Naxcel 200mg

Description

Description

Naxcel 200mg is an antibiotic suspension that contains ceftiofur (as crystalline-free acid) as the active substance. It is available as a suspension for injection into the muscle of the neck (for pigs) or under the skin at the base of the ear (for cattle).

Naxcel 200mg/ml Suspension for Injection for Cattle.

Presentation

Naxcel 200mg/ml Suspension for Injection for Cattle is an opaque white to light brown suspension for injection. A one ml dose contains 200mg ceftiofur (as ceftiofur crystalline free acid).

Uses

For use in cattle for the treatment of acute interdigital necrobacillosis, also known as Panaritium or foot rot (foul in the foot).

For use in cattle for the treatment of acute post-partum (puerperal) metritis, in cases where treatment with another antimicrobial has failed.

Dosage and administration

A 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.

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.

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•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 appropriate restraint of the animal (chute or head restraint for example) and using appropriate needles (1 inch (2.54 cm) long, 16 gauge).

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

Fig. 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)	Fig. 2 Subcutaneous administration of Naxcel at the posterior aspect of the ear where it attaches to the head (base of ear). Diagram of the head showing the direction for the base of the ear injections administered toward the animal’s opposite eye

Contra-indications, warnings, etc

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

Do not use as prophylaxis in cases of retained placenta.

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 other antimicrobials. Increased use, including use of the product deviating from the instructions given in the SPC/datasheet, 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.

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

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 (i.e. in less than 1-10 out of 10000 animals), 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.

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.

Operator Warnings

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 and show the package leaflet or label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are serious reactions and require urgent medical attention.

Withdrawal period

Meat and offal: 9 days.

Milk: zero days.

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

Pharmaceutical precautions

Do not store above 25°C.

Shelf-life after first broaching the vial: 28 days.

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

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

For animal treatment only.

Keep out of the reach and sight of children.

Legal category

POM-V

Packaging Quantities

Cardboard box containing one glass vial of 100 ml.

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