Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 02 February 2017
Of these patients, 55 % (700) were male and 45 % (572) were female.
Of the 1271 patients who received Gadopentetate dimeglumine Injection and for whom race was reported, 82.1 % (1043) were Caucasian, 9.7 % (123) were Black, 5.3 % (67) were Hispanic, 2.1 % (27) were Oriental/Asian, and 0.9 % (11) were other.
The majority of
1 % of patients included:
The following additional
Cardiovascular: Hypotension, hypertension, tachycardia, migraine, syncope, vasodilatation, pallor.
Respiratory System: Throat
Skin: Rash, sweating (hyperhidrosis), pruritus, urticaria (hives), facial edema.
Postmarketing Experience The following additional
Because these reactions are reported voluntarily from
The most serious reactions were nephrogenic systemic fibrosis (see Boxed
Life threatening and/or
The most frequently
Conditions: Nephrogenic systemic fibrosis (see Warnings and Precautions),
Hypersensitivity Reactions: Anaphylactic/
Renal and Urinary:
Vascular: Thrombophlebitis, deep vein thrombophlebitis, compartment syndrome requiring surgical
Ear and Labyrinth
Musculoskeletal and Connective Tissue
Skin: Erythema multiforme, pustules (rash pustular).
DOSAGE AND ADMINISTRATION The
Dosing for patients in excess of 286 lbs has not been studied systematically.
DOSE AND DURATION OF Gadopentetate dimeglumine INJECTION BY BODY WEIGHT BODY WEIGHT Total Volume, mL * lb kg 22 10 2 44 20 4 66 30 6 88 40 8 110 50 10 132 60 12 154 70 14 176 80 16 198 90 18 220 100 20 242 110 22 264 120 24 286 130 26 * Rate of injection: 10 mL/15 sec Drug Handling: To ensure
The imaging procedure should be completed within 1 hour of injection of Gadopentetate dimeglumine Injection.
As with other gadolinium contrast agents, Gadopentetate dimeglumine Injection has not been
Parenteral products should be inspected visually for particulate matter and
Nursing Mothers Gadopentetate dimeglumine is excreted in human milk.
Gadopentetate dimeglumine Injection was administered intravenously to 18 lactating women with normal renal function at a dose of 0.1 mmol/ kg body weight.
In these women, less than 0.04 % of the administered gadolinium was excreted into the breast milk during the
Breast milk obtained during the 24 hours following dosing revealed the
The amount transferred from a 70 kg woman (receiving 0.1 mmol/ kg body weight) to an infant by breastfeeding over a period of 24 hrs translates into less than 3 micromoles of gadolinium.
The overall duration of excretion of gadolinium into breast milk is unknown.
The extent of the absorption of Gadopentetate dimeglumine Injection in infants and its effect on the breast-fed child remains unknown.
|Date Last Revised||15-02-2014|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Alvogen, Inc|
NEPHROGENIC SYSTEMIC FIBROSIS (NSF) Gadolinium-based contrast agents (GBCAs) increase the risk for
NSF may result in
• Do not administer gadopentetate dimeglumine to patients with:?
• Screen patients for
For patients at risk for chronically