Zuprevo - patient leaflet, side effects, dosage

Patient leaflet - Zuprevo

B. PACKAGE LEAFLET

PACKAGE LEAFLET FOR:

ZUPREVO 40 mg/ml solution for injection for pigs

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

Marketing authorisation holder :

Intervet International B. V.

Wim de Körverstraat 35

5831 AN Boxmeer

The NETHERLANDS

Manufacturer for the batch release :

Intervet International GmbH

Feldstrasse 1 a

85716 Unterschleissheim

GERMANY

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

ZUPREVO 40 mg/ml solution for injection for pigs tildipirosin

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

The veterinary medicinal product is a clear yellowish solution for injection containing 40 mg/ml of tildipirosin

4. INDICATIONS

Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensitive to tildipirosin.

The presence of the disease in the herd should be confirmed before metaphylaxis is implemented.

5. CONTRAINDICATIONS

Do not use in case of hypersensitivity to macrolide antibiotics, citric acid monohydrate or propylene glycol.

Do not administer intravenously.

Do not administer simultaneously with other macrolides or lincosamides (see section 12)

6. ADVERSE REACTIONS

In very rare cases, individual shock reactions with a potentially fatal outcome might occur.

In very rare cases, transient lethargy in piglets has been observed.

In target animal safety studies, administration of the maximum recommended injection volume (5 ml) very commonly caused slight swellings at the injection site that were not painful on palpation.

Swellings persisted for up to 3 days. Pathomorphological injection site reactions resolved completely within 21 days.

During clinical trials, pain on injection and injection site swellings were seen very commonly in treated pigs. These swellings resolved within 1 to 6 days.

Following the maximum recommended injection site volume of 5 ml, injection site reactions resolved completely within 21 days.

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

– very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
– common (more than 1 but less than 10 animals in 100 animals)
– uncommon (more than 1 but less than 10 animals in 1,000 animals)
– rare (more than 1 but less than 10 animals in 10,000 animals)
– very rare (less than 1 animal in 10,000 animals, including isolated reports).

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

7. TARGET SPECIES

Pigs

8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Intramuscular use.

Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/10 kg body weight) once only.

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.

9. ADVICE ON CORRECT ADMINISTRATION

Administer strictly intramuscularly. Special attention should be paid to using the appropriate injection site and to use the appropriate needle size and length (adjusted to the size and weight of animal) according to Good Veterinary Practice.

The recommended injection site is the location just behind the ear at the highest point of the base of the ear, at the transition from bald to hairy skin.

Injection should be given in a horizontal direction and a 90° angle to the body axis.

Recommended needle size and diameter per production stage

	Needle length (cm)	Needle diameter (mm)
Piglet, newborn	1.0	1.2
Piglet, 3–4 weeks	1.5 – 2.0	1.4
Growing	2.0 – 2.5	1.5
Growing-finishing	3.5	1.6
Finishing/sows/boars	4.0	2.0

The injection volume should not exceed 5 ml per injection site.

The rubber stopper of the vial may be safely punctured up to 20 times. Otherwise, the use of a multiple-dose syringe is recommended.

To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

10. WITHDRAWAL PERIOD

Meat and offal: 9 days.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 25 °C.

Do not use after the expiry date stated on the vial after EXP. Shelf life after first opening the container: 28 days.

12. SPECIAL WARNINGS

In line with responsible use principles, metaphylactic use of Zuprevo is only indicated in severe outbreaks of SRD caused by the indicated pathogens. Metaphylaxis implies that clinically healthy animals in close contact with diseased animals are administered the product at the same time as the treatment of the clinically diseased animals, to reduce the risk for development of clinical signs.

The efficacy of metaphylactic use of Zuprevo was demonstrated in a placebo controlled multi-centre field study, when outbreak of clinical disease was confirmed (i.e. animals in at least 30% of the pens sharing the same airspace showed clinical signs of SRD, including at least 10% animals per pen within 1 day; or 20% within 2 days or 30% within 3 days). Following metaphylactic use, approximately 86% of the healthy animals remained free of clinical signs of disease (as compared to approximately 65% of animals in the untreated control group).

Special precautions for use in animals:

Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing. Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.

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

Special caution should be taken to avoid accidental self-injection, as toxicology studies in laboratory animals showed cardiovascular effects after intramuscular administration of tildipirosin. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Do not use in automatically powered syringes which have no additional protection system.

