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Package Leaflet: Information for the user

Magnevist® 2 mmol/l solution for injection

dimeglumine gadopentetate

dimeglumine gadopentetate

Summary of Product Characteristics

Magnevist® 2 mmol/l solution for injection

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

►    Keep this leaflet. You may need to read it again.

►    If you have any further questions, please ask the doctor giving you Magnevist 2 mmol/l (the radiologist) or the hospital/MRI-centre staff.

►    If you get any side effects, talk to your doctor, radiologist or the hospital/MRI-centre staff.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Magnevist 2 mmol/l is and what it is used for

2.    What you need to know before you are given Magnevist 2 mmol/l

3.    How you will be given Magnevist 2 mmol/l

4.    Possible side effects

5.    How to store Magnevist 2 mmol/l

6.    Contents of the pack and other information

1. What Magnevist 2 mmol/l is and what it is used for

Magnevist 2 mmol/l is used together with a technique called Magnetic Resonance Imaging (MRI) to create artificial contrast or enhancement to help make an MRI scan of your joints clearer.

MRI is a modern scanning technique which produces very high quality pictures ofvarious parts of your body without using X-rays. The use of MRI can provide a quick, early and accurate diagnosis.

The scanner uses a strong magnetic field and radiowaves to measure the magnetic properties of body tissues. Using a computer, this information is converted into a black and white picture which can help your doctor see and investigate the differences between normal and abnormal tissue.

Sometimes MRI is used in areas where it cannot produce a clear black and white picture. This is when Magnevist 2 mmol/l is used. Magnevist 2 mmol/l produces a clearer image and allows the doctor to see the area of interest better. Sometimes several scans will be taken before Magnevist 2 mmol/l is injected and then further scans taken after the injection.

This medicine is for diagnostic use only.

2. What you need to know before you are given Magnevist 2 mmol/l

Do not use Magnevist 2 mmol/l:

►    if you are allergic to dimeglumine gadopentetate or any of the other ingredients of this medicine (listed in section 6)

►    if you have a heart pacemaker or if there are any implants or clips containing iron inside your body. (This is not because of an interaction with Magnevist 2 mmol/l but because if you have any of these, you should not be placed in a strong magnetic field).

Warnings and precautions

Talk to your radiologist or MRI-centre staff before receiving

Magnevist 2 mmol/l

Your doctor will need to take special care when giving you

Magnevist 2 mmol/l if:

►    you have a history of allergy (e.g. hay fever, hives), asthma, or have had a reaction to another type of contrast media.

This is because you may be more likely to have an allergic reaction. If you have had any of these in the past, tell the radiologist or MRI-centre staff.

►    you have an infected joint.

Before you receive Magnevist 2 mmol/l, you must tell the

radiographer or MRI-centre staff if any of these apply to you.

Other medicines and Magnevist 2 mmol/l

Tell the radiologist or MRI-centre staff ifyou are taking, have

recently taken or might take any other medicines.

Pregnancy and breast-feeding

Ifyou are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, ask the MRI-centre staff for advice before receiving this medicine. A very small amount of Magnevist enters the breast milk, but this isn’t likely to cause any harm.

Driving and using machines

The volume of Magnevist 2 mmol/l injected into your joint may limit your movement. Do not drive if your movement is affected.

Magnevist 2 mmol/l contains sodium

This medicinal product contains 3.4 mg sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

B. How you will be given Magnevist 2 mmol/l

You will be asked to sit or lie down and Magnevist 2 mmol/l will be injected into the joint which is being investigated. Scanning may start immediately after the Magnevist 2 mmol/l injection. The MRI staff will observe you for at least 30 minutes after the injection just in case you have any side effects.

Adults:

The dose of Magnevist 2 mmol/l varies depending on which joint is investigated. For most joints, 20 ml is used, but up to 50 ml may be used for the knee joint. The doctor will decide how much Magnevist 2 mmol/l is needed for your investigation. Children:

Magnevist 2 mmol/l is not recommended for use in children. Ifyou receive more Magnevist 2 mmol/l than you should

Overdosing is unlikely. If this does occur no serious ill-effects are expected.

Ifyou have any further questions on the use of this medicine, ask the MRI-centre staff.

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1.    NAME OF THE MEDICINAL PRODUCT

Magnevist 2 mmol/l solution for injection

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml aqueous solution contains 1.876 mg gadopentetic acid, dimeglumine salt as active ingredient (equivalent to 0.002 mmol gadopentetic acid, dimeglumine, containing 0.32 mg gadolinium).

Excipient with known effect: sodium chloride Magnevist 2 mmol/contains 3.4 mg sodium per ml.

For the full list of excipients, see section 6.1.

B. PHARMACEUTICAL FORM

Solution for injection.

4. CLINICAL PARTICULARS

4.1    Therapeutic indications

For contrast enhancement in direct magnetic resonance arthrography.

This medicinal product is for diagnostic use by intraarticular administration only.

4.2    Posology and method of administration

The usual precautions for MRI (e.g. exclusion of cardiac pacemakers and other ferro-magnetic objects including vascular clips etc) must be observed.

Posology

The recommendations for the use of Magnevist 2 mmol/l apply to a field strength between 0.2 Tesla and 1.5 Tesla. Intraarticular administrations of contrast agents are to be given with the patient lying or sitting. After the end of the injection, the patient should be kept under supevision for at least half an hour.

