Tulissin - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Tulissin 100 mg/ml solution for injection for cattle, pigs and sheep

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

VIRBAC

1ère avenue 2065m LID

06516 Carros

France

Manufacturers responsible for batch release:

VIRBAC

1ère avenue 2065m LID

06516 Carros

France

FAREVA

Zone Industrielle,

29 route des Industries

37530 Pocé-sur-Cisse

France

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Tulissin 100 mg/ml solution for injection for cattle, pigs and sheep.

tulathromycin

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each ml contains:

Active substance:

Tulathromycin 100 mg

Excipients:

Monothioglycerol

Clear colourless to slightly coloured solution.

Cattle

Treatment and metaphylaxis of bovine respiratory disease associated with Mannheimia haemolytica , Pasteurella multocida, Histophilus somni and Mycoplasma bovis susceptible to tulathromycin. The presence of the disease in the group must be established before the product is used.

Treatment of infectious bovine keratoconjuncti­vitis (IBK) associated with Moraxella bovis susceptible to tulathromycin.

Pigs

Treatment and metaphylaxis of swine respiratory disease associated with Actinobacillus pleuropneumoniae , Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica susceptible to tulathromycin. The presence of the disease in the group must be established before the product is used. The veterinary medicinal product should only be used if pigs are expected to develop the disease within 2–3 days.

Sheep

Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.

• 5. CONTRAINDI­CATIONS

Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients.

• 6. ADVERSE REACTIONS

Subcutaneous administration of the veterinary medicinal product to cattle causes very commonly transient pain reactions and local swellings at the injection site that can persist for up to 30 days. No such reactions have been observed in pigs and sheep after intramuscular administration.

Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are very common for approximately 30 days after injection in cattle and pigs.

In sheep, transient signs of discomfort (head shaking, rubbing injection site, backing away) are very common after intramuscular injection. These signs resolve within a few minutes.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Cattle, pigs and sheep.

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Cattle

Subcutaneous use.

A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).

For treatment of cattle over 300 kg bodyweight, divide the dose so that no more than 7.5 ml are injected at one site.

Pigs

Intramuscular use.

A single intramuscular injection in the neck of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).

For treatment of pigs over 80 kg bodyweight, divide the dose so that no more than 2 ml are injected at one site.

Sheep

Intramuscular use.

A single intramuscular injection in the neck of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).

• 9. ADVICE ON CORRECT ADMINISTRATION

For any respiratory disease, it is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection. If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved.

To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing. When treating groups of animals in one run, use a draw-off needle or an automatic dosing device to avoid excess broaching. The stopper may be safely punctured up to 20 times.

• 10. WITHDRAWAL PERIOD(S)

Cattle (meat and offal): 22 days.

Pigs (meat and offal): 13 days.

Sheep (meat and offal): 16 days.

Not authorised for use in lactating animals producing milk for human consumption.

Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.

Shelf life after first opening the container: 28 days.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

Cross resistance occurs with other macrolides. Do not administer simultaneously with antimicrobials with a similar mode of action such as other macrolides or lincosamides.

Sheep:

The efficacy of antimicrobial treatment of foot rot might be reduced by others factors, such as wet environmental conditions, as well as inappropriate farm management. Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment.

Antibiotic treatment of benign foot rot is not considered appropriate. Tulathromycin showed limited efficacy in sheep with severe clinical signs or chronic foot rot, and should therefore only be given at an early stage of foot rot.

Special precautions for use in animals:

Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Official, national and regional antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the package leaflet may increase the prevalence of bacteria resistant to tulathromycin and may decrease the effectiveness of treatment with other macrolides, lincosamides and group B streptogramins, due to the potential for cross resistance. If a hypersensitivity reaction occurs, appropriate treatment should be administered without delay.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Tulathromycin is irritating to eyes. In case of accidental eye exposure, flush the eyes immediately with clean water.

Tulathromycin may cause sensitisation by skin contact resulting in e.g. reddening of the skin (erythema) and/or dermatitis. In case of accidental spillage onto skin, wash the skin immediately with soap and water.

