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HSA Approval

OCTREOSCAN FOR INJECTION

SIN11244P

OCTREOSCAN FOR INJECTION

OCTREOSCAN FOR INJECTION

December 16, 1999

QT INSTRUMENTS (S) PTE LTD

QT INSTRUMENTS (S) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantQT INSTRUMENTS (S) PTE LTD
Licence HolderQT INSTRUMENTS (S) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, POWDER, FOR SOLUTION

**II. Posology and method of administration** The dose for planar scintigraphy is 110 MBq in one single intravenous injection. Careful administration is necessary to avoid paravasal deposition of activity. For single photon emission tomography the dose depends on the available equipment. In general, an activity dose of 110 to 220 MBq in one single intravenous injection should be sufficient. No special dosage regimen for elderly patients is required. There is limited experience on administrations in paediatric patients, but when the use in a child is considered to be necessary, the amount of activity administered should be reduced according to standard body weight or body surface calculations. A practical approach is to adopt the recommendations of the Paediatric Task Group, European Association of Nuclear Medicine. 3 kg = 0.122 kg = 0.5042 kg = 0.784 kg = 0.1424 kg = 0.5344 kg = 0.806 kg = 0.1926 kg = 0.5646 kg = 0.828 kg = 0.2328 kg = 0.5848 kg = 0.8510 kg = 0.2730 kg = 0.6250 kg = 0.8812 kg = 0.3232 kg = 0.6552-54 kg = 0.9014 kg = 0.3634 kg = 0.6856-58 kg = 0.9216 kg = 0.4036 kg = 0.7160-62 kg = 0.9618 kg = 0.4438 kg = 0.7364-66 kg = 0.9820 kg = 0.4640 kg = 0.7668 kg = 0.99 Scintigraphy takes place approx. 24 hours after administration. When activity in the abdomen is observed at 24 hours which cannot be interpreted with certainty as uptake in tumour or activity in bowel contents, scintigraphy should be repeated at 48 hours. In some cases, scintigraphy after 4 hours gives acceptable results. Physiologic uptake occurs in spleen, liver, kidneys and bladder. Thyroid, pituitary and intestines are visible in most patients.

INTRAVENOUS

Medical Information

**I. Indications** 111In pentetreotide specifically binds to receptors for somatostatin. OctreoScan 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. Tumours which do not bear receptors will not be visualised. In a number of patients suffering from GEP or carcinoid tumours the receptor density is insufficient to allow visualisation with OctreoScan. Notably in approximately 50% of patients suffering from insulinoma the tumour cannot be visualised.

**III. Contraindications** No specific contraindications have been identified.

NA

xna

Manufacturer Information

QT INSTRUMENTS (S) PTE LTD

Curium Netherlands B.V.

Active Ingredients

PENTETREOTIDE

10 mcg/vial (in vial B)

Pentetreotide

INDIUM (IN 111) CHLORIDE

122 MBq/1.1 ml (in vial A)

Indium

Documents

Package Inserts

04 CON 4920 Singapore PI 15052019_clean.doc

Approved: June 30, 2020

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