Venofer

Package Leaflet: Information for the User

Warning!

The leaflet should be kept. Information on the immediate packaging in a foreign language.

Venofer

Venofer, 20 mg iron(III)/ml, solution for injection and infusion

Ferri hydroxidum saccharum

It is essential to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if their disease symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Venofer and what is it used for
• 2. Important information before administering Venofer to the patient
• 3. How to administer Venofer
• 4. Possible side effects
• 5. How to store Venofer
• 6. Contents of the pack and other information

1. What is Venofer and what is it used for

Venofer solution for intravenous injection replenishes the body's iron stores.
Iron is used in the bone marrow to produce hemoglobin (Hb).
Venofer is used to treat cases of iron deficiency that require replenishment.
The medicine is used especially:

• if there is a clinical need for rapid replenishment of systemic iron stores,
• in patients who do not tolerate oral iron preparations or in whom such medicinal products cannot be administered,
• if oral iron preparations are ineffective (e.g., active inflammatory bowel disease).

2. Important information before administering Venofer to the patient

When not to take Venofer:

• if the patient has anemia that is not caused by iron deficiency;
• if the patient's iron level is too high or their body does not use iron properly;
• if the patient is allergic (hypersensitive) to the medicine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had serious allergic reactions (hypersensitivity) to other injectable iron preparations.

Venofer should not be administered if any of the above points apply. In case of doubt before starting treatment with Venofer, the doctor should be consulted.

Warnings and precautions

Before starting treatment with Venofer, the following should be discussed with the doctor or nurse:

• if the patient has a history of drug allergy;
• if the patient has systemic lupus erythematosus;
• if the patient has rheumatoid arthritis;
• if the patient has severe asthma, eczema, or other atopic allergy;
• if the patient has any infections;
• if the patient has liver problems.

In case of doubt as to whether the above points apply, the doctor or pharmacist should be consulted before starting treatment with Venofer.

Venofer and other medicines

As with all parenteral iron preparations, Venofer should not be used simultaneously with oral iron preparations, as the absorption of oral preparations is reduced in this case.

Pregnancy and breastfeeding

Venofer has not been studied in pregnant women during the first three months of pregnancy. It is essential to inform the doctor if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant.
In case of pregnancy during treatment, the doctor's advice should be sought.
The doctor will decide whether the patient should receive the medicine.
During breastfeeding, the doctor's advice should be sought before taking Venofer.

Driving and using machines

After administration of Venofer, symptoms such as dizziness, confusion, or drowsiness may occur. In this case, the patient should not drive or operate machines until the symptoms have resolved. In case of doubt, the doctor should be consulted.

Venofer contains sodium

Venofer contains up to 7 mg of sodium (the main component of common salt) per ml. This corresponds to 0.4% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to administer Venofer

The doctor will decide what dose of Venofer should be administered. The doctor will also decide how often and for how long the medicine should be administered. To adjust the dose, the doctor will perform blood tests.
The doctor or nurse will administer Venofer in one of the following ways:

• slow intravenous injection - 1 to 3 times a week;
• as an intravenous infusion - 1 to 3 times a week;
• during dialysis - the medicine will be administered into the venous line of the dialysis apparatus. Venofer may only be administered in locations where immediate and appropriate medical care is possible in case of an allergic reaction.

After each administration of the medicine, the patient should remain under the supervision of the doctor or nurse for at least 30 minutes to detect any side effects.

4. Possible side effects

Like all medicines, Venofer can cause side effects, although not everybody gets them.
The most commonly reported side effects in clinical trials were: changes in taste, such as metallic taste, low or high blood pressure, reaction at the injection/infusion site, nausea.
Allergic reactions(may affect up to 1 in 100 people)
If the patient experiences an allergic reaction, they should immediately inform their doctor. Symptoms may include:

• Low blood pressure (dizziness, fainting, fainting).
• Swelling of the face.
• Difficulty breathing.
• Chest pain, which may be a sign of a sometimes severe allergic reaction called Kounis syndrome. If the patient thinks they have had an allergic reaction, they should immediately inform their doctor or nurse.

Other side effects:

Common(may affect up to 1 in 10 people)

• Changes in taste, such as metallic taste. This symptom usually does not persist for a long time.
• Low or high blood pressure.
• Nausea.
• Reactions at the injection/infusion site, such as pain, irritation, itching, hematoma, or skin discoloration due to extravasation of the medicine.

Uncommon(may affect up to 1 in 100 people)

• Headache or dizziness.
• Abdominal pain or diarrhea.
• Vomiting.
• Wheezing, difficulty breathing.
• Itching, rash.
• Muscle spasms, cramps, or muscle pain.
• Feeling of tingling or numbness.
• Decreased sensation of touch.
• Phlebitis.
• Flushing, feeling of burning.
• Constipation.
• Joint pain.
• Pain in the limbs.
• Back pain.
• Chills.
• Weakness, fatigue.
• Swelling of the hands and feet.
• Pain.
• Increased activity of liver enzymes (ALT, AST, GGT) in the blood.
• Increased ferritin levels in serum.

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

• Fainting.
• Drowsiness or lethargy.
• Palpitations.
• Change in urine color.
• Chest pain.
• Excessive sweating.
• Fever.
• Increased activity of lactate dehydrogenase in the blood.

