Thiamacare 10 mg/ml Oral Solution for Cats

Composition

Each ml contains:

Active substance:

Thiamazole 10 mg

Excipients:

Clear, colourless to pale yellow, homogeneous solution

3

Pharmacological properties

4.1 ATCvet code:

QH03BB02.

4.2 Pharmacodynamics

Thiamazole acts by blocking the biosynthesis of thyroid hormone in vivo. The primary action is to inhibit binding of iodide to the enzyme thyroid peroxidase, thereby preventing the catalysed iodination of thyroglobulin and T3 and T4 synthesis.

4.3 Pharmacokinetics

Following oral dosing in healthy cats, thiamazole is rapidly and completely absorbed with a bioavailability of >75 %. However, there is a considerable variation between animals. Elimination of the drug from cat plasma is rapid with a half-life of 2.6-7.1 hours. Peak plasma levels occur within a maximum of 1 hour after dosing. Cmax is 1.6 ± 0.4 μg/ml.

In rats thiamazole has been shown to be poorly bound to plasma protein (5 %); 40 % was bound to red blood cells. The metabolism of thiamazole in cats has not been investigated, however, in rats thiamazole is rapidly metabolized. For man and rats, it is known that the drug can cross the placenta and concentrates in the foetal thyroid gland. There is also a high rate of transfer into breast milk.

3

Target species

Cats

3

Indications

For the stabilisation of hyperthyroidism in cats prior to surgical thyroidectomy. For the long-term treatment of feline hyperthyroidism.

3

Dosage

For oral use.

The veterinary medicinal product should be administered directly into the mouth of the cat. Do not administer in food as efficacy of the veterinary medicinal product when administered via this route has not been established.

For the stabilisation of feline hyperthyroidism prior to surgical thyroidectomy and for the long term treatment of feline hyperthyroidism, the recommended starting dose is 5 mg of thiamazole (0.5 ml of the veterinary medicinal product) per day. The total daily dose should be divided into two and administered morning and evening. In order to enhance stabilisation of the hyperthyroid patient the same dosing schedule relative to feeding should be used daily.

Haematology, biochemistry and serum total T4 should be assessed before initiating treatment and after 3 weeks, 6 weeks, 10 weeks, 20 weeks, and thereafter every 3 months. At each of the recommended monitoring intervals, the dose should be titrated to effect according to the total T4 and to clinical response to treatment. Standard dose adjustments should be made in increments of 2.5 mg of thiamazole (0.25 ml of the veterinary medicinal product) and the aim should be to achieve the lowest possible dose rate. In cats that require particularly small dose adjustments, increments of 1.25 mg of thiamazole (0.125 ml of the veterinary medicinal product) can be used. If total T4 concentration drops below the lower end of the reference interval, and particularly if the cat is showing clinical signs of iatrogenic hypothyroidism (e.g. lethargy, inappetence, weight gain and/or dermatological signs such as alopecia and dry skin), consideration should be given to reducing the daily dosage and/or dosing frequency.

If more than 10 mg of thiamazole per day is required animals should be monitored particularly carefully.

The dose administered should not exceed 20 mg of thiamazole per day.

For long-term treatment of hyperthyroidism, the animal should be treated for life.

3

Contraindications

Do not use in cats suffering from systemic disease such as primary liver disease or diabetes mellitus.

Do not use in cats showing signs of autoimmune disease.

Do not use in animals with disorders of white blood cells, such as neutropenia and lymphopenia.

Do not use in animals with platelet disorders and coagulopathies (particularly thrombocytopenia).

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in pregnant and lactating females (refer to section 3.7).

3

Adverse reactions

Cats:

Adverse reactions have been reported following long term control of hyperthyroidism. In many cases, signs may be mild and transitory and not a reason for withdrawal of treatment. The more serious effects are mainly reversible when medication is stopped and.

Uncommon (1 to 10 animals / 1,000 animals treated):

Vomiting1, Inappetence1/Anorexia1, Lethargy1

Pruritus1,2, Excoriations1,2, Bleeding1,3,4 Icterus1,4, Hepatopathy1

Eeosinophilia1, Lymphocytosis1, Neutropenia1, Lymphopenia1, Leucopenia1), Agranulocytosis1, Thrombocytopenia1,5,6, Haemolytic anaemia1

Rare (1 to 10 animals / 10,000 animals treated):

Serum anti-nuclear antibodies

Anaemia

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Lymphadenopathy5,

1 Resolve within 7-45 days after cessation of thiamazole therapy.

2 Severe, in head and neck.

3 Sign of a bleeding diathesis.

4 Associated with hepatopathy.

5 Treatment should be stopped immediately and alternative therapy considered, following a suitable period for recovery

Following long-term treatment with thiamazole in rodents, an increased risk of neoplasia in the thyroid gland has been shown to occur, but no evidence is available in cats.

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 the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species

If more than 10 mg per day is required animals should be monitored particularly carefully.

