Dotarem

Leaflet attached to the packaging: information for the user

DOTAREM, 0.5 mmol/ml

injection solution in a pre-filled syringe
Gadoteric acid

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or a radiologist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, radiologist, or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is DOTAREM and what is it used for
• 2. Important information before using DOTAREM
• 3. How to use DOTAREM
• 4. Possible side effects
• 5. How to store DOTAREM
• 6. Contents of the packaging and other information

1. What is DOTAREM and what is it used for

DOTAREM is a diagnostic agent used in adults and children. It belongs to a group of contrast agents used in magnetic resonance imaging (MRI). DOTAREM is used to increase the contrast of images obtained during MRI examinations. Such contrast enhancement improves the visibility and definition of:

• pathological changes in the brain, spinal cord, and surrounding tissues;
• pathological changes in the liver, kidneys, pancreas, pelvis, lungs, heart, breast, and musculoskeletal system;
• pathological changes and stenosis in arteries, especially coronary arteries (only in adults).

This medicine is intended for diagnostic use only.

2. Important information before using DOTAREM

When not to use DOTAREM

Warnings and precautions

The doctor or radiologist should be informed if any of the following apply to the patient:

• the patient has had a reaction to a contrast agent during an examination;
• the patient has asthma;
• the patient has had an allergic reaction in the past (e.g., allergy to shellfish, hives, hay fever);
• the patient is being treated with a beta-adrenergic blocker (a medicine used to treat heart rhythm disorders and high blood pressure, such as metoprolol);
• the patient's kidneys do not work properly;
• the patient has recently undergone or is awaiting a liver transplant;
• the patient has a heart or blood vessel disease;
• the patient has had seizures or is being treated for epilepsy.

In all such cases, the doctor or radiologist will assess the benefit-risk ratio and decide whether DOTAREM can be used in the patient. If DOTAREM is used in the patient, the doctor or radiologist will take necessary precautions, and the administration of DOTAREM will be closely monitored. The doctor or radiologist may decide to perform a blood test to check the patient's kidney function before using DOTAREM, especially in patients over 65 years of age. Newborns and infants Due to the immaturity of kidney function in newborns up to 4 weeks of age and infants up to 1 year of age, DOTAREM will be used in such patients only after careful consideration by the doctor. Before the examination, all metal objects that the patient may be wearing should be removed. The doctor or radiologist should be informed if the patient has:

• a pacemaker,
• a vascular clip,
• an infusion pump,
• a nerve stimulator,
• a cochlear implant (an implant in the inner ear),
• any suspected metal foreign body, especially in the eye. This is very important, as MRI equipment uses very strong magnetic fields.

DOTAREM and other medicines

The doctor or radiologist should be informed about all medicines that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take. In particular, the doctor, radiologist, or pharmacist should be informed about the use of or recent use of medicines for heart rhythm disorders and high blood pressure, such as beta-adrenergic blockers, vasoactive agents, angiotensin-converting enzyme inhibitors, or angiotensin II receptor antagonists.

DOTAREM with food and drink

No interactions between DOTAREM and food or drink are known. However, the doctor, radiologist, or pharmacist should be asked whether it is necessary to avoid eating or drinking before the examination.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or radiologist before using this medicine. PregnancyGadoteric acid may pass through the placenta. It is not known whether this affects the fetus. DOTAREM should not be used during pregnancy unless it is absolutely necessary. BreastfeedingThe doctor or radiologist will discuss with the patient whether she can continue breastfeeding or should stop for 24 hours after DOTAREM administration.

Driving and using machines

There is no available data on the effect of DOTAREM on the ability to drive or use machines. If the patient feels unwell after the examination, e.g., nausea (feeling sick), they should not drive or operate machinery.

3. How to use DOTAREM

DOTAREM will be administered by intravenous injection. During the examinationthe patient will be closely monitored by the doctor or radiologist. A needle will be left in the patient's vein, so that the doctor or radiologist can quickly inject emergency medicines if needed. If the patient has an allergic reaction, the administration of DOTAREM will be stopped immediately. DOTAREM can be injected manually or using an automatic injector. In newborns and infants, the medicine will be injected manually only. The procedure can be performed in a hospital, clinic, or private office. Medical staff knows what precautions to take during the examination and is also aware of potential complications that may occur. Dosage The doctor or radiologist will determine the dose suitable for the patient and will supervise the administration of the medicine.

Dosage in special patient groups

DOTAREM is not recommended for patients with severe kidney function disorders or those who have recently undergone or are awaiting a liver transplant. However, if DOTAREM needs to be used, the patient should receive only one dose of the medicine during the examination and should not receive another dose for at least 7 days.

