Micafungin Zentiva

Leaflet accompanying the packaging: patient information

Micafungin Zentiva, 50 mg, powder for concentrate for solution for infusion

Micafungin Zentiva, 100 mg, powder for concentrate for solution for infusion

Micafungin

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Micafungin Zentiva and what is it used for
• 2. Important information before taking Micafungin Zentiva
• 3. How to take Micafungin Zentiva
• 4. Possible side effects
• 5. How to store Micafungin Zentiva
• 6. Contents of the packaging and other information

1. What is Micafungin Zentiva and what is it used for

Micafungin Zentiva contains the active substance micafungin. The medicine is an antifungal medicine, as it is used to treat infections caused by fungal cells. Micafungin Zentiva is used to treat fungal infections caused by fungal cells or yeast called Candida. Micafungin Zentiva is effective in treating systemic infections (those that have spread throughout the body). It affects the process of creating a component of the fungal cell wall. An intact cell wall is necessary for the proper development and growth of fungal cells. Micafungin Zentiva damages the cell wall, preventing further development and growth of the fungus. Your doctor will prescribe Micafungin Zentiva in the following cases, if no other suitable antifungal treatment is available (see section 2): treatment of adults, adolescents, and children, including newborns, with severe fungal infections called invasive candidiasis (an infection that penetrates the body); treatment of adults and adolescents aged 16 years and older with fungal infection of the esophagus, where the medicine is to be administered into a vein (intravenous administration); prophylaxis of Candidainfections in patients undergoing allogeneic hematopoietic stem cell transplantation or in patients who are expected to develop neutropenia (decreased number of neutrophils, a type of white blood cell) lasting 10 days or more.

2. Important information before taking Micafungin Zentiva

When not to take Micafungin Zentiva

If the patient is allergic (hypersensitive) to micafungin, other echinocandins (Ecalta or Cancidas), or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Long-term treatment with micafungin in rats led to liver damage and subsequently to liver tumors. The potential risk of developing liver tumors in humans is unknown; before starting treatment, the doctor will assess the benefits and risks of using Micafungin Zentiva. You should tell your doctor if you have severe liver disease (e.g., liver failure or hepatitis) or if abnormal liver function test results have been found. During treatment, liver function will be closely monitored. Before starting Micafungin Zentiva, you should discuss this with your doctor or pharmacist if you are allergic to any medicine; if you have hemolytic anemia (anemia caused by red blood cell breakdown) or hemolysis (red blood cell breakdown); if you have kidney disease (e.g., kidney failure and abnormal kidney function test results). In this case, your doctor may order closer monitoring of kidney function. Micafungin Zentiva may cause severe inflammation and (or) skin and mucous membrane lesions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Micafungin Zentiva and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. It is especially important to tell your doctor about the use of amphotericin B deoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressive medicine), or nifedipine (a calcium antagonist used to treat high blood pressure). Your doctor may decide to adjust the dose of these medicines.

Micafungin Zentiva with food and drink

Since Micafungin Zentiva is administered intravenously (into a vein), there are no restrictions on taking the medicine with food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. Micafungin Zentiva should not be used during pregnancy unless your doctor considers it absolutely necessary. While taking Micafungin Zentiva, you should not breastfeed.

Driving and using machines

It is unlikely that Micafungin Zentiva will affect your ability to drive or use machines. However, some patients may experience dizziness while taking this medicine, and in such cases, you should not drive or use machines. You should inform your doctor if you experience any effects that may cause difficulties in driving or using machines.

Micafungin Zentiva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml, which means the medicine is considered "sodium-free".

3. How to take Micafungin Zentiva

Micafungin Zentiva must be prepared and administered by a doctor or other medical personnel. Micafungin Zentiva should be administered once a day in a slow intravenous infusion (into a vein). The daily dose of the medicine is determined by your doctor.

Use in adults, adolescents aged 16 years and older, and elderly patients

In the treatment of invasive Candidainfection, a dose of 100 mg per day is usually used for patients with a body weight greater than 40 kg, and 2 mg/kg body weight per day for patients with a body weight of 40 kg or less. In the treatment of Candidaesophagitis, the daily dose is 150 mg for patients with a body weight greater than 40 kg, and 3 mg/kg body weight per day for patients with a body weight of 40 kg or less. In the prophylaxis of invasive Candidainfections, a dose of 50 mg per day is usually used for patients with a body weight greater than 40 kg, and 1 mg/kg body weight per day for patients with a body weight of 40 kg or less.

Use in children over 4 months of age and adolescents under 16 years of age

In the treatment of invasive Candidainfection, a dose of 100 mg per day is usually used for patients with a body weight greater than 40 kg, and 2 mg/kg body weight per day for patients with a body weight of 40 kg or less. In the prophylaxis of invasive Candidainfections, a dose of 50 mg per day is usually used for patients with a body weight greater than 40 kg, and 1 mg/kg body weight per day for patients with a body weight of 40 kg or less.

Use in children and newborns under 4 months of age

In the treatment of invasive Candidainfection, a dose of 4 mg/kg body weight per day to 10 mg/kg body weight per day is usually used. In the prophylaxis of invasive Candidainfections, a dose of 2 mg/kg body weight per day is usually used.

Using a higher dose of Micafungin Zentiva than recommended

Your doctor will determine the correct dose of Micafungin Zentiva based on your response to treatment and your health condition. If you are unsure whether too high a dose of Micafungin Zentiva has been used, you should contact your doctor or other medical personnel immediately.

