Magnegita 500 Micromol/Ml Solution For Injection
UK
UK
Read all of this leaflet carefully before you start using
this medicine.
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• Ifany of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. See section 4.
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BEFORE YOU ARE GIVEN MAGNEGITA
PACKAGE LEAFLET:
INFORMATION FOR THE USER
MAGNEGITA 500 MICROMOL/ML SOLUTION FOR INJECTION
Gadopentetate dimeglumine
In this leaflet:
1. What Magnegita is and what it is used for
2. Before you are given Magnegita
3. How to use Magnegita
4. Possible side effects
5. How to store Magnegita
6. Further information
Magnegita contains gadopentetate dimeglumine, a product which enhances contrast.
This medicine is for diagnostic use only.
Magnegita is used in examinations with Magnetic Resonance Imaging (MRI).
Magnegita is used during cranial (head), spinal and whole body MRI scans including head and neck region, the chest including heart and female breast, the belly including pancreas and liver, the kidneys, the pelvis including prostatic gland, bladder and womb, the muscles and the bones.
It may be used to facilitate the visualization, detection and characterisation of several different types of tumours (growths) or lesions in the head, spine and various sites of the body.
In addition the visualisation of all blood vessels (MR-angiography) is possible (with exception of the arteries of the heart), especially for diagnosis of narrowing or obstructions of the vessels.
The blood supply to the heart muscle under stress conditions, for example induced by drugs, can be measured and viability of the heart muscle can be diagnosed ("delayed enhancement").
Do not take Magnegita
• ifyou are allergic (hypersensitive) to gadopentetate dimeglumine or any of the other ingredients of Magnegita
• ifyou suffer from severe renal impairment
(GFR < 30 ml/min/1.73 m2).
Take special care with Magnegita
• if you have a heart pacemaker, an iron-based (ferromagnetic) clip or an implant or an insulin pump, please inform your radiologist/doctor about this. It is a condition where MRI is not suitable.
• because Magnegita may trigger allergic or other specific individual reactions that may have consequences on your heart, on your respiratory tract or on your skin.
You should not be given Magnegita if you suffer from severe kidney problems, or if you are a patient who is about to have or has recently had a liver transplant, as use of Magnegita in patients with these conditions has been associated with a disease called nephrogenic systemic fibrosis (NSF). NSF is a disease involving thickening of the skin and connective tissues. NSF may result in severe joint immobility, muscle weakness or may affect the normal working of internal organs which may potentially be life threatening.
Magnegita should also not be given to newborn babies up to age of 4 weeks.
Tell your doctor if:
• your kidneys do not work properly
• you have recently had, or soon expect to have, a liver transplant.
If an allergic reaction occurs, the radiologist/doctor will stop the administration of the contrast medium at once and, if necessary, will start appropriate treatment of the allergic reactions.
Therefore, it is recommended that you have a flexible in-dwelling catheter during the examination, to enable immediate action in case of emergencies.
Very rarely severe reactions, including shock, may occur. Therefore, you should read the following very carefully:
• if you have, or if you have ever had, bronchial asthma or other allergies or a previous allergic reaction to contrast media you may be more likely to have an allergic reaction during the examination. Tell your radiologist/doctor if you suffer from these conditions. You may be given another medicine before the examination to prevent them.
• if you are taking a beta-blocker (medicines used against high blood pressure, heart problems and other conditions) you should tell your radiologist/doctor. Patients treated with beta-blockers do not necessarily respond to other medicines usually used for the treatment of allergic reactions.
• if you have any heart problems (e. g. severe heart failure, coronary artery disease) you are more susceptible to serious or even fatal outcomes of severe allergic reactions.
• if you have fits or seizures you may have an increased risk of suffering from one during the examination.
• ifyou suffer from moderate renal impairment (GFR 30-59 ml/min/1.73 m2) you should tell your radiologist/doctor. Before you receive Magnegita, you will need to have a blood test to check how well your kidneys are working.
Magnegita should not be used in newborn babies up to the age of 4 weeks. As kidney function is immature in infants up to 1 year of age, Magnegita will only be used in infants after careful consideration by the doctor.
Using Magnegita with food and drink
It is very important that you do not eat anything for 2 hours prior to the investigation.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially: Beta blockers (medicines used for high blood pressure, heart problems and other conditions).
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Pregnancy
You must tell your doctor if you think you are or might become pregnant as Magnegita should not be used during pregnancy unless strictly necessary.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding should be discontinued for at least 24 hours after you receive Magnegita.
