（商品説明）

有効成分：チアマゾール5mg。

ネコの甲状腺機能亢進症の長期治療と、甲状腺外科手術前の猫の甲状腺機能亢進症の安定化に非常に効果的です。

有効成分チアマゾールが血中濃度を引き起こす可能性があるため、猫には常に飲料水を多飲させる必要があります。

在庫保有不可能商品ですので、ご注文後、都度ヨーロッパの専門サプライヤーよりの取り寄せ発送となります。

ご注文頂いてからお手元に届くまで２～３週間ほどかかりますこと、ご了承下さい。

＜ヨーロッパ製＞

（使用法）

（１）外科的甲状腺切除前のネコ甲状腺機能亢進症の安定化およびネコ甲状腺機能亢進症の長期治療のために、推奨される開始用量は1日あたり5mgです。

（２）可能な限り、1日の総投与量を2回に分けて、朝と夕方に投与する必要があります。錠剤の分割は不可です。

（３）コンプライアンスの理由から、5 mgの錠剤を1日1回投与することが望ましい場合は、これは許容されますが、短期的には2.5mgの錠剤を1日2回投与する方が効果的です。

 （４）5 mgの錠剤は、より高い投与量を必要とする猫に適しています。

（５）血液学、生化学的に治療を開始する前、および3週間後、6週間後、10週間後、20週間後、その後3か月ごとに状況を評価する必要があります。

（６）推奨されるモニタリング間隔のそれぞれの期間で、また治療に対する臨床反応に応じて、用量を滴定する必要があります。

（７）用量調整は2.5mgの増分で行われることが推奨されています。

（８） 1日あたり10mg以上が必要な場合は、特に注意深く監視する必要があります。

（９）投与量は20mg /日を超えてはなりません。

（10）高血圧性甲状腺機能亢進症の場合は一生投与による治療が勧められています。

＜禁忌＞

・原発性肝疾患や糖尿病などの全身性疾患を患っている猫には使用しないでください。

・自己免疫疾患の兆候を示している猫には使用しないでください。

・好中球減少症やリンパ球減少症などの白血球障害のある動物には使用しないでください。

・血小板障害および凝固障害（特に血小板減少症）のある動物には使用しないでください。

・妊娠中または授乳中の雌猫には使用しないでください。

（使用期限）

ご注文日より１年以上有効のもの

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Thiafeline 5mg 60tabs for cats

Description

Thiafeline Film-coated Tablets for Cats.

Thiafeline 5mg Film-coated Tablets for Cats (AT, BE, CZ, DE, EE, EL, ES, FR, HU, IE, IS, IT, LT, LU, LV, PL, PT, RO, SE, SK, UK)
Thiafeline vet 2.5mg Film-coated Tablets for cats (FI)
Thiafeline Vet (DK, NO)

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substance:
Thiamazole    5mg

Excipient(s):
Titanium dioxide (E171)  0.15  mg
Sunset Yellow FCF (E110)   0.09  mg
Quinoline Yellow WS (E104)  0.075 mg

PHARMACEUTICAL FORM

Film-coated tablet.
Orange biconvex tablets 5.5 mm diameter.

CLINICAL PARTICULARS

Target species

Cats.

Indications for use, specifying the target species

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

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 pregnant or lactating females. Refer to section 4.7.
Do not use in cats with hypersensitivity to thiamazole or the excipient, polyethylene glycol.

Special warnings for each target species

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

Special precautions for use

Special precautions for use in animals
If more than 10 mg per day is required animals should be monitored particularly carefully.
Use of the 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.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use.
In the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Thiamazole may cause vomiting, epigastric distress, headache, fever, arthralgia, pruritus and pancytopaenia. Treatment is symptomatic.
Wash hands with soap and water after handling litter used by treated animals.
Do not eat, drink or smoke while handling the tablet or used litter.
Do not handle this product if you are allergic to anti-thyroid products. 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 doctor.
Do not break or crush tablets.
As thiamazole is a suspected human teratogen, women of child-bearing age and pregnant women should wear gloves when handling litter of treated cats.
Pregnant women should wear gloves when handling this product.

Adverse reactions (frequency and seriousness)

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. Adverse reactions are uncommon. The most common clinical side effects reported include vomiting, inappetance/anorexia, lethargy, severe pruritus and excoriations of the head and neck, bleeding diathesis and icterus associated with hepatopathy, and haematological abnormalities (eosinophilia, lymphocytosis, neutropenia, lymphopenia, slight leucopenia, agranulocytosis, thrombocytopenia or haemolytic anaemia). These side effects resolved within 7-45 days after cessation of thiamazole therapy.
Possible immunological side effects include anaemia with rare side effects including thrombocytopenia and serum anti-nuclear antibodies, and, very rarely, lymphadenopathy can occur. 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.

Use during pregnancy, lactation or lay

Laboratory studies in rats and mice have shown evidence of teratogenic and embryotoxic effects of thiamazole. The safety of the product was not assessed in pregnant or lactating cats. Do not use in pregnant or lactating females.

Interaction with other medicinal products and other forms of interaction

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.

Amounts to be administered and administration route

For oral administration only.
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 per day.
Wherever possible, the total daily dose should be divided into two and administered morning and evening. Tablets should not be split.
If, for reasons of compliance, once daily dosing with a 5 mg tablet is preferable, then this is acceptable although   the 2.5 mg tablet given twice daily may be more efficacious in the short term. The 5 mg tablet is also suitable for cats requiring higher dose rates. 
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. Dose adjustments should be made in increments of 2.5 mg and the aim should be to achieve the lowest possible dose rate.
If more than 10 mg per day is required animals should be monitored particularly carefully.
The dose administered should not exceed 20 mg/day.
For long term treatment of hyperthyroidism the animal should be treated for life.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In tolerance studies in young healthy cats, the following dose-related clinical signs occurred at doses of up to 30 mg/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/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 per 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 4.6: Adverse reactions.
If overdosage occurs, stop treatment and give symptomatic and supportive care.

Withdrawal period(s)

Not applicable.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:antithyroid preparations, sulphur-containing imidazole derivates.
ATC Vet Code: QH03BB02.

Pharmacodynamic properties

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.

Pharmacokinetic particulars

Absorption
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.
Peak plasma levels occur approximately 0.5-1 hour after dosing (tmax = 0.69 h). Cmax is between 1.1 and 2.7 µg/ml (1.78 µg/ml) and half-life is 3.3 h.
Distribution
From 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.
The drug residence time in the thyroid gland is assumed to be longer than in the plasma.
Metabolism and elimination
The metabolism of thiamazole in cats has not been investigated, however, in rats thiamazole is rapidly metabolised in the thyroid gland. About 64 % of the administered dose being eliminated in the urine and only 7.8 % excreted in faeces. This is in contrast with man where the liver is important for the metabolic degradation of the compound.

PHARMACEUTICAL PARTICULARS

List of excipients

Tablet core:
Lactose monohydrate
Povidone
Sodium starch glycolate Type A
Silica, colloidal anhydrous
Magnesium stearate

Coating:
Hypromellose
Cellulose, microcrystalline
Lactose monohydrate
Macrogol
Titanium dioxide (E171)
Sunset Yellow FCF (E110)
Quinoline Yellow WS (E104)

Incompatibilities

Not applicable.

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale:  30 months.

Special precautions for storage

Keep the blister in the outer package in order to protect from light.