279.3 mg/ml Solution for injection

1. What Dotarem is and what it is used for

Pharmaceutical group

Dotarem is a medicine for adults and children that is used in X-ray examinations. It belongs to a group of contrast agents for magnetic resonance imaging (MRI) (layer X-ray) and magnetic resonance angiography (MRA) (method for blood vessel imaging).

What is Dotarem used for?

The dot strap is used to increase the contrast of the images obtained during MRI and MRA examinations. This increase, in contrast, improves the visibility and demarcation of certain areas in the body.

This medicine is used only to make a diagnosis.

2. What you need to know before you get Dotarem

You should NOT receive Dotarem

  • 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 gadolinium-containing medicines (like other contrast products used for MRI).

Warnings and cautions

Talk to your doctor before receiving Dotarem if:

  • you have previously had a hypersensitivity reaction to a contrast agent during an examination
  • you have asthma
  • you have allergies (eg shellfish allergy, hives, pollen allergy )
  • 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 any disease that affects the heart or blood vessels
  • you have had seizures or you are being treated for epilepsy

In all these cases, your doctor will decide if you should receive Dotarem. If you receive Dotarem, your doctor will take the necessary safety precautions and the administration of Dotarem will be closely monitored.

Your doctor may decide to take a blood test to check how well your kidneys are working before deciding to use Dotarem, especially if you are 65 years of age or older.

Newborns and infants

As the renal function is immature in children up to 4 weeks of age and infants up to 1 year of age, Dotarem will only be used in these patients after careful consideration by the physician.

Remove any metal objects you are wearing before the examination. Tell your doctor if you have:

  • a pacemaker
  • a vascular clamp
  • an infusion pump
  • a nerve stimulator
  • a cochlear implant ( implant in the inner ear)
  • any suspicious foreign particles of metal in the body, especially in the eye.

This is important as these can lead to serious problems, as magnetic resonance imaging devices use very strong magnetic fields.

Other medicines and Dotarem

Tell your doctor if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor or pharmacist if you are taking or have recently taken medicines for heart and blood pressure diseases such as beta-blockers, substances that affect the vascular one, ACE inhibitors (inhibiting angiotensin-converting enzyme ), angiotensin II receptor antagonists.

Dotarem with food and drink

There are no known links between Dotarem and food and drink. However, you should ask your doctor or pharmacist if you must refrain from eating or drinking before the examination.

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Dotarem should not be used during pregnancy unless clearly necessary.

Breast-feeding

Discuss with your doctor if you should continue breast-feeding or if you should stop breastfeeding for a period of 24 hours after receiving Dotarem.

Driving and using machines:

There is no information on the effects of Dotarem on the ability to drive. If you feel unwell after the examination, such as nausea, 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 sharpened 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 you will get Dotarem

Dosage instructions

Dotarem is given to you via intravenous injection.

During the examination, you will be monitored by a doctor. A needle is left in your vein; in this way, the doctor can inject appropriate emergency medicines if needed. If you get an allergic reaction, the administration of one of Dotarem will be stopped.

Dotarem can be administered by hand or with an automatic syringe pump. For newborns and infants, the product is given only by hand.

The procedure is performed in a hospital, clinic, or private practice. The staff present knows what precautions must be taken during the examination. They also know what possible complications can occur.

Dosage

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

Dosage in special patient groups

The use of Dotarem is not recommended for patients with severe kidney problems and patients who have recently undergone, or are expected to undergo, a liver transplant. However, if use is necessary, you should only receive one dose ofDotarem during an examination and you should not receive another injection for at least 7 days.

Newborns, infants, children, and adolescents

Because babies up to 4 weeks of age and infants up to 1 year of age have an immature renal function, Dotarem will only be used in these patients after careful consideration by their doctor. Children should only receive one dose of Dotarem during an examination and should not receive a second injection before at least 7 days have passed.

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 may have a blood test to check how well your kidneys are working.

If you take more Dotarem then you should

It is very unlikely that you would get an overdose. You are given Dotarem in a medical setting by a trained person. If you really get an overdose, Dotarem 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 Dotarem, 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 Dotarem injection.

There is a small risk that you may get an allergic reaction to Dotarem. Such reactions can be severe and lead to shock (a type of allergic reaction that can be life-threatening). The following symptoms may be the first signs of shock. Tell a doctor or healthcare professional immediately if you notice any of them:

  • swelling of the face, mouth, or throat that may make it difficult to swallow or breathe
  • swelling in hands or feet
  • fainting ( hypotension )
  • breathing difficulties
  • wheezing
  • cough
  • itching
  • Runny nose
  • sneezing
  • eye irritation
  • hives
  • rash

Uncommon side effects (may affect up to 1 in 100 people)

  • hypersensitivity
  • headache
  • unusual taste in the mouth
  • dizziness
  • drowsiness
  • stinging sensation, the feeling of heat, cold, and/or pain
  • low or high blood pressure
  • nausea
  • abdominal pain
  • rash
  • feel hot or cold
  • powerlessness
  • injection site discomfort, injection site reaction, injection site cold sensation, injection site swelling, the spread of the product outside blood vessels that may lead to inflammation ( redness and local pain)

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

  • anxiety, weakness (dizziness and feeling faint)
  • swollen eyelids
  • palpitation
  • sneezing
  • vomiting
  • diarrhea
  • increased salivation
  • hives, itching, sweating
  • chest pain, chills

