MYOVIEW Kit, Powder for solution for injection (2017)

Βιβλιογραφική αναφορά

Συγγραφείς

Medi-Physics Inc. dba GE Healthcare

Λέξεις κλειδιά

17156-026

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1. Indications and Usage

1.1 Myocardial Perfusion Imaging Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium ...

2. Dosage and Administration

2.1 Radiation Safety – Drug Handling Technetium Tc99m tetrofosmin is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration ...

3. Dosage Forms and Strengths

Kit for the preparation of technetium Tc99m tetrofosmin injection: 30 mL multiple-dose, clear, glass vial with a white sterile, non-pyrogenic, lyophilized powder of 1.38 mg tetrofosmin, 0.09 mg stannous ...

4. Contraindications

None.

5. Warnings and Precautions

5.1 Risks Associated with Exercise or Pharmacologic Stress Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, ...

6. Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.3)].

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of MYOVIEW cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of MYOVIEW. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

8.1. Pregnancy

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. ...

8.2. Lactation

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 ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5. Geriatric Use

Of 2300 subjects in clinical studies of MYOVIEW, 1053 (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, ...

11. Description

11.1 Chemical Characteristics MYOVIEW 30 mL is a kit for the preparation of technetium Tc99m tetrofosmin injection for intravenous use. Technetium Tc99m tetrofosmin is a radioactive diagnostic agent. Each ...

12.1. Mechanism of Action

Technetium (99mTc) tetrofosmin is a lipophilic, cationic complex which diffuses passively through the cell membrane and is locally retained actively due to the presence of intact mitochondria reflecting ...

12.2. Pharmacodynamics

The relationship between Tc99m tetrofosmin plasma concentrations and successful imaging has not been explored in clinical trials.

12.3. Pharmacokinetics

Uptake in the myocardium is dependent on coronary flow and reaches a maximum of 1.2% of the injected dose (i.d.) at 5 minutes and 1% of the i.d. at 2 hours, respectively. Background activities in the blood, ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been conducted to evaluate carcinogenic potential or effects on fertility. Tetrofosmin sulphosalicylate was not mutagenic in vitro in the Ames test, mouse lymphoma, or human lymphocyte ...

14. Clinical Studies

14.1 Exercise/Resting Myocardial Perfusion Imaging Studies A total of 252 subjects with ischemic heart disease or atypical chest pain were studied in two open-label, multi-center, clinical studies (study ...

16.1. How Supplied

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, ...

16.2. Storage and Handling

Store the kit at 2°-8°C (36°-46°F). Protect the kit from light. This reagent kit is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of ...

17. Patient Counseling Information

Instruct patients to remain hydrated and void frequently following administration to decrease radiation exposure. Advise a lactating woman to pump and discard breast milk for 60 hours (10 half-lives) after ...