Gadoteric acid farmak

Package leaflet: Information for the user

Gadoteric Acid Farmak, 0.5 mmol/mL
solution for injection
Acidum gadotericum
Please read carefully the entire leaflet before the medicine is administered, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor or radiologist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or radiologist immediately. See section 4.

Table of contents

1. What Gadoteric Acid Farmak is and what it is used for
2. What you need to know before being given Gadoteric Acid Farmak
3. How Gadoteric Acid Farmak will be administered
4. Possible side effects
5. How to store Gadoteric Acid Farmak
6. Contents of the pack and other information

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

Gadoteric Acid Farmak is a diagnostic agent intended for use in adults and children. It belongs to
a group of contrast agents used in magnetic resonance imaging (MRI).
Gadoteric Acid Farmak is used to enhance the contrast of images obtained during
MRI scans. This contrast enhancement improves the visibility and delineation of:

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

Gadoteric Acid Farmak is intended for diagnostic use only.

2. Information before the patient is given Gadoteric Acid Farmak

The patient will NOT be given Gadoteric Acid Farmak

• if the patient is allergic to gadoteric acid or any of the other ingredients of this medicine (listed in section 6.);
• if the patient is allergic to medicines containing gadolinium (such as other contrast agents used in magnetic resonance imaging).

Warnings and precautions
Please inform the doctor or radiologist if:

• the patient has previously experienced a reaction to a contrast agent during an examination;
• the patient suffers from asthma;
• the patient has a history of allergies (e.g. to seafood, hives, hay fever);
• the patient is being treated with beta-blockers (medicines used to treat heart conditions and high blood pressure, such as metoprolol);
• the patient's kidneys are not functioning properly;
• the patient has recently undergone or is scheduled to undergo a liver transplant in the near future;
• the patient has a disease affecting the heart or blood vessels;
• 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 determine whether Gadoteric Acid Farmak can be administered to the patient. If the patient receives Gadoteric Acid Farmak, the doctor or radiologist will take necessary precautions and closely monitor the administration of this medicine.
The doctor or radiologist may decide to perform a blood test to check the patient's kidney function before administering Gadoteric Acid Farmak, especially in patients aged 65 years and older.

Newborns and infants
Due to immature kidney function in newborns up to 4 weeks of age and infants up to 1 year of age, Gadoteric Acid Farmak will be administered to such patients only after careful consideration by the doctor.

Before the examination, all metal objects the patient may be wearing should be removed. Please inform the doctor or radiologist if the patient has any of the following implanted:

• a cardiac pacemaker,
• a vascular clip,
• an infusion pump,
• a nerve stimulator,
• a cochlear implant (an implant in the inner ear),
• any suspected metallic foreign body, especially in the eye.
  This is very important because metallic objects may cause serious problems, as magnetic resonance imaging equipment uses very strong magnetic fields.

Gadoteric Acid Farmak and other medicines
Please inform the doctor or radiologist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, inform the treating physician, radiologist, or pharmacist if the patient is taking or has recently taken medicines for heart conditions and high blood pressure, such as beta-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, please consult the doctor, radiologist, or pharmacist whether fasting (not eating or drinking) is required before the examination.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or radiologist before receiving this medicine.

Pregnancy
Gadoteric acid may cross the placenta. It is not known whether this affects the unborn child. Gadoteric Acid Farmak should be used during pregnancy only if clearly necessary.

Breastfeeding
The doctor or radiologist will discuss with the patient and advise whether she can continue breastfeeding or should interrupt it for 24 hours after administration of Gadoteric Acid Farmak.

Driving and operating machinery
There are no available data on the effects of Gadoteric Acid Farmak on the ability to drive or operate machinery. If the patient experiences discomfort after the examination, such as nausea (feeling sick), the patient should not drive or operate machinery.

3. How the patient will be given Gadoteric Acid Farmak

Gadoteric Acid Farmak will be administered as an intravenous injection.
During the examination, the patient will be closely monitored by a physician or radiologist. An intravenous cannula will remain in place so that, if necessary, the physician or radiologist can quickly administer life-saving medications. If the patient experiences an allergic reaction, administration of Gadoteric Acid Farmak will be stopped immediately.
Gadoteric Acid Farmak may be injected manually or using an automated injector. In neonates and infants, this medicine will be administered only manually.
The procedure may be performed in a hospital or outpatient clinic. The medical staff are aware of the precautions to be taken during the examination and are familiar with potential complications that may occur.

Dosage
The physician or radiologist will determine the appropriate dose for the patient and will supervise the injection of the medicine.

Dosage in special patient groups
Gadoteric Acid Farmak is not recommended for patients with severe renal function impairment or for patients who have recently undergone or are scheduled to undergo liver transplantation. However, if administration of Gadoteric Acid Farmak is necessary, the patient should receive only a single dose during the examination and should not receive another dose within at least 7 days.

Use in neonates, infants, children, and adolescents
Due to immature kidney function in neonates 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 physician. Children should receive only a single dose during the examination and should not receive another injection within 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 aged 65 years and older; however, blood tests to assess kidney function may be necessary.

