ADREVIEW Solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Medi-Physics Inc.
Λέξεις κλειδιά
17156-235
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1. Indications and Usage
1.1 Pheochromocytoma and Neuroblastoma AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic ...
2. Dosage and Administration
2.1 Radiation Safety AdreView emits radiation and must be handled with appropriate safety measures to minimize radiation exposure to clinical personnel and patients. Radiopharmaceuticals should be used ...
3. Dosage Forms and Strengths
Single use vials containing 5 mL solution for intravenous injection (2 mCi/mL at calibration time).
4. Contraindications
AdreView is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate.
5. Warnings and Precautions
5.1 Hypersensitivity Reactions Hypersensitivity reactions have been reported following AdreView administration. Prior to administration, question the patient for a history of prior reactions to iodine, ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ...
7. Drug Interactions
The following drugs have the potential to decrease the uptake of norepinephrine and cause false negative imaging results: antihypertensives that deplete norepinephrine stores or inhibit reuptake (e.g., ...
8.1. Pregnancy
Risk Summary Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of an appropriate thyroid blocking agent is recommended before use of AdreView ...
8.2. Lactation
Risk Summary Iodine 123 (I 123), the radionuclide in AdreView, is present in human milk. There is no information on the effects on the breastfed infant or on milk production. Advise a lactating woman to ...
8.4. Pediatric Use
The safety and effectiveness of AdreView have been established in the age groups 1 month to 16 years in patients with known or suspected neuroblastoma <em>[see Clinical Studies (14.1)]</em>. Safety and ...
8.5. Geriatric Use
In clinical studies of AdreView in heart disease, 27% of subjects were 65-74 years of age and 17% of subjects were 75 years of age or over. No overall differences in safety or effectiveness were observed ...
10. Overdosage
The major manifestations of overdose relate predominantly to increased radiation exposure, with the long term risks for neoplasia.
11. Description
AdreView (Iobenguane I 123 Injection) is a sterile, pyrogen-free radiopharmaceutical for intravenous injection. Each mL contains 0.08 mg iobenguane sulfate, 74 MBq (2 mCi) of I 123 (as iobenguane sulfate ...
12.1. Mechanism of Action
Iobenguane is similar in structure to the antihypertensive drug guanethedine and to the neurotransmitter norepinephrine (NE). Iobenguane is, therefore, largely subject to the same uptake and accumulation ...
12.2. Pharmacodynamics
AdreView is a diagnostic radiopharmaceutical which contains a small quantity of iobenguane that is not expected to produce a pharmacodynamic effect <em>[see Description (11)]</em>. To minimize radiation ...
12.3. Pharmacokinetics
Iobenguane is rapidly cleared from the blood and accumulates in adrenergically innervated tissues <em>[see Clinical Pharmacology (12.1)]</em>. Retention is especially prolonged in highly adrenergically ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Iobenguane hemisulfate was not mutagenic <em>in vitro</em> in the Ames bacterial mutation assay and in the <em>in vitro</em> mouse lymphoma test, and was negative in the <em>in vivo</em> micronucleus test ...
13.2. Animal Toxicology and/or Pharmacology
Iobenguane sulfate testing in dogs revealed electrocardiographic (ECG) changes after administration of 202 times the mg/m² conversion of the maximum human dose for a 60 kg adult; the no observable effect ...
14. Clinical Studies
14.1 Pheochromocytoma and Neuroblastoma The safety and efficacy of AdreView were assessed in an open-label, multicenter, multinational trial of 251 subjects with known or suspected neuroblastoma or pheochromocytoma. ...
16.1. How Supplied
AdreView is supplied in 10 mL glass vials containing a total volume of 5 mL of solution with a total radioactivity of 370 MBq (10 mCi) at calibration time. Each vial is enclosed in a lead container of ...
16.2. Storage and Handling
Storage Store AdreView at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP]. This product does not contain a preservative. Store within the original lead container or equivalent ...
17. Patient Counseling Information
Instruct patients to inform their physician or healthcare provider if they: are pregnant. Advise a pregnant woman of the potential risks of fetal exposure to radiation doses with AdreView <em>[see Use ...