OCTREOSCAN Kit for radiopharmaceutical preparation (2016)
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Περιεχόμενα
1. Name of the medicinal product
Octreoscan 111 MBq/mL, kit for radiopharmaceutical preparation.
2. Qualitative and quantitative composition
Octreoscan is supplied as two vials which cannot be used separately. Vial A with 1.1 mL solution contains at activity reference time: Indium(111In)chloride 122 MBq (111 MBq/mL). Vial B contains: Pentetreotide ...
3. Pharmaceutical form
Kit for radiopharmaceutical preparation. The kit consists of two vials: <u>Vial A:</u> Radiopharmaceutical precursor. Clear and colourless solution. <u>Vial B:</u> Powder for solution for injection. White ...
4.1. Therapeutic indications
This medicinal product is for diagnostic use only. Indium(111In)pentetreotide specifically binds to receptors for somatostatin. After radiolabelling pentetreotide with indium( 111In)chloride, the solution ...
4.2. Posology and method of administration
Posology Adults and elderly population The activity to be administered for single photon emission tomography (SPECT) depends on the available equipment. In general for an adult of 70 kg, an activity of ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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
No interactions have been described to date.
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
Octreoscan has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Adverse effects attributable to the administration of Octreoscan are uncommon (1/1000 to <1/100). Specific effects have not been observed. The symptoms reported are suggestive of vasovagal reactions or ...
4.9. Overdose
The pharmaceutical form (monodose injection) makes inadvertent overdosing improbable. In the event of administration of a radiation overdose with indium(<sup>111</sup>In)pentetreotide, the absorbed dose ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Diagnostic radiopharmaceuticals for tumour detection ATC code: V09IB01 Mechanism of action Octreoscan attaches to somatostatin receptors (mainly subtype 2 and subtype 5) in tissues ...
5.2. Pharmacokinetic properties
Organ uptake Indium(<sup>111</sup>In)pentetreotide is taken up by the following organs: liver (approximately 2% at 24 hours) and spleen (approximately 2.5% at 24 hours). Uptake in thyroid and pituitary ...
5.3. Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. No testing has been done on ...
6.1. List of excipients
<u>Vial A:</u> Hydrochloric acid Water for injections Ferric chloride hexahydrate <u>Vial B:</u> Sodium citrate dihydrate Citric acid monohydrate Inositol Gentisic acid
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
6.3. Shelf life
Vial A and vial B expire 24 hours after the activity reference time/date of the indium(<sup>111</sup>In). After reconstitution: 6 hours. Store below 25°C.
6.4. Special precautions for storage
Store below 25°C. For storage conditions of the reconstituted medicinal product, see section 6.3. Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials. ...
6.5. Nature and contents of container
Octreoscan is supplied as one pack containing two vials: <u>Vial A:</u> a 10 ml quartz-coated, type I glass vial with a teflon-coated bromobutyl rubber stopper and shielded with lead containing 1.1. ml ...
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 is subject ...
7. Marketing authorization holder
Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, Netherlands
8. Marketing authorization number(s)
PA690/1/1
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 08 June 1995 Date of last renewal: 20 December 2009
10. Date of revision of the text
November 2016
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