Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, Netherlands
Octreoscan 111 MBq/mL, kit for radiopharmaceutical preparation.
| Pharmaceutical Form |
|---|
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Kit for radiopharmaceutical preparation. The kit consists of two vials: Vial A: Radiopharmaceutical precursor. Clear and colourless solution. Vial B: Powder for solution for injection. White lyophylised powder. |
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 10 micrograms.
After reconstitution and labelling the obtained solution contains indium(111In)pentetreotide 111 MBq/ mL.
Indium(111In) decays with a half-life of 2.83 days to stable cadmium( 111Cd).
Emission characteristics:
Gamma-rays 172 keV (90 % abundance)
Gamma-rays 247 keV (94 % abundance)
X-rays 23-26 keV
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Indium ¹¹¹In pentetreotide |
Indium(111In)pentetreotide specifically binds to receptors for somatostatin. After radiolabelling pentetreotide with indium( 111In)chloride, the solution obtained is indicated for use as adjunct in the diagnosis and management of receptor bearing gastro-entero-pancreatic neuroendocrine (GEP) tumours and carcinoid tumours, by aiding in their localisation. |
| List of Excipients |
|---|
|
Vial A: Hydrochloric acid Vial B: Sodium citrate dihydrate |
Octreoscan is supplied as one pack containing two vials:
Vial A: a 10 ml quartz-coated, type I glass vial with a teflon-coated bromobutyl rubber stopper and shielded with lead containing 1.1. ml of indium(111In)chloride solution corresponding to 122 MBq at activity reference time.
Vial B: 10 mL type I glass vial closed with a bromobutyl rubber stopper and orange flip off cap, containing 10 micrograms of pentetreotide.
The vials cannot be used separately. Both vials are sealed with an aluminium crimp cap and packed in a closed, folded tin. Enclosed in the tin is a Sterican Luer Lock 0.90 × 70 mm / 20 G x 2 4/5 needle to be used for the labelling procedure.
Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, Netherlands
PA690/1/1
Date of first authorisation: 08 June 1995
Date of last renewal: 20 December 2009
| Drug | Countries | |
|---|---|---|
| OCTREOSCAN | Austria, Spain, France, Ireland, Japan, Singapore, United Kingdom |
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