IRENAT Oral drops (2011)
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Περιεχόμενα
1. Name of the medicinal product
Irenat Drops. 300 mg sodium perchlorate, oral drops. Sodium perchlorate monohydrate.
2. Qualitative and quantitative composition
1 ml solution (approximately 15 drops) contains 344.2 mg sodium perchlorate monohydrate (equivalent to 300 mg sodium perchlorate). For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral drops.
4.1. Therapeutic indications
For the treatment of hyperthyroidism, for thyroid blockade in the context of radionuclide studies of other organs using radioactively labelled iodine or of immunoscintigraphy to detect tumours using antibodies ...
4.2. Posology and method of administration
Posology Adults receive 4-5 10 Irenat drops daily (equivalent to 800-1000 mg sodium perchlorate) or, exceptionally, 5 15 Irenat drops daily (equivalent to 1500 mg sodium perchlorate) as an initial dose ...
4.3. Contraindications
Irenat drops must not be taken in the following circumstances: retrosternal goitre, hypersensitivity to perchlorates or to any of the excipients listed in section 6.1; if administration of perchlorate ...
4.4. Special warnings and precautions for use
Regular and repeated monitoring of thyroid function is necessary during antithyroid therapy so as to allow adjustment of the dosage of Irenat drops to the patients changing metabolism and to avoid overtreatment, ...
4.5. Interaction with other medicinal products and other forms of interaction
Uptake of radioiodine or 99mTc-pertechnetate is dose-dependently inhibited by perchlorate. The ability of TSH to stimulate radioiodine uptake is not affected by perchlorate. If perchlorate is used concomitantly ...
4.6. Pregnancy and lactation
Irenat drops should not be taken during pregnancy, as insufficient experience is available regarding a possible risk to the unborn child. Irenat drops cross the placenta to the fetus unhindered. The fetal ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Evaluation of undesirable effects is based on the following frequencies: common (≥1% to <10%), uncommon (≥0.1% to <1%), rare (≥0.01% to <0.1%), very rare (<0.01% or unknown). The occurrence of undesirable ...
4.9. Overdose
If Irenat drops are taken undiluted, they may (e.g. in children) have a severe local irritant effect, with symptoms such as vomiting, abdominal pain and diarrhoea. Acute fatal intoxication with perchlorates ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> thyroid/antithyroid drugs <b>ATC code:</b> H03BC Perchlorate competitively inhibits the thyroids iodine uptake mechanism, iodination and affects iodisation by flushing ...
5.2. Pharmacokinetic properties
Absorption of perchlorate occurs within a matter of minutes. The onset of action in thyroid cells after oral administration is very rapid. After a single dose, the blockade of iodine uptake lasts only ...
5.3. Preclinical safety data
a) Acute toxicity Oral administration of 1 or 2 g showed no toxic effects in humans. I.v. injection of 250 mg sodium perchlorate in rabbits had no toxic effects, although intracardiac injection of 500 ...
6.1. List of excipients
Ammonium chloride Magnesium chloride Calcium chloride Purified water
6.2. Incompatibilities
None known. Miscellaneous Irenat drops should be discontinued at least 3 days prior to thyroid scintigraphy or measurement of radionuclide uptake. Use during pregnancy and lactation: see section 4.6. ...
6.3. Shelf life
The shelf life is 4 years. Once opened, vials should not be used for longer than 26 weeks at room temperature. This medicinal product is not to be used after the expiry date.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Irenat drops are available in a vial containing 40 ml solution.
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Bayer Vital GmbH, D-51368 Leverkusen Tel.: (02 14) 30 – 51348 Fax: (02 14) 30 – 51603 Email address: bayer-vital@bayerhealthcare.com
8. Marketing authorization number(s)
6044463.00.00
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 09.10.1996 Date of latest renewal: 22.11.2001
10. Date of revision of the text
10/2011
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