PROSPECTO: INFORMATION FOR THE USER

FERIV 20 mg/ml Injectable Solution or Concentrate for Infusion Solution

(Iron)

Read this prospectus carefully before starting to use the medication.

Content of the prospectus:

1. What FERIV is and for what it is used
2. Before FERIV is administered to you
3. Possible adverse effects
4. Storage of FERIV
5. Additional information

FERIV belongs to the group of medications known as iron preparations.

FERIV is indicated for the intravenous treatment of iron deficiency in the following situations:

• Due to demonstrated intolerance to oral iron preparations.
• In cases where there is a clinical need for rapid iron supply to iron stores.
• In active inflammatory intestinal disease, when oral iron preparations are ineffective or poorly tolerated.
• Confirmed non-compliance with oral iron therapy by the patient.

The diagnosis of iron deficiency should be established based on appropriate laboratory tests (e.g. serum ferritin, plasma iron, transferrin saturation, and hypochromic red blood cells).

Inform your doctor if you are allergic or have had any allergic reaction to the active ingredient of this medication, to any of its components, or to any other medication, as well as any muscle pain or weakness you may experience.

Do not use FERIV

• If you are allergic (hypersensitive) to the product or to any of the other components of this medication (listed in section 6).
• If you have experienced severe allergic reactions (hypersensitivity) to other injectable iron preparations.
• If you have iron deficiency anemia.
• If you have a history of iron overload or alterations in iron utilization.
• If you have had or currently have any liver disease.
• If you have an acute or chronic infection, as the administration of intravenous iron may reactivate a bacterial or viral infection.

Warnings and precautions

Consult with your doctor or nurse before starting to receive FERIV:

- If you have a history of allergies to medications.

- If you have systemic lupus erythematosus.

- If you have rheumatoid arthritis.

- If you have severe asthma, eczema, or other allergies.

- If you have an infection.

- If you have liver problems.

Intravenous iron preparations may cause severe allergic reactions that may require immediate administration of adrenaline along with other resuscitation measures.

In the case of mild allergic reactions, administration of antihistamines may be sufficient.

Patients with low iron-binding capacity and/or folate deficiency are more prone to allergic reactions.

Reactions have been frequently described that include joint pain when the recommended dose is exceeded.

It is possible to experience episodes of hypotension if the injection is administered too quickly.

Use of other medications

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

Like other parenteral iron preparations, FERIV should not be administered concurrently with oral iron preparations, as this reduces oral absorption. Therefore, oral iron therapy should only be initiated at least five days after the last FERIV injection.

Pregnancy and lactation

Consult with your doctor or pharmacist before using any medication.

Pregnancy

FERIV has not been evaluated in pregnant women. If you are pregnant or breastfeeding, or think you may be pregnant, consult with your doctor before using this medication.

If you become pregnant during treatment, consult with your doctor, who will decide whether to administer the medication or not.

Lactation

If you are breastfeeding, consult with your doctor before receiving FERIV.

Driving and operating machinery

There are no data on how FERIV administration affects driving or operating machinery, so avoid tasks that require special attention until you determine how you tolerate the medication.

Important information about some of the components of FERIV

This medication contains less than 23 mg (1 mmol) of sodium per ampoule, making it essentially "sodium-free".

Your doctor will tell you how long to take FERIV. Do not stop treatment before then.

How FERIV is administered

The doctor or nurse will administer FERIV intravenously; FERIV will be administered in a facility where allergic reactions can be treated properly and quickly.

After each administration, you will stay under observation for at least 30 minutes under the supervision of the doctor or nurse.

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

Adults and Elderly:

The total accumulated dose of FERIV, equivalent to the total iron deficit (mg), is determined by the patient's hemoglobin concentration and weight. For each patient, the dose and dosing regimen of FERIV must be calculated based on the total iron deficit calculation (see section 6 Additional Information).

