Omniscan

Leaflet included in the packaging: patient information

Omniscan, 0.5 mmol/ml, solution for injection
Gadodiamide
You should carefully read the contents of this 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.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Omniscan and what is it used for

This product is intended exclusively for diagnostic purposes.
Omniscan is a non-ionic, paramagnetic contrast agent containing gadodiamide as the active substance at a dose of 287 mg/ml. Administration of the preparation causes signal enhancement in areas where the blood-brain barrier has been damaged by disease processes.
This allows for more complete information to be obtained than during an examination without the use of a contrast agent. The absence of enhancement does not exclude disease changes: the signal in some types of tumors or inactive changes in multiple sclerosis does not increase. This effect can be used to differentiate pathological changes. The medicine is excreted by the kidneys. About 85% of the administered dose is found in the urine within 4 hours, and 95-98% within 24 hours after intravenous administration. No metabolites of the preparation have been detected.

Indications for use of Omniscan

Omniscan is a contrast agent for intravenous administration, used for magnetic resonance imaging (MRI) of the head and spinal cord, as well as the whole body, including the head and neck, thoracic and cardiac, limbs, abdomen and pelvis (prostate and urinary bladder), breast, pancreas and liver, retroperitoneal space (kidneys), musculoskeletal system and blood vessels (angiography).
Omniscan causes contrast enhancement and facilitates imaging of abnormal structures and changes in various parts of the body, including the central nervous system.
In cardiac magnetic resonance imaging (MRI), the product is indicated for the diagnosis of coronary artery disease (CAD) using magnetic resonance imaging (MRI) to image myocardial perfusion (rest and stress testing, as well as delayed contrast enhancement), in order to detect and localize coronary artery disease (CAD) and differentiate areas of ischemia and infarction in patients with a history of coronary artery disease (CAD) or suspected coronary artery disease (CAD).

2. Important information before using Omniscan

When not to use Omniscan

• in patients with severe kidney function disorders or acute kidney failure, as well as after kidney transplantation. In this group of patients, the use of Omniscan is associated with a disease called nephrogenic systemic fibrosis (NSF). NSF is a disease that causes skin and connective tissue thickening. NSF can cause joint stiffness, muscle weakness, or impairment of internal organ function, which can lead to life-threatening conditions.
• in newborns under 4 weeks of age.

Warnings and precautions

Particular caution should be exercised in the following cases:

You should tell your doctor:

Before performing an examination with Omniscan, a blood test should be performed to assess the patient's kidney function.
Omniscan is contraindicated in newborns under 4 weeks of age. Due to the insufficiently developed kidney function in infants under 1 year of age, Omniscan should only be used in infants after careful consideration by the doctor of the justification for such a procedure. The doctor should be informed about existing diseases and allergic reactions.

Omniscan and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This also applies to over-the-counter medicines.
Omniscan affects calcium measurements in serum using some colorimetric methods (complexometric methods) commonly used in hospital laboratories. It may also affect the determination of other electrolytes (e.g., iron). Therefore, it is recommended that these measurement methods not be used before 12-24 hours after administration of the preparation. If these tests are necessary, it is recommended to use other laboratory methods.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
Omniscan should not be used in pregnant women unless it is absolutely necessary.
There are insufficient data on the use of gadodiamide in pregnant women. Animal studies have shown a harmful effect on reproduction. The medicine should not be used during pregnancy unless the MRI examination with contrast enhancement is essential and there is no possibility of using a safer diagnostic technique. Omniscan may be used during pregnancy only in cases where the potential benefits outweigh the potential risk to the fetus.
Breastfeeding
You should tell your doctor if you are breastfeeding or plan to breastfeed.
It is not known whether gadodiamide passes into breast milk. Animal studies have shown a low level of gadodiamide penetration into breast milk.
It is recommended to interrupt breastfeeding for at least 24 hours after administration of the product.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. Due to the possibility of dizziness, it is not recommended to drive and use machines after administration of the medicine.
Omniscan containscalcium disodium edetate, sodium hydroxide, or hydrochloric acid to adjust the pH. The medicine contains sodium, which should be taken into account in patients controlling their sodium intake.
The glass packaging of the medicine is closed with rubber stoppers, which can cause allergic reactions.

3. How to use Omniscan

The medicine should be drawn into a syringe immediately before administration. Each package (except for glass bottles with a capacity of 100 ml) is intended for one patient; any unused portion should be discarded.
The medicine is administered intravenously. Both in adults and children, the recommended dose should be administered using a single injection technique. Immediately after administration of the medicine, the venflon should be flushed with a 0.9% sodium chloride solution to ensure administration of the entire dose of the contrast agent.
Omniscan should not be mixed with other medicines in the same syringe.
Regarding packages with a capacity of 100 ml:
Omniscan can be administered using an infusion pump or injector. The part of the set connected to the patient after use should be replaced.
Any unused medicine, administration sets, and disposable equipment should be removed at the end of the day. The manufacturer's instructions should be followed.

