Gadoteric Acid Farmak

Package Leaflet: Information for the User

Gadoteric Acid Farmak, 0.5 mmol/ml

injection solution
Gadoteric acid

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or radiologist.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor, radiologist, or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Gadoteric Acid Farmak and what is it used for

Gadoteric Acid Farmak is a diagnostic agent for use in adults and children. It belongs to the group of contrast agents used in magnetic resonance imaging (MRI).
Gadoteric Acid Farmak 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).

Gadoteric Acid Farmak is intended for diagnostic use only.

2. Important information before using Gadoteric Acid Farmak

When not to use Gadoteric Acid Farmak

• if the patient is allergic to gadoteric acid or any other component of this medicine (listed in section 6).
• if the patient is allergic to gadolinium-containing contrast agents (such as other MRI contrast agents).

Warnings and precautions

The patient should inform their doctor or radiologist if any of the following apply:

• the patient has had a reaction to a contrast agent during an examination;
• the patient has asthma;
• the patient has had an allergic reaction (e.g., allergy to seafood, hives, hay fever);

allergies);

• 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 function 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 to use Gadoteric Acid Farmak in the patient. If the patient receives Gadoteric Acid Farmak, the doctor or radiologist will take necessary precautions and closely monitor the administration of the medicine.
The doctor or radiologist may decide to perform a blood test to check the patient's kidney function before using Gadoteric Acid Farmak, especially in patients over 65 years of age.
Before the examination, all metal objects that the patient may be wearing should be removed. The patient should inform their doctor or radiologist if they have:

• 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 because metal objects can cause serious problems due to the strong magnetic fields used in MRI machines.

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, Gadoteric Acid Farmak will be used in such patients only after careful consideration by the doctor.

Gadoteric Acid Farmak and other medicines

The patient should tell their doctor or radiologist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, they should inform their doctor, radiologist, or pharmacist about taking or recently taking medicines for heart rhythm disorders and high blood pressure, such as beta-adrenergic blockers, vasoactive agents, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin II receptor antagonists.

Gadoteric Acid Farmak with food and drink

No interactions between Gadoteric Acid Farmak and food or drink are known. However, the patient should ask their doctor, radiologist, or pharmacist if they can eat or drink before the examination.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or radiologist before using this medicine.
Pregnancy
Gadoteric acid may pass through the placenta. It is not known whether this affects the fetus. Gadoteric Acid Farmak should only be used during pregnancy if it is absolutely necessary.
Breastfeeding
The doctor or radiologist will discuss with the patient whether to continue breastfeeding or stop for 24 hours after receiving Gadoteric Acid Farmak.

Driving and using machines

There is no available data on the effect of Gadoteric Acid Farmak on the ability to drive and use machines. If the patient feels unwell after the examination, they should not drive or operate machinery.

3. How to use Gadoteric Acid Farmak

Gadoteric Acid Farmak will be administered by intravenous injection.
During the examination, the patient will be closely monitored by the doctor or radiologist. A needle will be left in the patient's vein, allowing the doctor or radiologist to quickly administer any necessary emergency medication if needed. If the patient has an allergic reaction, the administration of Gadoteric Acid Farmak will be stopped.
Gadoteric Acid Farmak 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 personnel are aware of the necessary precautions to take during the examination and are 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 patients with kidney function disorders and after liver transplantation

Gadoteric Acid Farmak is not recommended for use in patients with severe kidney function disorders or those who have recently undergone or are awaiting liver transplantation. However, if the use of Gadoteric Acid Farmak is necessary, 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 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, Gadoteric Acid Farmak 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.
Gadoteric Acid Farmak is not recommended for use in 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 Gadoteric Acid Farmak

It is very unlikely that the patient will receive too much of the medicine. Gadoteric Acid Farmak will be administered in a medical facility by properly trained personnel. In case of actual overdose, Gadoteric Acid Farmak can be removed from the body by hemodialysis (blood purification).
In case of any further doubts about the use of this medicine, the patient should consult their doctor or radiologist.

4. Possible side effects

Like all medicines, Gadoteric Acid Farmak can cause side effects, although not everybody gets them.
After administration, the patient will be monitored for at least half an hour. Most side effects occur immediately or with some delay. Some side effects may occur within 7 days of using Gadoteric Acid Farmak.
The risk of allergic reactions to Gadoteric Acid Farmak is low.Such reactions can be severe and cause anaphylactic shock (a life-threatening allergic reaction). The following symptoms may be the first signs of anaphylactic shock. If the patient notices any of these 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,
• drowsiness (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 (vomiting),
• abdominal pain,
• rash,
• feeling of heat, feeling of cold,
• general 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 inflammation (redness and local pain).