Adults:

In general, for all joints the administration of up to 20 ml (knee joint up to 50 ml) Magnevist 2 mmol/l is sufficient for good opacification and to answer all the relevant clinical questions.

A volume leading to a slight distension of the joint capsule should be injected. Only so much contrast medium should be injected until discrete resistance is felt and/or the patient experiences a mild feeling of pressure.

Guidelines on volumes to be administered:

Paediatric population:

The safety and efficacy of Magnevist 2 mmol/l in children aged up to 18 years has not yet been established. No data are available. Magnevist 2 mmol/l is not recommended in the paediatric age group until further data become available. Method of administration

The dose required is administered via intraarticular injection under strict aseptic technique and according to the instructions provided in section 6.6.

Contrast-enhanced MRI can be commenced immediately afterwards.

4.4    Special warnings and precautions for use

Strict aseptic technique is required to prevent infection. Fluoroscopic control should be used to ensure proper needle placement and prevent extracapsular injection. Undue pressure should not be exerted during injection.

Intraarticular injections of Magnevist 2 mmol/l should be avoided in infected joints.

►    Flypersensitivity

Severe systemic hypersensitivity reactions cannot be totally excluded (see section 4.8).

Mild angioedema, conjunctivitis, coughing, pruritus, rhinitis, sneezing and urticaria, which can occur irrespective of the amount administered and the mode of administration, may be the first signs of incipient state of shock.

As with other contrast agents, delayed reactions may occur (hours later or up to several days).

As with other contrast enhanced diagnostic procedures, postprocedure obsevation of the patient is recommended.

Medication for the treatment of hypersensitivity reactions as well as readiness for institution of emergency measures are necessary. Appropriate drugs and instruments (e.g. endotracheal tube and ventilator) must be readily available.

The risk of hypersensitivity reactions is higher in case of:

►    previous reaction to contrast media,

►    history of bronchial asthma,

►    history of allergic disorders

The decision to use Magnevist 2 mmol/l must be made after particularly careful evaluation of the risk-benefit-ratio in patients with an allergic disposition.

►    Magnevist 2 mmol/l contains sodium

This medicinal product contains 3.4 mg sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

4.5    Interaction with other medicinal products and other forms of interaction

As for all other gadolinium containing contrast media, no interactions with other medicaments have been observed.

Formal drug interaction studies have not been carried out. See also section 6.2.

Magnevist should be administered without the addition of iodinated contrast media as iodinated contrast media reduce the level of contrast achievable with Magnevist (see section 6.6).

4.6    Fertility, pregnancy and lactation

►    Pregnancy

For gadopentetic acid, dimeglumine no clinical study data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to embryonal / foetal development (see section 5.3).

Caution should be exercised using Magnevist 2 mmol/l in pregnant women.

►    Breast-feeding

No data exist concerning intra-articular administration in lactating women. After intravascular use minimal amounts of gadopentetic acid, dimeglumine salt (a maximum of 0.04%) of the intravenously administered dose enters the breast milk.

From experience gained so far, harm to the breast-fed infant is considered unlikely.

4.7    Effects on ability to drive and use machines

No effects of Magnevist 2 mmol/l on driving ability and use of machinery can be expected. However, joint effusion may affect the ability to drive due to a limited joint mobility.

4.8 Undesirable effects

Frequency of adverse reactions from clinical trial data

Based on experience in more than 4,900 patients, the undesirable effects listed below have been observed and classified by investigators as drug-related.

Adverse reactions with the use of Magnevist 2 mmol/l are usually of mild to moderate intensity.

The most frequently reported reactions were local injection site reactions, i.e. injection site pain and joint pressure sensations which are mainly related to the procedure itself.

The table below reports adverse reactions by MedDRA system organ classes (MedDRASOCs).

The most appropriate MedDRA term is used to describe a reaction and its synonyms and related conditions.

►    Immune system disorders/Hypersensitivity/Allergic reaction Systemic hypersensitivity may occur rarely in the form of skin reactions. The possibility of a severe hypersensitivity reaction cannot be totally excluded (see section 4.4).

►    General disorders and administration site conditions Injection of Magnevist 2 mmol/l into the joint is commonly associated with transient discomfort, e.g. pressure and pain due to the injected volume. Severe pain may often result from undue use of pressure or the injection of large volumes.

Other adverse reactions commonly known from intravenous injection of gadolinium chelates were so far not observed with Magnevist 2 mmol/l, due to the low dose and the topical administration.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important, it allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No signs of intoxication secondary to an overdose have so far been obseved or reported on clinical use.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: paramagnetic contrast media,

ATC code: V08CA01

Magnevist 2 mmol/l is a paramagnetic contrast agent for magnetic resonance imaging. The contrast-enhancing effect is mediated by the di-N-methylglucamine salt of gadopentetic acid, dimeglumine - the gadolinium complex of pentetic acid (diethylene triamine pentaacetic acid = DTPA). When a suitable scanning sequence (e.g. Tj-weighted spin-echo technique) is used in proton magnetic resonance imaging, the gadolinium ion-induced shortening of the spin-lattice relaxation time of excited atomic nuclei leads to an increase of the signal intensity and, hence, to an increase of the image contrast of certain tissues.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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This leaflet was last revised in April 2015,

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Magnevist® 2 mmol/l solution for injection

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Bayer

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