STAMICIS Kit for radiopharmaceutical preparation (2016)
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Περιεχόμενα
1. Name of the medicinal product
STAMICIS 1 mg kit for radiopharmaceutical preparation.
2. Qualitative and quantitative composition
Each vial contains 1 mg [Tetrakis (2-methoxyisobutyl isonitrile) copper (I)] tetrafluoroborate. The radionuclide is not part of the kit. <u>Excipients with known effect:</u> One ml of solution contains ...
3. Pharmaceutical form
Kit for radiopharmaceutical preparation. White powder.
4.1. Therapeutic indications
This medicinal product is for diagnostic use only. This is indicated for adults. For paediatric population see section 4.2. After radiolabelling with sodium pertechnetate (<sup>99m</sup>Tc) solution, the ...
4.2. Posology and method of administration
Posology Adults and elderly population Posology may vary depending on gamma camera characteristics and reconstruction modalities. The injection of activities greater than local DRLs (Diagnostic Reference ...
4.3. Contraindications
Hypersensitivity to the active substances to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical. In myocardial scintigraphy investigations under ...
4.4. Special warnings and precautions for use
Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous ...
4.5. Interaction with other medicinal products and other forms of interaction
Medicinal products which affect myocardial function and/or blood flow may cause false negative results in the diagnosis of coronary arterial disease. Particularly beta-blockers and calcium antagonists ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who ...
4.7. Effects on ability to drive and use machines
STAMICIS has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The following table presents how the frequencies are reflected in this section: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), ...
4.9. Overdose
In the event of administration of a radiation overdose with technetium (99mTc) sestamibi the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, Technetium (99mTc) compounds ATC code: V09GA01 Pharmacodynamic effects At the chemical concentrations used for diagnostic examinations, technetium ...
5.2. Pharmacokinetic properties
After reconstitution with sodium pertechnetate (99m Tc), the following technetium (<sup>99m</sup>Tc) sestamibi complex is formed: [<sup>99m</sup>Tc (MIBI)<sub>6</sub>]<sup>+</sup> Where: MIBI = 2-methoxyisobutylisonitrile ...
5.3. Preclinical safety data
In acute intravenous toxicity studies in mice, rats and dogs, the lowest dose of the reconstituted kit that resulted in any deaths was 7 mg/kg (expressed as Cu (MIBI)4 BF4 content) in female rats. This ...
6.1. List of excipients
Stannous chloride dihydrate Cysteine hydrochloride monohydrate Sodium citrate Mannitol
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
6.3. Shelf life
1 year. After reconstitution and radiolabelling, do not store above 25°C and use within 10 hours.
6.4. Special precautions for storage
Do not store above 25°C. Keep the vials in the outer carton, in order to protect from light. For storage conditions of the reconstituted after radiolabelling of the medicinal product, see section 6.3. ...
6.5. Nature and contents of container
15 mL multidose glass vial, type I borosilicate glass sealed with a bromobutyl rubber stopper and an aluminium caps. <u>Pack size:</u> 5 vials.
6.6. Special precautions for disposal and other handling
General warnings Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject ...
7. Marketing authorization holder
CIS bio international, B.P.32, F-91192 Gif sur-Yvette Cedex
10. Date of revision of the text
05/2016
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