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DOTAREM is a brand name for Gadoterate Meglumine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DOTAREM (gadoterate meglumine injection) is a medicinal product for diagnostic use only. DOTAREM is indicated in adults and pediatrics (from term neonates) for: • contrast enhancement during cranial and spinal MRI investigations. See 4.2 Recommended Dose and Dosage Adjustment for specific dosage recommendations. 1.1…
Verbatim from this product's HC label. Tap a section to expand.
, and 14 CLINICAL TRIALS – Cardiac Effects: QT Interval. 2 Geriatrics Geriatrics (> 65 years): No special precautions are required in elderly patients unless renal function is impaired (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX and 7 WARNINGS AND PRECAUTIONS – Renal).
2 CONTRAINDICATIONS • Gadoterate meglumine injection is contraindicated for subarachnoid (or epidural) administration. • Gadoterate meglumine injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
1 Adverse Reaction Overview As with other contrast media, delayed allergoid reactions occurring hours or days after administration have been observed, though rarely. Anaphylactoid reactions may occur. Patients with a history of previous reaction to contrast media, allergic disposition or bronchial asthma suffer more frequently from hypersensitivity reactions than others (see 7 WARNINGS AND PRECAUTIONS – Hypersensitivity).
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 9 years). 1%), mostly mild or moderate in intensity. 6%) were assessed to be related to DOTAREM.
No adverse drug reaction occurred at a rate greater than 1%. 3%). Overall Safety profile The data described below reflect DOTAREM exposure in 2867 patients, including 185 pediatric patients. Overall, 55% of the patients were men. In clinical trials where ethnicity was recorded the ethnic distribution was 80% Caucasian, 12% Asian, 4% Black, and 4% others.
1 to 97 years). 0% of patients reported at least one adverse reaction, primarily occurring immediately or several days following DOTAREM administration. Most adverse reactions were mild or moderate in severity and transient in nature.
0%. 2% patients who received DOTAREM. 1 Clinical Trial Adverse Reactions – Pediatrics During clinical trials, 185 pediatric patients (52 aged < 24 months, 33 aged 2 - 5 years, 57 aged 6 - 11 years and 43 aged 12 - 17 years) received DOTAREM.
5%) reported at least one adverse reaction following DOTAREM administration. For the patient below 2 years, the adverse reaction was a rash of moderate intensity. 5%). Other adverse reactions reported for no more than one patient were pruritus, dizziness, nausea, vomiting, haematuria, asthenia, injection site urticaria.
– Renal). 2 CONTRAINDICATIONS • Gadoterate meglumine injection is contraindicated for subarachnoid (or epidural) administration. • Gadoterate meglumine injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING (see 7 WARNINGS AND PRECAUTIONS – Hypersensitivity). 73m2). In these patients, avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast-enhanced magnetic resonance imaging (MRI).
NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. 2 Recommended Dose and Dosage Adjustment) and allow a sufficient period of time for elimination of the agent from the body prior to any re-administration.
) NOT FOR INTRATHECAL USE Intrathecal administration of GBCAs can cause serious, life-threatening, and fatal reactions. DOTAREM is not approved for intrathecal use (see 2 CONTRAINDICATIONS; 7 WARNINGS AND PRECAUTIONS, Risks of Intrathecal Use).
1 Dosing Considerations • DOTAREM is for intravenous administration only. • Use of macrocyclic agents may be preferable in certain patients such as those for whom repeated GBCA doses may need to be considered due to individual clinical circumstances and in other potentially vulnerable patients such as children and pregnant women (See 7 WARNINGS AND PRECAUTIONS).
• Pediatrics < 2 years of age: DOTAREM should be administered intravenously with manual bolus injection at a rate of about 1-2 mL/sec followed by saline flush at the same flow rate. A patient IV line has to be established and maintained throughout the examination.
• Gadoterate meglumine injection is contraindicated for subarachnoid (or epidural) administration. • Gadoterate meglumine injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING (see 7 WARNINGS AND PRECAUTIONS – Hypersensitivity). Product Monograph DOTAREM Gadoterate meglumine injection Page 6 of 43 Protected B / Protégé B
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Most adverse events were mild in intensity and transient in nature, and all patients recovered without treatment. All adverse events, regardless of relationship to product administration, reported in pediatric patients below 2 years of age in the clinical study DGD-44-063 are listed in table 4.
3 Less Common Clinical Trial Adverse Reactions Less Common Clinical Trial Adverse Drug Reactions (<1%) Table 5 lists all adverse events considered as drug-related. 1%) Cardiac disorders Palpitations Eye disorders Eyelid oedema Gastrointestinal disorders Nausea Diarrhoea Abdominal pain upper Dry mouth Vomiting Abdominal pain Abdominal pain lower Oral discomfort Paraesthesia oral Salivary hypersecretion General disorders and administration site conditions Injection site pain Injection site coldness Fatigue Feeling hot Feeling cold Asthenia Injection site inflammation Pain Injection site extravasation Injection site swelling Injection site warmth Extravasation Catheter site haemorrhage Chest pain Chills Injection site discomfort Injection site pruritus Injection site urticaria Vessel […]
1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1-2 mL/second for pediatric patients. Table 1 provides weight-adjusted dose volumes.
Product Monograph DOTAREM Gadoterate meglumine injection Page 7 of 43 Protected B / Protégé B • For special populations (pediatrics, geriatrics, hepatic impairment, renal impairment), no dosage adjustment is recommended and the adult dose applies.
• The lowest effective dose should be used. 5 5 1 10 2 20 4 30 6 40 8 50 10 60 12 70 14 80 16 90 18 100 20 110 22 120 24 130 26 140 28 150 30 To ensure complete injection of DOTAREM the injection may be followed by normal saline flush.
Contrast MRI can begin immediately following DOTAREM injection. 3 Reconstitution Not applicable. 4 Administration Visually inspect DOTAREM for particulate matter prior to administration. Do not use the solution if particulate matter is present or if the container appears damaged.
DOTAREM should be a clear, colorless to yellow solution. Do not mix with other drugs or parenteral nutrition. DOTAREM should be drawn into the syringe and administered immediately using sterile technique. Unused portions of the drug must be discarded.
The rubber stopper should never be pierced more than once. 5 Missed Dose Not applicable. 3 mmol/kg was tolerated in a manner similar to lower doses. Adverse reactions to overdosage with DOTAREM have not been reported. Use of products of a similar class to DOTAREM has resulted in cases of acute renal failure in general in patients with pre-existing renal impairment.
2 Recommended Dose and Dosage Adjustment). In the event of inadvertent overdosage, DOTAREM can be removed from the body by hemodialysis. However, it is unknown if hemodialysis prevents NSF. (See 7 WARNINGS AND PRECAUTIONS – Renal). There is a higher risk of overdose in children younger than 2 years of age.
The recommended volumes should be strictly followed and manual injection should be used in this group of patients in order to prevent potential overdose. For management of a suspected drug overdose, contact your regional poison control centre.
6 mg of meglumine. s. 1 mL. 0. No preservative is added. 5 mmol/mL). It is supplied in vials and pre-filled syringes and the contents are sterile. For vial presentation, DOTAREM is packaged in Type II clear glass vials, closed with an Route of Administration Dosage Form / Strength/Composition […]