Patient Information Leaflet

Carboxymaltose Iron Teva 50 mg/ml Injectable Suspension and for Infusion

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

Table of Contents

1. What is Carboxymaltose Iron Teva and what it is used for
2. What you need to know before using Carboxymaltose Iron Teva
3. How to administer Carboxymaltose Iron Teva
4. Possible side effects
5. Storage of Carboxymaltose Iron Teva
6. Contents of the pack and additional information

Carboximaltosa Ferrica Tevais a medication that contains iron.

Iron-containing medications are used when there is not enough iron in the body. This condition is called iron deficiency.

Carboximaltosa Ferricais used to treat iron deficiency when:

• oral iron is not sufficiently effective.
• you cannot tolerate oral iron.
• your doctor decides that you need iron very quickly to replenish your iron reserves.

Your doctor will determine if you have iron deficiency by performing a blood test.

Do not receive Carboximaltosa férrica Teva

• if you are allergic (hypersensitive) to carboximaltosa férrica 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 anemianotcaused by iron deficiency.
• if you have iron overload (too much iron in the body) or problems with iron utilization.

Warnings and precautions

Consult with your doctor or nurse before starting to receive carboximaltosa férrica:

• 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 any infection.
• if you have any liver disorder.
• if you have or have had low levels of phosphate in the blood.

Incorrect administration of carboximaltosa férrica may cause product loss at the administration site, which may lead to skin irritation and a brown discoloration of the administration site that may last for a long time. If this occurs, administration should be stopped immediately.

Pediatric population

Do not administer carboximaltosa férrica to children under 1 year of age.

Other medications and Carboximaltosa férrica Teva

Inform your doctor if you are using, have used recently, or may need to use any other medication, including medications obtained without a prescription. If carboximaltosa férrica is administeredtogether with oral iron preparations, the oral preparations may be less effective.

Pregnancy

There are few data on the use of carboximaltosa férrica in pregnant women. If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

If you become pregnant during treatment, you should consult your doctor; in this way, the doctor can decide whether to administer the medication or not.

Lactation

If you are breastfeeding, consult with your doctor before receivingcarboximaltosa férrica. It is unlikely that carboximaltosa férricawill pose a risk to the infant.

Driving and operating machines

It is unlikely thatcarboximaltosa férricawill affect the ability to drive and operate machines.

Carboximaltosa férrica Teva contains sodium

2 ml vial of dispersion: This medication contains less than 1 mmol of sodium (23 mg) per vial, which is essentially “sodium-free”.

10 ml vial of dispersion: This medication contains up to 46 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 2.3% of the maximum daily sodium intake recommended for an adult.

20 ml vial of dispersion: This medication contains up to 92 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 4.6% of the maximum daily sodium intake recommended for an adult.

Your doctor will decide how much carboxymaltose iron to administer, how often you need it, and for how long.

Your doctor will perform a blood test to determine the dose you need.

Adults and adolescents 14 years or older

The doctor or nurse will administer this medication undiluted by injection, diluted by intravenous infusion, or during dialysis:

• By injection, you may be administered up to 20 ml of carboxymaltose iron, which corresponds to 1,000 mg of iron, once a week, directly into a vein.
• With infusion, you may be administered up to 20 ml of carboxymaltose iron, which corresponds to 1,000 mg of iron, once a week directly into a vein. Since carboxymaltose iron is diluted with sodium chloride solution for intravenous infusion, the solution volume may be up to 250 ml and will have a brown appearance.
• If you undergo dialysis, you may receive carboxymaltose iron during a hemodialysis session through the dialyzer.

Children and adolescents 1 to 13 years

The doctor or nurse will administer this medication undiluted by injection or diluted by intravenous infusion:

• Your child will receive carboxymaltose iron directly into the vein. It will have a brown appearance.
• If your child undergoes dialysis, carboxymaltose iron should not be administered.

Carboxymaltose iron will be administered in a facility where allergic reactions can be treated promptly and adequately. After each administration, you will remain under observation for at least 30 minutes under the supervision of the doctor or nurse.

If you receive more Carboxymaltose Iron Teva than you should

Since this medication will be administered by a qualified medical professional, it is unlikely that you will receive an excessive dose.

Overdose may cause iron accumulation in the body. Your doctor will monitor your iron parameters to prevent iron accumulation.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects:

Inform your doctor immediately if you experience any of the following signs and symptoms that may indicate a severe allergic reaction: skin rash (e.g., hives), itching, difficulty breathing, wheezing, and/or swelling of the lips, tongue, throat, or body, and chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

In some patients, these allergic reactions (affecting fewer than 1 in 1,000 people) may be severe or potentially life-threatening (known as anaphylactic reactions) and may be associated with cardiovascular or circulatory problems and loss of consciousness.