Children:

The use of FERIV in children has not been adequately studied, and therefore, its use is not recommended.

The total dose of FERIV must be administered in single doses of 100 mg of iron (one vial of FERIV) at a maximum of three times a week. However, when clinical circumstances require a rapid supply of iron to the body's deposits, the dosing regimen may be increased to 200 mg of iron at a maximum of three times a week. For more information, see section 6 of this prospectus.

If you take more FERIV than you should

If you are given more FERIV than you should, consult your doctor immediately so that they can apply the necessary treatment.

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

Like all medicines, FERIV can cause side effects, although not everyone will experience them.

After administration of FERIV, the following side effects have been reported as possible:

Nervous system disorders

Frequent(affects between 1 and 10 in every 100 people): Temporary changes in taste (particularly metallic taste).

Uncommon(affects between 1 and 10 in every 1,000 people): Headache; dizziness.

Rare(affects between 1 and 10 in every 10,000 people): Tingling.

Isolated cases: Decreased alertness, sensation of dizziness, confusion.

Cardiac disorders

Uncommon: Low blood pressure and collapse; increased heart rate, palpitations.

Respiratory, thoracic and mediastinal disorders

Uncommon: Wheezing, respiratory difficulty.

Gastrointestinal disorders

Uncommon: Nausea; vomiting; abdominal pain; diarrhea.

Skin and subcutaneous tissue disorders

Uncommon:Itching; skin rash, erythema, flushing.

Musculoskeletal and connective tissue disordersdisorders

Uncommon:Muscle cramps, muscle pain.

Isolated cases: Joint inflammation.

General disorders and administration site conditions

Uncommon:Fever, tremors, pruritus; chest pain and oppression. Burning, swelling, and similar reactions (sometimes affecting veins) around the injection site.

Rare:Allergic reactions (rarely including joint pain and very rarely, severe allergic reactions, accompanied by low blood pressure, facial swelling, and difficulty breathing); hand and foot swelling; fatigue, weakness; general feeling of malaise.

Isolated cases:Facial and tongue swelling.

Other side effects of unknown frequency: Injection site reactions: Phlebitis causing thrombophlebitis; symptoms may include red, swollen, or painful skin, or hardening of the skin at the injection site.

Inform your doctor immediately if you experience chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Flu-like illness may occur several hours or days after injection and is usually characterized by symptoms such as elevated temperature and muscle and joint pain.

You should consult a doctor if you experience worsening fatigue, muscle or bone pain (pain in the arms or legs, joints, or back). This may be a sign of a decrease in phosphate levels in the blood that could cause your bones to soften (osteomalacia). This condition can sometimes cause bone fractures. The doctor may also monitor phosphate levels in the blood, especially if you need multiple treatments with iron over time.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national notification system,Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not store at a temperature above25°C.

Store in the original packaging to protect from light.

Do not freeze.

Do not use FERIV after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

After the first opening of the packaging, the product must be used immediately.

Once the medication is diluted in a 0.9% sodium chloride solution, it must be used immediately. If not used immediately, the solution should not exceed 3 hours at room temperature unless the dilution was performed in validated and controlled aseptic conditions.

FERIV is presented as a translucent, dark brown aqueous solution. Before use, a visual inspection of the ampoules must be performed to check for sediment or damage. Only ampoules without sediment and with a homogeneous solution should be used.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

Composition of FERIV

• The active principle is iron. Each ampoule of 5 ml contains 100 mg of iron, as iron saccharate [saccharate complex of iron (III) and iron hydroxide].

• The other components are: water for injection preparations and sodium hydroxide.

Appearance of the product and contents of the package

FERIV is presented as an injectable solution or a concentrated solution for perfusion. Each package contains5 ampollas of 5 ml.

Holder of the marketing authorization

Altan Pharmaceuticals, S.A.

c/ Cólquide nº 6, Portal 2, 1ª planta, office F

Edificio Prisma

28230 - Las Rozas. MADRID

Spain

Responsible for manufacturing

RAFARM S.A.