Use of the veterinary medicinal product in cats with renal dysfunction should be subject to careful risk:benefit assessment by the clinician. Due to the effect thiamazole can have on reducing the glomerular filtration rate, the effect of therapy on renal function should be monitored closely as deterioration of an underlying condition may occur.

Haematology must be monitored due to risk of leucopenia or haemolytic anaemia. Any animal that suddenly appears unwell during therapy, particularly if they are febrile, should have a blood sample taken for routine haematology and biochemistry. Neutropenic animals (neutrophil counts <2.5 x 109/l) should be treated with prophylactic bactericidal antibacterial drugs and supportive therapy.

Please refer to section 3.9 for monitoring instructions.

As thiamazole can cause haemoconcentration, cats should always have access to drinking water.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity (allergy) to thiamazole, or vanillin should avoid contact with the veterinary medicinal product. If allergic symptoms develop, such as a skin rash, swelling of the face, lips or eyes or difficulty in breathing, you should seek medical attention immediately and show the package leaflet or label to the physician. Thiamazole may cause gastrointestinal disturbances, headache, fever, joint pain, pruritus (itching) and pancytopaenia (decrease in blood cells and platelets). The veterinary medicinal product may also cause skin irritation.

Avoid dermal and oral exposure, including hand-to-mouth contact.

Do not eat, drink or smoke while handling the veterinary medicinal product or used litter.

Wash hands with soap and water after administration and handling of the veterinary medicinal product and cleaning the vomit of, or litter used by, treated animals. Wash any spillages or splatter from skin immediately.

Following administration of the veterinary medicinal product any residual veterinary medicinal product remaining on the tip of the dosing syringe should be wiped clean with a tissue. The contaminated tissue should be immediately disposed of. The used syringe should be stored with the veterinary medicinal product in the original carton.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

This veterinary medicinal product may cause eye irritation.

Avoid eye contact including hand to eye contact.

In case of accidental eye contact, rinse eyes immediately with clean running water. If irritation develops, seek medical advice.

As thiamazole is a suspected human teratogen, women of child-bearing age must wear non-permeable single-use gloves when administering the veterinary medicinal product or handling the litter/vomit of treated cats.

If you are pregnant, think you may be pregnant or are attempting to conceive, you should not administer the veterinary medicinal product or handle the litter/vomit of treated cats.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3

Use during pregnancy, lactation or lay

Pregnancy and Lactation:

Do not use during pregnancy or lactation

Laboratory studies in rats and mice have shown evidence of teratogenic and embryotoxic effects of thiamazole. In cats, the safety of the veterinary medicinal product has not been established during pregnancy or lactation.

3

Interactions

Concurrent treatment with phenobarbital may reduce the clinical efficacy of thiamazole.

Thiamazole is known to reduce the hepatic oxidation of benzimidazole wormers and may lead to increases in their plasma concentrations when given concurrently. Thiamazole is immunomodulatory, therefore this should be taken into account when considering vaccination programmes.

3

Overdose

In tolerance studies in young healthy cats, the following dose-related clinical signs occurred at doses of up to 30 mg thiamazole/animal/day: anorexia, vomiting, lethargy, pruritus and haematological and biochemical abnormalities such as neutropenia, lymphopenia, reduced serum potassium and phosphorus levels, increased magnesium and creatinine levels and the occurrence of anti-nuclear antibodies. At a dose of 30 mg thiamazole/day some cats showed signs of haemolytic anaemia and severe clinical deterioration. Some of these signs may also occur in hyperthyroid cats treated at doses of up to 20 mg thiamazole / day. Excessive doses in hyperthyroid cats may result in signs of hypothyroidism. This is however unlikely, as hypothyroidism is usually corrected by negative feedback mechanisms. Please refer to Section 3.6: Adverse reactions.

If overdosage occurs, stop treatment and give symptomatic and supportive care.

3

Special warnings

In order to enhance stabilisation of the hyperthyroid patient the same feeding and dosing schedule should be used daily.

3

Withdrawal period

Not applicable.

3

Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

3

Immediate packaging

30 ml amber glass type III bottle with a clear white polypropylene or polyethylene syringe adapter and a child-proof white polypropylene screw cap. The veterinary medicinal product is supplied with one clear polypropylene oral syringe of 1.0 ml dosing device graduated in 1.25 mg increments or 0.1 mg up to 10 mg of thiamazole.

Package size:

Cardboard box with 1 bottle of 30 ml and an oral syringe of 1.0 ml graduated in 0.1 mg.

Cardboard box with 1 bottle of 30 ml and 1 oral syringe of 1.0 ml graduated in 1.25 mg.

Not all pack sizes may be marketed.

3

Storage

Keep the bottle tightly closed.

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 3 months.

3

Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

3

Additional information

Vm 32742/4013

8 DATE OF FIRST AUTHORISATION

26 March 2020

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

January 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 04 June 2025

3

Registration holder

Ecuphar NV

3