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

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Clariscan is and what it is used for 
2. What you need to know before you are given Clariscan 
3. How Clariscan is given 
4. Possible side effects 
5. How to store Clariscan 
6. Contents of the packaging and other information 

1. What Clariscan is and what it is used for

What is Clariscan?

Clariscan contains the active substance gadoteric acid. It belongs to a group of medicines called “contrast agents” for magnetic resonance imaging (MRI).

What Clariscan is used for

Clariscan is used to increase the contrast of the images obtained during MRI scans.

In adults and children and adolescents (0-18 years):

– MRI of the central nervous system including defects (injuries) in the brain, spine / spinal cord, and surrounding tissue.

In adults and children and adolescents (6 months-18 years):

– Full-body MRI including defects (injuries)

In adult patients only:

– magnetic resonance angiography (MRA) including defects (injuries) or narrowing of arteries (stenosis), except in coronary arteries.

This medicine is used only to make a diagnosis.

How Clariscan works

Clariscan makes the images from an MRI scan easier to interpret, by increasing the contrast between the body part being examined and the rest of the body. This allows the doctor to see different parts of the body better.

Gadoteric acid contained in Clariscan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

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

Do not use Clariscan

  • if you are allergic to gadoteric acid or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to medicines containing gadolinium or any other contrast medicine used for MRI.

Warnings and cautions

Remove any metal objects you are wearing before the examination.

Talk to your doctor or radiologist before receiving Clariscan if:

  • you have previously had a hypersensitivity reaction to a contrast agent
  • you have asthma
  • you have allergies are – e.g. shellfish allergy, pollen allergy, hives (intense itching)
  • you are being treated with a beta-blocker (medicines for heart and blood pressure diseases such as metoprolol )
  • your kidneys are not functioning normally
  • you have recently undergone, or probably will soon undergo, a liver transplant
  • you have had seizures (seizures or seizures) or you are being treated for epilepsy.
  • you have serious heart problems
  • you have any disease that affects your heart or your blood vessels
  • you have a “pace-maker”, vascular clamps that contain iron (ferromagnetic), an implant or an insulin pump, or foreign objects of metal in/on the body, especially in the eye. In these cases, MRI scans are not appropriate.

If any of the above applies to you, talk to your doctor before receiving Clariscan.

Risk of serious side effect s

As with all MRI contrast agents, there is a risk of side effect. The side effects are usually less severe and transient but cannot be predicted. However, there is a risk that they may endanger your life:

• any serious side effects may occur immediately or within one hour of receiving the medicine

• minor side effects may occur up to 7 days after treatment. Side effects are more likely if you have previously had a hypersensitivity reaction to an MRI contrast agent (see section 4 “Possible side effects”)

• tell your doctor before giving Clariscan if you have had a reaction in the past. Your doctor will only give you Clariscan if the benefits outweigh the risks. If you receive Clariscan, you will be closely monitored by your doctor.

Samples and examinations

Your doctor may decide to take a blood sample before you receive Clariscan, especially if you are over 65 years old. This is to check how well your kidneys are working.

Children and young people

Use for angiography is not recommended for children under 18 years of age.

Newborns and infants

Your doctor will carefully consider whether your child can be given Clariscan. This is because the kidneys are immature in newborns up to 4 weeks of age and infants up to 1 year of age.

Use in whole-body MRI is not recommended for children under 6 months.

Other medicines and Clariscan

Tell your doctor if you are taking, have recently taken, or might take any other medicines. 

In particular, tell your doctor if you are taking or have recently taken medicines for heart disease and high blood pressure such as:

  • Beta-blockers, medicines that slow down your heart (eg metoprolol )
  • substances that enlarge (dilate) your blood vessels and lower blood pressure: vasoactive substances (such as doxazosin ), ACE inhibitors (such as ramipril), angiotensin II receptor antagonists (such as valsartan).

Tell your doctor if you are taking or have recently taken any of the medicines listed above.

Clariscan with food and drink

Nausea and vomiting are known possible side effects when using contrast agents in MRI. The patient should therefore refrain from eating later than 2 hours before the examination.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Clariscan should not be used during pregnancy unless clearly necessary by your doctor.

Breast-feeding

If you are breast-feeding or planning to breast-feed, talk to your doctor before using this medicine. Discuss with your doctor if you should continue breast-feeding or if you should stop breastfeeding for a period of 24 hours after receiving Clariscan.

Driving and using machines

There is no information on the effects of Clariscan on the ability to drive. Take into account any side effects such as dizziness (symptoms of low blood pressure ) and nausea when driving or using machines. If you feel unwell after the examination, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.

Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How Clariscan is given

How to use Clariscan

Clariscan is given to you via intravenous injection.

The procedure is performed in a hospital, clinic, or private practice.

The staff knows what precautions must be taken during the examination.

They also know what possible complications can occur.

During the examination, you will be monitored by a doctor.

  • A needle is left in your vein.
  • In this way, the doctor can inject suitable emergency medicines if needed.

If you get an allergic reaction, the administration of Clariscan is stopped.

How much medicine will you get?

The doctor decides what dose to take and monitors the injection.

Patients with liver or kidney problems

Clariscan is not recommended for use in patients with severe kidney problems and patients who have recently had, or are expected to undergo, a liver transplant.

If your doctor still thinks you should get Clariscan:

  • You should only receive one dose of Clariscan during an MRI scan
  • and you should not receive any more injection in at least 7 days.

Use for newborns, infants, children, and adolescents

Clariscan should only be given to these patients after careful consideration by your doctor.

If your doctor thinks your child should get Clariscan:

• the child should only receive one dose of Clariscan, during an MRI scan

• and the child should not receive another injection for at least 7 days.

