Each ml contains:
Ceftiofur (as hydrochloride) 50mg
Ketoprofen 10 mg
INDICATION: 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.
ADMINISTRATION: Intramuscular use
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
ADVICE ON CORRECT ADMINISTRATION
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. 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
Subsequent intramuscular injections must be given at different sites. Not more than 16 ml should be administered per injection site.
-lactam antibiotics. Do not
use in cases of hypersensitivity to ketoprofen.
Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans.
Do not use in cases of known resistance to other cephalosporins or beta-lactam antibiotics. Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids concurrently or within 24 hours of each other.
Do not use 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.
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, were commonly observed in studies.
Hypersensitivity reactions (e.g. skin reactions, anaphylaxia) unrelated to dose and discolouration of the subcutaneous tissue and/or muscle can very rarely be observed.
Gastric or renal intolerance can be observed very rarely in certain individuals, in common with all NSAIDs due to their action of inhibition of prostaglandin synthesis
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 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). Alternatively you can report via your national reporting system.
Keep this and all drugs out of the reach of children.
Meat and offal: 8 days. Milk: zero hours..
SPECIAL STORAGE PRECAUTIONS
Do not freeze.
Keep the glass vial in the outer carton in order to protect from light. Keep out of the sight and reach of children.
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 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 of 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 .
1 x 100 ml
ASIA ANIMAL PHARMACEUTICAL
130, 1A Highway, Ba Lang Ward, Cai Rang District, Can Tho city, Vietnam,