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 may sometimes cause fractures in the bones. The doctor may also monitor phosphate levels in the blood, especially if you need multiple treatments with iron over time.

Your doctor is aware of these possible side effects and will monitor you during and after the administration of ferric carboxymaltose.

Other side effects that you should inform your doctor if they become severe:

Frequent(may affect up to 1 in 10 people):

Headache, dizziness, feeling of heat (flushing), hypertension, nausea, and reactions at the injection/infusion site (see also section 2).

Infrequent(may affect up to 1 in 100 people):

Numbness, tingling, or prickling sensation in the skin, change in sense of taste, increased heart rate, low blood pressure, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diarrhea, itching, hives, skin redness, skin rash, muscle pain, joint pain, and/or back pain, pain in the arms or legs, muscle spasms, fever, fatigue, chest pain, swelling of the hands and/or feet, chills, and general discomfort.

Rare(may affect up to 1 in 1,000 people):

Vein inflammation, anxiety, fainting, feeling of weakness, excessive wheezing, (flatulence), sudden swelling of the face, mouth, tongue, or throat that may make breathing difficult, paleness and change in skin color in other parts of the body different from the administration site.

Unknown(frequency cannot be estimated with available data):

Loss of consciousness and facial swelling.

Psuedogripal illness (may affect up to 1 in 1,000 people) may occur several hours or days after injection and is usually characterized by symptoms such as elevated temperature and muscle and joint pain.

Some blood parameters may be temporarily altered, which could be detected in laboratory tests.

It is common for the following changes in blood parameters to occur: decrease in blood phosphate levels.

The following changes in blood parameters are infrequent: increase in certain liver enzymes called alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, and alkaline phosphatase, and increase in an enzyme called lactate dehydrogenase.

Consult your doctor for more information.

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

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

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging/label after CAD.The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

To know the storage conditions after dilution or after the first opening of the medication, see the section “This information is intended solely for healthcare professionals”.

Normally, it will be the doctor or the hospital that stores this medication.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment

Composition of Carboxymaltose Ferric Teva

The active ingredient is carboxymaltose ferric, a carbon hydrate iron compound.

The iron concentration present in the product is 50 mg per milliliter.

Each 2 ml vial contains 100 mg of iron (as carboxymaltose ferric).

Each 10 ml vial contains 500 mg of iron (as carboxymaltose ferric).

Each 20 ml vial contains 1,000 mg of iron (as carboxymaltose ferric)

The other components (excipients) are sodium hydroxide (to adjust the pH), hydrochloric acid (to adjust the pH), and water for injectable preparations..

Appearance of the product and contents of the package

Carboxymaltose Ferric Tevais a dark brown, non-transparent injectable and perfusion dispersion.

Carboxymaltose Ferric Tevais presented in glass vials containing:

• 2 ml of dispersion. Available package sizes: 1, 2, and 5 vials.
• 10 ml of dispersion. Available package sizes: 1, 2, and 5 vials.
• 20 ml of dispersion. Available package size: 1 vial.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible for manufacturing:

PLIVA Croatia Ltd.,

Prilaz baruna Filipovica 25,

10000 Zagreb,

Croatia

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

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

Date of the last review of this leaflet:February 2024

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning with your smartphone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89432/P_89432.html

QR code + URL

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This information is intended solely for healthcare professionals

Closely monitor patients for signs and symptoms of hypersensitivity reactions during and after each administration of Carboxymaltose Ferric Teva.

Carboxymaltose ferric 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 administration of carboxymaltose ferric for potential adverse effects.

The dosage of carboxymaltose ferric should follow the following gradual guidelines:

Step 1: Determination of the necessary iron

The individual iron needs for replacement with carboxymaltose ferric are determined based on the patient's body weight and hemoglobin (Hb) level. Consult Table 1 for the determination of the total necessary iron. Two doses may be necessary to replace all the necessary iron, consult Step 2 for the maximum individual iron doses.

The iron deficiency should be confirmed with analytical tests.

Table 1: Determination of the total necessary iron

Step 2: Calculation and administration of the maximum individual iron dose

Based on the total necessary iron determined, the appropriate dose of carboxymaltose ferric should be administered, taking the following into account:

Adults and adolescents 14 years or older

A single administration of carboxymaltose ferric should not exceed:

• 15 mg of iron/kg of body weight (for intravenous injection) or 20 mg of iron/kg of body weight (for intravenous perfusion)
• 1,000 mg of iron (20 ml of carboxymaltose ferric)

The maximum recommended weekly accumulated dose of carboxymaltose ferric is 1,000 mg of iron (20 ml of carboxymaltose ferric). If the total necessary iron is higher, the administration of an additional dose should be made at least 7 days after the first dose.