Wash hands after use.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

If there is suspicion of a hypersensitivity reaction following accidental exposure (recognised by e.g. itching, difficulty in breathing, hives, swelling on the face, nausea, vomiting) appropriate treatment should be administered. Seek medical advice immediately and show the package leaflet or the label to the physician.

Pregnancy and lactation:

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.

Interaction with other medicinal products and other forms of interaction: None known.

Overdose (symptoms, emergency procedures, antidotes):

In cattle at dosages of three, five or ten times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake. Mild myocardial degeneration has been observed in cattle receiving fiv e to six times the recommended dose.

In young pigs weighing approximately 10 kg given three or five times the therapeutic dose, transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness. Lameness was also observed when the hind leg was used as the injection site.

In lambs (approx. 6 weeks old), at dosages of three or five times the recommended dose, transient signs attributed to injection site discomfort were observed and included walking backwards, head shaking, rubbing the injection site, lying down and getting up, bleating.

Incompatibili­ties:

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ().

Pack sizes:

Cardboard box containing 1 vial of 20 ml.

Cardboard box containing 1 vial of 50 ml.

Cardboard box containing 1 vial of 100 ml.

Cardboard box containing 1 vial of 250 ml with or without a protective sleeve.

Cardboard box containing 1 vial of 500 ml with or without a protective sleeve.

Not all pack sizes may be marketed.

500 ml vials must not be used for pigs and sheep.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

Belgie/Belgiqu­e/Belgien VIRBAC BELGIUM NV Esperantolaan 4 BE-3001 Leuven Tél/Tel : +32-(0)16 387 260	Lietuva VIRBAC 1ère avenue 2065 m LID FR-06516 Carros Prancüzija Tel: +33-(0)4 92 08 73 00
PenySnuKa EBnrapun VIRBAC 1ere avenue 2065 m LID FR-06516 Carros OpaH^ua Ten: +33-(0)4 92 08 73 00	Luxembourg/Lu­xemburg VIRBAC BELGIUM NV Esperantolaan 4 BE-3001 Leuven Belgique / Belgien Tél/Tel: +32-(0)16 387 260
Česká republika VIRBAC 1ere avenue 2065 m LID FR-06516 Carros Francie	Magyarország VIRBAC HUNGARY KFT Szent Istvàn krt.11.II/21. HU-1055 Budapest Tel: +36703387177

Tel: +33-(0)4 92 08 73 00

Danmark VIRBAC Danmark A/S Profilvej 1 DK-6000 Kolding Tlf: +45 75521244	Malta VIRBAC 1ere avenue 2065 m LID FR-06516 Carros Franza Tel: + 33-(0)4 92 08 73 00
Deutschland VIRBAC Tierarzneimittel GmbH Rögen 20 DE-23843 Bad Oldesloe Tel: +49-(4531) 805 111	Nederland VIRBAC Nederland BV Hermesweg 15 NL-3771 ND-Barneveld Tel : +31-(0)342 427 127
Eesti VIRBAC 1ere avenue 2065 m LID FR-06516 Carros Prantsusmaa Tel: +33-(0)4 92 08 73 00	Norge VIRBAC Danmark A/S Profilvej 1 DK-6000 Kolding Danmark Tel: + 45 75521244
EZZaöa VIRBAC HELLAS A.E. 13o 7/41 E.O. A0nvóv – Aapiag EL-14452, MeTapnppoon Tql: +30 2106219520	Österreich VIRBAC Österreich GmbH Hildebrandgasse 27 A-1180 Wien Tel: +43-(0)1 21 834 260
España VIRBAC ESPAÑA SA Angel Guimerá 179–181 ES-08950 Esplugues de Llobregat (Barcelona) Tel. : + 34-(0)93 470 79 40	Polska VIRBAC Sp. z o.o. ul. Pulawska 314 PL 02–819 Warszawa Tel.: + 48 22 855 40 46
France VIRBAC France 13e rue LID FR-06517 Carros Tél : 0805 05 55 55	Portugal VIRBAC de Portugal Laboratorios LDA R.do Centro Empresarial Ed13-Piso 1– Esc.3 Quinta da Beloura PT-2710–693 Sintra Tel: + 351 219 245 020
Hrvatska VIRBAC 1ere avenue 2065 m LID FR-06516 Carros Francuska Tel: + 33-(0)4 92 08 73 00	Romania VIRBAC 1ere avenue 2065 m LID FR-06516 Carros Franta Tel: + 33-(0)4 92 08 73 00
Ireland VIRBAC 1ere avenue 2065m LID FR-06516 Carros France Tel: + 33-(0)4 92 08 73 00	Slovenija VIRBAC 1ere avenue 2065 m LID FR-06516 Carros Francija Tel : + 33-(0)4 92 08 73 00

