Tyromel medical leaflet

[craftyang]

Hi all,

Does anyone have a link to an English translation of a Tyromel (T3) medical leaflet/patient information please?

Thank you in advance.

Angie

[galathea]

There is a pdf here, on tpa... tpauk.com/main/wp-content/u...

[craftyang]

Thank you very much.

[humanbean]

I got this from an old thread on here which has been deleted. I had to get it from Google cache. It is a Google Translation of a Turkish Summary of Product Characteristics, so is not perfect by any means, and is not official in any way.

Tiromel tablets Summary of Product Characteristics

Endocrine System » Thyroid Drugs » Thyroid preparations » Thyroid Hormones » Liyotro the

SUMMARY OF PRODUCT INFORMATION

1. NAME OF THE MEDICINAL PRODUCT

TİROMEL tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances maddeyardımc

60 mg Lactose

For excipients, see for 6. TA.

3. PHARMACEUTICAL FORM

Tablet

1 ^ containing a straight face TİROMEL white middle round notched 100 tablets blister

is presented in packaging.

4. CLINICAL FEATURES

4.L Therapeutic indications

Mild, moderate and severe hypothyroidism, myxedema me in cretinism, simple goitre is used in congenital hypothyroidism.

Also used for the test for the differentiation from other thyroid disease suppression of hypothyroidism for the TSH suppression.

4.2. Dosage and Administration

Dosage / application frequency and time:

receiving one dose per day is recommended tiromel. Thyroid hormonlarmm dosage to be used is determined based on the indications and dosage must be individualized for each patient according to the treatment response and laboratory findings.

Mild hypothyroidism: The recommended starting dose of 25 micrograms is my day. The daily dose every 1 to 2 weeks 12.5 - 25 micrograms can be increased. geneuikl a maintenance dose of 25-75 micrograms per day.

Myxedema; The recommended starting dose of 5 micrograms per day. A daily dose of 5-10 micrograms every 1 or 2 weeks may arttml. 25 micrograms of each reached a daily dose of 1 or 2 weeks 12.5 - 25 micrograms can be increased. Genellü a maintenance dose of 50 to 100 micrograms a day I am.

Congenital hypothyroidism: The recommended starting dose of 5 micrograms daily. Dosage until the desired therapeutic response may take a arttml 5 micrograms every 3-4 days. 0-1 years as a maintenance dose

from a maximum of 20 micrograms per day, administered daily maximum 50 micrograms over 1 year of age. 3 applied on the normal adult dose older.

Simple (non-toxic) goiter; The recommended starting dose of 5 micrograms per day. The daily dose is increased every 1 or 2 weeks 5-10 micrograms. 25 micrograms daily dose is reached by every one or two weeks 12.5 - 25 micrograms can be increased. I'm usually a maintenance dose of 75 micrograms per day.

Day for 7 days in thyroid suppression test 75-100 microgram dosage is recommended. Up-take of radioactive iodine is administered before and after treatment.

Suppression test in patients undergoing given based on the ability of the thyroid gland autonomy as an additive exogenous hormones endogenous hormone production may also take caution should be exercised.

Application:

Is administered orally.

Additional information on special populations;

Kidney / liver failure

tiromel kidney / liver diseases in the kuuanım the ihşk a warning not exist.

The pediatric population;

Treatment with daily maintenance dose of 5 micrograms dose başlanmah and up to ulaşılmca intervals recommended dose of 5 micrograms should be augmented.

Elderly

Treatment with daily maintenance dose of 5 micrograms dose başlanmah and up to ulaşılmca intervals recommended dose of 5 micrograms should be increased.

4.3. Contraindications

TİROMEL contraindicated in the following conditions:

• have been identified, but the case of untreated adrenal cortical insufficiency

• Untreated in thyrotoxicosis

• In case of hypersensitivity against substances in Composition

4.4.Özel Use is fit and measures Angina pectoris, cardiovascular and should be used with caution in elderly patients with multi system disease.

Anticoagulation in patients receiving anticoagulant dose is required to be set again.

In diabetic patients, high doses can disrupt stability in the almdığm.

Thyroid hormonlarmm obesity in UzdUr effect ofthe use alone or in combination with other drugs.

In the treatment of male or female infertility, thyroid hormone use alone or in combination with other drugs are useless if not associated with hypothyroidism.

Before applying the medication should be clarified whether morphological hypogonadism and nephrosis patients. Hypopituitarism adrenal insufficiency must be corrected before starting treatment, if any.

Severe and prolonged hypothyroidism causes a decrease in adrenocortical activity levels. When treated with thyroid hormone metabolism high level of interest than adrenocortical activity. This may accelerate the adrenocortical insufficiency. In this case, adrenocortical steroids may be required.

4.5. Interaction with other medicinal products and other forms of interaction

Thyroid hormone catabolism of vitamin K-dependent clotting factors increased the-IR. Compensatory increase in the synthesis of coagulation factors is affected when used in conjunction with oral anticoagulants. Thyroid hormone to patients stabilized on oral anticoagulants case when administered replacement therapy that patients have the beginning of therapy should be carefully monitored. May reduce the anticoagulant dose in a patient in real hypothyroidism. Maintenance thyroid replacement therapy in a patient stabilized oral anticoagulant therapy initiation of special prevention are required.

Insulin or oral hypoglycemic patients should be monitored from the very proximate to the initiation of thyroid replacement therapy.

Cholestyramine and intestines as well as T4 and T3 thyroid hormone from cholestyramine applications will connect to must have an intermediate between 4-5 hours.

