosin

Pharmaceutical form:

Granules for use in drinking water

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Chickens, Pigs, Turkeys

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2011-04-06

Summary of Product characteristics

                                Revised: March 2016
AN: 00632/2015
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pharmasin 100 % w/w Granules for Use in Drinking Water
for Pigs, Chickens, Turkeys and Calves.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1.1 g of granules contains
Active substance:
1000 mg of tylosin (equivalent to 1100 mg of tylosin tartrate)
3.
PHARMACEUTICAL FORM
Granules for use in drinking water.
White to light yellow coloured granules.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Calves, pigs, chickens, turkeys
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Calves: Treatment and prevention of pneumonia caused by _ Mycoplasma
spp _ when the
disease has been established in the herd.
Pigs:
Treatment
and
prevention
of
enzootic
pneumonia
caused
by
_Mycoplasma _
_hyopneumoniae_ and _Mycoplasma hyorhinis _when the disease has been
established in the
herd.
Treatment and prevention of Porcine Intestinal Adenomatosis (Ileitis)
associated with
_Lawsonia intracellularis _when the disease has been established in
the herd.
Chickens: Treatment and prevention of chronic respiratory diseases
(CRD) caused by
_Mycoplasma _
_gallisepticum_
and
_Mycoplasma _
_synoviae _
when
the
disease
has
been
established in the flock.
Treatment and prevention of necrotic enteritis caused by _Clostridium
perfringens_ when the
disease has been established in the flock
Turkeys:
Treatment
and
prevention
of
infectious
sinusitis
caused
by
_Mycoplasma _
_gallisepticum. _when the disease has been established in the flock
Revised: March 2016
AN: 00632/2015
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to tylosin or other
macrolides.
Do not use in cases of known resistance to tylosin or cross-resistance
to other macrolides
(MLS-resistance).
Do not use in animals vaccinated with tylosin-sensitive vaccines
either at the same time or
within 1 week previously.
Do not use in animals with hepatic disorders.
Do not use in horses because of danger for inflammation of the caecum.
4.4
S
                                
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