Dosing in special patient groups

Omniscan is contraindicated in patients with severe or acute kidney disease, as well as in patients who have undergone or are scheduled to undergo a kidney transplant.
Omniscan is contraindicated in newborns under 4 weeks of age.
In patients with moderate kidney failure, only one dose of the medicine should be used during a single examination, and the medicine should not be administered at intervals of less than 7 days.
Due to the insufficiently developed kidney function in infants under 1 year of age, only one dose of the medicine should be used, and the medicine should not be administered at intervals of less than 7 days.
When using the medicine in patients over 65 years of age, there is no need to adjust the dose, but a blood test should be performed to assess whether the kidneys are functioning properly.

• 1. Central nervous system examination: Dosing in adults and childrenThe recommended dose for patients with a body weight of up to 100 kg is 0.2 ml/kg body weight (0.1 mmol/kg body weight). In patients with a body weight over 100 kg, a dose of 20 ml is usually sufficient to achieve diagnostically effective contrast enhancement.

Dosing only in adults
Patients with suspected brain metastases and a body weight of up to 100 kg may be given 0.6 ml/kg body weight (0.3 mmol/kg body weight).
Over 100 kg body weight, a dose of 60 ml is usually sufficient.
A dose of 0.6 ml/kg body weight may be administered in a single intravenous injection.
In patients with an uncertain result of the MRI examination after administration of the medicine at a dose of 0.2 ml/kg body weight, an additional dose may have diagnostic value - a second intravenous injection of 0.4 ml/kg body weight. It should be administered within 20 minutes after administration of the first contrast dose.

• 2. Whole-body examination: Dosing only in adultsThe recommended dose for adults with a body weight of up to 100 kg is 0.2 ml/kg body weight (0.1 mmol/kg body weight). Sometimes, in adult patients with a body weight of up to 100 kg, a dose of 0.6 ml/kg body weight (0.3 mmol/kg body weight) may be administered. In patients with a body weight over 100 kg, a dose of 60 ml is usually sufficient to achieve diagnostically effective contrast enhancement.

Dosing in children under 6 months
The recommended dose is 0.2 ml/kg body weight (0.1 mmol/kg body weight).
The MRI examination of the central nervous system and whole body with contrast administration should be started shortly after administration of the contrast agent, depending on the pulse sequences and examination protocol used. Optimal enhancement is observed within the first few minutes after injection, depending on the type of lesion and tissue. The enhancement persists for approximately 45 minutes after administration of the contrast agent. The most suitable imaging technique for use with Omniscan is T1-weighted imaging.
The diameter of the syringe needle is too large for measuring small volumes of the medicine. It is recommended to use syringe needles with a capacity of more than 5 ml.

• 3. Angiography (MR): Dosing only in adultsThe recommended dose is 0.2 ml/kg body weight (0.1 mmol/kg body weight). In cases of abdominal aortic stenosis or iliac artery stenosis, a higher dose should be used - 0.6 ml/kg body weight (0.3 mmol/kg body weight). The examination should be started during the first passage of the contrast agent, during administration, or immediately after administration, depending on the equipment used, in order to achieve optimal contrast enhancement.

• 4. Coronary artery disease (CAD): Dosing only in adultsThe recommended dose for myocardial perfusion imaging is 0.3 ml/kg body weight (0.15 mmol/kg body weight) administered in two divided doses, each of 0.15 ml/kg body weight (0.075 mmol/kg body weight), administered at intervals of at least 10 minutes; one dose with pharmacological stress and one dose at rest. For bolus injection of the product in cardiac MRI, it is recommended to use an appropriate injector with an injection rate not exceeding 8 ml/second. The stress agent should be administered using a separate infusion set. If only delayed contrast enhancement is performed, the recommended total dose of the product is 0.15 mmol/kg body weight. The use of CAD has not been studied in children.

Use of a higher dose of Omniscan than recommended

So far, there have been no reports of clinical consequences of overdose. The occurrence of acute toxic symptoms in patients with normal kidney function is unlikely.
If necessary, symptomatic treatment is recommended. There is no specific antidote for this contrast agent. In patients with kidney failure, in whom the elimination period of the medicine may be prolonged, and in patients who have received large doses of the preparation, the contrast agent may be removed from the body by dialysis.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined as follows:

• very common: (occurring in more than 1 in 10 people);
• common: (occurring in 1 to 10 people in 100);
• uncommon: (occurring in 1 to 10 people in 1,000);
• rare: (occurring in 1 to 10 people in 10,000);
• very rare: (occurring in less than 1 in 10,000 people);
• unknown: (frequency cannot be estimated from the available data).

In clinical trials, the following side effects have been observed:
Commontransient feeling of generalized warmth, cooling, pressure, or pain at the injection site, headache, nausea.
Uncommon:hypersensitivity, allergic skin and mucous membrane reactions, dizziness, abnormal sensations, such as tingling, numbness, and prickling, taste disturbances, vomiting, diarrhea, vasodilation, which may manifest as, among other things, flushing and sweating.
Rare:taste disorders, seizures, shivering, chills, drowsiness, vision disturbances, breathing difficulties, joint pain, anxiety, chest pain, kidney function disorders (acute kidney failure), shortness of breath, cough, rash, and urticaria, facial swelling, and anaphylactoid reaction (a skin and mucous membrane disease characterized by the occurrence of edema), fever. In patients with existing kidney failure, acute kidney failure may occur, and an increase in serum creatinine levels may be observed.
Frequency unknown: skin thickening.
In patients with severe kidney failure, cases of nephrogenic systemic fibrosis (a disease associated with skin thickening, which can also affect soft tissues and internal organs) have been observed, manifesting as skin discoloration and thickening, which can be painful. As a result, joint mobility may be reduced, muscle weakness may occur, or internal organ function may be impaired.
Anaphylactic/pseudoanaphylactic reactions (severe, life-threatening reactions that occur, for example, after administration of the medicine) may occur, including accelerated heart rate, sneezing, throat irritation, and breathing difficulties.
Side effects usually occur within an hour of administration of the medicine. Rarely, side effects may occur within several hours or even days after administration of Omniscan.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects allows for more information to be collected on the safety of the medicine.

5. How to store Omniscan

Store at a temperature below 25°C. Store in the outer packaging to protect from light. Do not freeze.
Store in a place out of sight and reach of children.
Before using the preparation, you should check the expiration date stated on the packaging.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the given month.

6. Contents of the packaging and other information

What Omniscan contains

• The active substance of the medicine is gadodiamide (GdDTPA-BMA) at a dose of 287.0 mg/ml.
• The other ingredients are calcium disodium edetate, sodium hydroxide, or hydrochloric acid (to adjust the pH), and water for injections.

What Omniscan looks like and what the packaging contains

Colorless glass vials with rubber stoppers, colorless glass bottles with rubber stoppers, PP USB bottles, syringe needles in a cardboard box.

• A. Immediate packaging made of colorless glass. Outer packaging - cardboard box.
• 10 vials of 5 ml; 1 vial of 5 ml
• 10 vials of 10 ml; 1 vial of 10 ml
• 10 vials of 15 ml; 1 vial of 15 ml
• 10 vials of 20 ml; 1 vial of 20 ml
• 10 bottles of 100 ml

• B. Immediate packaging - PP USB bottles. Outer packaging - cardboard box.
• 10 bottles of 50 ml
• 10 bottles of 100 ml
• C. Immediate packaging - syringe needles. Outer packaging - cardboard box.
• 10 syringe needles with a capacity of 10 ml
• 10 syringe needles with a capacity of 15 ml
• 10 syringe needles with a capacity of 20 ml

Marketing authorization holder and manufacturer

GE Healthcare AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, NO-0401 Oslo, Norway
Manufacturer:
GE Healthcare AS, Nycoveien 1-2, NO-0401 Oslo, Norway
GE Healthcare Ireland Limited, IDA Business Park, Carrigtohill, Country Cork, Ireland

Date of last revision of the leaflet: January 2017

Information intended exclusively for medical professionals:
Before administering Omniscan to each patient, screening laboratory tests should be performed to assess kidney function disorders.
There have been reports of nephrogenic systemic fibrosis (NSF) associated with the use of Omniscan and some gadolinium-containing medicines in patients with acute or chronic severe kidney function disorders (GFR <30 ml min 1.73 m2). patients who have undergone kidney transplantation are particularly at risk, as the risk of acute failure in this group is high. therefore, omniscan should not be used with or severe failure, scheduled to undergo a transplant.
Omniscan should not be used in newborns under 4 weeks of age.
Due to the insufficiently developed kidney function in infants under 1 year of age, Omniscan should only be used in infants after careful consideration by the doctor of the justification for such a procedure, at a dose not exceeding 0.1 mmol/kg body weight. Due to the lack of information on the administration of multiple doses, an interval of at least 7 days should be maintained between consecutive injections of Omniscan.
Due to the potential reduced clearance of gadodiamide in elderly patients, particularly in those over 65 years of age, it is essential to perform screening tests for kidney function disorders in this age group.
Hemodialysis immediately after administration of Omniscan may facilitate the removal of Omniscan from the body.
There is no evidence to justify the initiation of hemodialysis to prevent or treat NSF in patients not undergoing hemodialysis.
Omniscan should not be used during pregnancy unless the clinical condition of the woman indicates the need for gadodiamide.
The patient should not breastfeed for at least 24 hours after administration of Omniscan.
In the patient's medical records, a self-adhesive control label should be attached from the {vial/bottle} to accurately document the use of the gadolinium-containing medicine. The administered dose should also be documented. If electronic medical records are kept, information about the product name, batch number, and dose should be entered.