WONDERCEF powder and solvent for solution for injection for horses not intended for the
production of foods for human consumption.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
WONDERCEF 1 g
Bottle of powder:
Active substance: ceftiofur sodium…………………………..1105 mg
equivalent to ceftiofur ……………………………………………………1060 mg
Bottle of solvent:
water for injections………………………….. 20 ml
WONDERCEF 4 g
Bottle of powder:
Active substance: ceftiofur sodium…………………………..4376 mg
equivalent to ceftiofur ……………………………………………………4200 mg
Bottle of solvent:
water for injections………………………….. .80 ml
1 ml of solution thus obtained contains ceftiofur 50
mg For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
4. CLINICAL PARTICULARS
4.1 Target species
Horses not intended for the production of foods for human consumption.
4.2 Indications for use, specifying the target species
WONDERCEF is indicated for the treatment of infections to the respiratory system of
horses due to bacteria sensitive to ceftiofur, associated with Streptococcus zooepidemicus,
Streptococcus equi and Pasteurella spp.
Do not use in animals with ascertained hypersensitivity to the active substance or to any
one of the excipients.
Do not use in poultry (including layers) due to the risk of the spread of antimicrobial
resistance to humans.
4.4 Special warnings for each target species
The product must not be administered to horses intended for the production of foods for
Administration of antimicrobial agents to horses under stress conditions may be
associated with acute diarrhoea, which may be fatal. In case of acute diarrhoea, suspend
administration of the veterinary medicinal product and perform suitable therapy.
4.5 Special precautions for use
Special precautions for use in animals
WONDERCEF selects resistant strains as bacterial vectors of extended spectrum betalactamases
(ESBL) and may constitute a risk for human health if these strains spread to
man, for example through foods. For this reason, WONDERCEF must be limited to the
treatment of clinical condition which have responded reply, or which it is considered may
respond, poorly (referring to very acute cases in which treatment must be started without
bacteriological diagnosis) to the first-line treatment. During use of the product, please
comply with the official national and regional regulations on the use of antimicrobial
products. More frequent use, including use of this product other than according to the
instructions supplied in the SPC, may lead to an increase in the incidence of this type of
resistance. Where possible, WONDERCEF must be used exclusively on the basis of
WONDERCEF is intended for the treatment of individual animals.
Do not use for the prevention of diseases or as part of health programmes for breeding
establishments. The treatment of groups of animals must be rigorously limited to ongoing
epidemics, according to the approved conditions of use.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Ceftiofur may cause mild irritation to excoriated skin, particularly after frequent contacts.
Antimicrobial drugs, including penicillin and the cephalosporins, may cause allergic
reactions in sensitive subjects. Therefore, in cases of known hypersensitivity, do not
handle the product. To reduce the possibility of these reactions, it is recommended that
direct contact of the skin and the mucosae with the medicinal product be avoided.
The occurrence of severe symptoms such as swelling of the face, lips and eyes or
respiratory difficulty require rapid treatment by a doctor.
Care must be taken during administration of the product to avoid accidental self-injection.
In case of accidental self-injection, see a doctor immediately and show him the package
leaflet or label of the product.
4.6 Adverse reactions (frequency and severity)
In the horse, a mild local muscle irritation has been found at the injection site. The lesions
evolve towards a muscle regeneration and, in a number of cases, small necrotic foci
Cases of anaphylactic reactions have been reported, with massive urticaria. Prolonged use
of the medicinal product may lead to a change to the intestinal bacterial flora, with
symptoms of colic.
4.7 Use during pregnancy and lactation
Data in the horse are not available. In rats, after oral administration, teratogenic effects,
cases of abortion or effects on reproductive capacity were not observed.
In any event, use only after an evaluation of the risk/benefit ratio by the attending
4.8 Interaction with other veterinary medicinal products and other forms of
The bactericidal properties of the cephalosporins are antagonised by the concurrent
administration of bacteriostatic antibiotics (macrolides, sulfonamides and tetracyclines).
4.9 Amounts to be administered and administration route
Reconstitute the solution of WONDERCEF, transferring the contents of the solvent
bottle to the bottle containing the powder, then shake. Reconstitution must be performed
Administer by the intramuscular route, taking the usual aseptic precautions, at the
following amounts to be administered:
1 ml/25 kg b.w. (equivalent to 2.2 mg of ceftiofur per kg b.w.) once a day for 10
consecutive days at 24-hourly intervals.
To ensure correct dosage, the body weight must be determined as precisely as possible, to
4.10 Overdose (symptoms, emergency procedures, antidotes)
In horses, dosages 5 times greater than those recommended, administered for 30 days,
were well tolerated.
4.11 Withdrawal periods
Not applicable. The product must not be administered to horses intended for the
production of foods for human consumption.
For horses not intended for the production of foods for human consumption.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: third generation cephalosporins – antibacterial agents for systemic
ATC Vet Code: QJ01DD90
5.1 Pharmacodynamic properties
WONDERCEF is a veterinary medicinal product based on ceftiofur, a broad spectrum,
Ceftiofur, interfering with the synthesis of the bacterial cell wall, acts bactericidally
against Gram-positive and Gram-negative bacteria, including beta-lactamase producing
Its solubility in water is conditioned by the pH (with a pH higher than 5.5 it is greater
than 400 mg/ml).
Ceftiofur is active, both in vivo and in vitro, against Streptococcus zooepidemicus,
Streptococcus equi and Pasteurella spp., microorganisms involved in infections to the
respiratory system in horses.
5.2 Pharmacokinetic particulars
In the horses, the product distributes very rapidly to the tissues.
After intramuscular administration of 2.2 mg of ceftiofur/kg of body weight the
maximum plasma concentration of 4.46 µg/ml (Cmax.) is reached in 1.25 hours (Tmax.), with
a half-life of 3.15 hours (T 1/2).
The plasma and pulmonary concentrations, 24 hours after administration, are still higher
than the MICs of the microorganisms responsible for respiratory disorders in the horse.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Potassium phosphate monobasic
Water for injections
Do not mix with other veterinary medicinal products.
Shelf-life of the veterinary medicinal product as packaged for sale:
– powder: 2 years
– solvent: 4 years.
The shelf-life refers to the individual bottles of powder and solvent. The box containing
both the bottle of powder and the bottle of solvent has the shorter shelf-life of 2 years.
Shelf-life after reconstitution according to directions:
– 12 hours if stored at temperature between 15°C and 30°C;
– 7 days if stored in a refrigerator (2° – 8°C).
6.4 Special precautions for storage
Store in a refrigerator (2° – 8°C) protected from light.
After reconstitution: to be used within 12 hours if stored at a temperature between 15°C
and 30°C and 7 days if stored in a refrigerator (2°C – 8°C).
6.5 Nature and composition of the immediate packaging
Powder: 30 ml and 100 ml bottles in Type II glass with elastomer cap sealed with an
Solvent: 20 ml and 100 ml bottles in Type II glass with elastomer cap sealed with an
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused product or waste materials should be disposed of in accordance with national
7. MARKETING AUTHORISATION HOLDER
FATRO S.p.A. – Via Emilia, 285 – Ozzano dell’Emilia – Bologna – Italy
8. MARKETING AUTHORISATION NUMBERS
Box containing 1 x 1 g bottle of powder + 1 x 20 ml bottle of solvent – Marketing Authorisation
Box containing 1 x 4 g bottle of powder + 1 x 80 ml bottle of solvent – Marketing Authorisation no.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 11.06.2008
Date of renewal: 18.12.2012
10. DATE OF REVISION OF THE TEXT
Medicinal product subject to non-renewable veterinary medical prescription in one copy