Pharmasin 20000 IU/g Oral Granules for Pigs

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Tylosin

Tersedia dari:

Huvepharma N.V.

Kode ATC:

QJ01FA90

INN (Nama Internasional):

Tylosin

Bentuk farmasi:

Granules

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Pigs

Area terapi:

Antimicrobial

Status otorisasi:

Authorized

Tanggal Otorisasi:

2009-11-04

Karakteristik produk

Revised: July 2020
AN: 01504/2019
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pharmasin 20 000 IU/g Oral Granules for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
Active substance:
Tylosin (as tylosin phosphate) : 20 000 IU
Excipients:
For the full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Granules
Light tan coloured, free flowing granules.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
Pigs:
-
Treatment and metaphylaxis of clinical signs of porcine proliferative
enteritis (porcine intestinal adenomatosis, proliferative hemorrhagic
enteropathy, ileitis) associated with Lawsonia intracellularis when
the
disease has been diagnosed at the group level.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substance
and/or to any of the excipients of the product.
Do not use in animals with known hypersensitivity to tylosin and other
macrolides.
Do not use where cross-resistance to other macrolides (MLS resistance)
is
suspected.
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 – danger of inflammation of the cecum.
Revised: July 2020
AN: 01504/2019
Page 2 of 5
4.4
SPECIAL WARNINGS (FOR EACH TARGET SPECIES)
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
This product is only for administration in small quantities of feed
for
immediate consumption, to individual animals. Animals with acute
infections may have a reduced feed intake and should be treated with a
suitable injectable product first.
‘Due to likely variability (time, geographical) in susceptibility of
bacteria
for tylosin, bacteriological sampling and susceptibility testing are
recommended.
Inappropriate use of the veterinary medicinal product may increase the
prevalence of bacteria resistant to Tylosin and other macrolid