Naxcel 200 mg solution for injection for cattle 100 ml
Treatment of acute interdigital necrobacillosis in cattle also known as Panaritium or foot rot in cattles
NAXCEL 200 mg/ml suspension for injection for cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
One ml contains:
Active substance: Ceftiofur (as crystalline free acid) 200 mg. For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM:
Suspension for injection.
Opaque white to light brown suspension.
4. CLINICAL PARTICULARS:
4.1 Target species:
4.2 Indications for use, specifying the target species:
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.
Do not use in cases of hypersensitivity to ceftiofur or other beta-lactam antibiotics, or to any of the excipients.
4.4 Special warnings for each target species:
4.5 Special precautions for use Special precautions for use in animals:
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, 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).
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 and show the package leaflet or the label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are serious reactions and require urgent medical attention.
4.6 Adverse reactions (frequency and seriousness):
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 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).
4.7 Use during pregnancy, lactation or lay:
Laboratory studies in mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Laboratory studies in rats have shown no evidence of teratogenic effects but maternotoxic (soft faeces) and foetotoxic (reduced foetal weight) effects were observed. No effects on the reproductive performance were observed in both species. No specific studies have been conducted in pregnant cows. Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
This veterinary medicinal product can be used during lactation.
No specific studies have been conducted in breeding cattle. Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction:
4.9 Amounts to be administered and administration route:
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. Base of the ear administration:
• Administer in the posterior part of the ear base.
• 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.
• 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 (2.54 cm) long, 16 gauge]. Injection location for the subcutaneous administration of NAXCEL at the posterior aspect of the ear where it attaches to the head (base of ear). 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. If clinical signs have not improved 48 hours after treatment, the diagnosis and treatment of the condition should be re-evaluated.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary:
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.
4.11 Withdrawal period(s):
Meat and offal:
It is essential that NAXCEL is only administered subcutaneously at the base of ear location in nonedible tissue, as described in section 4.9, in order to comply with the meat withdrawal period.
5. PHARMACOLOGICAL PROPERTIES:
Antibacterials for systemic use, third-generation cephalosporins.
5.1 Pharmacodynamic properties:
Ceftiofur is a third generation cephalosporin antibiotic, which is active against many Gram-positive and Gram-negative pathogens. Ceftiofur inhibits the bacterial cell wall synthesis, thereby exerting bactericidal properties.
In cattle, ceftiofur is active against the following micro-organisms which are involved in acute postpartum (puerperal) metritis: Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum; and interdigital necrobacillosis: Bacteroides spp., Fusobacterium necrophorum, Porphyromonas spp. and Prevotella spp. Desfuroylceftiofur is the principal active metabolite. It has an antimicrobial activity similar to that of ceftiofur against the target pathogens.
5.2 Pharmacokinetic particulars:
Ceftiofur is well absorbed in cattle following base of the ear injection. After administration, ceftiofur is quickly metabolised to desfuroylceftiofur, the principal active metabolite. Protein binding of ceftiofur and its major metabolite is high, approximately 70% – 90%. One hour after a single administration, plasma concentrations are greater than 1 µg/ml. Maximum concentrations in plasma (about 5 µg/ml) occurred from 12 hours following administration. Total plasma concentrations above 0.2µg/ml and 1µg/ml of ceftiofur and its active metabolites are maintained for at least 7 and 4 days, respectively.
6. PHARMACEUTICAL PARTICULARS:
6.1 List of excipients:
Oily vehicle (vegetable origin): Triglycerides, medium chain Cottonseed oil.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life:
Shelf life of the veterinary medicinal product as packaged for sale:
Shelf life after first opening the vial:
6.4 Special precautions for storage.
Do not store above 25ºC.
6.5 Nature and composition of immediate packaging:
Cardboard box with one type I glass vial of 100 ml with a chlorobutyl-isoprene rubber stopper and an aluminium cap.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products:
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal 10 product should be disposed of in accordance with local requirements.