Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
GADOPENTETATE DIMEGLUMINE (UNII: RH248G8V27) (GADOPENTETATE - UNII:V7OK6J19HQ)
Bayer HealthCare Pharmaceuticals Inc.
GADOPENTETATE DIMEGLUMINE
GADOPENTETATE DIMEGLUMINE 469.01 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Magnevist injection is indicated for use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. Magnevist injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors. Magnevist injection is indicated for use with MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck. Magnevist injection is indicated for use in MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body. Magnevist is contraindicated in patients with: Risk Summary GBCAs cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data
Magnevist injection is a clear, colorless to slightly yellow solution containing 469.01 mg/mL of gadopentetate dimeglumine. Magnevist injection is supplied in the following sizes: Magnevist injection should be stored at controlled room temperature, between 15–30° C (59–86° F) and protected from light. DO NOT FREEZE. Should freezing occur in the bottle, Magnevist injection should be brought to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, Magnevist injection should return to a clear, colorless to slightly yellow solution. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. Should solids persist, discard bottle.
New Drug Application
Bayer HealthCare Pharmaceuticals Inc. ---------- Medication Guide MEDICATION GUIDE MAGNEVIST (mag-na-vist) (gadopentetate dimeglumine) Injection for intravenous use What is Magnevist? • Magnevist is a prescription medicine called a gadolinium-based contrast agent (GBCA). Magnevist, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner. • An MRI exam with a GBCA, including Magnevist, helps your doctor to see problems better than an MRI exam without a GBCA. • Your doctor has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam. What is the most important information I should know about Magnevist? • Magnevist contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years). • It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys. • Rarely, patients can feel pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium. • There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist, or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance. • People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body. • Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive Magnevist. Do not receive Mag Läs hela dokumentet
MAGNEVIST- GADOPENTETATE DIMEGLUMINE INJECTION BAYER HEALTHCARE PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MAGNEVIST PHARMACY BULK PACKAGE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MAGNEVIST. MAGNEVIST (GADOPENTETATE DIMEGLUMINE) INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1988 PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ GADOLINIUM-BASED CONTRAST AGENTS (GBCAS) INCREASE THE RISK FOR NSF AMONG PATIENTS WITH IMPAIRED ELIMINATION OF THE DRUGS. AVOID USE OF GBCAS IN THESE PATIENTS UNLESS THE DIAGNOSTIC INFORMATION IS ESSENTIAL AND NOT AVAILABLE WITH NON-CONTRASTED MRI OR OTHER MODALITIES. • • • DO NOT EXCEED THE RECOMMENDED MAGNEVIST DOSE AND ALLOW A SUFFICIENT PERIOD OF TIME FOR ELIMINATION OF THE DRUG FROM THE BODY PRIOR TO ANY RE-ADMINISTRATION. (5.1) RECENT MAJOR CHANGES INDICATIONS AND USAGE Magnevist is a gadolinium-based contrast agent indicated for intravenous use in diagnostic MRI in adults and children (2 years of age and older) to facilitate the visualization of lesions and abnormal vascularity in: • • • DOSAGE AND ADMINISTRATION Magnevist is administered intravenously, 0.2 mL/kg (0.1 mmol/kg), at a rate not to exceed 10 mL per 15 seconds. See the dosage table to determine the amount to be administered based on body weight. (2) DOSAGE FORMS AND STRENGTHS Magnevist contains 0.5 mmol gadopentetate dimeglumine/mL (equivalent to 469.01 mg gadopentetate dimeglumine/mL) and is available in vials and prefilled syringes. (3) CONTRAINDICATIONS Magnevist is contraindicated in patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m2) or acute kidney injury, or history of severe hypersensitivity reactions to Magnevist. (4) WARNINGS AND PRECAUTIONS • • • ® DO NOT ADMINISTER MAGNEVIST TO PATIENTS WITH: • CHRONIC, SEVERE KIDNEY DISEASE (GFR < 30 ML/MIN/1.73M ), Läs hela dokumentet