OCTREOSCAN Kit for radiopharmaceutical preparation Ref.[10963] Active ingredients: Indium ¹¹¹In pentetreotide

Source: Health Products Regulatory Authority (IE)  Revision Year: 2016  Publisher: Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, Netherlands

Product name and form

Octreoscan 111 MBq/mL, kit for radiopharmaceutical preparation.

Pharmaceutical Form

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.

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 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
Water for injections
Ferric chloride hexahydrate

Vial B:

Sodium citrate dihydrate
Citric acid monohydrate
Inositol
Gentisic acid

Pack sizes and marketing

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.

Marketing authorization holder

Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, Netherlands

Marketing authorization dates and numbers

PA690/1/1

Date of first authorisation: 08 June 1995

Date of last renewal: 20 December 2009

Drugs

Drug Countries
OCTREOSCAN Austria, Spain, France, Ireland, Japan, Singapore, United Kingdom

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