TECHNESCAN PYP Kit for radiopharmaceutical preparation (2016)
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1. Name of the medicinal product
Technescan PYP, 20 mg kit for radiopharmaceutical preparation.
2. Qualitative and quantitative composition
Sodium pyrophosphate decahydrate 20 mg. The radionuclide is not part of the kit. <u>Excipient with known effect:</u> Stannous chloride dihydrate 4 mg corresponding to stannous 2.1 mg For a full list of ...
3. Pharmaceutical form
Kit for radiopharmaceutical preparation. White pellets or powder.
4.1. Therapeutic indications
This medicinal product is for diagnostic use only. After radiolabeling with sodium pertechnetate (<sup>99m</sup>Tc) solution, the solution obtained is indicated for A) In-vivo or in-vivo/in-vitro red blood ...
4.2. Posology and method of administration
Posology Adults A) Blood pool scintigraphy The average activity administered by single injection after in-vivo or in-vitro labelling is 890 MBq (740-925 MBq). B) Determination of blood volume The average ...
4.3. Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical.
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
Reduction in red blood cell labelling yield has been reported with heparin, tin overload, aluminium, prazosin, methyldopa, hydralazin, digitalis related compounds, quinidine, ß-adrenergic blockers (e.g. ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential When an administration of radioapharmaceutical 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
Technescan PYP has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 7.9 mSv when the maximal recommended activity of 925 MBq is ...
4.9. Overdose
In the event of administration of an overdose with Technescan PYP very little supportive treatment can be undertaken since its elimination is entirely dependent on the normal haemolytic process. Forced ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Diagnostic radiopharmaceuticals (<sup>99m</sup>Tc) Technetium compounds. ATC code: V09GA06 At doses used for diagnostic procedures, neither stannous pyrophosphate, sodium (<sup> ...
5.2. Pharmacokinetic properties
Distribution Intravenous injection of stannous salts induces a stannous loading of erythrocytes. Subsequent sodium (<sup>99m</sup>Tc) pertechnetate injection results in an accumulation and a retention ...
5.3. Preclinical safety data
There are no preclinical safety data specific to technetium labelled erythrocytes. The toxicity of pertechnetate ion and stannous salts has been studied and reported in the literature. Systemic toxical ...
6.1. List of excipients
Stannous chloride dihydrate Hydrochloric acid Sodium hydroxide
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 radiolabelling: 4 hours. Store at 2°C-8°C after radiolabelling.
6.4. Special precautions for storage
Store at 2-8°C. For storage conditions after radiolabeling of the medicinal product see section 6.3. Storage of radiopharmaceuticals should be in accordance with national regulations for radioactive material. ...
6.5. Nature and contents of container
10 ml glass vial (Type 1 Ph. Eur) closed with a bromobutyl rubber stopper sealed with an aluminium crimp cap. TechneScan PYP is supplied as five vials in a carton.
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
Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, The Netherlands
8. Marketing authorization number(s)
PA 690/10/1
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 29th June 2001 Date of last renewal: 29th June 2006
10. Date of revision of the text
January 2016