NEPHROMAG 200 micrograms KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Package Leaflet: Information for the User

NephroMAG 200 micrograms radiopharmaceutical preparation kit

Mertiatide

Read all of this leaflet carefully before you start using this medicine

• Keep this leaflet, you may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours

If you experience any of the following side effects, or any other side effects not mentioned in this leaflet, inform your doctor

• If you think any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor

Contents of the package leaflet:

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

Additional information

1. What is NephroMAG and what is it used for

This medicinal product is for diagnostic use only.

It belongs to a group of medicines called radiopharmaceuticals.

After reconstitution and labeling with sodium pertechnetate (99mTc) solution, a radiopharmaceutical called technetium (99mTc) mertiatide is formed, which will be administered into a vein. Since 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, and an image known as a scintigram can be obtained. This scintigram will show the renal elimination of the radiopharmaceutical, providing the doctor with valuable information about the morphology and function of the kidneys and how the urinary system eliminates the radiopharmaceutical afterwards.

2. Before using NephroMAG

Before administering 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, develop before the medical examination, the need for intervention should be considered.

• Be careful with NephroMAG

• When this medicine is administered to you, as it involves exposure to small amounts of radiation. Although your doctor will always consider the potential risks and benefits.
• If you have reduced kidney function, as you may be more exposed to radiation.
• If you are under 18 years of age, as radiation exposure is proportionally greater than in adults.

Use of other medicines:

Tell 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 whether technetium (99mTc) mertiatide interferes with commonly used medicines in patients who require its administration (e.g., antihypertensives or medication used to treat or prevent organ transplant rejection).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are a woman of childbearing age (age at which you can become pregnant)you should always rule out pregnancy. If you experience a delay in your menstrual period, you should think you are pregnant until proven otherwise. In case of doubt, it is essential that radiation exposure is minimal to obtain the desired clinical information. The possibility of using alternative techniques that do not involve ionizing radiation should be considered.

If you are pregnantyou should not receive this medicine unless it is strictly necessary, as the fetus will receive a small amount of radiation, or when the benefit to you outweighs the risk to the fetus.

If you are breastfeedingyou should consider delaying the test with this medicine until you have stopped breastfeeding, and you should consider whether the most suitable radiopharmaceutical has been selected, taking into account the secretion of activity in breast milk. If administration during breastfeeding is unavoidable, breastfeeding should be discontinued for 24 hours after administration of NephroMAG, and the expressed milk should be discarded during this period. You should consider expressing milk before administration of NephroMAG and storing it for later use. It is recommended that you avoid close contact with the baby during the first 24 hours after injection to avoid transmission of radioactivity. Breastfeeding can be resumed when the level of radioactivity in breast milk does not pose a radiation dose to the child greater than 1 mSv.

Driving and using machines

No effects on the ability to drive and use machines have been described.

Important information about some of the components of NephroMAG

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

3. How to use NephroMAG

This medicine should only be administered by authorized personnel who will indicate the instructions to follow at all times.

Your doctor will decide the amount of NephroMAG to be administered to you. This will be the minimum amount necessary to obtain a scintigram with the necessary quality to provide the required information.

NephroMAG is always administered into a vein.

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

If you think the action of NephroMAG is too strong or too weak, tell your doctor or pharmacist.

If you are given more NephroMAG than you should

Since NephroMAG is administered by a doctor under strict control conditions, any overdose is very unlikely.

However, in case you are given an excessive dose of NephroMAG, the absorbed radiation dose should be reduced by increasing the elimination of the radiopharmaceutical from the body, for which you will be advised to empty your bladder.

In case of overdose or accidental ingestion, consult the Toxicological Information Service.

Telephone 91 5620420.

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

4. Possible side effects

Like all medicines, NephroMAG can have side effects, although not everyone gets them.

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

For all patients: exposure to ionizing radiation should be justified based on the expected medical objective, obtained with the minimum possible dose of radiation received by the patient. Exposure to ionizing radiation is associated with the induction of cancer and the possibility of developing hereditary defects. However, the absorbed radiation dose is likely to be much lower than the radioactivity to which you are naturally exposed during a year in your normal environment. The probability of these reactions occurring is low due to the low doses of radiation received.

In patients with reduced kidney function:careful indication is required, as they may be more exposed to radiation.

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

Reporting of side effects:

If you experience any side effects, consult your doctor or nurse, even if they are possible side effects not mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. Storage of NephroMAG

Keep out of the reach and sight of children.

Before opening the container for the first time, the product should be stored at a temperature between 2°C and 8°C.

Storage of this product before preparation should be in its original container.

Storage of the prepared and radiolabeled product should be in the original lead container or equivalent shielding.

Storage should be carried out in accordance with national regulations on radioactive materials.

Expiration date

Before opening the container for the first time, the validity period is 9 months from the date and time of manufacture.

The labeled product has a validity period 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 of vial (1) are: tin(II) chloride dihydrate, (R-R)-disodium 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 product and container contents

This medicine is presented as a radiopharmaceutical preparation kit.

It is supplied in a box of 10 vials, 5 of which are type vial (1) and 5 of which 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 labeled product is presented as a clear, transparent, or 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]

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Curium Pharma Spain S.A.

Avda. Doctor Severo Ochoa, 29

28100 Alcobendas, Madrid

Spain

This medicine 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 voor Radiofarmaceutisch Preparaat

Finland NephroMAG 0.2 mg Kit for radiopharmaceutical preparation

Greece NephroMAG, 0.2 mg, Τυποποιημ?νη συσκευασ?α για ραδιοφαρμακευτικ?

σκευ?σματα

France NephroMAG 0.2 mg Trousse pour prèparation radiopharmaceutique

Portugal Mertioscan 0.2 mg Conjunto para preparaçoes radiofarmacèuticas

Sweden NephroMAG 0.2 mg Beredningssats för radioaktiva läkemedel

Belgium NephroMAG 0.2 mg Trousse pour prèparation radiopharmaceutique

Norway Nephromag 0.2 mg Kit for radiopharmaceutical preparation

Italy MAG3 ROTOP

This leaflet was approved in August 2016

This information is intended only for healthcare professionals:

The full technical data sheet of NephroMAG is included as a detachable section at the end of this leaflet, in order to provide doctors or healthcare professionals with scientific information and practical information on the administration and use of this radiopharmaceutical.