Tildipirosin may cause sensitisation by skin contact. If accidental skin exposure occurs, wash the skin immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with clean water.

Wash hands after use.

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy or lactation. However, there was no evidence for any selective developmental or reproductive effects in any of the laboratory studies. Use only accordingly to the benefit-risk assessment by the responsible veterinarian. Interaction with other medicinal products and other forms of interaction:

There is cross resistance with other macrolides. Therefore, the product should not be administered with antimicrobials with a similar mode of action such as other macrolides or lincosamides.

Overdose (symptoms, emergency procedures, antidotes):

In piglets, intramuscular administration of tildipirosin (on three occasions in intervals of 4 days) at 8, 12 and 20 mg/kg bodyweight (2, 3 and 5 times the recommended clinical dose), resulted in transient slightly subdued behaviour in one piglet each from the 8 and 12 mg/kg bodyweight group and 2 piglets from the 20 mg/kg bodyweight group following the first or second injection. Muscle tremors to the hind legs were observed following the first treatment in one pig each from the 12 and 20 mg/kg bodyweight group.

At 20 mg/kg bodyweight one of eight animals showed transient generalized body tremors with inability to stand after the first administration and the animal showed transient unsteadiness on its feet after the third administration. Another animal developed treatment related shock after the first administration and was euthanised on welfare grounds. Mortality was observed at doses of 25 mg/kg body weight and higher.

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

Ask your veterinary surgeon/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 product is available on the website of the European Medicines Agency ( ).

15. OTHER INFORMATION

Box containing 1 vial of 20 ml, 50 ml, 100 ml or 250 ml.

Not all pack sizes may be marketed.

PACKAGE LEAFLET FOR:

ZUPREVO 180 mg/ml solution for injection for cattle

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

Marketing authorisation holder :

Intervet International B. V.

Wim de Körverstraat 35

5831 AN Boxmeer

The NETHERLANDS

Manufacturer for the batch release :

Intervet International GmbH

Feldstrasse 1 a

85716 Unterschleissheim

GERMANY

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

ZUPREVO 180 mg/ml solution for injection for cattle tildipirosin

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

ZUPREVO is a clear yellowish solution for injection containing 180 mg/ml of tildipirosin

4. INDICATIONS

For the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida and Histophilus somni sensitive to tildipirosin.

The presence of the disease in the herd should be confirmed before preventive treatment.

5. CONTRAINDICATIONS

Do not use in case of hypersensitivity to macrolide antibiotics, citric acid monohydrate or propylene glycol.

Do not administer simultaneously with other macrolides or lincosamides (see section 12).

6. ADVERSE REACTIONS

In very rare cases, anaphylactic reactions, with a potentially fatal outcome, might occur.

Pain on injection and injection site swellings are very common in treated animals. Following the maximum recommended injection site volume of 10 ml, injection site swellings may be associated with pain on palpation for about one day in individual animals. The swellings are transient and will usually resolve within 7 to 16 days; in individual animals swellings may persist for 21 days. Injection site reactions will largely resolve within 35 days.

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

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

– very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
– common (more than 1 but less than 10 animals in 100 animals)
– uncommon (more than 1 but less than 10 animals in 1,000 animals)
– rare (more than 1 but less than 10 animals in 10,000 animals)
– very rare (less than 1 animal in 10,000 animals, including isolated reports).

7. TARGET SPECIES

Cattle

8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Subcutaneous use.

Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/45 kg body weight) once only.

It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 2 to 3 days after injection. If clinical signs of respiratory disease persist or increase, treatment should be changed using another antibiotic, and continued until clinical signs have resolved.

9. ADVICE ON CORRECT ADMINISTRATION

For treatment of cattle over 450 kg body weight, divide the dose so that no more than 10 ml are injected at one site.

The rubber stopper of the vial may be safely punctured up to 20 times. Otherwise, the use of a multiple-dose syringe is recommended.

To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

10. WITHDRAWAL PERIOD

Meat and offal: 47 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.

Do not store above 25 °C.

Do not use after the expiry date which is stated on the vial after EXP.

Shelf life after first opening the container: 28 days.

12. SPECIAL WARNINGS

Special precautions for use in animals:

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

Do not use in automatically powered syringes which have no additional protection system.

Wash hands after use

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. However, there was no evidence for any selective developmental or reproductive effects in any of the laboratory studies. Use only accordingly to the benefit-risk assessment by the responsible veterinarian.

Interaction with other medicinal products and other forms of interaction: