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PROHANCE is a brand name for Gadoteridol, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: • ProHance® (gadoteridol injection) is indicated in adults and children including term neonates for contrast enhancement of magnetic resonance imaging (MRI) of brain, spine and surrounding tissues in conditions with expected vascular abnormality or defective blood-brain barrier. • ProHance (gadoteridol injection) is…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • The lowest effective dose should be used. • 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).
1 mmol/kg) is recommended; the recommended dose should not be exceeded in pediatric patients <2 years of age. 3 Pediatrics). 2 mL/kg), administered as a rapid intravenous infusion (up to 1 mL/sec) or as a bolus. 2 mL/kg), administered as a rapid intravenous infusion (up to 1 mL/sec) or as a bolus.
Health Canada has not authorized this indication for pediatric use (see 1 INDICATIONS). PROHANCE® (Gadoteridol injection) Page 6 of 31 Unclassified / Non classifié Sequential or Repeat Administrations If in the clinical judgment of a healthcare professional, sequential or repeat examinations are required, a suitable interval of time between administrations should be observed to allow for normal clearance of the drug from the body.
In clinical trials with ProHance, repeat injections have been safely administered within 30 minutes of an initial injection in adult patients with normal renal function. ProHance has been shown to be dialyzable in a clinical study in subjects with end-stage renal disease undergoing hemodialysis.
3 Pediatrics). 3 Reconstitution Not applicable. 4 Administration • ProHance should be inspected visually for particulate matter and discoloration prior to administration. If either is present, the vial should be discarded. • 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 ProHance. • ProHance is supplied in single dose vials, pharmacy bulk vials and single dose syringes. Unused portions of solution should be discarded. • The product should not be frozen.
See section 12 SPECIAL HANDLING INSTRUCTIONS for the Pharmacy Bulk Package. 5 Missed Dose Not applicable.
). The cautious utilization of the lowest possible dose of ProHance is recommended in the pediatric population; the recommended dose should not be exceeded in pediatric patients < 2 years of age. No studies have been conducted in pediatric patients with renal dysfunction and in premature infants.
1 Dosing Considerations). No cases of NSF associated with ProHance or any other GBCA has been identified in pediatric patients ages 6 years and younger. Pharmacokinetic studies suggest that clearance of ProHance is similar in pediatric patients and adults, including pediatric patients younger than 2 years of age.
73m2 at birth and increases to mature levels around 1 year of age, reflecting growth in both glomerular function and relative body surface area. 73m2 (age 6 to 12 months). Use of macrocyclic agents may be preferable in potentially vulnerable patients such as children.
4 Geriatrics No specific precautions other than those pertinent to MRI and ProHance in general are applicable for elderly patients. The drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to ProHance may be greater in patients with impaired renal function.
3 Pharmacokinetics, Geriatrics). 1 Adverse Reaction Overview Patients with a history of previous reaction to contrast media, allergic disposition or bronchial asthma suffer more frequently from hypersensitivity reactions than others.
As with other contrast media, delayed allergic reactions occurring hours or days after administration have been observed, though rarely. Anaphylactoid reactions may occur (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity). GBCAs increase the risk for NSF in patients with impaired renal elimination of drugs (see 3 SERIOUS WARNINGS AND PRECAUTIONS, 7 WARNINGS AND PRECAUTIONS, Renal).
4%. 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 PROHANCE® (Gadoteridol injection) Page 12 of 31 Unclassified / Non classifié compared to the rates in the clinical trials of another drug.
1 Pregnant Women 2024-03 3 SERIOUS WARNINGS AND PRECAUTIONS, NOT FOR INTRATHECAL USE 2025-11 7 WARNINGS AND PRECAUTIONS, Risks of Intrathecal Use 2025-11 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES .......................................................................................... 2 TABLE OF CONTENTS ............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS .............................................................................................................
1 Pediatrics................................................................................................................ 2 Geriatrics ................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................
1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ...................................................... 3 Reconstitution ........................................................................................................
4 Administration ....................................................................................................... 5 Missed Dose ...........................................................................................................
ProHance 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 (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity).
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. PROHANCE® (Gadoteridol injection) Page 5 of 31 Unclassified / Non classifié
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The following adverse events and related adverse reactions were reported in clinical trials involving 3174 subjects (including 2896 adults and 278 pediatric subjects ages 0 to 17 years) exposed to ProHance.
Approximately 48% of the subjects were men and ethnic distribution was 78% Caucasian, 6% Black, 3% Hispanic, 6% Asian, and 2% other. In 5% of the subjects, race was not reported. 15 mmol/kg. 8% reported related adverse reactions during a follow-up period that ranged from 24 hours to 7 days after ProHance administration.
Adverse reactions associated with the use of ProHance were usually mild to moderate in severity and transient in nature resolving spontaneously with no intervention. 9%) subjects who received ProHance. 0%) adult study subjects. 0%), adverse events were considered mild or moderate in intensity.
5%. 1%) of the 2,854 patients in the adult patient population, each of whom was enrolled in a CNS study with ProHance. In 2 of the 3 cases, the serious adverse events (aneurysm ruptured, Grand Mal convulsion) were considered unrelated to ProHance, but may have been related to underlying disease processes.
In both of these cases, the outcome was fatal. In the third case (suspected vasospastic event), a relationship to ProHance was considered possible and the patient was reported to have recovered from the event. 3 mmol/kg (17 subjects).
38 years (range, 1 day to 17 years). 5%) […]
6 5 OVERDOSAGE............................................................................................................ 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 7 7 WARNINGS AND PRECAUTIONS .................................................................................
1 Special Populations .............................................................................................. 1 Pregnant Women ............................................................................................. 2 Breast-feeding ..................................................................................................
3 Pediatrics.......................................................................................................... 4 Geriatrics ..........................................................................................................
11 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview ................................................................................. 2 Clinical Trial Adverse Reactions ...........................................................................
1 Clinical Trial Adverse Reactions – Pediatrics.................................................... 3 Less Common Clinical Trial Adverse Reactions .................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data.............................................................................................................
5 Post-Market Adverse Reactions........................................................................... 14 9 DRUG INTERACTIONS .............................................................................................. 2 Drug Interactions Overview .................................................................................
3 Drug-behavioural interactions ............................................................................. 4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions ........................................................................................
6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions....................................................................... 15 10 CLINICAL PHARMACOLOGY ......................................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics .................................................................................................
16 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 18 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 18 PART II: SCIENTIFIC INFORMATION .....................................................................................
19 13 PHARMACEUTICAL INFORMATION .......................................................................... 19 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trials by Indication .................................................................................. 19 15 MICROBIOLOGY ......................................................................................................
21 16 NON-CLINICAL TOXICOLOGY […]