Cemay, 50 mg/ml, suspension for injection for pigs and cattle
 
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:    
Active substance:
Ceftiofur (as ceftiofur hydrochloride)     50.0 mg
 
PHARMACEUTICAL FORM
Suspension for injection.
A white or slightly yellow coloured opaque suspension.

Target species
Pigs and cattle.
 
Indications for use, specifying the target species
Infections associated with bacteria sensitive to ceftiofur:
In pigs:
-    For the treatment of bacterial respiratory disease associated with Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis.

In cattle:
-    For the treatment of bacterial respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida and Haemophilus somnus.
-    For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharolytica).
-    For treatment of the bacterial component of acute post-partum (puerperal) metritis within 10 days after calving associated with Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum, sensitive to ceftiofur.
The indication is restricted to cases where treatment with another antimicrobial has failed.

Contraindications
Do not administer to an animal previously found to be hypersensitive to ceftiofur and other -lactam antibiotics or to any of the excipients.  
Do not inject intravenously.
The product should not be used in cases of known resistance to ceftiofur or other beta-lactam antibiotics.
Do not use in poultry (including eggs) due to risk of spread antimicrobial resistance to humans.

Special warnings for each target species
None known.
 
Special precautions for use

Special precautions for use in animals
Shake the bottle well for 30 seconds before use to bring the veterinary medicinal product back into suspension.
In case of the occurrence of allergic reaction the treatment should be withdrawn.
Cemay 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, Cemay 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. 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, Cemay should only be used based on susceptibility testing.
Cemay is intended for treatment of individual animals. Do not use for disease prevention or as a part of herd health programmes. Treatment of groups of animals should be strictly restricted to ongoing disease outbreaks according to the approved conditions of use.
Do not use as prophylaxis in case of retained placenta.

Special precautions to be taken by the person administering the 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.
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.
Handle this product with great care to avoid exposure. Wash hands after use.

Adverse reactions (frequency and seriousness)
Hypersensitivity reactions unrelated to dose can occur. Allergic reactions (e.g. skin reactions, anaphylaxia) may occasionally occur. In case of the occurrence of allergic reaction the treatment should be withdrawn.
In pigs, mild reactions at the injection site, such residual lesions in the intermuscular connective tissue consisting of round clear areas, have been observed in some animals for up to 20-22 days after injection.
In cattle, mild inflammatory reactions at the injection site, such as tissue oedema and discoloration of the subcutaneous tissue and/or fascial surface of the muscle may be observed. Clinical resolution is reached in most animals by 10 days after injection, although slight tissue discoloration may persist for 32 days or more.

Use during pregnancy, lactation or lay
Studies in laboratory species have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Safety has not been established in the target species during pregnancy or lactation. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

Interaction with other medicinal products and other forms of interaction
The bactericidal properties of cephalosporins are antagonized by simultaneous use of bacteriostatic antibiotics (macrolides, sulphonamides and tetracyclines).
 
Amounts to be administered and administration route
Pigs:
3 mg ceftiofur /kg bw/day for 3 days via intramuscular route, i.e. 1 ml/16 kg bw at each injection.

Cattle:
Respiratory disease: 1 mg ceftiofur /kg bw/day for 3 to 5 days by subcutaneous injection, i.e 1 ml/50 kg bw at each injection.
Acute interdigital necrobacillosis: 1 mg/kg bw/day for 3 days by subcutaneous injection, i.e 1 ml/50 kg bw at each injection.
Acute post-partum metritis within 10 days after calving: 1 mg/kg bw/day for 5 consecutive days by subcutaneous injection, i.e. 1 ml/50 kg bw at each injection.
In case of acute post-partum metritis, additional supportive therapy might be required in some cases.
A maximum volume of 6 ml may be administered in each injection site.
Subsequent injections must be given at different sites.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
As the vial cannot be broached more than 40 times, the user should choose the more appropriate vial size.

 Overdose (symptoms, emergency procedures, antidotes)
The low toxicity of ceftiofur has been demonstrated in pigs using ceftiofur sodium at doses in excess of 8 times the recommended daily dose of ceftiofur intramuscularly administered for 15 consecutive days.
In cattle, no signs of systemic toxicity have been observed following substantial parenteral overdosages.

Withdrawal period
Pigs:
-    Meat and offal: 5 days.
Cattle:
-    Meat and offal: 8 days
-     Milk: zero days.

Incompatibilities
In the absence of compatibility studies, this product should not be mixed with other veterinary medicinal products.
 
Shelf life
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
This veterinary medicinal product does not require any special storage conditions.
 
Nature and composition of immediate packaging
Cardboard boxes with one 100 ml or one 250 ml plastic bottle of polypropylene with closures of bromobutyl rubber and aluminium cap.
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 products should be disposed of in accordance with local requirements.