TRIMETOXIN VETERINARY

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

SULFADIMETHOXINE; TRIMETHOPRIM

Disponibbli minn:

ROMAT LTD

Għamla farmaċewtika:

SOLUTION (ORAL)

Kompożizzjoni:

TRIMETHOPRIM 40 MG/G; SULFADIMETHOXINE 200 MG/G

Rotta amministrattiva:

PER OS

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

CHEMIPHARMA S.P.A., ITALY

Indikazzjonijiet terapewtiċi:

Broilers and turkeys: Treatment of respiratory and urogenital infections caused by micro-organisms gram-positive and gram-negative sensitive to sulfamides and trimethoprim.

Data ta 'l-awtorizzazzjoni:

2021-07-31

Fuljett ta 'informazzjoni

CONSUMER LEAFLET FOR A VETERINARY PRODUCT
This medicine is marketed according to a veterinarian’s prescription
only.
For animal use only
1.
NAME OF THE VETERINARY MEDICINE, FORM AND STRENGTH
Trimetoxin veterinary, solution for administration in drinking water,
for Broilers
and Turkeys.
2.
ACTIVE SUBSTANCES and their quantity in a dose unit
SULFADIMETHOXINE 200 mg/g
TRIMETHOPRIM 40 mg/g
For the list of inactive ingredients in the preparation, see Section
13
“Additional information”
3.
WHAT IS THE MEDICINE INTENDED FOR?
Broilers and turkeys: Treatment of respiratory and urogenital
infections
caused by microorganisms gram-positive and gram-negative sensitive to
sulfamides and trimethoprim.
Therapeutic group:
Trimethoprim - bacteriostatic antibiotic
Sulfadimetoxine - antibiotic of the sulphonamide group
4.
CONTRA-INDICATIONS
Do not use for a prolonged period.
Not to be used in animals sensitive to sulphonamides, trimethoprim or
to any
of the other ingredients of the medicine (see Section 13 “Additional
information”).
Not to be used in egg-laying hens.
5.
SIDE EFFECTS
Cases of anaphylactic reactions (acute allergic reactions) are
possible in
sensitive animals.
Side effects can be reported to the Ministry of Health by clicking on
the link
"Adverse Drug Reactions Repot" that appears on the home page of the
Ministry of Health web site (www.health.gov.il), which leads to an
online form
for reporting side effects. Alternatively you can use the following
link:
https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=adv
[e-mail]
6.
TARGET ANIMALS: Broilers and turkeys
7.
DOSAGE AND ADMINISTRATION
Administration in drinking water - according to the instructions in
Section 8.
Dosage:
For broilers and turkeys, in drinking water, 10.0 - 20.0 g for every
100 kg of
body weight (equivalent to 2.0 - 4.0 g of sulfadimethoxine + 0.4 - 0.8
g
trimethoprim for every 100 kg body weight) according to the age,
weight and
water consumption of the animals, for 5 consecutive days.
8.
HOW TO USE THE PROD

Karatteristiċi tal-prodott

1
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
TRIMETOXIN VETERINARY
2. QUALITATIVE-QUANTITATIVE COMPOSITION
1 g contains:
Active substances:
Trimethoprim
40
mg
Sulfadimethoxine
200
mg
For a full list of excipients, see section 6.1.
3.PHARMACEUTICAL FORM
Solution for oral use to be diluted in drinking water.
4. CLINICAL INFORMATION
4.1 TARGET SPECIES
Broilers and turkeys
4.2 INDICATIONS FOR USE
Broilers and turkeys: Treatment of respiratory and urogenital
infections caused by microorganisms
gram-positive and gram-negative sensitive to sulfamides and
trimethoprim.
4.3 CONTRAINDICATIONS
Do not administer for a protracted period.
Do not administer to animals sensitive to sulphonamides or to any of
the excipients listen in section 6.1.
Do not administer to laying hens.
4.4. SPECIAL WARNINGS
Use only after having ascertained the sensitivity of the germs to the
active principle. It is recommended to
make an antibiogram before starting the treatment.
4.5 SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
None.
ii.
Specail precautions to be taken by the person administering the
veterinary medicinal product to
animals
Avoid direct contact with the product while handling it.
4.6 ADVERSE REACTIONS
Some anaphylactic cases in sensitive subjects may occur.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal
product. Any suspected adverse events
should be reported to the Ministry of Health according to the National
Regulation by using an online form
https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=[e-mail]
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Do not administer to animals producing eggs for human food
consumption.
2
4.8 INTERACTIONS WITH OTHER DRUGS AND OTHER FORMS OF INTERACTION
None
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Remove from the drinking trou