Children and adolescents 1 to 13 years

A single administration of carboxymaltose ferric should not exceed:

• 15 mg of iron/kg of body weight
• 750 mg of iron (15 ml of carboxymaltose ferric)

The maximum recommended weekly accumulated dose of carboxymaltose ferric is 750 mg of iron (15 ml of carboxymaltose ferric). If the total necessary iron is higher, the administration of an additional dose should be made at least 7 days after the first dose.

Step 3: Evaluations after iron replacement

The doctor should perform a new evaluation based on the patient's particular clinical picture. The hemoglobin level should be reevaluated at least 4 weeks after the last administration of carboxymaltose ferric, to allow sufficient time for erythropoiesis and iron utilization. If the patient needs more iron replacement, the iron needs should be recalculated (see Step 1).

Children under 1 year

The use of carboxymaltose ferric is not recommended in children under 1 year.

Patients with chronic nephropathy who depend on hemodialysis

In adults and adolescents 14 years or older, a single daily maximum dose of 200 mg of iron should not be exceeded in patients with chronic nephropathy who depend on hemodialysis.

The use of carboxymaltose ferric is not recommended in children 1 to 13 years with chronic nephropathy who need hemodialysis.

Administration form

Before use, the vials should be visually inspected for sediment or defects. Only those vials whose dispersion is homogeneous and free of sediment should be used.

Each vial of carboxymaltose ferric is only for single use.

Carboxymaltose ferric should only be administered intravenously:

• by injection or
• by perfusion or
• during a hemodialysis session without diluting directly in the venous arm of the dialyzer.

Carboxymaltose ferric should not be administered subcutaneously or intramuscularly.

Care should be taken to avoid paravenous spillage when administering carboxymaltose ferric. Paravenous spillage of carboxymaltose ferric at the administration site may cause skin irritation and possible long-term brown discoloration. In case of paravenous spillage, administration of carboxymaltose ferric should be stopped immediately.

Intravenous injection

Carboxymaltose ferric can be administered by intravenous injection using the undiluted dispersion. In adults and adolescents 14 years or older, the maximum single dose is 15 mg of iron/kg of body weight, but should not exceed 1,000 mg of iron. In children 1 to 13 years, the maximum individual dose is 15 mg/kg of body weight, but should not exceed 750 mg of iron. The administration guidelines are shown in Table 2:

Table 2: Administration guidelines for intravenous injection of carboxymaltose ferric

Intravenous perfusion

Carboxymaltose ferric can be administered by intravenous perfusion, in which case it should be diluted. In adults and adolescents 14 years or older, the maximum single dose is 20 mg of iron/kg of body weight, but should not exceed 1,000 mg of iron. In children 1 to 13 years, the maximum individual dose is 15 mg of iron/kg of body weight, but should not exceed 750 mg of iron.

For perfusion, carboxymaltose ferric can only be diluted in a sterile 0.9% sodium chloride solution as shown in Table 3. Note: for stability reasons, carboxymaltose ferric should not be diluted to concentrations below 2 mg of iron/ml (excluding the volume of the carboxymaltose ferric dispersion).

Table 3: Dilution guidelines for carboxymaltose ferric for intravenous perfusion

Incompatibilities

The oral absorption of iron is reduced when administered simultaneously with parenteral iron preparations. Therefore, if necessary, oral iron therapy should not be started until at least 5 days have passed since the last administration of carboxymaltose ferric.

Overdose

The administration of carboxymaltose ferric in amounts exceeding the amount necessary to correct the iron deficiency at the time of administration may lead to the accumulation of iron in deposits, which will eventually produce hemosiderosis. Monitoring of iron parameters such as serum ferritin and transferrin saturation (TSAT) may help recognize iron accumulation. If iron accumulation occurs, treatment should be made in accordance with standard medical practice, i.e., considering the use of an iron chelator.

Stability in use

Validity periodonce the package is opened:

From a microbiological point of view, unless the opening method excludes the risk of microbial contamination, parenteral preparations should be used immediately.

Unless used immediately, the times and conditions of conservation prior to use are the responsibility of the user.

Validity periodafter dilution with sterile 0.9% sodium chloride solution:

Chemical and physical stability has been demonstrated for 24 hours between 15°C and 25°C.

From a microbiological point of view, parenteral preparations should be used immediately. Unless used immediately, the times and conditions of conservation prior to use are the responsibility of the user and, generally, should not exceed 24 hours between 15°C and 25°C, unless the dilution is carried out in controlled and validated aseptic conditions.