12 korinthou St. N.Psyhico

15451 Athens – Greece

or

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo s/n

01118 Bernedo (Álava)

Spain

This prospectus was approved in November 2021.

The detailed and updated information on this medication is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for doctors or healthcare professionals:

Monitor patients closely for signs and symptoms of hypersensitivity reactions during and after each administration of FERIV.

FERIV should only be administered when there is immediate availability of trained personnel to evaluate and treat anaphylactic reactions, in an environment where a complete resuscitation device can be guaranteed. The patient should be observed for at least 30 minutes after each injection of FERIV for any adverse effects.

POSOLLOGY AND ADMINISTRATION METHOD

Adults and Elderly:

The total accumulated doseof FERIV, equivalent to the total iron deficit (mg), is determined by the patient's hemoglobin concentration and weight. For each patient, the dose and dosing regimen of FERIV should be calculated based on the calculation of their total iron deficit.

Total iron deficit [mg]=body weight [kg] x (Hb target - Hb actual) [g/l] x 0.24* + iron deposit [mg]

Up to35 kgof body weight: Hb target = 130 g/l regarding iron deposit = 15 mg/kg body weight.

Over35 kgof body weight: Hb target = 150 g/l regarding iron deposit = 500 mg.

* Factor0.24= 0.0034 x0,07x 1000(Iron content of hemoglobin?0.34%

/Blood volume?7 % of body weight /

Factor 1000 = conversion of g to mg)

The determination of the total amount of FERIV required will be established by the above calculation or in accordance with the following table (based on a Hb target of 130 g/l for a body weight?35 kgand 150 g/l for a body weight >35 kg):

To convert Hb (mM) to Hb (g/l), multiply the first by 16.1145.

Dose:

The total dose of FERIV should be administered in a single dose of 100 mg of iron (one ampoule of FERIV) at most three times a week. However, when clinical circumstances require a rapid supply of iron to the body's deposits, the dosing regimen may be increased to 200 mg of iron at most three times a week.

Administration:

FERIV should be administered only by intravenous route, either by slow intravenous injection or by intravenous perfusion by drip. However, the preferred route of administration is intravenous perfusion by drip, as this can reduce the risk of hypotension and venous extravasation episodes.

FERIV is a strongly alkaline solution and should never be administered subcutaneously or intramuscularly. Also, venous extravasation should be avoided, as extravasation of FERIV at the injection site can cause pain, inflammation, tissue necrosis, sterile abscess, and brown skin discoloration.

Intravenous perfusion by drip:FERIV should only be diluted in a 0.9% sodium chloride solution (normal saline solution). It should bediluted in a maximum of 100 ml of 0.9% sodium chloride solution. For stability reasons, dilutions of lower concentrations of FERIV are not permitted.

The dilution should be performed immediately before perfusion and the solution should be administered as follows:

• 100mg of iron (5ml of FERIV) in 15 minutes or more
• 200mg of iron (10ml of FERIV) in 30 minutes or more

Intravenous injection:The administration of FERIV by slow intravenous injection may be carried out at a rate of 1 ml of undiluted solution per minute (i.e., 5 minutes per ampoule), without exceeding2 ampollas of FERIV (200 mg iron) per injection.

After an intravenous injection, the patient's arm should be extended and elevated, and pressure applied to the injection site for a minimum of 5 minutes to reduce the risk of extravasation.

Injection into a dialyzer::FERIV can be administered during half of a hemodialysis session, directly into the dialyzer's venous line, following the procedures indicated for its intravenous administration.

FERIV should only be mixed with a 0.9% sodium chloride solution. Other intravenous dilution solutions and therapeutic agents should not be used due to the possibility of precipitation and/or interaction. The compatibility of the product with containers other than glass, polyethylene, or PVC is unknown.