Isemid
Authorised
This medicine is authorised for use in the European Union
Torasemide
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
Isemid is a veterinary medicine used to treat signs related to congestive heart failure in dogs. Congestive heart failure is a condition when the heart cannot pump enough blood around the body. This can lead to exercise intolerance (inability to carry out physical activity), difficulty breathing and fluid retention. Isemid contains the active substance torasemide.
Isemid is available as tablets and can only be obtained with a prescription. It is given once daily and the starting dose depends on bodyweight. The tablet can be given with food or directly into the mouth if the dog does not take it easily. The usual dose is 0.13 to 0.25 mg torasemide per kg bodyweight once daily. This may be increased for up to 5 days to a maximum of 0.4 mg per kg bodyweight once daily in dogs with moderate to severe fluid retention in the lungs. The dose is then reduced and adjusted according the dog’s response.
For more information about using Isemid, see the package leaflet or contact your veterinarian or pharmacist.
Torasemide is a diuretic medicine. It works by increasing the loss of water and salt in the urine. This decreases the overall blood volume, reducing the effort needed for the heart to pump blood and thereby improving its function.
In a field study involving 321 dogs with congestive heart failure, treatment with Isemid was compared with another established diuretic medicine, furosemide. The main measure of effectiveness was a reduction in scores for lung fluid and cough (both are signs of congestive heart failure) after 14 days of treatment and no worsening of difficulty in breathing or exercise intolerance scores. The study showed Isemid to be as least as effective as furosemide for the treatment of signs related to congestive heart failure with 74% of dogs in each group being successfully treated.
The most common side effects with Isemid (which may affect more than 1 in 10 animals) are poor function of the kidneys, alterations in blood tests measuring kidney function, haemoconcentration (increase in the concentration of red blood cells circulating in the blood), and changes in electrolyte (salt) levels (chloride, sodium, potassium, phosphorus, magnesium and calcium).
Isemid must not be given in cases of kidney failure, dehydration, a decrease in circulating blood volume or low blood pressure. Isemid must not be given at the same time as other diuretics which work in the same way as torasemide.
For the full list of side effects and restrictions of Isemid, see the package leaflet.
Isemid may increase urination, and lead to thirst, gut disturbances, low blood pressure and dehydration if ingested. Any part-used tablets should be returned to the blister pack and then to the original carton to keep them out of the reach of children. If the product is accidentally swallowed by a person, particularly by a child, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
This medicine may also cause hypersensitivity (allergic) reactions. People who are hypersensitive to torasemide, sulfonamides or to any of the other ingredients in Isemid should avoid contact with the medicine. If symptoms of allergy occur, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Hands should be washed after handling the medicine.
The European Medicines Agency decided that Isemid’s benefits are greater than its risks and it can be authorised for use in the EU.
Isemid received a marketing authorisation valid throughout the EU on 09/01/2019.
Product information
09/01/2019
Product details
- Name of medicine
- Isemid
- Active substance
- Torasemide
- International non-proprietary name (INN) or common name
- Torasemide
- Species
- Dogs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QC03CA04
Pharmacotherapeutic group
- High-ceiling diuretics
- Sulfonamides, plain
Therapeutic indication
For treatment of clinical signs related to congestive heart failure in dogs, including pulmonary oedema.
News on Isemid
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