Administration of a higher than recommended dose of Gadoteric Acid Farmak
It is highly unlikely that the patient would receive too high a dose of the medicine. Gadoteric Acid Farmak will be administered in a medical facility by appropriately trained personnel. In the event of actual overdose, Gadoteric Acid Farmak can be removed from the body by hemodialysis.

Additional information on the use and handling of this medicine by medical personnel is provided at the end of this leaflet.
If there are any further questions regarding the use of this medicine, please consult your physician or radiologist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
After administration, the patient will be monitored for at least half an hour. Most adverse
reactions occur immediately or with some delay. Some adverse reactions may occur within 7 days
after injection of Gadoteric Acid Farmak.

The risk of allergic reactions to Gadoteric Acid Farmak is low. Such reactions may be severe and
may cause shock (a case of an allergic reaction which may be life-threatening). The following
symptoms may be early signs of shock. If the patient notices any of the symptoms listed below,
they should immediately inform the doctor, radiologist, or another healthcare professional:

• swelling of the face, lips and (or) throat, which may cause difficulty in swallowing or breathing,
• swelling of the hands or feet,
• dizziness (low blood pressure),
• difficulty breathing,
• wheezing,
• cough,
• skin itching,
• watery nasal discharge,
• sneezing,
• eye irritation,
• urticaria,
• skin rash.

Uncommon adverse reactions (may occur in up to 1 in 100 people)

• hypersensitivity,
• headache,
• unusual taste in the mouth,
• dizziness,
• drowsiness,
• sensation of tingling, warmth or cold and (or) pain,
• increased or decreased blood pressure,
• nausea,
• abdominal pain,
• rash,
• feeling of warmth, feeling of cold,
• asthenia (loss of energy, weakness),
• discomfort at injection site, reaction at injection site, feeling of cold at injection site, swelling at injection site, extravasation of the product outside blood vessels, which may lead to inflammation (redness and local pain).

Rare adverse reactions (may occur in up to 1 in 1,000 people)

• anxiety, syncope (dizziness and feeling of impending fainting),
• eyelid swelling,
• palpitations,
• sneezing,
• vomiting,
• diarrhoea,
• increased salivation,
• urticaria, itching, sweating,
• chest pain, chills.

Very rare adverse reactions (may occur in up to 1 in 10,000 people)

• anaphylactic or anaphylactoid reactions,
• restlessness,
• stupor, seizures, fainting (short-term loss of consciousness), disturbances in smell (perception of often unpleasant odours), tremor,
• conjunctivitis, eye redness, blurred vision, excessive tearing,
• cardiac arrest, rapid or slow heartbeat, arrhythmia, vasodilation, pallor,
• respiratory arrest, pulmonary oedema, breathing difficulties, wheezing, nasal congestion, cough, dry throat, throat tightness with sensation of suffocation, respiratory muscle spasms, throat oedema,
• rash, skin redness, swelling of lips and local swelling in the oral cavity,
• muscle spasms, muscle weakness, back pain,
• weakness, chest discomfort, fever, facial swelling, extravasation of the drug outside blood vessels, which may lead to tissue necrosis at the injection site, phlebitis,
• decreased oxygen content in blood.

There have been reports of nephrogenic systemic fibrosis (which causes skin hardening and may also affect soft tissues and internal organs), which occurred mainly in patients who received Gadoteric Acid Farmak together with other contrast agents containing gadolinium. If, in the weeks following an MRI examination, the patient notices changes in the colour and (or) thickness of the skin anywhere on the body, the patient should inform the radiologist who performed the examination.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should inform their doctor or radiologist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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, website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Gadoteric Acid Farmak

Keep this medicine out of the sight and reach of children.
No special precautions for storage are required.
Do not use this medicine after the expiry date stated on the vial and carton after "EXP". The expiry date refers to the last day of the specified month.
It is highly unlikely that a patient will be asked to dispose of any remaining Gadoteric Acid Farmak.

6. Contents of the Package and Other Information

What Gadoteric Acid Farmak Contains

• The active substance is gadoteric acid. One millilitre of injection solution contains
  279.32 mg of gadoteric acid (as meglumine salt), equivalent to 0.5 mmol
  of gadoteric acid (as meglumine salt).

• The other components are meglumine and water for injections.

What Gadoteric Acid Farmak Looks Like and Contents of the Pack
Gadoteric Acid Farmak is a clear, colourless to pale yellow solution for intravenous injection.
Available in glass vials with a capacity of 5, 10, 15, 20, 60, and 100 mL, closed with a bromobutyl rubber stopper.
Packaged in boxes containing either 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Farmak International Sp. z o.o.
Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06

Importer
Farmak International Sp. z o.o.
Chełmżyńska 249
04-458 Warsaw

This medicinal product is authorised in the European Economic Area under the following names:
Estonia: Dotascan
Poland: Gadoteric Acid Farmak
Czech Republic: Gadoteric acid FMK
Spain: Ácido gadotérico Farmak 0,5 mmol/mL solución inyectable en EFG

Information intended exclusively for medical professionals or healthcare personnel:

Dosage
Adults:

