tis, deep vein thrombophlebitis, compartment syndrome requiring surgical intervention.
Digestive: Gastrointestinal distress, stomach pain, teeth pain, increased salivation, abdominal pain, vomiting, constipation, diarrhea.
Nervous System: Agitation, anxiety, thirst, anorexia, nystagmus, drowsiness, diplopia, stupor, convulsions (including grand mal), paresthesia.
Respiratory System: Throat irritation, rhinorrhea, sneezing, dyspnea, wheezing, laryngismus, cough, respiratory complaints.
Skin: Rash, sweating, pruritus, urticaria (hives), facial edema, erythema multiforme, epidermal necrolysis, pustules.
Special Senses: Tinnitus, conjunctivitis, visual field defect, taste abnormality, dry mouth, lacrimation disorder (tearing), eye irritation, eye pain, ear pain.
OVERDOSAGE
Systemic consequences associated with overdosage of MAGNEVIST Injection have not been reported.
DOSAGE AND ADMINISTRATION
The recommended dosage of MAGNEVIST Injection is 0.2 mL/kg (0.1 mmol/kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 lbs has not been studied systematically.
Drug Handling:
To ensure complete injection of the contrast medium, the injection should be followed by a 5-mL normal saline flush. The imaging procedure should be completed within 1 hour of injection of MAGNEVIST Injection.
As with other gadolinium contrast agents, MAGNEVIST Injection has not been established for use in magnetic resonance angiography.
Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present.
Pharmacy Bulk Package Preparation: NOT FOR DIRECT INFUSION
The Pharmacy Bulk Package is used as a multiple dose container with an appropriate transfer device for filling empty sterile syringes.
a) The transfer of MAGNEVIST Injection from the Pharmacy Bulk Package must be performed in an aseptic work area, such as a laminar flow hood, using aseptic technique.
b) Once the Pharmacy Bulk Package is punctured, it should not be removed from the aseptic work area during the entire 24 hour period of use.
c) The contents of the Pharmacy Bulk Package after initial puncture should be used within 24 hours.
d) Any unused MAGNEVIST Injection must be discarded 24 hours after the initial puncture of the bulk package.
IV tubing and syringes used to administer MAGNEVIST Injection must be discarded at the conclusion of the radiological examination.
Any unused portion must be discarded in accordance with regulations dealing with the disposal of such materials
HOW SUPPLIED
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:
50 mL Pharmacy Bulk Package, rubber stoppered, 10 per box NDC 50419-188-58
50 mL Pharmacy Bulk Package (RFID), rubber stoppered, 10 per box NDC 50419-188-48
100 mL Pharmacy Bulk Package, rubber stoppered, 10 per box NDC 50419-188-11
100 mL Pharmacy Bulk Package (RFID), rubber stoppered, 10 per box NDC 50419-188-49
STORAGE
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 tempera |
