Baycox Iron
Authorised
This medicine is authorised for use in the European Union
toltrazuril / iron (III) ion
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
Baycox Iron is a veterinary medicine. It is used in young piglets on farms which have been affected in the past by the parasitic infection coccidiosis to prevent diarrhoea caused by a new coccidiosis infection. Coccidiosis is a disease of the gut which results in reduced growth due to diarrhoea. Infected piglets shed disease spores (oocysts) in their faeces that can spread the infection. Baycox Iron is also used to reduce spread of the infection through passage of oocysts in faeces, and at the same time to prevent iron deficiency anaemia due to the limited iron reserves of new-born piglets, low iron content of milk and high growth rate of suckling piglets.
Baycox Iron contains the active substances toltrazuril and gleptoferron (an iron-containing compound).
Baycox Iron is available as an injection and can only be obtained with a prescription. It is given as a single injection into the muscle behind the ear of piglets between 48 and 72 hours old. The injection should not be repeated.
For more information about using Baycox Iron, see the package leaflet or contact your veterinarian or pharmacist.
Toltrazuril is an antiparastic medicine which interferes with the enzymes needed by coccidia parasites to produce energy. As a result it is able to kill the parasites at all stages of their development and prevent the symptoms of coccidiosis and the spread of infection.
The other active substance in Baycox Iron, gleptoferron, is an iron-containing compound. Iron is an essential nutrient needed to make haemoglobin to transport oxygen in the blood, as well as certain key enzymes, and without additional iron, piglets raised under intensive farming conditions will develop anaemia within 10 days after birth. Following injection into the muscle, gleptoferron is absorbed and broken down to release iron for use and/or storage depending on the need for iron in suckling piglets. Excess iron is stored mainly in the liver.
In a field study performed in 3 EU countries and involving 968 piglets on farms with a history of coccidiosis, a single intramuscular injection of Baycox Iron given at 3 days of age was effective in preventing iron deficiency anaemia, and reducing oocyst excretion and diarrhoea associated with coccidiosis caused by the coccidia parasite Cystoisospora suis, in comparison with giving iron only (as gleptoferron) at 3 days of age.
Baycox Iron must not be given to piglets suspected to have insufficient levels of vitamin E or selenium.
The most common side effects with Baycox Iron (which may affect up to 1 in 10 piglets) are short-lived tissue discolouration and slight swelling at the injection site.
For the full list of side effects and restrictions of Baycox Iron, see the package leaflet.
People who are hypersensitive (allergic) to iron compounds or toltrazuril should avoid contact with Baycox Iron.
Care should be taken to avoid accidental self-injection. In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Baycox Iron may be harmful for the unborn child. Pregnant women and women intending to conceive should avoid contact with the medicine, especially accidental self-injection.
Hands should be washed after using the medicine.
The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
The withdrawal period for meat from pigs treated with Baycox Iron is 53 days.
The European Medicines Agency decided that Baycox Iron’s benefits are greater than its risks and it can be authorised for use in the EU.
Baycox Iron received a marketing authorisation valid throughout the EU on 20 May 2019.
Product information
Latest procedure affecting product information:
IG/1213
31/03/2020
Product details
- Name of medicine
- Baycox Iron
- Active substance
- Iron(iii) ion
- toltrazuril
- International non-proprietary name (INN) or common name
- toltrazuril
- iron (III) ion
- Species
- Pigs (piglets)
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QP51AJ51
Pharmacotherapeutic group
toltrazuril, combinationsTherapeutic indication
For the concurrent prevention of clinical signs of coccidiosis (such as diarrhoea) in neonatal piglets on farms with a confirmed history of coccidiosis caused by Cystoisospora suis, and prevention of iron deficiency anaemia.
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