Tyluvet 20% w/v, Solution for Injection

Summary of Product characteristics

                                Revised: February 2010
AN: 02037/2008
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Tyluvet 20% w/v, Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances
per ml
% w/v
Tylosin
200 mg
20
Excipients
Benzyl Alcohol
41.66 mg
4.166
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
_A clear, sterile, yellow solution._
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment in pigs of diseases involving organisms sensitive to
tylosin,
such
as
swine
erysipelas
(_Erysipelothrix _
_rhusiopathiae_),
and
pneumonia
(_Mycoplasma hyopneumoniae_)
4.3
CONTRAINDICATIONS
Not to be used in animals known to be hypersensitive to the active
ingredient.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Not applicable
Revised: February 2010
AN: 02037/2008
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Not recommended for horses.
Use of the product deviating from the instruction given in the SPC may
increase the prevalence of bacteria resistant to tylosin and may
decrease the
effectiveness of treatment with other macrolide antimicrobials, due to
potential
for cross resistance.
Official, national and regional antimicrobial policies should be taken
into
account when the product is used.
ii.
Special precautions to be taken by the person administering the
product
Care should be taken to avoid accidental self-injection. If accidental
self-
injection
occurs,
seek
medical
attention
immediately.
In
the
event
of
accidental skin contact, wash thoroughly with soap and water. In case
of
accidental eye contact, flush the eyes with plenty of clean, running
water.
Wash hands after use. Tylosin may induce irritation. Macrolides, such
as
tylosin, may also cause hypersensitivity (allergy) following
injection, inhalation,
ingestion or contact with skin or eye. Hypersensitivity to tylosin may
lead to
cross reactions to other macrolides and vice versa. Allergic reactions
t
                                
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