THYSAT Tablet (2020)
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Περιεχόμενα
Name of the medicinal product
ThySat 65 mg tablets.
Qualitative and quantitative composition
Each tablet contains 65.00 mg potassium iodide equivalent to 50.00 mg iodine. For a full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. The tablets are white to yellowish slightly marbled round tablets, with a smooth surface without any defects, cross-scored for ease of breaking. The tablet can be divided into equal quarters. ...
Therapeutic indications
Potassium iodide is indicated as a thyroid-blocking agent to prevent the uptake of radioactive iodine, for example after a nuclear accident or during a nuclear medicine investigation before administering ...
Posology and method of administration
Posology Nuclear accident Iodine prophylaxis should be performed in case of a nuclear accident, when radioactive iodine is released, in all people involved including children and pregnant and breastfeeding ...
Contraindications
Hypersensitivity to potassium iodide (see also sections 4.2 and 4.5) or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
In cases of exposure to radioiodine from nuclear accidents, dosing of potassium iodide should be based on emergency plans and predetermined operational intervention levels. Risk benefit of administration ...
Interaction with other medicinal products and other forms of interaction
Several drugs, such as captopril and enalapril can cause hyperkalaemia and this effect may be enhanced if potassium iodide is also administered. The effect of quinidine on the heart is increased by increased ...
Fertility, pregnancy and lactation
Pregnancy Teratogenic effects such as congenital goitre and hypothyroidism have been reported when iodides are administered to pregnant women. Prophylactic administration of iodide to the pregnant mother ...
Effects on ability to drive and use machines
ThySat 65 mg tablets have no or negligible influence on the ability to drive and use machines.
Undesirable effects
Undesirable effects are listed by MedDRA System Organ Classes. Assessment of undesirable effects is based on the following frequency groupings: Very common: ≥1/10, Common: ≥1/100 to <1/10, Uncommon: ≥1/1,000 ...
Overdose
In overdose, symptoms of iodism such as headache, pain and swelling of the salivary glands, fever or laryngitis, swelling or inflammation of the throat, gastrointestinal upset and diarrhoea can occur. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antidotes ATC code: V03AB21 Potassium iodide When exposed to radioactive iodine, potassium iodide prevents damage by radioactive iodine to the thyroid gland due to saturation ...
Pharmacokinetic properties
The human body contains 20 to 50 mg of iodine. The average daily consumption is 150 to 200 µg. Iodine uptake by the thyroid gland is 80-fold higher compared with other organs. The human body is able to ...
Preclinical safety data
A single high dose has been found to be teratogenic in rats. In another study in rats, the administration of high daily iodine doses led to incomplete parturition, failure of lactation and reduced mothering ...
List of excipients
Cellulose, microcrystalline Talc Macrogol 6000 Silica, colloidal anhydrous
Incompatibilities
Not applicable.
Shelf life
6 years.
Special precautions for storage
Do not store above 25°C. Keep the blister in the outer carton in order to protect from light and moisture.
Nature and contents of container
Blister (white, opaque PVC/PVDC foil / Al foil with printing), package insert leaflet, outer paper folder. Size of packing: 4, 10 or 100 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
hameln pharma ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK
Marketing authorization number(s)
PL 01502/0082
Date of first authorization / renewal of the authorization
Date of first authorisation: 25/11/2011
Date of revision of the text
01/04/2020
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