CARBOXIMALTOSA FERRICA SANDOZ 50 mg/ml INJECTABLE DISPERSION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Carboxymaltose Iron Sandoz 50 mg/ml Injectable Dispersion and Perfusion EFG

carboxymaltose iron

Read the entire package leaflet carefully before you are given this medicine,

because it contains important information for you.

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

Contents of the Package Leaflet

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

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

Carboxymaltose Iron Sandoz is a medicine that contains iron.

Medicines that contain iron 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 very quickly to replenish your iron stores.

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

2. What you need to know before you start using Carboxymaltose Iron Sandoz

Do not use Carboxymaltose Iron Sandoz

• if you are allergic (hypersensitive) to carboxymaltose iron or any of the other ingredients of this medicine (listed in section 6),
• if you have experienced severe allergic reactions (hypersensitivity) to other injectable iron preparations,
• if you have anemia that is not caused by iron deficiency,
• if you have iron overload (too much iron in the body) or problems with iron use.

Warnings and precautions

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

• if you have a history of allergies to medicines,
• 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 phosphate levels in the blood.

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

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

Other medicines and Carboxymaltose Iron Sandoz

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

Pregnancy

There are limited data on the use of carboxymaltose iron in pregnant women. It is important that you inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. If you become pregnant during treatment, you should consult your doctor. Your doctor will decide whether you should be given the medicine or not.

Breast-feeding

If you are breast-feeding, consult your doctor before you are given carboxymaltose iron. It is unlikely that carboxymaltose iron will pose a risk to breast-fed infants.

Driving and using machines

It is unlikely that carboxymaltose iron will affect your ability to drive or use machines.

Carboxymaltose Iron Sandoz contains sodium

Vial with 2 ml of dispersion: This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially "sodium-free".

Vial with 10 ml of dispersion: This medicine contains a maximum of 59 mg of sodium (main component of table/cooking salt) in each vial. This corresponds to 2.95% of the maximum recommended daily sodium intake for an adult.

Vial with 20 ml of dispersion: This medicine contains a maximum of 118 mg of sodium (main component of table/cooking salt) in each vial. This corresponds to 5.9% of the maximum recommended daily sodium intake for an adult.

3. How Carboxymaltose Iron Sandoz is administered

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 and older

Your doctor or nurse will administer carboxymaltose iron diluted by perfusion, undiluted by injection, or during dialysis:

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

Children and adolescents 1 to 13 years

The doctor or nurse will administer carboxymaltose iron undiluted by injection or diluted by intravenous perfusion:

• Your child will receive carboxymaltose iron in the vein. It will have a brown appearance.
• If your child is on dialysis, carboxymaltose iron should not be administered.

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

If you are given more Carboxymaltose Iron Sandoz than you should

Since this medicine will be administered by trained medical personnel, it is unlikely that you will receive too high a dose. Overdose may lead to iron accumulation in the body. Your doctor will monitor your iron parameters to avoid iron accumulation.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious 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 (which affect less than 1 in 1,000 people) can be severe or potentially life-threatening (known as anaphylactic reactions) and may be associated with heart or circulatory problems and loss of consciousness.

You should consult a doctor if you get worse tiredness, muscle or bone pain (pain in the arms or legs, joints, or back). This may be a sign of decreased phosphate in the blood, which could cause your bones to soften (osteomalacia). This condition may sometimes cause bone fractures. Your doctor may also check your phosphate levels in the blood, especially if you need several 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 tell your doctor about if they become serious:

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

headache, dizziness, feeling of heat (flushes), hypertension, nausea, and reactions at the injection/perfusion site (see also section 2).

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

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

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

inflammation of a vein, anxiety, fainting, feeling of weakness, wheezing, excessive flatulence, sudden swelling of the face, mouth, tongue, or throat that may make breathing difficult, paleness, and change in skin coloration in areas of the body other than the administration site.

Unknown (frequency cannot be estimated from the available data):loss of consciousness and swelling of the face.

Pseudo-flu syndrome (may affect up to 1 in 1,000 people) may occur a few hours or several days after the 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.

• The following change in blood parameters is common: decrease in blood phosphate.
• The following changes in blood parameters are uncommon: increase in certain liver enzymes called alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, and alkaline phosphatase, and increase in an enzyme called lactate dehydrogenase.

Ask your doctor for more information.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this package leaflet.

You can also report side effects 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.

5. Storage of Carboxymaltose Iron Sandoz

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

Do not use this medicine after the expiry date which is stated on the label after CAD/EXP. The expiry date is the last day of the month stated.

Do not store above 30 °C. Do not freeze. For information on storage conditions after dilution or opening of the medicine, see the section "This information is intended only for healthcare professionals".

Carboxymaltose Iron Sandoz will normally be stored by your doctor or hospital.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Carboximaltosa ferrica Sandoz

The active ingredient is iron (as carboximaltosa ferrica, an iron carbohydrate compound). One ml of dispersion contains 50 mg of iron (as carboximaltosa ferrica).

The other components (excipients) are sodium hydroxide (to adjust pH) (E 524), concentrated hydrochloric acid (E 507) (to adjust pH), and water for injectable preparations.

