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ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
NAME OF VETERINARY MEDICINAL PRODUCT
COLINDOX 100,
100mg/g - premix for medicated feed for swine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g product contains:
Active ingredient:
tiamuline
100 mg
(from tiamulin hydrogen fumarate 125 mg)
Eccipients:
colouring agent E122 2 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Premix for medicated feed
4.
CLINICAL INFORMATION
4.1
Target species
Swine
4.2
Indications for use, specifying the target species
Mycoplasmosis, enzoothic pneumonia (M. hyopneumoniae, M. hyorhinis,
P. multocida, Haemophilus spp., Actynomyces pyogenes, Staphylocccus
spp. And Streptococcus spp), and superficial necrotic enteritis
(Brachyspira hyodysenteriae) caused by tiamulin-susceptible bacteria.
4.3
Contraindications
Do not use in case of hypersensitivity to active substance or to any of
the excipients.
4.4
Special warnings for each target species
The intake of the drug by the animals may be altered according to the
type and severity of the disease. Animals which show a reduced appetite
for feed should be treated through the parental route, with an injectable
product prescribed by the veterinarian.
Repeated or prolonged use of the product has to be avoided, by
increasing the hygiene management through cleaning and disinfection.
4.5
Special precautions for use
Special precautions for use in animals:
If it’s possible, tiamulin has to be used after the indication of
antibiograms. Any use of the product different to what is included in the
Summary of the Product Characteristics, could lead to the prevalence of
bacteria resistant to tiamulin.
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Special precautions to be taken by the person administering the
veterinary medicinal product to animals
The product has a controlled emission factor with reduction of the dust
exposure risks; it’s suggested to avoid direct contact.
Handling the product wearing protective clothes, gloves and mask; do
not inhale. Avoid the contact with skin and eyes. Rinse thoroughly with
water and soap in case of accidental contact with eyes or skin.
Do not eat, drink or smoke during handling; wash hands after use.
Persons with known hypersensitivity to the active substance should
avoid contact with the veterinary medicinal product.
4.6
Adverse reactions (frequency and seriousness)
There could be possible alteration of the bacterial intestinal flora,
diarrhoea and soft faeces.
Rare cases of hypersensitive to tiamulin may occur with acute dermatitis,
cutaneous erythemas and intense itching. If these undesired effects
appear, immediately stop the treatment and consult the veterinarian.
If any very severe adverse reactions or other reaction not mentioned in
this SPC occur, please inform the veterinarian.
4.7
Use during pregnancy, lactation or lay
During pregnancy and during lactation, use only accordingly to the
benefit/risk assessment by the responsible veterinarian.
4.8
Interaction with other medicinal products and other forms of
interaction.
The concomitant administration of ionophores (monensin, nararasin,
salinomycin) and tiamulin, causes in swine toxic phenomena
accompanied by anatomohistopathology alterations.
Therefore in swine feed do not administer ionophore products with
tiamulin treatments unless the ionophores will be added to the swine
feed at least 7 days after or before the treatment, otherwise severe
nanism or death can occur.
Tiamulin can reduce the antibacterial activity of beta-lactamic antibiotics
whose the efficacy depends of the bacterial multiplication.
Rarely, in swine tiamulin can cause hypersensitivity reactions when
administrated with feed contaminated by mycotoxins.
4.9 Amount to be administrated and administration route
The medicinal product has to be administrated accurately mixed in feed
at the dosage of 1.25 – 2 g/kg of feed (equivalent to 125 - 200 mg
tiamulin/kg of feed), corresponding to 4-10 mg of active substance/kg
b.w., for 3-5 days.
To ensure the administration of a correct dosage of the medicinal
product, the
animal body weight has to be accurately evaluated to avoid any subdosage. Use calibrated means to achieve the right dosage.
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4.10
4.11
Overdose (symptoms, emergency procedures, antidotes), if n
necessary
Data not available. Do not exceed the recommended doses.
Withdrawal period(s)
Meat and offals: 10 days
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic Group:systemic antibiotics - pleuromutiline
ATCvet Code: QJ01XQ01
5.1
Pharmacodynamic properties
Tiamulin is an semi-synthetic antibiotic from the pleuromuline class
with bacteriostatic activity. Mechanism of action: inhibition of the
bacterial protein synthesis by link to bacterial ribosomal subunit 50S.
Tiamulin shows an in vitro efficacy against a wide range of
pathogenic microorganism, such us:
Mycoplasmas
M. gallisepticum MIC 0.05-0.1 µg/ml,
M. hyopneumoniae MIC 0.03-0.06 µg/ml,
M. hyorhinis MIC 0.2-0.78 µg/ml,
M. hyosinoviae MIC 0.013-0.1 µg/ml,
M. synoviae MIC 0.05-0.1 µg/ml;
Gram-positive
Clostridium perfringens MIC 0.39-0.78 µg/ml,
Erysipelotrix spp. MIC 2.5-3.12 µg/ml,
Listeria monocytogenes MIC 3.12-5 µg/ml,
Staphylococcus spp. MIC 0.5-2 µg/ml,
Streptococcus spp. MIC 0.039-0.062 µg/ml);
Gram-negative
A.pleuropneumoniae MIC 8-32 µg/ml,
Brachyspira hyodysenteriae MIC 0.016-32 µg/ml,
Klebsiella pneumoniae MIC 0.062-2.5 µg/ml,
Lawsonia intracellularis MIC 4 µg/ml,
Leptospira spp. MIC 0.07-2.5 µg/ml.
5.2
Pharmacokinetic particulars
After oral administration, tiamulin is absorbed very quickly and almost
completely (about 90% of the administered dose); serum peak is achieved in
2 to 6 hours.
Once absorbed, the drug distributes in all tissues, with the highest
concentration at lungs level; the metabolytes are bacteriologically inactive,
and excreted mostly through the bile and less through the urine.
After the administration of a single dose of 10 mg or 25 mg of a.s. tiamulin/Kg
b.w., the obsverved Cmax values, microbiologically evaluated, were 1.03 μg/ml
and 1.82 μg/ml respectvely, and the Tmax was achieved in 2 hours for both
dosages.
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The observed AUC after administration of 10 mg active substance/Kg b.w., by
gavage or through medicated feed (180 ppm), was respectively of 0.88 and
2.5 μg.h/ml.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Vaseline oil.
Sorbitole 70%.
Colouring agent E122.
Hazel nut fibre.
6.2 Incompatibilities
In absence of compatibility studies, do not mix with other veterinary drugs.
6.3 Shelf life
Shelf life of the veterinary medicinal product packaged for sale: 24 months.
Shelf life after first opening of the immediate packaging: 30 days
Shelf life after incorporation into meal or pelleted feed: 60 days
6.4 Special precautions for storage
This veterinary medicinal product does not require any special temperature
storage conditions.
After each use, keep the container tighly closed to protect the medicinal
product from light and humidity.
6.5 Nature and composition of immediate packaging
Multilayer paper bag, internally aluminated, containing 20Kg of product.
6.6 Special precautions for the disposal of the unused veterinary
medicinal product or waste materials from the use of such
products
Any unused veterinary medicinal product or waste materials derived from
such veterinary medicinal product should be disposed of in accordance with
local requirements.
7.
Marketing Authorisation Holder
DOX-AL ITALIA SPA
Largo Donegani 2 -20121 Milano
8.
Μarketing authorisation number
CY00079V
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9.
Date of first Authorisation/Renewal of the authorization
30/4/2004,16/7/2015
10. Date of revision of the text
16/7/2015
Mode of use
To be sold and used only upon veterinary prescription
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