CARBOXIMALTOSA FERRICA TEVA 50 MG/ML Injectable Dispersion and Perfusion Solution

Introduction

Patient Information: Summary of Product Characteristics

Carboxymaltose Iron Teva 50 mg/ml Injectable and Infusion Suspension

Read this entire leaflet carefully before starting to take this medication, as 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 side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What Carboxymaltose Iron Teva is and what it is used for
2. What you need to know before taking Carboxymaltose Iron Teva
3. How Carboxymaltose Iron Teva is administered
4. Possible side effects
5. Storage of Carboxymaltose Iron Teva
6. Package contents and additional information

1. What Carboxymaltose Iron Teva is and what it is used for

Carboxymaltose Iron Teva is 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.

Carboxymaltose iron is used to treat iron deficiency when:

• oral iron is not effective enough.
• you cannot tolerate oral iron.
• your doctor decides that you need iron quickly to replenish your iron stores.

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

2. What you need to know before taking Carboxymaltose Iron Teva

Do not receive Carboxymaltose Iron Teva

• if you are allergic (hypersensitive) to carboxymaltose iron or 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 anemia notcaused by iron deficiency.
• if you have iron overload (too much iron in the body) or problems with iron use.

Warnings and Precautions

Consult your doctor or nurse before starting to receive carboxymaltose iron:

• 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 disease.
• if you have low phosphate levels in your blood.

Incorrect administration of carboxymaltose iron can cause product loss at the injection site, leading to skin irritation and a brown discoloration of the injection site that can last for a long time. If this occurs, administration should be stopped immediately.

Pediatric Population

Carboxymaltose iron should not be administered to children under 1 year of age.

Other Medications and Carboxymaltose Iron Teva

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

E

There is limited data on the use of carboxymaltose iron in pregnant women. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

If you become pregnant during treatment, you should consult your doctor; this will allow the doctor to decide whether you should receive the medication or not.

Breastfeeding

If you are breastfeeding, consult your doctor before carboxymaltose iron is administered. It is unlikely that carboxymaltose iron poses a risk to breastfed infants.

C

Carboxymaltose iron is unlikely to affect your ability to drive or use machines

Carboxymaltose Iron Teva contains sodium

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

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

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

3. How Carboxymaltose Iron Teva is administered

Your doctor will decide how much carboxymaltose iron to administer, how often, 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 receive up to 20 ml of carboxymaltose iron, which corresponds to 1,000 mg of iron, once a week, directly into a vein.
• By infusion, you may receive 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 infusion via the intravenous route, the volume of the solution may be up to 250 ml and will have a brown appearance.
• If you are undergoing 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 is undergoing dialysis, carboxymaltose iron should not be administered.

Carboxymaltose iron will be administered in a facility where immunological allergic reactions can be treated adequately and promptly. After each administration, you will be monitored 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 trained medical personnel, 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 avoid iron accumulation.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Severe side effects:

Tell 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 less than 1 in 1,000 people) can be severe or potentially life-threatening (known as anaphylactic reactions) and may be associated with cardiovascular 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 decreased phosphate levels in the blood, which could cause your bones to soften (osteomalacia). This condition can sometimes cause bone fractures. Your doctor may also monitor phosphate levels in your blood, especially if you need repeated iron treatments over time.

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

Other side effects that you should report to 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).

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

Numbness, tingling, or a sensation of pins and needles in the skin, change in 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 malaise.

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

Venous inflammation, anxiety, fainting, feeling of weakness, wheezing, (flatulence), sudden swelling of the face, mouth, tongue, or throat that may make breathing difficult, pallor, and change in skin coloration in areas of the body other than the injection site.

Unknown(frequency cannot be estimated from available data):

Loss of consciousness and swelling of the face.

Pseudo-flu syndrome (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 pain in the muscles and joints.

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

A frequent change in blood parameters is a decrease in phosphate levels in the blood.

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

Ask your doctor for more information.

Reporting side effects

If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Carboxymaltose Iron Teva

Keep this medication out of the sight and reach of children

Do not use this medication after the expiration date stated on the packaging/label after EXP. The expiration date is the last day of the month indicated.

Do not store 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 only for healthcare professionals".

Normally, the medication will be stored by the doctor or hospital.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Carboxymaltose Iron Teva

The active ingredient is carboxymaltose iron, an iron carbohydrate complex.

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

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

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

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

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

Appearance of the product and package contents

Carboxymaltose Iron Teva is a dark brown, non-transparent injectable and infusion suspension.

