STRONTIUM CHLORIDE SR-89- strontium chloride sr-89 injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

STRONTIUM CHLORIDE SR-89 (UNII: 5R78837D4A) (STRONTIUM - UNII:YZS2RPE8LE)

Tillgänglig från:

BIO NUCLEONICS INC

INN (International namn):

STRONTIUM CHLORIDE SR-89

Sammansättning:

STRONTIUM CHLORIDE SR-89 1 mCi in 1 mL

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

STRONTIUM CHLORIDE Sr-89 INJECTION, USP is indicated for the relief of bone pain in patients with painful skeletal metastases. The presence of bone metastases should be confirmed prior to therapy. None.

Produktsammanfattning:

STRONTIUM CHLORIDE Sr-89 INJECTION, USP is supplied in a 5 mL vial containing 148 MBq, 4 mCi. The vial is shipped in a transportation shield-container with a package insert, and two therapeutic agent-warning labels. The vial and its contents should be stored inside its transportation container at room temperature (15-25°C, 59-77°F). The calibration date (for radioactivity content) and expiration date are quoted on the vial label. The expiration date will be 28 days after calibration. Stability studies have shown no change in any of the product characteristics monitored during routine product quality control over the period from manufacture to expiration. This radiopharmaceutical is licensed by the Florida Department of Health, Bureau of Radiation Control for distribution to persons licensed pursuant to Chapter 64E-5 Florida Administrative Code or under equivalent licenses of the U.S. Nuclear Regulatory Commission or an Agreement State. NDC65909-089-01 PRODUCT INFORMATION ISSUED: JANUARY 1, 2009 Manufactured by: Bio-Nucleonics, Inc. 10425 NW 37th Terrace Doral, FL 33178 Printed in U.S.A. L-089-01I

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

STRONTIUM CHLORIDE SR-89- STRONTIUM CHLORIDE SR-89 INJECTION
BIO NUCLEONICS INC
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STRONTIUM CHLORIDE SR-89
DESCRIPTION
STRONTIUM CHLORIDE Sr-89 INJECTION, USP 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 CHARACTERISTIC
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 ß- particles 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=calibration1.00
* Days before (-) or after (+) the calibration date stated on the
vial.
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
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 bones.
Excretion