Medicinal Products

DOTAREM 05 mmol / mL Injectable IV box of 1 pre-filled syringe (+ necessary administration) of 20 ml

Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
active ingredients: Gadoteric acid
laboratory: Guerbet

IV injectable solution
All forms

Indication

This medicine is for diagnostic use only.

Magnetic resonance imaging for:

· Cerebral and medullary pathologies,

· Pathologies of the spine,

· And other pathologies of the whole body (including angiography).

Dosage DOTAREM 05 mmol / mL Injectable IV box of 1 pre-filled syringe (+ necessary administration) of 20 ml

This medicine is for diagnostic use only.

Magnetic resonance imaging for:

· Cerebral and medullary pathologies,

· Pathologies of the spine,

· And other pathologies of the whole body (including angiography).

Against indications

History of hypersensitivity to gadoteric acid or gadolinium contrast media, meglumine.

Dotarem side effects

In clinical studies in 1941 patients, 3.6% of patients experienced an adverse effect related to the administration of gadoteric acid, the most common being pain and sensation of heat or cold at the injection site and nausea.

The adverse effects associated with the use of gadoteric acid are generally mild to moderate, and transient in nature.

In clinical trials, headache and paraesthesia were very commonly observed (> 1/10), and nausea, vomiting and skin reactions such as rash and itching were frequently (> 1 / 100 to <1/10).

The most common side effects with gadoteric acid since marketing are nausea, vomiting, pruritus, and hypersensitivity reactions.

In hypersensitivity reactions, the most commonly observed effects are cutaneous effects, which can be localized, extensive or generalized. These reactions are most often of immediate occurrence (during the injection or within one hour after the start of the injection) or sometimes delayed (one hour to a few days after the injection), and are then in the form of skin reactions.

Immediate reactions include one or more effects of concomitant or sequential onset, most often including cutaneous, respiratory and / or cardiovascular manifestations, which can each be a sign of a beginning state of shock and very rarely until death.

Isolated cases of systemic nephrogenic fibrosis (NSF) have been reported with gadoteric acid, most often in patients who have also received other gadolinium-containing contrast agents (see Warnings and Precautions ).

Adverse reactions are presented in the table below by Class Organ System and by frequency using the following categories: very common (³ 1/10), common (³ 1/100 to 1 <1/10), uncommon ( ³ 1/1000 to 1 <1/100), rare (1/10 000 to <1/1000), very rare (<1 / 10, 000), not known (can not be estimated from the data available). The frequencies presented are based on data from an observational study of 82, 103 patients.

Class Organ System

Frequency: adverse effect

Immune system disorders

Uncommon: hypersensitivity, anaphylactic reaction, anaphylactoid reaction

Psychiatric disorders

Very rare: agitation, anxiety

Nervous system disorders

Very common: paresthesia, headache

Rare: dysgeusia

Very rare: coma, convulsion, syncope, presyncope, vertiginous sensation, parosmia, tremor

Eye disorders

Very rare: conjunctivitis, ocular hyperemia, blurred vision, increased lacrimal secretion, eyelid edema

Heart conditions

Very rare: cardiac arrest, bradycardia, tachycardia, arrhythmia, palpitations

Vascular disorders

Very rare: hypotension, hypertension, vasodilatation, pallor

Respiratory, thoracic and mediastinal disorders

Very rare: respiratory arrest, pulmonary edema, bronchospasm, laryngospasm, pharyngeal edema, dyspnea, nasal congestion, sneezing, cough, dry throat

Gastrointestinal disorders

Common: nausea, vomiting

Very rare: diarrhea, abdominal pain, salivary hypersecretion

Skin and subcutaneous tissue disorders

Common: pruritus, erythema, rash

Rare: urticaria, hyperhidrosis

Very rare: eczema, Quincke's edema (angioedema)

Not known: nephrogenic systemic fibrosis

Musculoskeletal and systemic disorders

Very rare: muscle contractures, muscle weakness, backache

General disorders and administration site conditions

Frequent: feeling of warmth, feeling cold, pain at the injection site

Very rare: malaise, chest pain, chest discomfort, fever, chills, facial edema, asthenia, discomfort at the injection site, injection site reaction, injection site edema, extravasation at the injection site. injection, inflammation at the injection site in case of extravasation, necrosis at the injection site in case of extravasation, superficial phlebitis

investigations

Very rare: decreased oxygen saturation

The following side effects have been reported with other intravenous contrast agents for MRI. They may also occur during a treatment with Dotarem:

Class Organ System

Undesirable effect

Blood and lymphatic system disorders

hemolysis

Psychiatric disorders

Confusion

Eye disorders

Transient blindness, eye pain

Affections of the ear and labyrinth

Tinnitus, ear pain

Respiratory, thoracic and mediastinal disorders

Asthma

Gastrointestinal disorders

Dry mouth

Skin and subcutaneous tissue disorders

Bullous dermatitis

Renal and urinary disorders

Urinary incontinence, renal tubular necrosis, acute renal failure

investigations

PR prolongation of electrocardiogram, increased serum iron, increased bilirubinemia, increased ferritinemia, abnormal liver function tests

Side effects in children

Adverse effects related to gadoteric acid are uncommon in children. The expected nature of these effects is identical to that reported in adults. When they occur, these effects are less severe than in adults.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers Website: www.ansm.sante.fr

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