Carboxymaltose Iron Teva is available in glass vials containing:

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer:

PLIVA Croatia Ltd.,

Prilaz baruna Filipovica 25,

10000 Zagreb,

Croatia

For further information about this medication, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Date of the last revision of this leaflet:February 2024

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your smartphone. 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 Carboximaltosa ferrica Teva.

Carboximaltosa ferrica should only be administered when immediate availability of trained personnel to evaluate and treat anaphylactic reactions is present, 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 carboximaltosa ferrica in case adverse effects occur.

The dosage of carboximaltosa ferrica should follow these guidelines gradually:

Step 1: Determination of iron needed

Individual iron needs for replacement with carboximaltosa ferrica are determined based on the patient's body weight and hemoglobin (Hb) level. Refer to Table 1 for the determination of total iron needed. Two doses may be necessary to replace all the necessary iron; refer to Step 2 for maximum individual iron doses.

Iron deficiency should be confirmed with analytical tests.

Table 1: Determination of total iron needed

Step 2: Calculation and administration of maximum individual dose(s) of iron

According to the determined total iron need, the appropriate dose of carboximaltosa ferrica should be administered, taking into account the following:

Adults and adolescents 14 years or older

A single administration of carboximaltosa ferrica 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 infusion)
• 1,000 mg of iron (20 ml of carboximaltosa ferrica)

The recommended maximum cumulative dose of carboximaltosa ferrica per week is 1,000 mg of iron (20 ml of carboximaltosa ferrica). If the total iron needed is higher, the administration of an additional dose should be done at least 7 days after the first dose.

Children and adolescents 1 to 13 years

A single administration of carboximaltosa ferrica should not exceed:

• 15 mg of iron/kg of body weight
• 750 mg of iron (15 ml of carboximaltosa ferrica)

The recommended maximum cumulative dose of carboximaltosa ferrica is 750 mg of iron (15 ml of carboximaltosa ferrica) per week. If the total iron needed is higher, the administration of an additional dose should be done at least 7 days after the first dose.

Step 3: Evaluations after iron replacement

The doctor should carry out a new evaluation based on the patient's particular clinical picture. The Hb level should be reevaluated once at least 4 weeks have passed after the last administration of carboximaltosa ferrica, to allow sufficient time for erythropoiesis and iron use. If the patient needs further iron replacement, iron needs should be recalculated (see Step 1).

Children under 1 year

The use of carboximaltosa ferrica is not recommended in children under 1 year.

Patients with chronic kidney disease undergoing hemodialysis

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

The use of carboximaltosa ferrica is not recommended in children 1 to 13 years with chronic kidney disease requiring hemodialysis.

Method of administration

Before use, vials should be visually inspected for sediment or defects. Only use vials with a homogeneous dispersion and no sediment.

Each vial of carboximaltosa ferrica is for single use only.

Carboximaltosa ferrica should only be administered intravenously:

• by injection or
• by infusion or
• during a hemodialysis session without direct dilution in the dialyzer's venous arm.

Carboximaltosa ferrica should not be administered subcutaneously or intramuscularly.

Caution should be taken to avoid paravenous spillage when administering carboximaltosa ferrica. Paravenous spillage of carboximaltosa ferrica at the administration site may cause skin irritation and possible long-lasting brown discoloration. In case of paravenous spillage, administration of carboximaltosa ferrica should be immediately interrupted.

Intravenous injection

Carboximaltosa ferrica 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. Administration guidelines are shown in Table 2:

Table 2: Administration guideline for intravenous injection of carboximaltosa ferrica

Intravenous infusion

Carboximaltosa ferrica can be administered by intravenous infusion, 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 infusion, carboximaltosa ferrica can only be diluted in a sterile 0.9% m/V sodium chloride solution as shown in Table 3. Note: For stability reasons, carboximaltosa ferrica should not be diluted to concentrations below 2 mg of iron/ml (excluding the volume of the carboximaltosa ferrica dispersion).

Table 3: Dilution guideline for carboximaltosa ferrica for intravenous infusion

Incompatibilities

Oral iron absorption 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 carboximaltosa ferrica.

Overdose

Administration of carboximaltosa ferrica in quantities greater than the amount needed to correct iron deficiency at the time of administration may lead to iron accumulation in deposits, which in the long term will 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 according to usual medical practice, i.e., consider the use of an iron chelator.

Stability in use

Validity period once the container is opened:

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

If not used immediately, the times and conditions of storage prior to use are the responsibility of the user.

Validity period after dilution with sterile 0.9% m/V sodium chloride solution:

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

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