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Omniscan

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Document: Omniscan solution for injection and solution for injection, pre-filled syringe ENG PL change


Package leaflet:Information for the user


Omniscan 0.5 mmol/ml solution for injection

Omniscan 0.5 mmol/ml solution for injection, pre-filled syringe


Gadodiamide


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


What is in this leaflet

1. What OMNISCAN is and what it is used for

2. What you need to know before you are given Omniscan

3. How to use Omniscan

4. Possible side effects

How to store Omniscan

Contents of the pack and other information


What OMNISCAN is and what it is used for


This medicine is for diagnostic use only.

Omniscan is a contrast medium which is used in Magnetic Resonance Imaging (MRI) examinations of the brain or spine, and for whole body examinations like the head and neck region, the thoracic cavity including the heart, extremities (arms and legs), organs in the abdominal cavity (prostate, urinary bladder, pancreas and liver), kidney, female breast, musculosceletal system and blood vessels.


Omniscan can help some medical conditions to be seen more clearly. This helps the doctor to find and examine these conditions more easily, and can improve the information needed to make a diagnosis.


What you need to know before you are given Omniscan


Do not use Omniscan

- if you are allergic (hypersensitive) to gadodiamide or any of the other ingredients of Omniscan (listed in section 6)


You should not be given Omniscan if you suffer from severe and/or acute kidney problems, or if you are a patient who is about to have or has recently had a liver transplant, as use of Omniscan 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.

Omniscan should also not be given to newborn babies up to age of 4 weeks.


Warning and precautions

Talk to your doctor before using Omniscan

- if you have a heart pacemaker or any implants containing iron in your body

- if you have previously experienced a severe reaction after receiving contrast media

- if you have or have had any allergies (e.g. allergies to seafood, hay fever, nettle rash), asthma or other

allergic respiratory disorders.

- if you suffer from heart diseases or disorders of the central nervous system

(epilepsy or brain lesions).

- if you suffer from moderate kidney problems.


Tell your doctor if:

- your kidneys do not work properly

- you have recently had, or soon expect to have, a liver transplant


Before you receive Omniscan, you will need to have a blood test to check how well your kidneys are working.


Children and adolescents

Omniscan 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, Omniscan will only be used in infants after careful consideration by the doctor.


Other medicines and Omniscan

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tell your doctor if you are having blood samples taken on the same day and within 12-24 hours after Omniscan injection. Omniscan interferes with some of the methods commonly used for measuring content of electrolytes (e.g. iron and calcium) in blood.


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 Omniscan should not be used during pregnancy unless strictly necessary.


Breast-feeding

Tellyour 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 Omniscan.


Driving and using machines

Driving should be avoided since nausea may occur after the investigation.


Omniscan contains 0.62 mg/ml Sodium. This needs to be considered for people on a low sodium diet.


How to use Omniscan


Dosage and administration

Omniscan will be injected into one of your veins usually as a single injection before or during your MRI examination. Occasionally a second injection may be of additional diagnostic value.


The amount injected will depend upon your weight and what part of the body you are having examined. The usual dose is 0.2 ml/kg body weight or occasionally up to 0.6 ml/kg body weight. Even if you weigh more than 100 kg you will normally not receive more than 20 ml or for some conditions up to 60 ml.


If you have any further questions on the use of this product, ask your doctor or pharmacist.


Dosage in special patient groups


You should not be given Omniscan if you suffer from severe kidney problems and/or acute kidney injury or if you are a patient who is about to have or has recently had a liver transplant. Omniscan should also not be used in newborn babies up to the age of 4 weeks.


If you have moderate kidney problems, you should only receive one dose of Omniscan during a scan and you should not receive a second injection for at least 7 days.


As kidney function is immature in infants up to 1 year of age, infants should only receive one dose of Omniscan during a scan and should not receive a second injection for at least 7 days.


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.


4. Possible side effects

Like all medicines, Omniscan can cause side effects, although not everybody gets them.


The following rare symptoms may be serious. Contact your doctor immediately if you experience:


This is a list of side effects which may occur during or after the examination:


Common ( may affect up to 1 in 10 people):


Uncommon (may affect up to 1 in100 people):


Rare (may affect up to 1 of 1,000 people):


Not known ( frequency cannot be estimated from the available data)


Most of the allergic reactions occur within half an hour after injection. In rare cases side effects may occur after hours or days.


Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: [To be completed nationally]

By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Omniscan


Keep out of the sight and reach of children.

