OSTEOCIS Kit for radiopharmaceutical preparation (2020)
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Περιεχόμενα
1. Name of the medicinal product
OSTEOCIS 3mg kit for radiopharmaceutical preparation.
2. Qualitative and quantitative composition
Each vial contains 3mg of sodium oxidronate (or hydroxymethylene diphosphonate, HMDP). The radionuclide is not part of the kit. <u>Excipient with known effect:</u> Each vial contains 4.5 mg of sodium. ...
3. Pharmaceutical form
Kit for radiopharmaceutical preparation. White pellet.
4.1. Therapeutic indications
This medicinal product is for diagnostic use only. After radiolabelling with sodium pertechnetate (<sup>99m</sup>Tc) solution the solution of technetium (<sup>99m</sup>Tc) oxidronate obtained is indicated ...
4.2. Posology and method of administration
This medicinal product is intended for use in designated nuclear medicine facilities only, and should only be handled by authorised personnel. Posology Adults and elderly population The average activity ...
4.3. Contraindications
Hypersensitivity to the active substance (diphosphonates), to any of the excipients listed in section 6.1 or to any of the components of the labeled 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
The accumulation of technetium (<sup>99m</sup>Tc) oxidronate in the skeleton, and thus the quality of the scintigraphic procedure, may be decreased after medication with: chelates, diphosphonates, tetracycline ...
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
Osteocis 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 the administration of a radiation overdose with technetium [99mTc] oxidronate the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> radiopharmaceutical preparation for diagnostic use <b>ATC code:</b> V09BA01 At the chemical concentrations used for diagnostic examinations, technetium (<sup>99m</sup> ...
5.2. Pharmacokinetic properties
Distribution Intravenously administered technetium (<sup>99m</sup>Tc) oxidronate is rapidly distributed throughout the extracellular space. Organ uptake Skeletal uptake begins almost immediately and proceeds ...
5.3. Preclinical safety data
Toxicological studies with rats have demonstrated that with a single intravenous injection of 30 mg/kg no deaths were observed. Minimal liver abnormalities were seen at this dose level. Toxicity with repeated ...
6.1. List of excipients
Stannous chloride dihydrate Ascorbic acid Sodium chloride Sodium hydroxide (pH adjustment) Under nitrogen atmosphere
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. The expiry date is indicated on the outer packaging and on each vial. After radiolabelling, do not store the labelled product above 25°C and use within 8 hours.
6.4. Special precautions for storage
Store the kit at 2°C-8°C (in a refrigerator). For storage conditions after radiolabelling, see section 6.3. Storage for radiopharmaceuticals should be in accordance with national regulations on radioactive ...
6.5. Nature and contents of container
15ml, colourless, European Pharmacopoeia type I, drawn glass vials, closed with chlorobutyl rubber stoppers and aluminium caps. <u>Pack sizes:</u> Kit of 5 multidose vials.
6.6. Special precautions for disposal and other handling
General warning 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, BP 32, 91192 Gif-Sur-Yvette Cedex, France
8. Marketing authorization number(s)
PA0677/007/001
9. Date of first authorization / renewal of the authorization
Date of first Authorization: 26th May 2000 Date of next renewal: 26th May 2010
10. Date of revision of the text
21 May 2020
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