• Brain and spinal MRI: In neurological imaging, doses range from 0.1 to 0.3 mmol/kg body weight (b.w.), corresponding to 0.2 to 0.6 mL/kg b.w. After administering 0.1 mmol/kg b.w., an additional dose of 0.2 mmol/kg b.w. in patients with brain tumours may improve tumour visibility and assist in treatment decisions.
• Whole-body MRI and angiography: The recommended intravenous dose providing adequate diagnostic contrast is 0.1 mmol/kg b.w. (i.e., 0.2 mL/kg b.w.). Angiography: In exceptional circumstances (e.g., when satisfactory image quality covering a large vascular area has not been achieved), administration of a second dose of 0.1 mmol/kg b.w. (corresponding to 0.2 mL/kg b.w.) may be justified. However, if two consecutive doses of Gadoteric Acid Farmak are anticipated before starting angiography, it may be beneficial to administer 0.05 mmol/kg b.w. (i.e., 0.1 mL/kg b.w.) for each dose, depending on the available imaging equipment.

Children and adolescents (0–18 years):

• Brain and spinal MRI / Whole-body MRI: The recommended and maximum dose of Gadoteric Acid Farmak is 0.1 mmol/kg body weight. More than one dose should not be administered during a single imaging session. Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Gadoteric Acid Farmak should be used in these patients only after careful consideration and at a dose not exceeding 0.1 mmol/kg b.w. More than one dose should not be administered during a single imaging session. Due to lack of data on repeated administration, injections of Gadoteric Acid Farmak should not be repeated unless the interval between administrations is at least 7 days.
• Angiography: The use of Gadoteric Acid Farmak for angiography in children under 18 years of age is not recommended due to insufficient data on efficacy and safety for this indication.

Special patient groups:

• Patients with renal impairment: In patients with mild to moderate renal impairment (GFR <30 mL/min/1.73 m²), the adult dose should be used. See section "Renal Impairment" below.
• Patients with hepatic impairment: In these patients, the adult dose should be used. Caution is recommended, especially in the perioperative period related to liver transplantation.

Method of Administration
Gadoteric Acid Farmak is indicated for intravenous use only.
Infusion rate: 3–5 mL/min (in angiographic procedures, a higher infusion rate up to 120 mL/min, i.e., 2 mL/sec, may be used).
Optimal imaging: within 45 minutes after injection
Optimal imaging sequence: T1-weighted sequences
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 30 minutes, as experience shows that most adverse reactions occur during this period.
The rubber stopper should be punctured only once using an appropriate withdrawal device (spike). The device should ideally consist of the following components: a trocar, a sterile air filter, a Luer connector, and a protective sealing cap. It may be used with a syringe (sterile), for manual single use, to administer a single-dose protocol or a second contrast injection if clinically necessary.
An automated injection system may be used for multiple administrations of the medicinal product, but only for one single patient.
After the procedure, any remaining product in the vial and in single-use devices must be discarded no later than 24 hours after piercing the rubber stopper. The manufacturer’s instructions for the use of the device must be strictly followed.
The injection solution should be inspected visually before use. Only clear, particle-free solutions should be used.

Children and adolescents (age 0–18 years)
Depending on the amount of Gadoteric Acid Farmak to be administered to a child, it is recommended to use vials of Gadoteric Acid Farmak with a single-use syringe of appropriate capacity to ensure higher precision of the injected dose.
In neonates and infants, the required dose should be administered manually.

Renal Impairment
It is recommended that all patients undergo laboratory tests to assess renal 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 renal impairment (GFR <30 mL/min/1.73 m²). Patients undergoing liver transplantation are at particular risk due to the high incidence of acute renal failure in this group. Due to the risk of NSF associated with the use of Gadoteric Acid Farmak, this product should be used in patients with severe renal impairment and in patients in the perioperative period of liver transplantation only after careful benefit-risk assessment and only when diagnostic information is essential and cannot be obtained by non-contrast MRI.
If Gadoteric Acid Farmak must be used, the dose should not exceed 0.1 mmol/kg b.w. More than one dose should not be administered during a single imaging session. Due to lack of data on repeated administration, injections of Gadoteric Acid Farmak should not be repeated unless the interval between administrations is at least 7 days.
Hemodialysis shortly after administration of Gadoteric Acid Farmak may facilitate elimination of the agent from the body. There is no evidence supporting the initiation of hemodialysis for prophylaxis or treatment of NSF in patients who are not currently undergoing hemodialysis.

Elderly Patients
Since renal clearance of gadoteric acid may be reduced in elderly patients, it is particularly important to assess renal function in patients aged 65 years and older prior to administration.

Neonates and Infants
See section "Dosage and Method of Administration: Children and Adolescents".

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 interrupt breastfeeding for 24 hours after administration of Gadoteric Acid Farmak should be made by the physician and the breastfeeding mother.

Instructions for Use of the Product
Adhesive identification labels from the vials should be attached to the patient's medical record to allow accurate identification of the gadolinium-containing contrast agent used. The administered dose should also be recorded. If an electronic patient record is used, the name of the medicinal product, batch number, and administered dose should be entered.