Medicinal Products

ARTIREM 0.0025 mmol / mL

Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
Active ingredients: Gadoteric acid, Corresponding to: DOTA, Gadolinium oxide
laboratory: Guerbet

Injectable solution
Box of 1 pre-filled syringe of 20 ml
All forms

Indication

This medicine is for diagnostic use only.

Arthrography in magnetic resonance imaging

Dosage ARTIREM 0.0025 mmol / mL Solution for injection Box of 1 pre-filled syringe of 20 ml

Dosage

The recommended dose depends on the territory to be explored and the size of the joint:

Joint

Recommended volume

Shoulder

5 to 25 ml

Hip

5 to 25 ml

Elbow

4 to 10 ml

Knee

20 to 40 ml

Wrist

3 to 9 ml

Ankle

4 to 19 ml

Imaging is optimal in about 45 minutes after injection.

Pediatric population

The efficacy and safety of Artirem have not been established in subjects under 18 years of age. Currently available data are described under Adverse Reactions but no dosage recommendation can be given.

Administration mode

The product must be administered intra-articularly under strict aseptic conditions, possibly after injection of a small amount of iodinated contrast medium to visualize the intra-articular cavity.

Against indications

Hypersensitivity to gadoteric acid, meglumine or any product containing gadolinium.

Adverse effects Artirem

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

The most common side effects with Artirem since marketing are mild pain or local discomfort at the image joint, and hypersensitivity reactions.

The most commonly observed hypersensitivity reactions were localized, extensive or generalized rashes. These reactions are most often immediate (during the injection or in the hour following the beginning of the injection) but are sometimes delayed (one hour to several days after the injection), and are then in the form of reactions. unwanted skin.

Immediate reactions include one or more effects of concomitant or sequential onset, most often including cutaneous, respiratory and / or cardiovascular manifestations, which may be suggestive of a state of early shock and very rarely result in death.

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 come from an observational study in 463 patients.

Class Organ System

Frequency: adverse effect

Immune system disorders

Uncommon: hypersensitivity

Musculoskeletal and systemic disorders

Uncommon : arthralgia

The following side effects have been reported with other intra-articular contrast agents. They are therefore likely to occur during a treatment with Artirem:

Class Organ System

Frequency: adverse effect

Nervous system disorders

Headache, dizziness

Vascular disorders

Vasovagal reactions

Gastrointestinal disorders

Nausea, vomiting

General disorders and administration site conditions

Pain at the injection site

Side effects in children

The expected nature of Artirem-related adverse events is similar to that reported in adults. Their frequency can not be estimated on the basis of available data.

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