Curacef Duo suspension for injection for cattle 100ml.
Indications for use, specifying the target species
For the treatment of bovine respiratory disease (BRD) caused by Mannheimia haemolytica and Pasteurella multocida susceptible to ceftiofur and the reduction of associated clinical signs of inflammation or pyrexia.
Do not use in cases of known resistance to other cephalosporins or beta-lactam antibiotics.
Do not use in case of hypersensitivity to ceftiofur and other ß-lactam antibiotics.
Do not use in case of hypersensitivity to ketoprofen.
Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans.
Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other.
Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia.
Special warnings for each target species
Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity.
Special precautions for use
i) Special precautions for use in animals
In case of the occurrence of allergic reaction the treatment should be withdrawn.
The product selects for resistant strains such as bacteria carrying extended spectrum betalactamases (ESBL) and may constitute a risk to human health if these strains disseminate to humans e.g. via food. For this reason, the product should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly (refers to very acute cases when treatment must be initiated without bacteriological diagnosis) to first line treatment.
When inflammation or pyrexia have subsided, the veterinarian should switch to a ceftiofur only-containing product in order to cover 3 to 5 days of continuous antibiotic treatment. Treating for an appropriate length of time is important to limit development of resistance.
Official, national and regional antimicrobial policies should be taken into account when the product is used. Increased use, including use of the product deviating from the instructions given in the SPC, may increase the prevalence of such resistance. Whenever possible, the product should only be used based on susceptibility testing.
The product is intended for treatment of individual animals. Do not use for disease prevention or as a part of heard health programmes. Treatment of groups of animals should be strictly restricted to ongoing disease outbreaks according to the approved conditions of use.
The concomitant use of diuretics or coagulant should be based on a benefit/risk assessment of the responsible veterinarian.
Avoid intra-arterial and intravenous injection.
Use preferably a 14 gauge needle.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy) 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.
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
Wash hands after use.
Avoid contact with eyes and skin. In case of contact, wash immediately with water.
If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning.
Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
In case of accidental self injection seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
Hypersensitivity reactions (e.g. skin reactions, anaphylaxia) unrelated to dose may occasionally occur.
In field studies, the product has been tested in cattle aged from 1 month old to 12 years without evidencing safety concern.
Mild inflammatory reactions at the injection site, such as tissue oedema, without pain in most cases, may be observed.
Discolouration of the subcutaneous tissue and/or muscle may be observed.
In common with all NSAIDs, due to their action of inhibition of prostaglandin synthesis, there can be the possibility in certain individuals of gastric or renal intolerance.
Use during pregnancy, lactation or lay
Even though studies in laboratory animals with ceftiofur or ketoprofen show no evidence of teratogenesis, abortion or influence on reproduction, the reproductive safety of the product has not been specifically investigated in pregnant cows.
Use only according to a benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects.
Concurrent administration with nephrotoxic drugs should be avoided.
The bactericidal properties of beta-lactams are neutralised by simultaneous use of bacteriostatic antibiotics (macrolides, sulphonamides and tetracyclines).
Amounts to be administered and administration route
1 mg ceftiofur/kg/day and 3 mg ketoprofen/kg/day by intramuscular injection, i.e. 1 ml/50 kg at each injection. The product should only be used when the disease is associated with clinical signs of inflammation or pyrexia. The product may be administered for 1 to 5 consecutive days depending upon the clinical response on a case by case basis. As the duration for the antibiotic treatment should not be less than 3 to 5 days, when inflammation and pyrexia have subsided, the veterinarian should switch to a ceftiofur only-containing product in order to cover 3 to 5 days of continuous antibiotic treatment. Only few animals are expected to require a fourth or fifth injection with the combined product.
Shake the bottle vigorously for 20 seconds before use to ensure an homogeneous suspension.
Resuspension could be longer after storage at low temperatures.
To ensure correct dosage body weight should be determined as accurately as possible to avoid underdosing.
The user should use the most appropriate vial size according to the number of animals to treat.
The 50 ml and 100 ml vials should not be pierced more than 10 times and the 250 ml not more than 18 times. The use of an aspirating needle may be recommended to avoid excessive broaching of the stopper.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No signs of systemic toxicity of the product have been observed at doses up to 5 times the recommended daily dose for 15 consecutive days.
Meat and offal: 8 days
Milk: zero hours
List of excipients
Hydrogenated soya lecithin
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 28 days.
Special precautions for storage
Do not freeze.
Keep the glass vial in the outer carton in order to protect from light.
Nature and composition of immediate packaging
Coloured, type II glass vial with bromobutyl rubber stopper and aluminium cap, packed in a cardboard box or amber coloured, translucent polypropylene (PP) vial containing a stainless steel ball, closed with bromobutyl rubber stopper and aluminium cap, packed in a cardboard box.
Pack sizes: 1 x 50 ml; 1 x 100 ml; 1 x 250 ml
Not all pack sizes may be marketed.
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 product should be disposed of in accordance with local requirements.
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