Ceftimed

QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of solution for injection contains:
Active substance: Ceftiofur (as ceftiofur hydrochloride).......50 mg
Excipients:
Aluminum monostearate...................10 mg
Polysorbate 80 ..................................10 mg
Triglycerides, medium-chain............ad 1 mL

INDICATIONS

Ceftimed is used with Infections associated with bacteria sensitive to ceftiofur .
Treatment of cattle

• For the treatment of bacterial respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
• 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.

Treatment of pigs - For the treatment of bacterial respiratory disease associated with Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis.

Treatment of dogs with diseases of the digestive tract (enteritis, gastroenteritis, gastroenterocolitis), respiratory diseases (bronchitis, bronchopneumonia, rhinitis) and the genitourinary system (metritis, endometritis, mastitis, agalactia, cystitis, urethritis, pyelonephritis), joints, skin and soft tissues; with acute and chronic otitis, surgical, wound, postpartum and other primary and secondary infections of bacterial etiology caused by microorganisms susceptible to ceftiofur.

CONTRAINDICATIONS

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

ADVERSE REACTIONS

• Hypersensitivity reactions unrelated to dose can occur. Allergic reactions (e.g. skin reactions, anaphylaxia) may occasionally occur.
• In swine, mild reactions at the injection site, such as discoloration of the fascia or fat, have been observed in some animals for up to 20 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 28 days or more.

TARGET SPECIES

Cattle, pigs and dogs.

DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINSITRATION

Cattle: at treatment of respiratory diseases – intramuscularly at dose 1 ml of product per 50 kg body weight once daily during 3-5 days; at treatment of acute necrobacteriosis – intramuscularly at dose 1 ml of product per 50 kg body weight once daily during 3 days; at treatment of acute postpartum metritis (in 10 days after calving) – subcutaneously at dose 1 ml of product per 50 kg body weight once daily during 5 days; at treatment of mastitis – intramuscularly at dose 1-2 ml of product per 50 kg body weight once daily during 5 days.
Pigs: intramuscularly at dose 1 ml of product per 16 kg body weight once daily during 3 days.
Dogs: intramuscularly at dose 0.5 ml of product per 10 kg body weight once daily during 3-5 days.
Each next injection must be done into the opposite side of the animal's body.
In the case of acute postpartum metritis, additional maintenance therapy may be necessary.

ADVICE ON CORRECT ADMINISTRATION

Before use, the vial should be shaken thoroughly.
The maximum recommended dose for a single injection for cattle is 10 ml of the drug; dogs – 5 ml.

WITHDRAWAL PERIOD

Meat is allowed for consumption in 5 days after last treatment. Milk for human consumption is allowed without any restriction.
Meat received before this time should be disposed or fed to non-productive animals, depending on conclusion of veterinarian.

SPECIAL STORAGE PRECAUTIONS

Keep out from the reach of children
Store in original package at temperature of 25oC,
Shelf life: 3 years
Shelf life after first opening 28 days

SPECIAL WARNINGS

• Shake the bottle well before use to bring the product back into suspension.
• In case of the occurrence of allergic reaction the treatment should be withdrawn.
• Ceftiofur 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, ceftiofur 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, ceftiofur should only be based on susceptibility testing.
• Ceftiofur 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 (see section 4.2 Indications for use, specifying the target species).
• 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 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.
• People with known hypersensitivity to penicillins or cephalosporins should avoid contact with the product.
• In the case of accidental self-injection or following exposure, if you develop symptoms such as a skin rash, seek medical advice immediately and show the package leaflet or the label to the physician.
• Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.