Metastron 37 MBq/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Strontium (89 sr) chloride

Available from:

GE Healthcare B.V.

ATC code:

V10BX; V10BX01

INN (International Name):

Strontium (89 sr) chloride

Dosage:

37 megabecquerel(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Various pain palliation radiopharmaceuticals; strontium (89Sr) chloride

Authorization status:

Not marketed

Authorization date:

1991-08-20

Summary of Product characteristics

Health Products Regulatory Authority
15 November 2019
CRN009G88
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metastron 37 MBq/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Strontium-89 chloride: 37 MBq/ml
A solution of the active ingredient strontium-89 chloride (150MBq) in
4ml water.
Strontium-89 is a pure beta emitter with an energy of 1.492MeV and a
half-life of 50.5 days.
_For the full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Metastron is indicated as an adjunct to and as an alternative to
external beam radiotherapy for the palliation of pain from bone
metastases secondary to prostatic carcinoma at the stage of hormone
therapy failure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
Metastron is an aqueous solution for intravenous injection and should
be used without dilution. The recommended dose is 150
MBq (4 mCi) per injection, based on the average patient weight of 70
kg.
Alternatively, in particularly heavy or light framed patients a dose
of 2 MBq (55 microCi)/kg 'fat-free' body weight may be used.
This dosage is suitable for the elderly. Repeat administrations should
not be performed within 3 months of the previous
Metastron injection. Further administrations are not indicated in
patients who have not responded to a previous administration
of Metastron.
Calcium-like flushing sensation can occur with rapid administration of
the product. Flushing sensation should not occur if the
compound is infused slowly.
ELDERLY POPULATION
No dose adjustment is recommended based on age.
RENAL IMPAIRMENT
Careful consideration of the activity to be administered is required
since an increased radiation exposure is possible in these
patients.
PAEDIATRIC POPULATION
The product is not for administration to children.
Health Products Regulatory Authority
15 November 2019
CRN009G88
Page 2 of 6
Method of administration
Metastron is for single us