RENOCIS Kit for radiopharmaceutical preparation (2019)
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Περιεχόμενα
1. Name of the medicinal product
RENOCIS 1 mg kit for radiopharmaceutical preparation.
2. Qualitative and quantitative composition
Each vial contains 1 mg of succimer (dimercaptosuccinic acid). The radionuclide is not part of the kit. <u>Excipient with known effect:</u> The product contains sodium. For the full list of excipients, ...
3. Pharmaceutical form
Kit for radiopharmaceutical preparation. White lyophilisate.
4.1. Therapeutic indications
This medicinal product is for diagnostic use only. After radiolabelling with sodium pertechnetate (<sup>99m</sup>Tc), the solution of technetium (<sup>99m</sup>Tc) succimer obtained is indicated for: ...
4.2. Posology and method of administration
Posology Adults The recommended activity is 30 to 120 MBq for a patient of 70 kg bodyweight. Renal impairment Careful consideration of the activity to be administered is required since an increased radiation ...
4.3. Contraindications
Hypersensitivity to the active substance or 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
Some chemical compounds or medicaments may affect the function of tested organs and influence the uptake of technetium (<sup>99m</sup>Tc) succimer: Ammonium chloride: may substantially reduce renal uptake ...
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
Renocishas no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The adverse events are presented in the table below by the MedDRA System Organ Class and with a not known frequency (cannot be estimated from the available data): MedDRA Body system SOCs Preferred term ...
4.9. Overdose
In the event of the administration of a radiation overdose with technetium (<sup>99m</sup>Tc) succimer, the absorbed dose to the patient should be reduced where possible by increasing the elimination of ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Diagnostic radiopharmaceuticals for the renal system Technetium (<sup>99m</sup>Tc) compounds <b>ATC code:</b> V09CA02 At the chemical concentrations used for diagnostic ...
5.2. Pharmacokinetic properties
Distribution Technetium (<sup>99m</sup>Tc) succimer is cleared from blood with a triphasic pattern in patients with normal renal function. Organ uptake The technetium (<sup>99m</sup>Tc) succimer localizes ...
5.3. Preclinical safety data
Toxicity with repeated administration of 0.66 mg/kg/day succimer and 0.23 mg/kg/day SnCl<sub>2</sub> over 14 days in rats was not observed. The dose usually administered to humans is 0.14 mg/kg succimer. ...
6.1. List of excipients
Stannous chloride dihydrate (E512) Inositol Ascorbic acid (E300) Sodium hydroxide (E524) (for pH adjustment) Nitrogen atmosphere (E941)
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
6.3. Shelf life
Kit: 1 year. After radiolabelling: 8 hours. Do not store above 25°C.
6.4. Special precautions for storage
Store kit in a refrigerator (2°C-8°C). Store in the original package in order to protect from light. For storage conditions after radiolabelling of the medicinal product, see section 6.3. Storage of radiopharmaceuticals ...
6.5. Nature and contents of container
15 ml, colourless, European Pharmacopoeia type I, drawn glass vials, closed with chlorobutyl rubber stoppers and aluminium capsules. <u>Pack size:</u> 5 multidose 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, Route Nationale 306 Saclay, BP 32, 91192 Gif-Sur-Yvette Cedex, France
8. Marketing authorization number(s)
PA0677/005/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 19 March 1999 Date of last renewal: 19 March 2009
10. Date of revision of the text
September 2019
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