In case of thyroid gland function and thyroid replacement therapy could verihne oral contraceptives containing estrogen or estrogen patients may need to increase the dose of thyroid hormone.

If used in conjunction with thyroid hormones may increase the effects of tricyclic antidepressants antidepressants. These applications are cardiac arrhythmias were observed during welding. The increase in thyroid hormone activity may occur.

Digitalis toxicity can be enhanced by thyroid hormone. Thyroid hormone replacement therapy accelerates metabolism requires that arttırılmasm of digitalis dose.

Thyroid hormone ketamine administration in patients can lead to hypertension and tachycardia.

Thyroid hormones catecholamines (epinephrine, norepinephrine) may increase adrenergic effects.

Thyroid hormones androgens of laboratory tests performed in patients receiving corticosteroids, estrogens, oral contraceptives containing estrogen, and salicylate-containing preparations containing iodine should not be forgotten that might be affected by most medications.

4.6. Pregnancy and lactation

Is a pregnancy category.

Women with childbearing potential / Birth control (contraception)

Sodium L-triiodothyronine on the pregnancy or the fetus / newborn child does not indicate that adverse health effects. Therefore there is no need for any special measures or practice contraception in females with childbearing potential.

Gestation

Well-managed epidemiological studies on L-triiodothyronine Sodium pregnancy or the fetus / newborn child is adverse impact on health.

TİROMEL be used during pregnancy,

Lactation

Minimal rate of sodium L-triiodothyronine breast milk is discarded. All the dosage ones of tiromel any effect on the nursing infant are not foreseen. Breastfeeding is stopped or stopping durdurulmayacağ the treatment of TİROMEL durdurulmayacağ Up / treatment should be decided on the kaçmılıp kaçımimayacağ.

reproductive / Fertility

There are no data on the effect of that tiromel on reproductive ability and fertility.

4.7. Vehicles and effects on the user machine

tiromel the car and there is no evidence that the effect on the machine is used.

4.8. Undesirable effects

L-triiodothyronine side effects observed with the sodium, the body system as follows smıflandırılmıştu- very common (> 1.10); commonly (> 1/100 to <1/10); Uncommon (> 1/1000 to <1/100); rare (> 1/10000 to <1/1000); very rare (<1/10000); not known (can not be estimated from the available data).

Endocrine disorders

Rare Hyperthyroidism, a reduction in growth hormone

Cardiac disorders

Common arrhythmia, tachycardia, respiratory and cardiac arrest, hypotension, myocardial infarction

Commonly induced,; Hypertension, angina, congestive heart failure, thrombophlebitis

Skin and subcutaneous tissue disorders

Rare: erythema, papules, blistering skin reactions including aleıjüc

Kas'iskelet disorders, connective tissue diseases

Rare: Postmenopausal osteoporosis

General disorders and administration site disorders

Common: Fever

4.9. Overdose Treatment

In excessive dosage dıunm, headache, irritability, sweating, irritability, tachycardia, increase in bowel movements and menstrual irregularities may occur. Angina pectoris, congestive heart failure may develop or worsen. Does the dosage should be reduced if excessive doses of the drug for the treatment or symptoms appear to be temporarily interrupted. Large quantities should be studied case of the removal of the central and peripheral effects of thyroid hormone should not be intended to reduce the intestinal absorption of drugs in the acute phase and m including increased sympathetic activity first. Symptomatic and supportive treatment should be administered. Ventilation maintenance can be given oxygen. If cardiac failure develops glycosides may be required. Fever, hypoglycemia, and take measures necessary for the loss of fluid. Antiadrenergic drugs used to increased sympathetic activity.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Pharmacotherapeutic group: Thyroid hormones ATC Code: H03AA02

TIROMEL is a synthetic thyroid hormone seen all kinds except transient hypothyroidism during the recovery phase of subacute thyroiditis is effective in the treatment of thyroid hormone deficiency. It quickly than other thyroid preparations is action. Would be effective in small doses.

5.2. Pharmacokinetic properties

Absorption : After oral administration of L-triiodothyronine TİROMEL taken almost completely absorbed (in the first four hours, 95 wt%).

Distribution: VI day up.

The Bivotransformasvo : It is metabolized in the liver.

Eliminasvo to: Ehm is through the kidneys.

5.3. Preclinical safety data

Has Bildirihne

6. PHARMACEUTICAL PARTICULARS

6.l list of excipients

Lactose

Polyvinylpyrrolidone

Starch

Magnesium stearate

6.2. Incomp

een reported.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

Store at room temperature, at 25 ° C under.

6.5. Nature and contents of container

100 tablets in blister packs.

6.6. Special precautions for disposal and the residue of the medicinal product

Any unused product or waste materials "Medical Waste Control Regulation" and "Packaging and Packaging Waste Control Regulation" what should be disposed of accordingly.

7. LICENSE HOLDER

Powder Hound of Abraham Veres

Old magic ^ creek Cad. Ayazağa Road No. 5 34398

Maslak / Istanbul

0212 366 84 00

0212 276 20 20

8. LICENSE NUMBER

119/91

9. DATE OF FIRST AUTHORISATION / RENEWAL OF REGISTRATION DATE

First registration date: 01/16/1975 License renovation; 28/04/1992

10. RENEWAL DATE CUBE

[humanbean in reply to humanbean]

For the original posting of the above you can thank helvella

[craftyang in reply to humanbean]

Thank you very much. I think this was the original that was shared with me but I didn't make a copy and as you said, the thread was deleted.