Use in newborns, infants, children, and adolescents

Due to the immaturity of kidney function in newborns up to 4 weeks of age and infants up to 1 year of age, DOTAREM will be used in such patients only after careful consideration by the doctor. Children should receive only one dose of the medicine during the examination and should not receive another dose for at least 7 days. DOTAREM is not recommended for angiography in children under 18 years of age.

Elderly patients

There is no need to adjust the dose in patients over 65 years of age; however, it may be necessary to perform a blood test to check kidney function.

Overdose of DOTAREM

It is very unlikely that the patient will receive too much of the medicine. DOTAREM will be administered in a medical facility by properly trained personnel. In case of actual overdose, DOTAREM can be removed from the body by hemodialysis (blood purification). Additional information on the use and handling of this medicine by medical personnel is provided at the end of this leaflet. If you have any further doubts about the use of this medicine, you should consult your doctor or radiologist.

4. Possible side effects

Like all medicines, DOTAREM can cause side effects, although not everybody gets them. After administrationthe patient will be monitored for at least half an hour. Most side effects occur immediately or with some delay. Some side effects may occur even up to seven days after the injection of DOTAREM.

There is a small risk of an allergic reaction to DOTAREM. Such reactions can

be severe and cause shock(a life-threatening allergic reaction). The following symptoms may be the first signs of shock. If the patient notices any of the following symptoms, they should immediately inform their doctor, radiologist, or other medical staff:

• swelling of the face, lips, and/or throat, which may cause difficulty swallowing or breathing,
• swelling of the hands or feet,
• feeling of dizziness (low blood pressure),
• difficulty breathing,
• wheezing,
• coughing,
• itching of the skin,
• 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
• feeling of tingling, heat, or cold and/or pain
• increased or decreased blood pressure
• nausea (feeling sick)
• abdominal pain
• rash
• feeling of heat, feeling of cold
• weakness
• discomfort at the injection site, reaction at the injection site, feeling of cold at the injection site, swelling at the injection site, extravasation of the product, which may lead to tissue necrosis (redness and local pain)

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

• anxiety, fainting (dizziness and loss of consciousness)
• swelling of the eyelids
• palpitations
• sneezing
• vomiting
• diarrhea
• increased salivation
• hives, itching, sweating
• chest pain, chills

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

• anaphylactic or anaphylactoid reactions
• agitation
• coma, seizures, fainting (short-term loss of consciousness), disturbances of smell (perception of often unpleasant odors), convulsions
• conjunctivitis, blurred vision, increased tearing
• sudden cardiac arrest, accelerated or slowed heart rate, arrhythmia, vasodilation, pallor
• respiratory arrest, pulmonary edema, difficulty breathing, wheezing, stuffy nose, coughing, dry throat, throat constriction with a feeling of suffocation, bronchospasm, swelling of the throat
• flushing, redness of the skin, swelling of the lips and local swelling in the mouth
• muscle spasms, muscle weakness, back pain
• weakness, discomfort in the chest, fever, swelling of the face, extravasation of the product, which may lead to tissue necrosis at the injection site, phlebitis
• decreased oxygen content in the blood.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with the use of gadolinium-containing contrast agents in patients with acute or chronic kidney function disorders (GFR <30 ml min 1.73 m). patients who have undergone liver transplantation are particularly at risk due to the high frequency of acute kidney injury in this group. nsf associated with dotarem, medicine should be used severe function disorders and during perioperative period only after careful benefit-risk assessment when diagnostic information is essential cannot obtained using mri without contrast enhancement. if dotarem needs used, dose not exceed 0.1 mmol kg body weight. no more than one administered examination. lack on repeated administration, injections unless interval between least 7 days. hemodialysis performed shortly administration may facilitate elimination from body. there evidence suggest that started as a preventive measure or treatment for currently receiving hemodialysis.< p>

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or radiologist should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products – Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected] Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store DOTAREM

The medicine should be stored out of sight and reach of children. Do not freeze. Do not use this medicine after the expiry date stated on the pre-filled syringe and carton after "EXP". The expiry date refers to the last day of the month. It is very unlikely that the patient will be asked to dispose of any leftover DOTAREM.