Do not use Omniscan after the expiry date which is stated on the label.


The peel-off tracking label on the vial/bottle and pre-filled syringe 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


Store the vial/bottle/polypropylene bottle and pre-filled syringe in the outer carton in order to protect from light.

Store the polypropylene bottles with twist-off top below 30C.

Do not freeze.
Do not use Omniscan if you notice severe discoloration, the occurrence of particulate matter or a defective container


Chemical and physical in-use stability has been demonstrated for 8 hours at 25 °C. From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, 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.



6. Contents of the pack and other information


What Omniscan contains


The active substance is gadodiamide (287 mg of gadodiamide per ml, equivalent to 0.5 mmol/ml)

1 ml contains 287 mg of gadodiamide, equivalent to 0.5 mmol.
5 ml contains 1.44 g of gadodiamide, equivalent to 2.5 mmol.
10 ml contains 2.87 g of gadodiamide, equivalent to 5.0 mmol.
15 ml contains 4.31 g of gadodiamide, equivalent to 7.5 mmol.
20 ml contains 5.74 g of gadodiamide, equivalent to 10.0 mmol.
50 ml contains 14.35 g of gadodiamide, equivalent to 25.0 mmol.
100 ml contains 28.70 g of gadodiamide, equivalent to 50.0 mmol.

The other ingredients are caldiamide sodium and sodium hydroxide solution 3.8 % or hydrochloric acid 3.65 % (for pH adjustment) and water for injections.


What Omniscan looks like and contents of the pack


Omniscan is a solution for injection. The product is a clear, colourless to slightly yellow, aqueous solution.


Omniscan is supplied as:


5 ml, 10 ml, 15 ml, 20 ml and 100 ml glass vials/bottle withchlorobutyl rubber stoppers (latex free).

Pack sizes of 10.


10 ml, 15 ml and 20 ml polypropylene bottles, with twist-off top and luer-lock.

Pack sizes of 10.


50 ml and 100 ml polypropylene bottles, with chlorobutyl rubber stopper, plastic screw cap and tamper proof ring.

Pack sizes of 10.


10 ml, 15 ml and 20 ml pre-filled syringes, with bromo-butyl or styrene-butadiene rubber plungers that do not contain latex.

Pack sizes of 10.


Not all pack sizes may be marketed.


Marketing Authorisation Holder


GE Healthcare AS

Nycoveien 1-2

P.O. Box 4220 Nydalen

NO-0401 OSLO, Norway


Manufacturer


GE Healthcare Ireland

IDA Business Park

Carrigtohill

Co. Cork, Ireland


Or


GE Healthcare AS,
Nycoveien 1-2,
P.O.Box 4220 Nydalen,
NO-0401 Oslo,
Norway


This medicinal product is authorised in the Member States of the EEA under the following names:

Germany: Omniscan 0,5 mmol/ml Injektionslösung

Ireland: Omniscan 0.5 mmol/ml Solution for Injection

Norway: Omniscan 0.5 mmol/ml Injeksjonsvaeske

Sweden: Omniscan 0.5 mmol/ml Injektionsvätska


This leaflet was last approved 2016-08-19

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The following information is intended for medical or healthcare professionals only:


Each vial/bottle and pre-filled syringe of contrast medium is intended for single use. Any unused portions must be discarded.


The diameter of the pre-filled syringe is too large to allow for accurate measurements of small volumes. The syringe should not be used for volumes below 5 ml.


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.


Prior to administration of Omniscan, 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 Omniscan and some other gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury. Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. Therefore Omniscan must not be used in patients in the perioperative liver transplantation period.

Omniscan 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/1.73 m2) is unknown, therefore, Omniscan should be only used after careful risk-benefit evaluation in patients with moderate renal impairment at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Omniscan 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, Omniscan should only be used in these patients after careful consideration at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Omniscan injections should not be repeated unless the interval between injections is at least 7 days. Omniscan should not be given to newborn babies up to age of 4 weeks.


As the renal clearance of gadodiamide may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.


Haemodialysis shortly after Omniscan administration may be useful at removing Omniscan 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.


Omniscan should not be used during pregnancy unless the clinical condition of the woman requires use of gadodiamide.


Breast-feeding should be discontinued for at least 24 hours after the administration of Omniscan.


The peel-off tracking label on the vials/bottles and syringes should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded.


Instruction for use of the polypropylene bottle