Label: information for the user

NephroMAG 200 micrograms kit for radiopharmaceutical preparation

Mertiatide

Read the entire label carefully before starting to use the medication

- Conserve this label, as you may need to refer to it again

- If you have any questions, consult your doctor or pharmacist

- This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

- If you consider any of the adverse effects you are experiencing to be severe or if you notice any effect not mentioned in this label, inform your doctor

Additional information

This medication is solely for diagnostic use.

It belongs to a group of medications known as radiopharmaceuticals.

After reconstitution and labeling with sodium pertecnetate (99mTc) solution, a radiopharmaceutical called technetium (99mTc) mertiatide is formed, which will be administered via a vein. Due to the radiopharmaceutical containing a small amount of radioactivity, it can be detected from the outside of the body using a specialized medical device called a gamma camera, and an image known as a gamma scan can be obtained. This gamma scan will show the renal elimination of the radiopharmaceutical, providing the doctor with valuable information about the morphology and functioning of the kidneys and how the urinary system eliminates the radiopharmaceutical afterwards.

Drink plenty of liquid before taking this medication to achieve optimal results.

No use NephroMAG

If you are allergic (hypersensitive) to the active ingredient or any of the other components of NephroMAG. If allergic symptoms, such as urticaria, nausea, or difficulty breathing develop before a medical examination, consider the need for intervention.

-Be especially careful with NephroMAG

-When you are administered this medication because it involves exposure to small amounts of radiation. Although your doctor will always consider the possible risks and benefits.

-If you have reduced kidney function because you may be exposed to more radiation.

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

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other

medications, including those obtained without a prescription.

No interference with commonly used medications by technetium (99mTc) mertiatide has been reported (for example, antihypertensives or medication used to treat or prevent organ transplant rejection).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are a fertile woman (age at which you can become pregnant)you must always rule out pregnancy. If you experience a delay in menstruation, consider that you may be pregnant until proven otherwise. In case of doubt, it is essential that radiation exposure be minimized to obtain the desired clinical information. Consider the possibility of performing alternative techniques that do not involve the use of ionizing radiation.

If you are pregnantdo not receive this medication unless it is strictly necessary because the fetus will receive a small amount of radiation, or when the benefit to you outweighs the risk to the fetus.

If you are breastfeeding your childconsider the possibility of delaying the test with this medication until you have stopped breastfeeding, and consider whether the selected radiopharmaceutical takes into account the secretion of activity in breast milk. If administration during breastfeeding is unavoidable, breastfeeding must be suspended for 24 hours after administration of NephroMAG and the milk expressed during that period must be discarded. 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 radiation transmission. Breastfeeding can be resumed when the level of radioactivity in breast milk does not represent a radiation dose for the child exceeding 1 mSv.

Driving and operating machinery

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

Important information about some components of NephroMAG

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

This medication must be administered exclusively by authorized personnel who will instruct you

at all times on the instructions to follow.

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

NephroMAG is administered always through a vein.

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

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

If you are administered more NephroMAG than you should

Since NephroMAG is administered by a doctor under strict control conditions, it is very difficult for any overdose to occur.

However, in the event that you are administered an excessive dose of NephroMAG, the dose of radiation absorbed by you must be reduced, causing an increase in the elimination of the radiocontrast agent from the body, for which you will be recommended 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.

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

Rare and mild adverse effects (in less than 1 in 10,000 patients) include itching, eyelid inflammation, and cough. In some cases, a mild circulatory alteration 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 linked to cancer induction and the possibility of developing hereditary defects.However, the absorbed radiation dose is likely to be much lower than the natural radiation exposure to which you are exposed in your normal environment over a year.The probability of these reactions occurring is low due to the low radiation doses received.

For patients with reduced renal function:careful indication is required, as

in them it is possible that radiation exposure may increase.

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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Keep out of reach and sight of children.

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

The storage of this product before its preparation must be carried out in its original packaging.

The storage of the prepared and radiactively labeled product must be carried out in an original lead container or any other equivalent shielding.

The storage must be carried out in accordance with national regulations on radioactive materials.

Expiration Date

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

The product marked has a validity period of 8 hoursstored below 25 °C.

Composition of NephroMAG

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

Appearance of the product and contents of the package

This medication is presented in the form of a reagent kit for radiofarmaceutical preparation.

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

The marked product is presented in the form of a colorless, transparent to slightly opalescent injectable solution.

Holder of the marketing authorization and responsible for manufacturing

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 about this medication can be requested 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 medication is authorized in the member states of the European Economic Area with the following names:

GermanyMAG-3 kit

HungaryNephroMAG, 0.2 mg, radiopharmaceutical preparation kit

LuxembourgNephroMAG 0,2 mg Trousse for radiopharmaceutical preparation.

NetherlandsNephroMAG 0,2 mg Kit for Radiofarmaceutical Preparation.

FinlandNephroMAG 0,2 mg Kit for radiopharmaceutical preparation.

GreeceNephroMAG, 0,2 mg,Τυποποιημ?νησυσκευασ?αγιαραδιοφαρμακευτικ?

σκευ?σματα

FranceNephroMAG 0,2 mg Trousse for radiopharmaceutical preparation.

PortugalMertioscan 0.2 mg Conjunto for radiofarmacèuticas preparation.

SwedenNephroMAG 0.2 mg Beredningssats for radioaktiva läkemedel.

BelgiumNephroMAG 0,2 mg Trousse for radiopharmaceutical preparation.

NorwayNephromag 0.2 mg. Kit for radiopharmaceutical preparation.

ItalyMAG3 ROTOP

This prospectus was approved in August 2016

This information is intended solely for doctors or healthcare professionals:

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