6. Contents of the packaging and other information

What DOTAREM contains

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

What DOTAREM looks like and contents of the pack

DOTAREM is a clear, colorless or yellow solution for intravenous injection. The packaging of DOTAREM contains:

• one plastic pre-filled syringe filled with 10, 15, or 20 ml of the injection solution, graduated in 1 ml increments, without a needle;
• or 10 plastic pre-filled syringes filled with 10, 15, or 20 ml of the injection solution, graduated in 1 ml increments, without needles.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

GUERBET BP 57400 95943 Roissy CdG cedex France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

DOTAREM

Date of last revision of the leaflet: 08.05.2024

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Information intended for healthcare professionals only:

Dosage

Adults:

• MRI of the brain and spinal cord: In studies of the nervous system, doses range from 0.1 to 0.3 mmol/kg body weight, which corresponds to 0.2 to 0.6 ml/kg body weight. After administration of 0.1 mmol/kg body weight to patients with brain tumors, an additional dose of 0.2 mmol/kg body weight may improve tumor visibility and facilitate treatment decisions.
• MRI of the whole body and angiography: The recommended dose for intravenous injection, providing contrast suitable for diagnosis, is 0.1 mmol/kg body weight (i.e., 0.2 ml/kg body weight).
• Angiography: In exceptional circumstances (e.g., when images of satisfactory quality covering an extensive vascular area cannot be obtained), a second consecutive dose of 0.1 mmol/kg body weight (corresponding to 0.2 ml/kg body weight) may be justified. However, if two consecutive doses of DOTAREM are planned before the start of angiography, it may be beneficial to administer 0.05 mmol/kg body weight (i.e., 0.1 ml/kg body weight) in each dose, depending on the available imaging equipment.

Children and adolescents (0-18 years):

• MRI of the brain and spinal cord / whole-body MRI: The recommended dose of DOTAREM is 0.1 mmol/kg body weight. No more than one dose should be administered during scanning. Due to the immaturity of kidney function in newborns up to 4 weeks of age and infants up to 1 year of age, DOTAREM should be used in such patients only after careful consideration by the doctor. The dose should not exceed 0.1 mmol/kg body weight. No more than one dose should be administered during the examination. Due to the lack of information on repeated administration, DOTAREM injections should not be repeated unless the interval between injections is at least 7 days.
• Angiography: DOTAREM is not recommended for angiography in children under 18 years of age due to insufficient data on its efficacy and safety in this indication.

Special patient groups:

• Patient with kidney function disorders: In patients with mild to moderate kidney function disorders (GFR ≥30 ml/min/1.73 m), the doses recommended for adults should be used. See "Kidney function disorders" below.
• Patient with liver function disorders: In such patients, the doses recommended for adults should be used. Caution is advised, especially in the perioperative period of liver transplantation.

Method of administration

DOTAREM is intended for intravenous use only. DOTAREM should not be administered by subarachnoid or intrathecal injection. Infusion rate: 3-5 ml/min (at angiographic examinations, a higher infusion rate of up to 120 ml/min, i.e., 2 ml/sec, can be used). Optimal imaging: within 45 minutes of injection Optimal imaging sequence: T1-weighted images Whenever possible, the contrast agent should be administered intravenously to the patient in a supine position. After administration, the patient should be monitored for at least half an hour, as experience shows that most side effects occur during this period. Turn the plunger rod and inject the required volume of DOTAREM into the vein. For single use only; any unused solution should be discarded. The injection solution should be visually inspected before use. Only a clear solution without visible particles should be used. Children and adolescents (0-18 years) Depending on the amount of DOTAREM to be administered to the child, it is recommended to use vials of DOTAREM in combination with a single-use syringe with a capacity adapted to that amount, in order to maintain higher precision of the injected dose. In newborns and infants, the required dose should be administered manually.

Kidney function disorders

It is recommended that all patients undergo laboratory tests to check kidney function before DOTAREM administration.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with the use of gadolinium-containing contrast agents in patients with acute or chronic kidney function disorders (GFR <30 ml min 1.73 m). patients who have undergone liver transplantation are particularly at risk due to the high frequency of acute kidney injury in this group. nsf associated with dotarem, medicine should be used severe function disorders and during perioperative period only after careful benefit-risk assessment when diagnostic information is essential cannot obtained using mri without contrast enhancement. if dotarem needs used, dose not exceed 0.1 mmol kg body weight. no more than one administered examination. lack on repeated administration, injections unless interval between least 7 days. hemodialysis performed shortly administration may facilitate elimination from body. there evidence suggest that started as a preventive measure or treatment for currently receiving hemodialysis.< p>

Elderly patients

As kidney clearance of gadoteric acid may be decreased in elderly patients, it is particularly important to check kidney function in patients over 65 years of age before DOTAREM administration.

Newborns and infants

See "Dosage and method of administration, use in children" above.

Pregnancy and breastfeeding

DOTAREM should not be used during pregnancy unless the clinical condition of the woman requires the use of gadoteric acid. The continuation or discontinuation of breastfeeding for 24 hours after DOTAREM administration should be left to the discretion of the doctor and the breastfeeding mother.

Instructions for use

Removable identification labels from the pre-filled syringes should be attached to the patient's documentation to allow for accurate identification of the contrast agent used. The dose administered should also be recorded. If an electronic patient card is used, the product name, batch number, and dose administered should be entered.