Use of full-body MRI is not recommended for children under 6 months.

Use for angiography is not recommended for children under 18 years of age.

Older

It is not necessary to adjust the dose if you are 65 years or older, but you will have to take a blood sample to examine how well your kidneys are working.

If you take more Clariscan than you should

It is very unlikely that you would get an overdose because you are being given Clariscan in a medical setting by a trained person.

If you really get an overdose, Clariscan can be removed from your body by hemodialysis (blood purification).

There is more information on use and handling for healthcare professionals at the end of this leaflet.

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

4. Possible side effects

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

After receiving the medicine, you will be monitored for at least half an hour. Most side effects occur immediately, but sometimes side effects can be delayed. Some effects may occur up to seven days after Clariscan injection.

There is a small risk that you may have an allergic reaction to Clariscan. Such reactions can be severe and in rare cases lead to shock (a very rare type of allergic reaction that can be life-threatening). The following symptoms may be the first signs of shock.

Tell your doctor or healthcare professional immediately if you experience any of the following symptoms – you may need urgent medical attention:

• swelling of the face, mouth, or throat which may make it difficult to swallow or breathe

• swelling of the hands or feet

• low blood pressure (feeling faint)

• breathing difficulties including whistling/wheezing

• cough

• itching

• Runny nose

• sneezing or eye irritation

• red rash, severe itching ( hives )

Other side effects are

Talk to your doctor if you experience any of the following side effects:

Very common (may affect more than 1 user in 10)

  • headache
  • stinging sensation

Common (may affect up to 1 in 10 people)

  • the feeling of heat or cold and/or pain at the injection site
  • nausea, vomiting
  • redness, itching, and rash

Uncommon (may affect up to 1 in 100 people)

  • allergic reactions

Rare (may affect up to 1 in 1,000 people)

  • unusual taste in the mouth
  • hives (red spots on the skin, severe itching )
  • increased sweating

Very rare (may affect up to 1 in 10,000 people)

  • worry or anxiety
  • coma , seizures, syncope (short-term loss of consciousness), weakness (dizziness and feeling that you are fainting), dizziness, odor disturbance (you often feel unpleasant odors), tremors
  • eye inflammation, red eyes, blurred vision, increased tear secretion, swollen eyes
  • cardiac arrest, faster or slower heartbeat, irregular heartbeat, palpitations, low or high blood pressure , dilation or relaxation of blood vessels (vasodilation) which can cause low blood pressure and slower heartbeat, pallor
  • sudden cessation of breathing (respiratory arrest), fluid in the lungs ( pulmonary edema ), difficulty breathing, feeling of tightness in the throat, wheezing, stuffy nose, sneezing, coughing, dryness in the throat
  • diarrhea, abdominal pain, increased salivation
  • eczema, other skin reactions (eg red rash)
  • muscle contractions, muscle weakness, back pain
  • feeling tired (general malaise or fatigue)
  • chest pain or discomfort in the chest
  • fever or chills
  • swelling of the face
  • swelling, reaction or discomfort at the injection site, redness and pain, leakage of the drug outside the blood vessels at the injection site may lead to inflammation tissue death of the skin, inflammation of a vein caused by a blood clot (superficial phlebitis )
  • decreased oxygen content in the blood

Has been reported (occurs in an unknown number of users)

Nitrogen systemic fibrosis

This is a disease that causes the skin to thicken and harden and can also affect soft parts and internal organs. This has most commonly occurred in patients receiving Clariscan with other contrast agents containing gadolinium.

Tell your doctor if you notice any changes in the color or thickness of your skin on any part of your body as this may be a sign of the condition listed above.

The following side effects have occurred with the use of similar contrast agents in MRI:

destruction of your red blood cells ( hemolysis ), confusion, temporary blindness, eye pain, ringing in the ears ( tinnitus ), earache, asthma, dry mouth, bladder-like eczema of the skin, inability to control urine ( incontinence ), kidney damage, acute renal failure, changes in electrocardiography ( ECG ) measurements of your heart, changes in blood tests (increase in iron in the blood, increased bilirubin ), abnormal liver tests.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Clariscan

Keep this medicine out of the sight and reach of children.

Vials (s): No special precautions for storage.

Pre-filled syringes: Do not freeze.

Do not use this medicine after the expiry date which is stated on the vial, vial, or pre-filled syringe and on the carton after “EXP”. The expiration date is the last day of the specified month.

Chemical and physical in-use stability has been demonstrated for 48 hours at room temperature. 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 – 8 ° C, unless handled under controlled and validated aseptic conditions.

6. Contents of the packaging and other information

Content declaration

Content declaration

– The active substance is gadoteric acid. One milliliter of solution for injectioncontains 279.32 mg of gadoteric acid (as meglumine salt), equivalent to 0.5 mmol of gadoteric acid.

– The other ingredients are meglumine, tetraxetane (DOTA) and water for injections. 

What the medicine looks like and the contents of the pack

Clariscan is a clear, colorless to pale yellow solution for intravenous injection.

Clariscan is available in the following pack sizes:

Glass vials (type 1, clear), filled with 5, 10, 15, and 20 ml.

Pre-filled syringes filled with 10, 15, and 20 ml.

Glass bottles (type 1, transparent) and plastic bottles, filled with 50 and 100 ml.

All packaging types are available in one-pack or in 10-pack.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

GE Healthcare AS

Nycoveien 1-2

PO Box 4220 Nydalen

NO-0401 OSLO

Norway

Local representative: 

GE Healthcare AB

Box 90

182 11 Danderyd


Muhammad Nadeem

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