CARDIOLITE Powder for solution, lyophilized (2019)

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

Myocardial Imaging CARDIOLITE, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing ...

2. Dosage and Administration

For Myocardial Imaging: The suggested dose range for I.V. administration of CARDIOLITE in a single dose to be employed in the average patient (70 Kg) is 370-1110 MBq (10-30 mCi). For Breast Imaging: ...

3. Dosage Forms and Strengths

CARDIOLITE Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a lyophilized mixture in a 5 mL vial.

4. Contraindications

None known.

5. Warnings and Precautions

5.1 Warnings In studying patients in whom cardiac disease is known or suspected, care should be taken to assure continuous monitoring and treatment in accordance with safe, accepted clinical procedure. ...

6. Adverse Reactions

Adverse events were evaluated in 3741 adults who were evaluated in clinical studies. Of these patients, 3068 (77% men, 22% women, and 0.7% of the patients genders were not recorded) were in cardiac clinical ...

7. Drug Interactions

Specific drug-drug interactions have not been studied.

8.1. Pregnancy

Risk Summary Limited available data with Technetium Tc99m Sestamibi use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. ...

8.2. Lactation

Risk Summary Limited data in the scientific literature on the presence of Technetium Tc99m Sestamibi in human milk, demonstrate that between 0.01% and 0.03% of maternal injected activity of technetium ...

8.4. Pediatric Use

Safety and effectiveness in the pediatric population have not been established. No evidence of diagnostic efficacy or clinical utility of CARDIOLITE scan was found in clinical studies of children and adolescents ...

8.5. Geriatric Use

Of 3068 patients in clinical studies of CARDIOLITE, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 693 patients were 65 or older and 121 were 75 or older. Of 673 patients in clinical ...

10. Overdosage

The clinical consequences of overdosing with CARDIOLITE are not known.

11. Description

Each 5 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate 1.0 mg Sodium Citrate Dihydrate 2.6 mg L-Cysteine Hydrochloride ...

12.1. Mechanism of Action

Technetium Tc99m Sestamibi is a cationic Tc99m complex which has been found to accumulate in viable myocardial tissue in a manner analogous to that of thallous chloride Tl-201. Scintigraphic images obtained ...

12.3. Pharmacokinetics

Pulmonary activity is negligible even immediately after injection. Blood clearance studies indicate that the fast clearing component clears with a t1/2 of 4.3 minutes at rest, and clears with ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In comparison with most other diagnostic technetium labeled radiopharmaceuticals, the radiation dose to the ovaries (1.5 rads/30 mCi at rest, 1.2 rads/30 mCi at exercise) is high. Minimal exposure (ALARA) ...

14. Clinical Studies

MYOCARDIAL IMAGING In a trial of rest and stress CARDIOLITE imaging, the relationship of normal or abnormal perfusion scans and long term cardiac events was evaluated in 521 patients (511 men, 10 women) ...

16.1. How Supplied

CARDIOLITE, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a 5 mL vial in kits of five (5) vials (NDC #11994-001-55) and twenty (20) vials (NDC #11994-001-20), sterile ...

16.2. Storage and Handling

The contents of the vial are lyophilized and stored under nitrogen. Store at 15-25°C (59-77°F) before and after reconstitution.

17. Patient Counseling Information

CARDIOLITE and MIRALUMA are different names for the same drug. Patients should be advised to inform their health care provider if they had an allergic reaction to either drug or if they had an imaging ...