METASTRON strontium chloride sr-89 injection powder lyophilized for solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Strontium Chloride Sr-89 (UNII: 5R78837D4A) (Strontium Cation SR-89 - UNII:06A33308KH)

Saatavilla:

Medi-Physics Inc.

INN (Kansainvälinen yleisnimi):

Strontium Chloride Sr-89

Koostumus:

Strontium Cation SR-89 1 mCi in 1 mL

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

METASTRON- STRONTIUM CHLORIDE SR-89 INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
MEDI-PHYSICS INC.
----------
METASTRON
(STRONTIUM-89 CHLORIDE INJECTION)
R ONLY
DESCRIPTION
Metastron is a sterile, non-pyrogenic, aqueous solution of
Strontium-89 Chloride for intravenous
administration. The solution contains no preservative.
Each milliliter contains:
Strontium Chloride 10.9 - 22.6 mg
Water for Injection q.s. to 1 mL
The radioactive concentration is 37 MBq/mL, 1 mCi/mL, and the specific
activity is 2.96-6.17 MBq/mg,
80-167 µCi/mg at calibration. The pH of the solution is 4 - 7.5.
PHYSICAL CHARACTERISTICS
Strontium-89 decays by beta emission with a physical half-life of 50.5
days. The maximum beta energy
is 1.463 MeV (100%). The maximum range of β- from Strontium-89 in
tissue is approximately 8 mm.
Radioactive decay factors to be applied to the stated value for
radioactive concentration at calibration,
when calculating injection volumes at the time of administration, are
given in Table 1.
TABLE 1: DECAY OF STRONTIUM-89
DAY
FACTOR
DAY
FACTOR
*
-24
1.39
+6
0.92
-22
1.35
+8
0.90
-20
1.32
+10
0.87
-18
1.28
+12
0.85
-16
1.25
+14
0.83
-14
1.21
+16
0.80
-12
1.18
+18
0.78
-10
1.15
+20
0.76
-8
1.12
+22
0.74
-6
1.09
+24
0.72
-4
1.06
+26
0.70
-2
1.03
+28
0.68
0=calibration
1.00
CLINICAL PHARMACOLOGY
Following intravenous injection, soluble strontium compounds behave
like their calcium analogs,
clearing rapidly from the blood and selectively localizing in bone
mineral. Uptake of strontium by bone
occurs preferentially in sites of active osteogenesis; thus primary
bone tumors and areas of metastatic
™
X
*
*
Days before (-) or after (+) the calibration date stated on the vial.
involvement (blastic lesions) can accumulate significantly greater
concentrations of strontium than
surrounding normal bone.
Strontium-89 Chloride is retained in metastatic bone lesions much
longer than in normal bone, where
turnover is about 14 days. In patients with extensive skeletal
metastases, well over half of the injected
dose is retained in the b