SUMMARY OF PRODUCT CHARACTERISTICS

1. Product Name

Amix Vet T 100/33 mg/g premix

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances

Tiamulini fumaras 3,3%

Chlortetracyclini hydrochloridum 10,0%

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Premix for medicated feed

4. PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmaco-therapeutic group: Veterinary premix

ATCvet cod: Q07AH

AUREOMIX 133 T premix is premix containing tiamulin and chlortetracycline. The product has a wide spectrum of antibacterial activity against gram positive and negative bacteria

The mode of action is by inhibition of ribosomal protein synthesis in sensitive bacteria.

Minimal inhibition concentration (MIC) of Chlortetracycline hydrochloride against some pathogenic bacteria:

Pathogen	MIC
Pasteurella multocida	0.1-0.5 mcg/ml
Streptococcus suis	0.025-0.1 mcg/ml
Streptococcus suis	0,45 mcg/ml
Actinobacillus pleuropneumoniae	0.39-0.45 mcg/ml *)

*) = MIC ₉₀

Tiamulin MIC against Mycoplasma hyopneumoniae is (MIC 0.13 mcg/ml), Pasteurella multocida (MIC 0.8 mcg/ml) and Hemophilus parasuis (MIC 0.9 mcg/ml).

Pharmacokinetic properties

Following oral administration, tiamulin hydrogen fumarate is rapidly absorbed and peak serum concentrations are achieved 2 – 4 hours after administration and concentrations in some tissues e.g. lung. Following administration, it is rapidly metabolised and excreted.

5. Clinical properties

5.1 Target species

Pigs

1. Indication

For treatment and prevention of respiratory and enetric infections associated with organisms sensitive to chlortetracycline and tiamulin (for example enzootic pneumonia, pleuropneumonie, hemophilic polyserositis, atrophic rhinitis, swine dysentery , E. coli infection, necrotic enteritis, secondary bacterial infections to swine viral diseases.

5.3 Contra-indications

Animals should not receive products containing monensin, narasin or salinomycin, during or for at least three days before or after treatment at dose level 3-4,5 kg/tone.

The lower dose level is compatible with such products.

5.4 Adverse reactions (frequency and seriousness)

On rare occasions erythema or mild oedema of the skin may occur in pigs following the use of tiamulin hydrogen fumarate.

5.5 Zvláštní opatření pro použití

When mixing, direct contact with the skin and eyes should be avoided by wearing impermeable rubber gloves and safety glasses

It should be kept out of reach of children.

5.6 Use during pregnancy, lactation or lay

Suitable for use in pigs during pregnancy and lactation

5.7 Interaction with other medicinal products and other forms of interaction

Products containing monensin, narasin or salinomycin, are incompatible

5.8 Amount(s) to be administered and administration route

Therapeutic dosage:

The dose is 180 mg tiamulin hydrogen fumarate per kg body weight daily

An inclusion rate of 3 kg Premix (equivalent to 300 g tiamulin hydrogen fumarate) per 1 tonne administered for 7 to 10 days.

For treatment of pleuropneumoni (A. pleuropneumoniae):

The dose is 270 mg tiamulin hydrogen fumarate per kg body weight daily

An inclusion rate of 4,5 kg Premix (equivalent to 450 g tiamulin hydrogen fumarate) per 1 tone administered for 7 to 10 days.

5.9 Overdosage

The product shows a wide margin of safety.

5.10 Special precautions for use in animals

To be used in pig rations only

5.11 Withdrawal time

Meat – 10 days

5.12 Special precautions for the person administering the veterinary medicinal product to animals

When mixing, direct contact with the skin and eyes should be avoided by wearing impermeable rubber gloves and safety glasses

6. PHARMACEUTICAL PARTICULARS

6.1 Incompatibilities

With products contains monensin, narasin a salinomycin.

6.2 Shelf life

Shelf-life of finished product: 2 years

Shelf-life after opening: 30 days

Shelf-life when incorporated into meal feed: 3 months

6.3. Special precautions for storage

Store at temperatre up to 25 °C, in dry places , keep out of chlidren

6.4 Nature and composition of immediate packaging

Polyethylene-lined paper bags

6.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused product or waste material should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

Cymedica spol. s r.o.

Hořovice

Czech Republic

1. MARKETING AUTHORISATION NUMBER(S):

In Czech Republic

98/165/98-C

In Slovak Republic

98/041/04-S