Driving and using machines
Your injection is unlikely to affect your ability to drive a car or to operate machinery.
However, while driving vehicles or operating machinery you should take account that nausea or low blood-pressure may incidentally occur.
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Magnegita will be given by an authorised healthcare professional directly into a vein (intravenously).
Ideally you should be recumbent during administration, and you will be kept under supervision for at least 30 minutes after the injection by your radiologist/doctor. This is the time where most undesired reactions (e. g. allergic reactions) may occur. However, in rare cases, reactions may occur after hours or days.
If this medicinal product is intended to be used with an automatic application system, its suitability for the intended use has to be demonstrated by the manufacturer of the medical device. Instructions for use of the medical device must be followed absolutely.
Adults, adolescents and children (over the age of two years)
The dose for cranial, spinal and whole body MRI used will depend on the type of lesion that is being investigated but it is usually between 0.2 and 0.6 ml/kg body weight for adults and between 0.2 and 0.4 ml/kg body weight for children.
Dosage in special patient groups
Neonates up to 4 weeks of age and infants up to 1 year of age
Magnegita should not be used in newborn babies up to the age of 4 weeks.
As kidney function is immature in infants up to 1 year of age, infants should only receive one dose of Magnegita during a scan and should not receive a second injection for at least 7 days. In infants up to 1 year of age Magnegita should only be used after careful consideration because the proper function of the kidneys is not fully developed in this age group.
Toddlers (from 1 - 2 years)
The dose is 0.2 ml/kg body weight in children under the age of 2 years.
Elderly (aged 65 years and above)
It is not necessary to adjust your dose if you are 65 years of age or older but you will have a blood test to check how well your kidneys are working.
Patients with impaired renal function
You should not be given Magnegita if you suffer from severe kidney problems or if you are a patient who is about to have or has recently had a liver transplant.
Patients with moderate renal impairment (if the value for assessment of renal function, the GFR (glomerular filtration rate) is 30-59 ml/min/1.73 m2)
The use of Magnegita must be carefully evaluated in patients with moderate renal impairment. The medicine will remain longer in the body of those patients than in patients without impaired renal function.
The doctor will screen you to see, if your kidneys are working properly.
If you have moderate kidney problems, you should only receive one dose of Magnegita during a scan and you should not receive a second injection for at least 7 days.
The following information is intended for medical or healthcare professionals only:
Prior to administration of Magnegita, all patients should be screened for renal dysfunction by obtaining laboratory
tests.
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Magnegita and some other gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. Therefore Magnegita must not be used in patients with severe renal impairment, in patients in the perioperative liver transplantation period.
Magnegita should also not be given to newborn babies up to the age of 4 weeks.
The risk for development of NSF in patients with moderate renal impairment (GFR 30-59 ml/min/1.73m2) is unknown, therefore, Magnegita should be only used after careful risk-benefit evaluation in patients with moderate renal impairment at a dose not exceeding 0.2 ml/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Magnegita injections should not be repeated unless the interval between injections is at least 7 days.
Due to immature renal function in infants up to 1 year of age,
Magnegita should only be used in these patients after careful consideration at a dose not exceeding 0.2 ml/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Magnegita injections should not be repeated unless the interval between injections is at least 7 days. Magnegita should not be given to newborn babies up to age of 4 weeks.
As the renal clearance of gadopentetate dimeglumine may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
4 POSSIBLE SIDE EFFECTS
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If you are given more Magnegita than you should
This medicine will be given to you by a healthcare professional. If you think that you have received too much medicine please tell your doctor or nurse immediately.
If you have any further questions on the use of this product, ask your doctor or radiographer or pharmacist.
Like all medicines, Magnegita can cause side effects, although not everybody gets them.
The most commonly reported undesirable effects with Magnegita are nausea, vomiting, headache, dizziness, pain and a feeling of warmth or coldness at the injection site or a feeling of warmth in general.
There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs).
Other undesirable effects that may occur have been listed by organ system and frequency. Frequencies are reported as:
Very common (more than 1 in 10 people)
Common (more than 1 in 100 people and less than 1 in 10 people)
Uncommon (more than 1 in 1,000 people and less than 1 in 100 people)
Rare (more than 1 in 10,000 people and less than 1 in 1,000 people)
Very rare (less than 1 in 10,000 people)
Reactions for which no frequency rate can be provided due to lack of clinical data, have been entered with "Not known".
