Tylovectin 200 Solution for Injection for Cattle, Goats and Pigs

Composition

Each ml contains:

Active substance:

Tylosin 200 000 IU

Excipients:

Benzyl alcohol (E1519) 40 mg

6.1 List of excipients

Benzyl alcohol (E1519)

Propylene glycol (E1520)

Water for injections

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Pharmaceutical form

Solution for injection.

A pale yellow to amber-coloured liquid.

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Pharmacological properties

Pharmacotherapeutic group: antibacterials for systemic use, macrolides

ATC Vet Code: QJ01FA90

5.1 Pharmacodynamic properties

Tylosin is a macrolide antibiotic with a pKa of 7.1 and structurally similar to erythromycin. It is produced by Streptomyces fradiae. Tylosin has a low solubility in water.

Tylosin exerts its antibiotic activity by a similar mechanism to other macrolides, i.e. by binding the 50 S fraction of the ribosomes resulting, in an inhibition of the synthesis of proteins. Tylosin has mainly a bacteriostatic activity.

Tylosin has an antibiotic effect against Gram positive cocci (Staphylococci, Streptococci), Gram positive bacilli, certain Gram-negative bacilles and Mycoplasma.

Resistance to macrolides is usually plasmid-mediated but modification of ribosomes may occur through chromosomal mutation. Resistance can occur by i) decreased entry into bacteria (most common with the gram-negative bacteria), ii) synthesis of bacterial enzymes that hydrolyze the drug and, iii) modification of the target (the ribosome).

This latter resistance type may also lead to cross-resistance with other antibiotics that preferentially bind to bacterial ribosome. Gram-negative anaerobic bacteria are often resistant.

5.2 Pharmacokinetic particulars

Absorption:

Following intramuscular injection, tylosin blood levels peak 3-4 hours post-injection.

Distribution, Biotransformation and Elimination:

The maximum concentration in milk of cattle and sows is 3 -6 times higher than the blood concentration about 6 hours following injection. In bovine and porcine lungs maximum tylosin concentrations of 7-8 times higher than the maximum concentrations in serum were found at 6 -24 hours following intramuscular injection.

In cattle (whether in heat or not) the Mean Residence Time (MRT) in uterus secretions of tylosin injected by intravenous route at a dose rate of 10 mg/kg was about 6 -7 times higher than the one measured in serum. This illustrates that in uterine secretions a single tylosin injection at a dose rate of 10 mg/kg during 24 hours can result in concentrations exceeding the MIC 90 of tylosin for Arcanobacterium pyogenes, one of the pathogens frequently isolated when metritis is diagnosed in cattle.

Elimination:

Tylosin is eliminated in unchanged form in bile and urine.

Environmental properties

Tylosin is persistent in some soils

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Target species

Cattle, goats and pigs.

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Indications

For the treatment of specific infections (listed below) caused by microorganisms susceptible to tylosin.

Cattle (ruminants):

Respiratory infections, metritis caused by Gram-positive microorganisms, mastitis caused by Streptococcus spp, Staphylococcus spp and interdigital necrobacillosis, i.e. panaritium or foot rot.

Cattle (calves)

Respiratory infections and necrobacillosis.

Pigs:

Enzootic pneumonia, haemorrhagic enteritis, erysipelas and metritis.

Arthritis caused by Mycoplasma spp. and Staphylococcus spp.

For information regarding swine dysentery see section 4.5.

Goats:

Respiratory infections, metritis caused by Gram-positive microorganisms, mastitis caused by Gram-positive microorganisms or Mycoplasma spp.

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Dosage

For intramuscular or slow intravenous (cattle only) injection

Cattle (ruminants) and cattle (calves): 5 000 - 10 000 IU tylosin/kg bodyweight per day for 3 days (2.5 to 5 ml solution for injection per 100 kg bodyweight).

Maximum injection volume per injection site should not exceed 15 ml in cattle.

Goats: 10 000 IU tylosin/kg bodyweight per day for 3 days (5 ml solution for injection per 100 kg bodyweight).

Pigs: 5 000 IU to 10 000 IU of tylosin per kg bodyweight per day during 3 days, i.e 2.5 to 5 ml of solution per 100 kg bodyweight.

In pigs do not administer more than 5 ml per injection site.

To ensure a correct dosage, body weight should be determined as accurately as possible.

The closures should not be broached more than 15 times. In order to prevent excessive broaching of the stopper, a suitable multiple dosing device should be used.

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Contraindications

Do not administer to chickens, turkeys or horses.

Do not use in cases of hypersensitivity to the active substance, other macrolides or any of the excipients.

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Adverse reactions

Cattle:

Very rare (<1 animal / 10.000 animals treated, including isolated report(s)):

- Injection site swelling, injection site inflammation

- Swollen vulva

- Anaphylactic shock

- Death

Undetermined frequency (cannot be estimated from available data):

- Hypersensitivity reaction

- Injection site lesion1

Can persist for up to 21 days following administration

Pigs:

Very rare (<1 animal / 10.000 animals treated, including isolated reports):

- Injection site swelling, Injection site inflammation

- Anaphylactic shock

- Rectal oedema

- Erythema

- Pruritus

- Rectal prolapse (partial)

- Death

Undetermined frequency (cannot be estimated from available data):

- Hypersensitivity reaction

- Injection site lesion2

Can persist for up to 21 days following administration

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for use in animals

Due to likely variability (time, geographical) in susceptibility of bacteria to tylosin, bacteriological sampling and susceptibility testing are recommended. Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used

Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to tylosin and may decrease the effectiveness of treatment with other macrolide antibiotics due to the potential for cross resistance.

A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the veterinary medicinal product will not be sufficiently efficacious against swine dysentery.

The efficacy data do not support the use of tylosin for the treatment of bovine mastitis caused by Mycoplasma spp.

Where repeat injections are to be administered, use different sites for each injection.

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

Care should be taken to avoid accidental self-injection.

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

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.

People with known hypersensitivity to tylosin, benzylalcohol or propylene glycol should avoid contact with the veterinary medicinal product.

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 to these substances may occasionally be serious and therefore direct contact should be avoided.

If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

Special precautions for the protection of the environment

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy:

Studies in laboratory animals have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. No studies have been conducted in the target species. Use only according to the benefit/risk assessment by the responsible veterinarian.

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Interactions

None known.

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Overdose

Pigs and cattle (calves): Intramuscular injection of 30 mg/kg bodyweight per day (three times maximum recommended dose) for five days produced no adverse effects.

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Special warnings

None.

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Withdrawal period

Cattle:

Meat and offal – 28 days

Milk – 108 hours

Goat:

Meat and offal – 42 days

Milk – 108 hours

Pigs:

Meat and offal – 16 days

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Incompatibilities

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

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Immediate packaging

The veterinary medicinal product is presented in 50ml, 100 ml or 250 ml Type II colourless glass bottles, sealed with a bromobutyl stopper and aluminium cap supplied in a carton. One bottle per carton.

Not all pack sizes may be marketed.

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Storage

Do not store above 25 °C.

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening of the immediate packaging: 28 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

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Additional information

Vm 30282/5011

9 DATE OF FIRST AUTHORISATION

28 November 2018

10 DATE OF REVISION OF THE TEXT

December 2023

PROHIBITION OF SALE, SUPPLY AND/OR USE

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Approved 08 December 2023

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Registration holder

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

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