Slovenská republika

VIRBAC

1ere avenue 2065 m LID

FR-06516 Carros

Francúzsko

Tel: + 33-(0)4 92 08 73 00

Suomi/Finland

VIRBAC

1ere avenue 2065 m LID

FR-06516 Carros

Puh/Tel : + 33-(0)4 92 08 73 00

Sverige

VIRBAC Danmark A/S Filial Sverige

SE-171 21 Solna

Tel: +45 75521244

United Kindgom (Northern Ireland)

VIRBAC

1ere avenue 2065 m LID

FR-06516 Carros

France

+ 33-(0)4 92 08 73 00

PACKAGE LEAFLET:

Tulissin 25 mg/ml solution for injection for pigs

• i. name and address of the marketing authorisation holder and OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

VIRBAC

1ère avenue 2065m LID

06516 Carros

France

Manufacturers responsible for batch release:

VIRBAC

1ère avenue 2065m LID

06516 Carros

France

FAREVA

Zone Industrielle,

29 route des Industries

37530 Pocé-sur-Cisse

France

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Tulissin 25 mg/ ml solution for injection for pigs

tulathromycin

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each ml contains:

Active substance:

Tulathromycin 25 mg

Excipients:

Monothioglycerol

Clear colourless to slightly coloured solution.

Treatment and metaphylaxis of swine respiratory disease associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Mycoplasma hyopneumoniae , Haemophilus parasuis and Bordetella bronchiseptica susceptible to tulathromycin. The presence of the disease in the group must be established before the product is used. The veterinary medicinal product should only be used if pigs are expected to develop the disease within 2–3 days.

5. CONTRAINDI­CATIONS

Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients.

Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are present for approximately 30 days after injection.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Pigs.

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Intramuscular use.

A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/10 kg bodyweight) in the neck.

For treatment of pigs over 40 kg bodyweight, divide the dose so that no more than 4 ml are injected at one site.

• 9. ADVICE ON CORRECT ADMINISTRATION

For any respiratory disease, it is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection. If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved.

To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing. When treating groups of animals in one run, use a draw-off needle or an automatic dosing device to avoid excess broaching. The stopper may be safely punctured up to 30 times.

• 10. WITHDRAWAL PERIOD(S)

Meat and offal: 13 days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.

Shelf life after first opening the container: 28 days.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

Cross resistance occurs with other macrolides. Do not administer simultaneously with antimicrobials with a similar mode of action such as other macrolides or lincosamides.

Special precautions for use in animals:

Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Official, national and regional antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the package leaflet may increase the prevalence of bacteria resistant to tulathromycin and may decrease the effectiveness of treatment with other macrolides, lincosamides and group B streptogramins, due to the potential for cross resistance. If a hypersensitivity reaction occurs, appropriate treatment should be administered without delay.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Tulathromycin is irritating to eyes. In case of accidental eye exposure, flush the eyes immediately with clean water.

Tulathromycin may cause sensitisation by skin contact resulting in e.g. reddening of the skin (erythema) and/or dermatitis. In case of accidental spillage onto skin, wash the skin immediately with soap and water.

Wash hands after use.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

If there is suspicion of a hypersensitivity reaction following accidental exposure (recognised by e.g. itching, difficulty in breathing, hives, swelling on the face, nausea, vomiting) appropriate treatment should be administered. Seek medical advice immediately and show the package leaflet or the label to the physician.

Pregnancy and lactation:

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.

Interaction with other medicinal products and other forms of interaction: None known.

Overdose (symptoms, emergency procedures, antidotes):

In young pigs weighing approximately 10 kg given three or five times the therapeutic dose transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness. Lameness was also observed when the hind leg was used as the injection site.

Incompatibili­ties:

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED