Nephromag 200 micrograms radiopharmaceutical preparation kit

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

NephroMAG 200 micrograms kit for radiopharmaceutical preparation

Mertiatide

Read the entire leaflet carefully before you start using the medicine

• Keep this leaflet, as you may need to read it again
• If you have any questions, ask your doctor or pharmacist
• This medicine has been prescribed for you and must not be given to other people, even if they have the

same symptoms, as it may harm them.

• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor

Leaflet contents:

1. What NephroMAG is and what it is used for
2. Before using NephroMAG
3. How to use NephroMAG
4. Possible side effects
5. Storage of NephroMAG

Additional information

1. What NephroMAG is and what it is used for

This medicine is for diagnostic use only.

It belongs to a group of medicines called radiopharmaceuticals.

After reconstitution and labelling with sodium pertecnetate (99mTc) solution, a radiopharmaceutical called technetium (99mTc) mertiatide is formed, which will be administered intravenously. Because the radiopharmaceutical contains a small amount of radioactivity, it can be detected from outside the body using a special medical device called a gamma camera, allowing an image to be obtained known as a scintigraphy. This scintigraphy will show the renal excretion of the radiopharmaceutical, providing the physician with valuable information about kidney morphology and function, as well as how the urinary system subsequently eliminates the radiopharmaceutical.

2. Before using NephroMAG

Before taking this medicine, drink plenty of fluids to achieve optimal results.

Do not use NephroMAG

If you are allergic (hypersensitive) to the active substance or any of the other components of NephroMAG. If allergic symptoms such as hives, nausea, or difficulty breathing occur before medical evaluation, consider the need for intervention.

• Take special care with NephroMAG

• When this medicine is administered to you, because it involves exposure to small amounts of radiation. Although your doctor will always weigh the potential risks and benefits.

• If you have reduced kidney function, because your exposure to radiation may increase.

• If you are under 18 years of age, because radiation exposure is proportionally greater than in adults.

Use of other medicines:

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

It is not known that technetium (99mTc) mertiatide interferes with commonly used medicines in patients requiring its administration (e.g., antihypertensives or medication used to treat or prevent organ transplant rejection).

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

If you are a woman of childbearing potential (age when you can become pregnant), pregnancy must always be ruled out. If you experience a delayed menstrual period, you should consider yourself pregnant until proven otherwise. In case of doubt, it is essential that exposure to radiation be kept to the minimum necessary to obtain the desired clinical information. Consideration should be given to using alternative techniques that do not involve ionizing radiation.

If you are pregnant, you should not receive this medicinal product unless strictly necessary, as the fetus will be exposed to a small amount of radiation, or when the benefit to you outweighs the risk to the fetus.

If you are breastfeeding, consideration should be given to reasonably postponing the test with this medicinal product until you have stopped breastfeeding. The choice of the most appropriate radiopharmaceutical should be carefully evaluated, taking into account the secretion of radioactivity into breast milk. If administration during breastfeeding is unavoidable, breastfeeding must be interrupted for 24 hours after administration of NephroMAG, and milk expressed during this period must be discarded. It is recommended to express milk prior to administration of NephroMAG and store it for later use. You are advised to avoid close contact with the infant during the first 24 hours after injection to prevent transmission of radioactivity. Breastfeeding may be resumed when the level of radioactivity in breast milk does not result in a radiation dose to the infant exceeding 1 mSv.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been reported.

Important information about some of the components of NephroMAG

This medicine contains less than 1 mmol (23 mg) of sodium per dose; therefore, it is essentially "sodium-free".

3. How to use NephroMAG

This medicine must be administered exclusively by authorized personnel, who will provide you with instructions to follow at each stage.

Your doctor will determine the dose of NephroMAG to be administered. This will be the minimum necessary amount required to obtain a scintigraphy image of sufficient quality to provide the needed information.

NephroMAG is always administered intravenously.

For detailed instructions on the proper administration/use of NephroMAG, see section 6.

If you think that the effect of NephroMAG is too strong or too weak, inform your doctor or pharmacist.

If you are given more NephroMAG than you should receive

Since NephroMAG is administered by a physician under strict control conditions, overdose is highly unlikely.

However, if an excessive dose of NephroMAG is administered, the absorbed radiation dose should be reduced by increasing the elimination of the radiopharmaceutical from the body. For this purpose, you will be advised to empty your bladder frequently.

In case of overdose or accidental ingestion, contact the Toxicology Information Service.

Telephone: 91 5620420.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, NephroMAG may have adverse effects, although not everyone will experience them.

Very rare (occurring in less than 1 in 10,000 patients) and mild adverse effects have been reported: itching, eyelid swelling, and cough. Occasionally, a mild circulatory disturbance has been reported, characterized by sudden dizziness or fainting.

For all patients: Exposure to ionizing radiation must be justified according to the expected medical benefit, achieved with the lowest possible radiation dose received by the patient. Exposure to ionizing radiation is associated with cancer induction and the possibility of developing hereditary defects. However, the absorbed radiation dose is likely to be much lower than the natural radioactivity to which a person is exposed during one year in their normal environment. The probability of these reactions occurring is low due to the low radiation doses received.

In patients with reduced renal function: careful consideration is required, as radiation exposure may be increased in these patients.

In the pediatric population (under 18 years of age): it should be taken into account that the radiation dose received is proportionally higher than in adults.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of NephroMAG

Keep out of the reach and sight of children.

Prior to first opening, the product must be stored at a temperature between 2°C and 8°C.

Storage of this product prior to preparation must be carried out in its original container.

The prepared and radiolabelled product must be stored in the original lead container or another equivalent shielding.

Storage must comply with national regulations regarding radioactive materials.

Expiry

Prior to first opening, the shelf life is 9 months from the date and time of manufacture.

The radiolabelled product has a shelf life of 8 hours when stored below 25°C.

6. Additional Information

Composition of NephroMAG

• The active substance is mertiatide. Each vial (1) contains 200 micrograms of mertiatide.
• The other components in vial (1) are: stannous chloride dihydrate, (R-R)-sodium tartrate dihydrate, sodium hydroxide and hydrochloric acid.
• The components of vial (2) are: disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, hydrochloric acid and water for injection.

Appearance of the medicinal product and contents of the pack

This medicine is presented as a reagent kit for the preparation of a radiopharmaceutical.

It is supplied in a box containing 10 vials, of which 5 are type vial (1) and 5 are type vial (2). Vial (1) contains a powder with 200 micrograms of mertiatide. Vial (2) contains 2.5 ml of phosphate buffer solution.

The labelled product is presented as a colorless, clear to slightly opalescent injectable solution.

Marketing Authorization Holder and Manufacturer

ROTOP Pharmaka GmbH

Bautzner Landstrasse 400

01328 Dresden, Germany

Telephone: +49 351 26 310 210

Fax: +49 351 26 310 313

Email: [email protected]

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Curium Pharma Spain S.A.

Avda. Doctor Severo Ochoa, 29

28100 Alcobendas, Madrid

Spain

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

Germany MAG-3 kit

Hungary NephroMAG, 0.2 mg, radiogyógyszer eloállítására szolgáló készlet

Luxembourg NephroMAG 0,2 mg Trousse pour prèparation radiopharmaceutique.

Netherlands NephroMAG 0,2 mg Kit for Radiopharmaceutical Preparation.

Finland NephroMAG 0.2 mg Kit for radiopharmaceutical preparation.

Greece NephroMAG, 0.2 mg, Τυποποιημένη συσκευασία για ραδιοφαρμακευτικά σκευάσματα

France NephroMAG 0,2 mg Trousse pour préparation radiopharmaceutique.

Portugal Mertioscan 0.2 mg Conjunto para preparações radiofarmacêuticas.

Sweden NephroMAG 0.2 mg Beredningssats för radioaktiva läkemedel.

Belgium NephroMAG 0,2 mg Trousse pour préparation radiopharmaceutique.

Norway Nephromag 0.2 mg. Kit for radiopharmaceutical preparation.

Italy MAG3 ROTOP

This patient information leaflet was approved in August 2016

This information is intended solely for doctors or healthcare professionals:

The complete NephroMAG summary of product characteristics is included as a detachable section at the end of this leaflet, to provide doctors and healthcare professionals with scientific information, as well as practical guidance on the administration and use of this radiopharmaceutical.