Other side effects with unknown frequency include: feeling of decreased concentration, feeling of confusion; loss of consciousness; anxiety; tremors or shaking; swelling of the face, lips, tongue, or throat, which may cause difficulty breathing; slow heart rate; fast heart rate; circulatory collapse; phlebitis causing thrombosis; acute bronchospasm; itching, hives, rash, or skin redness; cold sweat; general malaise; pallor; anaphylactic shock (a life-threatening allergic reaction). Flu-like symptoms may occur within a few hours to a few days after injection; typical symptoms include: high body temperature and muscle and joint pain.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to: Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Venofer

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store at a temperature below 25°C. Store the ampoules in the outer packaging to protect from light. Do not freeze.
Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Venofer contains

1 ml of solution contains 20 mg of iron in the form of iron(III) hydroxide sucrose complex.
1 ampoule (5 ml) contains 100 mg of iron.
Excipients: sodium hydroxide, solution (for pH adjustment), water for injections.

What Venofer looks like and contents of the pack

Venofer is a sterile, dark brown, non-transparent aqueous solution, intended for intravenous use only, in the form of injections or infusions (after dilution), containing iron(III) hydroxide sucrose complex. The solution also contains sodium hydroxide and water for injections.
Venofer is available in 5 ml ampoules, each containing 100 mg of iron. The ampoules are packaged in cardboard boxes; each box contains 5 ampoules.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in the Czech Republic, the country of export:

Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France

Manufacturer:

Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 12/051/04-C

Parallel import authorization number: 103/23

Date of leaflet approval: 05.06.2023

[Information about the trademark]
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Information intended for healthcare professionals only:

Administration

Patients should be carefully monitored to detect subjective and objective signs of hypersensitivity reactions during each administration of Venofer and after administration.
Venofer should only be administered under the direct supervision of trained medical personnel, in a location equipped with resuscitation equipment. The patient should be monitored for side effects for at least 30 minutes after each administration of Venofer.
Dosing
The cumulative dose of Venofer must be calculated for each patient and must not be exceeded.
Dose calculation:
The total cumulative dose of Venofer, equivalent to the total iron deficiency (mg), is determined based on hemoglobin concentration and body weight. The dose of Venofer must be calculated for each patient based on the total iron deficiency, according to the Ganzoni formula, for example:

Total iron deficiency [mg] = body weight [kg] x (target hemoglobin concentration - current hemoglobin concentration) [g/dl] x 2.4* + tissue iron stores [mg]

* Factor 2.4 = 0.0034 (iron content in hemoglobin = 0.34%) x 0.07 (blood volume = 7% of body weight) x 1000 (conversion factor [g] to [mg]) x 10
The total amount of Venofer (ml) to be administered, depending on the patient's body weight, current Hb concentration, and target Hb concentration*.

To convert hemoglobin concentration from mM to g/dl, multiply the first value by 1.6.
If the total required dose exceeds the maximum allowed single dose, the dose should be divided over time. If no improvement in hematological parameters is observed after 1-2 weeks, the correctness of the initial disease diagnosis should be reconsidered.
Calculating the iron dose in case of iron deficiency caused by blood loss and as a supportive measure during autologous transfusion
The dose of Venofer required to replenish iron deficiency may be calculated according to the following formulas:
If the volume of blood lost is known: administration of 200 mg of iron (10 ml of Venofer) should result in an increase in hemoglobin concentration corresponding to approximately one unit of blood (400 ml with a hemoglobin concentration of 15 g/dl).
If the hemoglobin concentration is lower than expected: the applied formula assumes that there is no need to replenish tissue iron stores. The required amount of iron [mg] = body weight [kg] x 2.4 (target hemoglobin concentration - current hemoglobin concentration) [g/dl]
Intravenous infusion
Venofer must be diluted in a sterile 0.9% m/V sodium chloride (NaCl) solution. The medicine should be diluted immediately before infusion and prepared according to the following instructions:

Intravenous injection
Venofer may be administered by slow intravenous injection at a rate of 1 ml of undiluted solution per minute, not exceeding a volume of 10 ml (200 mg of iron) per injection.
Injection into the venous line of a dialysis apparatus
Venofer may be administered during hemodialysis directly into the venous line of the dialysis apparatus, according to the instructions for intravenous injection.

Incompatibilities

The medicinal product should not be mixed with other medicinal products, except for sterile 0.9% sodium chloride solution for dilution. There is a possibility of precipitation and (or) interaction in the case of mixing with other solutions or medicinal products. The compatibility of the product with containers other than glass, polyethylene, or PCV is not known.

Special precautions for preparation and handling

Before use, the ampoules should be visually inspected for the presence of sediment and damage to the ampoule. Only ampoules containing a sediment-free, homogeneous solution should be used.

Stability and compatibility

Shelf-life after first opening of the container:
From a microbiological point of view, the product should be used immediately.
Shelf-life after dilution of the product in 0.9% m/V sodium chloride (NaCl) solution:
The chemical and physical stability of the solution after preparation is maintained at room temperature for up to 12 hours.
From a microbiological point of view, the preparation should be used immediately after dilution in 0.9% sodium chloride solution. Unless the solution is used immediately, the person who decided to administer the solution later is responsible for determining the storage time and conditions. This time should not exceed 3 hours at room temperature, unless the dilution of the medicine took place under controlled aseptic conditions.