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

• anxiety, fainting (dizziness and risk of loss of consciousness),
• swelling of the eyelids,
• palpitations,
• coughing,
• 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), olfactory disorders (perception of often unpleasant odors), convulsions,
• conjunctivitis, blurred vision, increased tearing,
• sudden cardiac arrest, rapid or slow heart rate, arrhythmia, vasodilation, pallor,
• respiratory arrest, pulmonary edema, difficulty breathing, wheezing, stuffy nose, cough, dry throat, laryngospasm with a feeling of suffocation, bronchospasm, throat swelling,
• erythema, skin redness, 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), which causes skin hardening and may also affect soft tissues and internal organs, predominantly in patients who received Gadoteric Acid Farmak along with other gadolinium-containing contrast agents. If the patient notices changes in skin color and/or thickness at any site on the body within weeks after the MRI examination, they should inform their radiologist.

Reporting side effects

If side effects occur, including any not listed in this package leaflet, the patient should inform their doctor or radiologist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides – Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Gadoteric Acid Farmak

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for the medicine.
The medicine should not be used after the expiration date stated on the vial and carton after "EXP". The expiration date refers to the last day of the month.
The medicine should not be used if visible signs of damage are observed (such as particles in the solution due to glass reflection from the vial).
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Gadoteric Acid Farmak contains

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

What Gadoteric Acid Farmak looks like and contents of the package

Gadoteric Acid Farmak is a clear, colorless to light yellow solution for intravenous injection.
It is available in glass vials with a fill volume of 5, 10, 15, 20, 60, 100 ml, closed with a bromobutyl rubber stopper. 1 vial or 10 vials in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Importer

Symphar Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

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

Estonia: Dotascan
Poland: Gadoteric Acid Farmak
Czech Republic: Gadoteric acid FMK
Spain: Gadoteric Acid Farmak 0.5 mmol/ml solution for injection in vial

Date of last revision of the package leaflet:

Information intended for healthcare professionals only:

Dosage

Adults:

• MRI of the brain and spinal cord: The dose is 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, an additional dose of 0.2 mmol/kg body weight may improve tumor visibility and facilitate treatment decisions in patients with brain tumors.
• 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 are not obtained), a second 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 Gadoteric Acid Farmak are planned before 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 Gadoteric Acid Farmak 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, Gadoteric Acid Farmak 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 imaging examination. Due to the lack of information on repeated administration, Gadoteric Acid Farmak injections should not be repeated unless the interval between consecutive injections is at least 7 days.
• Angiography: The use of Gadoteric Acid Farmak is not recommended in children under 18 years of age due to insufficient data on its efficacy and safety in this indication.

Special patient groups:

• Patients 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.< li>
• Patients with liver function disorders: In these patients, the doses recommended for adults should be used. Caution is advised, especially in the perioperative period related to liver transplantation.

Method of administration

Gadoteric Acid Farmak is indicated for intravenous use only. Gadoteric Acid Farmak should not be administered via 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.
Prepare a syringe with a needle. Remove the plastic disc. After cleaning the stopper with an alcohol swab, puncture the stopper with the needle. Draw up the required amount of Gadoteric Acid Farmak and administer it intravenously.
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 is suitable for use.
Children and adolescents (0-18 years)
Depending on the amount of Gadoteric Acid Farmak to be administered to the child, it is recommended to use vials of Gadoteric Acid Farmak in combination with a single-use syringe with a capacity adapted to the 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 administration of Gadoteric Acid Farmak.

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 after liver transplantation are particularly at risk due to the high frequency of acute kidney injury in this group. nsf associated with gadoteric acid farmak, product should be used severe function disorders and perioperative period only careful benefit-risk assessment when diagnostic information is essential cannot obtained using mri without contrast enhancement. if use farmak necessary, dose not exceed 0.1 mmol kg body weight. no more than one administered during imaging examination. lack on repeated administration, injections unless interval between consecutive least 7 days.
Hemodialysis performed shortly after administration of Gadoteric Acid Farmak may facilitate the elimination of Gadoteric Acid Farmak from the body. There is no evidence to support the initiation of hemodialysis as a prophylactic or therapeutic measure for NSF in patients who are not currently undergoing hemodialysis.

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.

Newborns and infants

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

Pregnancy and breastfeeding

Gadoteric Acid Farmak should not be used during pregnancy unless the clinical condition of the woman requires the use of gadoteric acid.
The decision to continue or stop breastfeeding for 24 hours after administration of Gadoteric Acid Farmak should be left to the doctor and the breastfeeding mother.

Instructions for use of the product

The detachable labels from the vial should be attached to the patient's documentation to allow for accurate identification of the contrast agent used. The administered dose should also be recorded.
9