PENTACIS Powder for solution for injection (2016)
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Περιεχόμενα
1. Name of the medicinal product
PENTACIS. Kit for the preparation of technetium (<sup>99</sup>mTc) pentetate injection.
2. Qualitative and quantitative composition
Calcium trisodium pentetate 9.10 mg/vial. The product contains no antimicrobial preservative. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection. Kit for radiopharmaceutical preparation. White freeze-dried product.
4.1. Therapeutic indications
This medicinal product is for diagnostic use only. a) After reconstitution with sodium pertechnetate (<sup>99</sup>mTc) solution the agent may be used for: Dynamic renal scintigraphy for perfusion, function ...
4.2. Posology and method of administration
In adults, the following administered doses are recommended (other doses may be justifiable): <u>For intravenous use:</u> Measurement of glomerular filtration rate from plasma: 1.8-3.7 MBq. Measurement ...
4.3. Contraindications
None known.
4.4. Special warnings and precautions for use
Special warnings This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject ...
4.5. Interaction with other medicinal products and other forms of interaction
Many drugs may affect the function of tested organ and modify the uptake of technetium (<sup>99</sup>mTc) pentetate (DTPA) i.e. <u>Diagnostic use of captopril:</u> dynamic renal scanning performed under ...
4.6. Pregnancy and lactation
Women of childbearing potential When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy. Any woman who ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
In isolated cases the following adverse reactions have been reported: flushing, dizziness, dyspnoea, pruritus, urticaria and hypotension. For each patient, exposure to ionising radiation must be justifiable ...
4.9. Overdose
In the event of the administration of a radiation overdose with technetium (<sup>99</sup>mTc) pentetate (DTPA) the absorbed dose to the patient should be reduced where possible by increasing the elimination ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Radiopharmaceutical preparation for diagnostic use <b>ATC codes:</b> V09CA01 and V09EA01 At the chemical concentrations and activities used for diagnostic procedures technetium ...
5.2. Pharmacokinetic properties
Following intravenous injection, technetium (<sup>99</sup>mTc) pentetate (DTPA) rapidly distributes throughout the extracellular fluid. Less than 5% of the injected dose is bound to the plasma proteins. ...
5.3. Preclinical safety data
This agent is not intended for regular or continuous administration. Repeated intravenous administration of CaNa<sub>3</sub>DTPA to rabbits and dogs for 14 days of doses that were 100 and 1000 times (respectively) ...
6.1. List of excipients
Stannous chloride dihydrate Sodium chloride Under a 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. After labelling, store at 2°C-8°C (in a refrigerator) and use within 4 hours with a maximum of 5 withdrawals per vial.
6.4. Special precautions for storage
Store at 2°C-8°C (in a refrigerator). For storage conditions of the reconstituted medicinal product, see section 6.3. Storage of radiopharmaceuticals should be in accordance with national regulation on ...
6.5. Nature and contents of container
15 ml, colourless, European Pharmacopoeia type I, drawn glass vials, closed with chlorobutyl rubber stoppers and aluminium caps. <u>Pack size:</u> Kit of 5 multidose vials.
6.6. Special precautions for disposal and other handling
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc. Radiation protection precautions in accordance with ...
7. Marketing authorization holder
CIS Bio International, Route National 306, BP 32, 91192 Gif-Sur-Yvette Cedex, France
8. Marketing authorization number(s)
PA 0677/002/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 04 March 1999 Date of last renewal: 04 March 2009
10. Date of revision of the text
July 2016
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