Blood Disorders
Rare short term increase in blood iron
Nervous System Disorders
Uncommon dizziness, numbness (paraesthesia), headache Rare agitation, confusion, speech, or smelling disturbance, fits,
tremor, coma, sleepiness
Eye Disorders
Rare eye pain, sight disturbance, eyes watering
Skin Disorders
Rare swelling of eyelids, face or lips, redness of the skin, itchiness
Musculoskeletal Disorders
Rare back pain or joint pain
Kidney Disorders
Rare urinary incontinence (urine leaking) or urgency, short term
changes in kidney function values or acute renal failure in patients with disturbed kidney function
General Disorders and Administration Site Conditions
Uncommon sensation of heat
Rare chest pain, chills, sweating, changes in body temperature, fever;
pain at the administration site, feeling of coldness or warmth, swelling, inflammation, degeneration of tissue (tissue necrosis), inflammation of the veins at the injection site
Not known cases of nephrogenic systemic fibrosis/nephrogenic fibrosing dermophathy (a condition in patients with kidney disease with hardening of the skin and other organs)
Immune System Disorders
Rare Hypersensivity/anaphylactic reaction: angiooedema,
inflammation of the eye (conjunctivitis), coughing, itching, runny nose, sneezing, skin rashes (urticaria), wheeziness, tightness of the voicebox (larynx), swelling of the voice box (larynx) and the throat (pharynx), low blood pressure, shock
Some people may find they have an allergic reaction to Magnegita. Tell your doctor immediately if any of the following rare severe allergy symptoms occur:
• Sudden wheeziness and tightness of the chest
• Swelling of eyelids, face or lips
• Skin rashes (urticaria), itchiness, fever
• Collapse
• Turning blue (cyanosis)
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
FURTHER INFORMATION
What Magnegita contains
• Theactive substance is gadopentetate dimeglumine.
• 1ml Magnegita solution for injection contains 469 mg of gadopentetate dimeglumine (corresponding to 500 micromol, corresponding to 78.63 mg gadolinium).
• Theother ingredients are pentetic acid, meglumine and water for injection
What Magnegita looks like and contents of the pack
Solution for injection.
Your medicinal product comes in a clear glass vial with a rubber stopper and aluminium cap that is packed into a carton along with this patient information leaflet (package leaflet).
The vial contains a clear, particle free solution for injection.
Magnegita is presented in the following packs:
1 vial with 5, 10, 15, 20, 30 and 100 ml solution for injection 10 vials with 5, 10, 15, 20, 30 and 100 ml solution for injection Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Agfa HealthCare Imaging Agents GmbH
Am Coloneum 4
50829 Koln, Germany
Tel: + 49 221 5717-660
Fax: + 49 221 5717-1051
E-mail: imagingagents@agfa.com
Manufacturer:
Biokanol Pharma GmbH Kehler StraBe 7 76437 Rastatt, Germany
This leaflet was last approved in MM/YYYY.
Haemodialysis shortly after Magnegita administration may be useful at removing Magnegita from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.
Magnegita should not be used during pregnancy unless the clinical condition of the woman requires use of gadopentetate dimeglumine.
Breast-feeding should be discontinued for at least 24 hours after the administration of Magnegita.
The peel-off tracking label on the vials should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.
5084-4-11/14
Ear Disorders
Rare pain of the ear, hearing disturbance
Heart Disorders
Rare changes in heart rate or rhythm, blood pressure changes, heart
stops beating
Vascular Disorders
Rare widening of the blood vessels and changes in blood flow
causing low blood pressure followed by fainting, fast heart rate (tachycardia), difficulties in breathing and turning blue possibly leading to unconsciousness and shock
Respiratory, Thoracic and Mediastinal Disorders
Rare short term changes in breathing rate, shortness of breath,
difficulty in breathing, stopping breathing, fluid in the lungs
Gastrointestinal Disorders
Uncommon nausea, vomiting
Rare abdominal pain, diarrhoea, taste disturbance, dry mouth,
excess saliva
Hepatobiliary Disorders
Rare short-term increase in liver enzymes and bilirubine value
Keep out of the reach and sight of children.
Do not use Magnegita after the expiry date that is stated on the label. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Chemical and physical in-use stability has been demonstrated 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.
Do not use Magnegita if you notice any visible signs of deterioration (such as particles in the solution or fissures in the vial).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
AGFA^^
Healthcare
Imaging Agents
080417_V22_Agfa_UK_Magnegita_PIL_360x250mm
Donnerstag, 19. Februar 2015 15:15:22