MYOVIEW- tetrofosmin injection, powder, lyophilized, for solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Tetrofosmin (UNII: 3J0KPB596Q) (Tetrofosmin - UNII:3J0KPB596Q)

Commercializzato da:

Medi-Physics Inc. dba GE Healthcare

INN (Nome Internazionale):

Tetrofosmin

Composizione:

Tetrofosmin 1.38 mg

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease. MYOVIEW is indicated for assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease. None. Risk Summary There are no data with technetium Tc99m tetrafosmin use in pregnant women to inform any drug associated risks. Animal reproduction studies with technetium Tc99m tetrofosmin have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering technetium Tc99m tetrafosmin administration to a pregnant woman advise the pregnant woman of risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Risk Summary Technetium Tc99m tetrofosmin is present in human milk in small amounts (<1% of maternal dose). There are no data available regarding the effects of technetium Tc99m tetrofosmin on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for MYOVIEW and any potential adverse effects on the breastfed child from MYOVIEW or from the underlying maternal condition. Clinical Considerations To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 60 hours (10 half-lives) after technetium Tc99m tetrofosmin administration. Safety and effectiveness in pediatric patients have not been established. Of 2,300 subjects in clinical studies of MYOVIEW, 1,053 (46%) were 65 or older and 270 (12%) were 75 or older. No overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Dettagli prodotto:

Five (5) multiple-dose kits, each containing a 30 mL glass vial with a sterile, non-pyrogenic, lyophilized powder containing 1.38 mg tetrofosmin, 0.09 stannous chloride dihydrate, 1.92 mg disodium sulphosalicylate, 3 mg sodium D-gluconate, 11 mg sodium hydrogen carbonate and 3 mg ascorbic acid. NDC 17156-026-30 The radionuclide is not part of the kit. Before radiolabeling with Tc99m, the contents of the kit are not radioactive. Store the kit at 2° to 8°C (36° to 46°F), protected from light. Store the radiolabeled vial at 2° to 25°C (36° to 77°F), using appropriate radiation shielding. Use within 12 hours of preparation. This reagent kit is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State; store and dispose of technetium Tc99m tetrofosmin in accordance with these regulations.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

MYOVIEW- TETROFOSMIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
MEDI-PHYSICS INC. DBA GE HEALTHCARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYOVIEW 30 ML SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MYOVIEW 30 ML.
MYOVIEW 30 ML (KIT FOR THE PREPARATION OF TECHNETIUM TC99M TETROFOSMIN
INJECTION) FOR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
MYOVIEW 30 mL is a kit for the preparation of technetium Tc99m
tetrofosmin for injection. Technetium
Tc99m tetrofosmin injection is a radioactive diagnostic agent
indicated for the following:
Myocardial perfusion imaging under rest and/or exercise or
pharmacologic stress conditions to
delineate regions of reversible myocardial ischemia or infarcted
myocardium in patients with known or
suspected coronary artery disease (1.1)
Assessment of left ventricular function (left ventricular ejection
fraction and wall motion) in patients with
known or suspected heart disease (1.2)
DOSAGE AND ADMINISTRATION
Use appropriate radiation safety measures and aseptic technique during
preparation and handling (2.1,
2.3)
The recommended dose range for MYOVIEW for rest or stress imaging is
185 to 1,221 megabecquerels
(MBq) [5 to 33 millicuries (mCi)] by intravenous administration (2.2)
When rest and stress injections are administered on the same day, the
first dose should be 185 to 444
MBq (5 to 12 mCi) followed by the second dose of 555 to 1,221 MBq (15
to 33 mCi) given approximately
1 to 4 hours later (2.2)
The recommended dose range for MYOVIEW for ventricular function
assessment is 185 to 1,221 MBq (5
to 33 mCi) as an intravenous injection (2.2)
See Full Prescribing Information for instructions for preparation and
determination of radiochemical
purity (2.4, 2.5)
Imaging may begin 15 minutes following administration of the agent
(2.6)
DOSAGE FORMS AND STRENGTHS
Kit for preparation injection: lyophilized powder containing 1.38 mg
tetrofosmin in a multiple-dose vial after
radiolabeli