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

  • allergic shock or allergy-like reactions
  • concern
  • coma, seizures, syncope (short-term loss of consciousness), olfactory disturbance (you often feel unpleasant odors), tremors
  • conjunctivitis, red eyes, blurred vision, increased tear secretion
  • cardiac arrest, faster or slower heartbeat, irregular heartbeat, vasodilation, pallor
  • respiratory arrest, pulmonary edema, shortness of breath, wheezing, stuffy nose, cough, dryness in the throat, constriction of the throat with a feeling of suffocation, cramps in the trachea, swelling in the throat,
  • eczema, redness of the skin, swelling of the lips and mouth,
  • muscle cramps, muscle weakness, back pain
  • feeling sick, chest discomfort, fever, swelling of the face, spreading of the product outside the blood vessels which can lead to tissue death at the injection site, inflammation of a vein
  • decreased oxygen content in the blood

There have been reports of nephrogenic systemic fibrosis (which causes the skin to thicken and harden and can also affect the soft tissues and internal organs), which most often occurred in patients receiving Dotarem with other contrast agents containing gadolinium. If you notice any changes in the color and/or thickness of your skin on any part of your body during the weeks after the MRI scan, you should inform the doctor who performed the scan.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly to:

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

By reporting side effects, you can help increase drug safety information.

5. How to store the Dotarem

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

Vials: 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 and carton after “EXP”. The expiration date is the last day of the specified month.

6. Contents of the packaging and other information

Content declaration

  • The active substance is gadoteric acid. One milliliter solution for injection contains 279.32 mg gadoteric acid (as meglumine salt), equivalent to 0.5 mmol gadoteric acid (as meglumine salt).
  • The other ingredients are meglumine and water for injections. 

What Dotarem looks like and the contents of the pack

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

The Dotarem package contains:

  • Glass vials, closed with 1×5 ml rubber stopper, 1×10 ml, 25×10 ml, 1×15 ml, 25×15 ml, 1×20 ml, 25×20 ml, 1×60 ml, and 1×100 ml respectively
  • a pre-filled syringe (in glass or plastic) with 10, 15, or 20 ml solution for injection, graduated per ml, without a needle.
  • or ten plastic pre-filled syringes with 10, 15, or 20 ml solution for injection, graduated per ml, without a needle.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Guerbet

PO Box 57400

95943 Roissy Charles de Gaulle Cedex

FRANCE

Tel: +33 1 45 91 50 00

This medicine is authorized in the European Economic Area under the name: Dotarem

This leaflet was last approved in :

2020-01-10

The following information is for physicians and healthcare professionals only:

The following information is intended for healthcare professionals only:

Dotarem is only suitable for intravenous use.

Before administration of Dotarem, it is recommended that all patients be examined for renal impairment using laboratory tests 

There have been reports of nephrogenic systemic fibrosis (NSF) associated with the use of certain contrast agents containing gadolinium in patients with acute or chronic severe renal impairment ( GFR <30 ml/min / 1.73 m²). Patients undergoing liver transplantation are particularly at risk because the incidence is one of acute renal failure is high in this group. Therefore, as there is a risk that NSF may occur in connection with the use of Dotarem, the product should not be used in patients with severe renal impairment and patients during the perioperative liver transplantation period until a careful benefit assessment has been performed and the diagnostic information is necessary. and cannot be obtained with MRI without contrast enhancement. If it is necessary to use Dotarem, the dose should not exceed 0.1 mmol/kg body weight. No more than one dose should be used during a study. Due to the lack of information on repeated administrations, Dotareminjection should not be repeated unless the interval between injections at least 7 days.

Depending on the amount of Dotarem to be given to a child, it is better to use Dotarem vials with a disposable syringe. The choice of the disposable syringe should be adjusted to the volume to be given for better accuracy in the injected volume.

For newborns and infants, the required dose should only be administered by hand. An automatic syringe pump must not be used.

Due to immature renal function in newborns up to 4 weeks of age and in infants up to 1 year of age, Dotarem should be administered to this group only after careful consideration at a dose not exceeding 0.1 mmol/kg body weight. No more than one dose should be used during a study. Due to the lack of information on repeated administrations, Dotarem injections should not be repeated unless the interval between injections is at least 7 days.

As renal clearance of Dotarem may be impaired in the elderly, it is particularly important to investigate patients aged 65 years and older with renal impairment.

Hemodialysis shortly after Dotarem administration may help remove Dotarem from the body. There is no evidence to support the introduction of hemodialysis for the prevention or treatment of NSF in patients not already undergoing hemodialysis.

Use of bottles and pre-filled syringes:

Vials: Prepare a syringe with a needle. Remove the plastic disc. Clean the stopper with a wipe dampened with alcohol and then puncture the stopper with the injection needle. Withdraw the amount needed for the examination and inject it intravenously.

Pre-filled syringes: Screw the plunger onto the syringe and inject intravenously the amount needed for the test.

Residual contrast medium in the vial, connecting hose, or another disposable component to the injection system must be discarded after completion of the examination.

The removable trace label on the vials/syringes should be affixed to the patient record to allow accurate documentation of the gadolinium-containing contrast agent used. The dose used must also be documented. If electronic patient records are used, the product name, batch number, and dose must be registered in the patient record.

Use of 60 ml and 100 ml bottles:

The contrast agent should be administered with an automatic injector, which is prohibited for infants.

The tube between the injector and the patient (patient tube) must be replaced after each examination.

All contrast medium solutions remaining in the bottle, the connecting hoses, and all disposable parts must be discarded after the examination has been completed.

Muhammad Nadeem

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