Naxcel - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Naxcel 100 mg/ml suspension 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 and manufacturer responsible for batch release:

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Naxcel 100 mg/ml suspension for injection for pigs ceftiofur

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

One ml contains:

Active substance:

Ceftiofur (as crystalline free acid) 100 mg.

• 4. INDICATION(S)

Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Haemophilus parasuis and Streptococcus suis.

Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.

• 5. CONTRAINDI­CATIONS

Do not use in cases of hypersensitivity to ceftiofur or other beta-lactam antibiotics, or to any of the excipients.

• 6. ADVERSE REACTIONS

Occasionally, transient local swelling may occur following intramuscular injection.

Mild tissue reactions at the injection site, such as small areas (less than 6 cm2) of discolouration and small cysts have been observed for up to 42 days after injection. Resolution has been observed at 56 days post-injection.

In very rare cases anaphylactic type reactions may occur following administration of the product.

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.

Dose of 5 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per 20 kg bodyweight) administered once in the neck by intramuscular injection.

• 9. ADVICE ON CORRECT ADMINISTRATION

Shake bottle vigorously for 30 seconds, or until all visual settlement has been resuspended.

To ensure a correct dosage, bodyweight should be accurately determined to avoid under-dosing.

It is recommended to limit injection volumes to a maximum of 4 ml.

Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.

• 10. WITHDRAWAL PERIOD(S)

Meat and offal: 71 days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 25 °C.

Shelf-life after first opening the container: 28 days.

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

• 12. SPECIAL WARNING(S)

Special precautions for use in animals:

Whenever possible, cephalosporins should only be used based on susceptibility testing.

For systemically administered broad spectrum cephalosporins (3rd and 4th generation, such as ceftiofur), it should be reflected that these are to be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to less critical antimicrobials. Increased use, including use of the product deviating from the instructions given above, may increase the prevalence of bacteria resistant to ceftiofur. Official, national and regional antimicrobial policies should be taken into account when the product is used.

When considering the treatment strategy, it is appropriate to consider improvement of the herd management practice and use supporting treatment with suitable local products (e.g. disinfectants).

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

Penicillins and cephalosporins such as ceftiofur may cause hypersensitivity in people and in animals following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this veterinary medicinal product.

Avoid contact with skin or eyes. In the event of contact, wash with clean water. If you develop symptoms following exposure such as a skin rash or persistent eye irritation, you should seek medical advice. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

Pregnancy and fertility :

No specific studies have been conducted in pregnant or lactating sows, or in breeding pigs. Use only according to the benefit-risk assessment by the responsible veterinarian.

Overdose (symptoms, emergency procedures, antidotes) :

Owing to the low toxicity of ceftiofur in pigs overdoses do not typically lead to any clinical signs, other than transient local swellings as described in section 6 (Adverse reactions).

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 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 ).

• 15. OTHER INFORMATION

Naxcel is available in 50 ml or 100 ml vials.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Naxcel 200 mg/ml suspension 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 and manufacturer responsible for batch release:

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Naxcel 200 mg/ml suspension for injection for cattle ceftiofur

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

One ml contains:

Active substance:

Ceftiofur (as crystalline free acid) 200 mg.

• 4. INDICATION(S)

Treatment of acute interdigital necrobacillosis in cattle also known as Panaritium or foot rot. Treatment of acute post-partum (puerperal) metritis in cattle, in cases where treatment with another antimicrobial has failed.

• 5. CONTRAINDI­CATIONS

Do not use in cases of hypersensitivity to ceftiofur or other beta-lactam antibiotics, or to any of the excipients.

• 6. ADVERSE REACTIONS

Visible swellings have been noted at the injection site in about two thirds of treated animals, two days after injection in field conditions. These reactions will resolve within a maximum of 23 days. Injection site swellings may result in mild to moderate pain in some animals in the initial days following injection.

In very rare cases, sudden death has been reported following administration of the product. In such cases, death has been attributed to intra-vascular administration of the product or anaphylaxis.

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.

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

Single subcutaneous injection of 6.6 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per

30 kg bodyweight) administered at the base of the ear.

• 9. ADVICE ON CORRECT ADMINISTRATION

To ensure a correct dosage, bodyweight should be accurately determined to avoid under-dosing.

It is recommended to limit injection volumes to a maximum of 30 ml per injection site.

Shake the bottle vigorously for 30 seconds, or until all visual settlement has been resuspended.

Base of the ear administration:

• Administer in the posterior part of the ear base (see Figure 1).
• Hold the syringe and insert the needle behind the animal’s ear so the needle and syringe point in the direction of an imaginary line that would pass through the head toward the animal’s opposite eye (see Figure 2).
• Take appropriate precautions to avoid intra-arterial or intravenous injection, such as restraining appropriately the animal (chute or head restraint for example) and using appropriate needles [1 inch (2.54cm) long, 16 gauge].

• Figure 1. Injection location for the subcutaneous administration of Naxcel at the posterior aspect of the ear where it attaches to the head (base of ear).

If clinical signs have not improved 48 hours after treatment, the diagnosis and treatment of the condition should be re-evaluated.

Meat and offal: 9 days.

Milk: zero days.

It is essential that Naxcel is only administered subcutaneously at the base of ear location in non-edible tissue, in order to comply with the meat withdrawal period.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 25 °C.

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 precautions for use in animals:

Whenever possible, cephalosporins should only be used based on susceptibility testing.

For systemically administered broad spectrum cephalosporins (3rd and 4th generation, such as ceftiofur), it should be reflected that these are to be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to less critical antimicrobials. Increased use, including use of the product deviating from the instructions given above, may increase the prevalence of bacteria resistant to ceftiofur. Official, national and regional antimicrobial policies should be taken into account when the product is used.

When considering the treatment strategy, it is appropriate to consider improvement of the herd management practice and use supporting treatment with suitable local products (e.g. disinfectants). Do not use as prophylaxis in case of retained placenta.

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

Penicillins and cephalosporins such as ceftiofur may cause hypersensitivity in people and in animals following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this veterinary medicinal product.

Avoid contact with skin or eyes. In the event of contact, wash with clean water. If you develop symptoms following exposure such as a skin rash or persistent eye irritation, you should seek medical advice. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

Pregnancy and fertility :

No specific studies have been conducted in pregnant cows or in breeding cattle. Use only according to the benefit-risk assessment by the responsible veterinarian.

Overdose (symptoms, emergency procedures, antidotes):

In cattle, although Naxcel has not been specifically tested for overdoses, no signs of systemic toxicity related to ceftiofur have been observed following 55 mg/kg parenteral daily overdoses of ceftiofur sodium for five days.

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 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