Metastron 150 MBq

Country: Noregur

Tungumál: norska

Heimild: Statens legemiddelverk

Virkt innihaldsefni:

Strontium (89Sr) klorid

Fáanlegur frá:

GE Healthcare B.V.

ATC númer:

V10BX01

INN (Alþjóðlegt nafn):

Strontium (89Sr) chloride

Skammtar:

150 MBq

Lyfjaform:

Injeksjonsvæske, oppløsning

Einingar í pakka:

Hetteglass i blyemballasje 4 ml

Gerð lyfseðils:

C

Leyfisstaða:

Markedsført

Leyfisdagur:

2006-07-14

Vara einkenni

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
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 for the palliation of pain from bone metastases
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 150MBq (4mCi) per injection. Alternatively in
particularly heavy
or light framed patients a dose of 2MBq (55

Ci)/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.
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.
Method of administration
Metastron is for single use only. (For repeat use after several weeks
see section 4.4)
The instructions for preparation of radiopharmaceuticals are given in
section 12.
For patient preparation, see section 4.4.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients
listed in section 6.1.
Metastron should not be used as a primary treatment for cord
compression secondary to spinal
metastases where more rapid treatment may be necessary.
Use of the product in patients with evidence of seriously compromised
bone marrow,
particularly low neutrophil and platelet counts, is not