Actionis 50 mg/ml, Suspension for Injection for Pigs and Cattle
Active ingredient: Ceftiofur
Form
Injection
Species
Manufacturer
Laboratorios SYVA S.A.
VMD MA No.
31592/5004
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Actionis 50 mg/ml, Suspension for Injection for Pigs and Cattle — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
Pigs:
For the treatment of bacterial respiratory disease associated with Pasteurella multocida
Actinobacillus pleuropneumoniae and .
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 Prevotella melaninogenica (Porphyromonas
asaccharolytica).
For treatment of the bacterial component of acute post-partum (puerperal) metritis within
10 days after calving associated with Escherichia coli, Trueperella pyogenes and
Fusobacterium necrophorum, sensitive to ceftiofur. The indication is restricted to cases
where treatment with another antimicrobial has failed.
Revised: November 2023
AN: 03395/2022
of the excipients.
Do not use in cases of known resistance to ceftiofur or other beta-lactam antibiotics.
Do not inject intravenously.
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Hypersensitivity reaction
Allergic reaction (e.g. skin reactions / anaphylaxis)
1
Unrelated to dose.
In this case, the treatment should be withdrawn.
Pigs:
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Injection site reaction (e.g. discoloration of the fascia or
fat)
1
Mild reactions, discoloration can persist in some animals for up to 20 days after injection.
Cattle:
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Injection site reaction (e.g. as tissue oedema,
discoloration
)
1
Subcutaneous tissue and/or fascial surface of the muscle.
Mild inflammatory reactions, clinical resolution is reached in most animals by 10 days
after injection although slight tissue discoloration may persist for 28 days or more.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See also the last section of the
package leaflet for respective contact details.
Special precautions for use in animals
This product does not contain an antimicrobial preservative.
The productselects 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 productshould 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, the productshould 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.
Do not use as prophylaxis in case of retained placenta.
Shake vigorously before use for 1 minute or until the complete resuspension of the
product.
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 veterinary medicinal product if you know you
are sensitised, or if you have been advised not to work with such preparations.
Handle this product with great care to avoid exposure taking all recommended
precautions.
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.
If you develop symptoms following exposure such as skin rash, you should seek medical
advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty in
breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
Revised: November 2023
AN: 03395/2022
Special precautions for the protection of the environment:
Not applicable
Other precautions
Not applicable
bacteriostatic antibiotics (macrolides, sulfonamides and tetracyclines).
Aminoglycosides may have a potentiating effect on cephalosporins.
Meat and offal: 6 days.
Milk: zero hours.
Revised: November 2023
AN: 03395/2022
Pigs:
Meat and offal: 6 days.
5.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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Related Conditions
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