Appearance of the Product and Container Content

Carboximaltosa ferrica Sandoz is a dark brown, non-transparent injectable and infusion dispersion.

Carboximaltosa ferrica Sandoz is supplied in closed glass vials with a gray rubber stopper and a flip-off aluminum cap, containing:

• 2 ml of dispersion corresponding to 100 mg of iron. Available in formats of 1, 2, and 5 vials.
• 10 ml of dispersion corresponding to 500 mg of iron. Available in formats of 1, 2, and 5 vials.
• 20 ml of dispersion corresponding to 1,000 mg of iron. Available in a format of 1 vial.

Only some package sizes may be marketed.

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d

Verovskova Ulica, 57

1526 Ljubljana

Slovenia

Date of Last Revision of this Leaflet:June 2024.

Other Sources of Information

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

This Information is Intended Only for Healthcare Professionals

Patients should be closely monitored for signs and symptoms of hypersensitivity reactions during and after each administration of carboximaltosa ferrica. Carboximaltosa ferrica Sandoz should only be administered when immediate availability of trained personnel to evaluate and treat anaphylactic reactions is ensured, 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 of adverse effects.

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 the total iron needed. Two doses may be required to replace all the necessary iron; refer to Step 2 for the maximum individual iron doses.

Table 1: Total Iron Needed Determination

Step 2: Calculation and Administration of the Maximum Individual Dose(s) of Iron

Based on the determined iron need, the appropriate dose of carboximaltosa ferrica should be administered, taking into account the following:

Adults and Adolescents 14 Years of Age or Older

A single administration of carboximaltosa ferrica should not exceed:

• 15 mg of iron/kg of body weight (for intravenous injection administration) or 20 mg of iron/kg of body weight (for intravenous infusion administration).
• 1,000 mg of iron (20 ml of Carboximaltosa ferrica Sandoz).

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

Children and Adolescents 1 to 13 Years of Age

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 maximum recommended accumulated 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 at least 7 days after the first dose.

Children Under 1 Year of Age

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

Patients with Chronic Kidney Disease Requiring Hemodialysis

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

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

Method of Administration

Visually inspect the vials for sediment and damage before use. Only use those that contain a homogeneous dispersion free of sediment.

Carboximaltosa ferrica should only be administered intravenously: by injection, by infusion, or during a hemodialysis session without direct dilution in the dialyzer venous line. Carboximaltosa ferrica should not be administered subcutaneously or intramuscularly.

Caution should be exercised 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 Sandoz can be administered by intravenous injection without dilution. In adults and adolescents 14 years of age or older, the maximum single dose is 15 mg of iron/kg of body weight, but not exceeding 1,000 mg of iron. In children 1 to 13 years of age, the maximum single dose is 15 mg of iron/kg of body weight, but not exceeding 750 mg of iron. The administration guidelines are shown in Table 2:

Table 2: Administration Guideline for Intravenous Injection of Carboximaltosa ferrica Sandoz

Intravenous Infusion

Carboximaltosa ferrica Sandoz can be administered by intravenous infusion, in which case it should be diluted. In adults and adolescents 14 years of age or older, the maximum single dose is 20 mg of iron/kg of body weight, but not exceeding 1,000 mg of iron. In children 1 to 13 years of age, the maximum single dose is 15 mg of iron/kg of body weight, but not exceeding 750 mg of iron.

For infusion, carboximaltosa ferrica Sandoz 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 Sandoz should not be diluted to concentrations below 2 mg of iron/ml (not including the volume of the carboximaltosa ferrica dispersion).

Table 3: Dilution Guideline for Carboximaltosa ferrica Sandoz for Intravenous Infusion

Monitoring Measures

The physician should perform a new assessment based on the patient's particular clinical picture. The Hb level should be reevaluated at least 4 weeks after the last administration of carboximaltosa ferrica to allow sufficient time for erythropoiesis and iron utilization. If the patient needs further iron replacement, iron needs should be recalculated using Table 1 above.

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 exceeding the amount necessary to correct the iron deficit at the time of administration may lead to iron accumulation in deposits, which can eventually cause hemosiderosis. Monitoring of iron parameters such as serum ferritin and transferrin saturation can help identify an iron accumulation situation. If iron accumulation occurs, treatment should be according to standard medical practice, for example, considering the use of an iron chelator.

Stability in Use

Validity Period After First Opening of the Vial:

From a microbiological point of view, parenteral preparations should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user. The product administration should be carried out under controlled and validated aseptic conditions.

Chemical and physical stability in use has been demonstrated for 7 days at room temperature (20 - 25 ºC).

Validity Period After Dilution in Polyethylene Bottles (After Dilution with Sterile 0.9% m/v Sodium Chloride Solution):

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions, before use, are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2 to 8 ºC, unless the preparation has taken place in controlled and validated aseptic conditions.

Chemical and physical stability in use has been demonstrated for 24 hours at room temperature (20-25 ºC) at concentrations of: 2 mg/ml, 4 mg/ml, and 5 mg/ml.

Validity Period in Polypropylene Syringe (Undiluted):

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions, before use, are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2 to 8 ºC, unless the preparation has taken place in controlled and validated aseptic conditions.

Chemical and physical stability in use has been demonstrated for 24 hours at room temperature (20 - 25 ºC).