Missing a dose of Micafungin Zentiva

Your doctor will decide whether treatment with Micafungin Zentiva is necessary based on your response to treatment and your health condition. If you are unsure whether you have missed a dose of Micafungin Zentiva, you should contact your doctor or other medical personnel immediately. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

If an allergic reaction or severe skin reaction (e.g., blistering and peeling of the skin) occurs

you should immediately inform your doctor or nurse. Micafungin Zentiva may cause the following other side effects: Common (may occur in up to 1 in 10 patients) abnormal blood test results (decreased white blood cell count [leukopenia; neutropenia]); decreased red blood cell count (anemia) decreased potassium levels in the blood (hypokalemia); decreased magnesium levels in the blood (hypomagnesemia); decreased calcium levels in the blood (hypocalcemia) headache inflammation of the vein wall (at the injection site) nausea (nausea); vomiting; diarrhea; abdominal pain abnormal liver function test results (increased alkaline phosphatase activity, increased aspartate aminotransferase activity, increased alanine aminotransferase activity) increased bilirubin levels in the blood (hyperbilirubinemia) rash fever chills Uncommon (may occur in up to 1 in 100 patients) abnormal blood test results (decreased blood cell count [pancytopenia]); decreased platelet count (thrombocytopenia); increased count of a certain type of white blood cell (eosinophils); decreased albumin levels in the blood (hypoalbuminemia) hypersensitivity increased sweating decreased sodium levels in the blood (hyponatremia); increased potassium levels in the blood (hyperkalemia); decreased phosphate levels in the blood (hypophosphatemia); anorexia (loss of appetite) insomnia (sleep problems); anxiety; confusion drowsiness (drowsiness); tremors; dizziness rapid heartbeat; stronger heartbeat; irregular heartbeat high or low blood pressure; flushing of the skin shortness of breath constipation; indigestion liver failure; increased activity of liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders); bile duct obstruction before it enters the intestine (cholestasis); liver enlargement; hepatitis itching rash; itching; skin redness (erythema) abnormal kidney function test results (increased creatinine levels in the blood; increased urea levels in the blood); worsening kidney failure increased activity of an enzyme called lactate dehydrogenase blood clot in the vein at the injection site; inflammation at the injection site; pain at the injection site; fluid retention in the body Rare (may occur in less than 1 in 1,000 patients) anemia caused by red blood cell breakdown (hemolytic anemia), red blood cell breakdown (hemolysis) Unknown (frequency cannot be estimated from available data) blood clotting disorder anaphylactic shock (allergic shock) liver cell damage, including fatal cases kidney problems; acute kidney failure.

Additional side effects occurring in children and adolescents

The following reactions were observed more frequently in pediatric patients than in adult patients: Common (may occur in up to 1 in 10 patients) decreased platelet count (thrombocytopenia) rapid heartbeat (tachycardia) high or low blood pressure increased bilirubin levels in the blood (hyperbilirubinemia); liver enlargement acute kidney failure; increased urea levels in the blood

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Micafungin Zentiva

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the vial and carton after EXP. The expiry date refers to the last day of that month. Closed vials do not require special storage conditions. The reconstituted concentrate and diluted solution for infusion should be administered immediately, as they do not contain any preservatives to prevent bacterial contamination. This medicine can only be prepared for use by a trained healthcare professional after carefully reading the entire instructions. Do not use the diluted solution if it is cloudy or contains precipitate. To protect from light, the bottle (bag) containing the diluted solution should be placed in a closed, non-transparent cover. The vial is for single use only. Any unused reconstituted concentrate should be discarded immediately.

6. Contents of the packaging and other information

What Micafungin Zentiva contains

• The active substance of the medicine is micafungin (as sodium salt). Each vial contains 50 mg or 100 mg of micafungin (as sodium salt).
• The other ingredients are lactose monohydrate, citric acid, and sodium hydroxide.

What Micafungin Zentiva looks like and contents of the pack

Micafungin Zentiva 50 mg or 100 mg, powder for concentrate for solution for infusion, is a white or off-white, lyophilized powder. Micafungin Zentiva is available in packs containing 1 vial.

Marketing authorization holder

Zentiva k.s. U Kabelovny 130 Dolni Měcholupy 102 37 Prague 10 Czech Republic

Manufacturer

LABORATORI FUNDACIÓ DAU C/C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Iceland, Poland Micafungin Zentiva

For further information about this medicine, you should contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw tel: +48 22 375 92 00

Date of last revision of the leaflet:

Information intended only for healthcare professionals:

Micafungin Zentiva should not be mixed or administered in infusion with other medicinal products, except for those listed below. Under aseptic conditions and at room temperature, Micafungin Zentiva should be prepared as follows: 1. The plastic cap should be removed from the vial and the stopper disinfected with alcohol. 2. Under aseptic conditions, 5 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) should be slowly injected into each vial, along the inner wall. Although the concentrate will foam, you should try to minimize the amount of foam formed. To obtain the correct dose of the medicine in mg, the concentrate should be prepared using the appropriate number of Micafungin Zentiva vials (see the table below). 3. The vial should be gently rotated along its longer axis. DO NOT SHAKE! The powder will dissolve completely. The reconstituted concentrate should be used immediately. The vial is for single use only. Any reconstituted but unused concentrate should be discarded immediately. 4. The entire contents of the reconstituted concentrate should be transferred from each vial to an infusion solution bottle (bag) from which the solution was initially taken. The diluted solution for infusion should be administered immediately. The reconstituted solution remains chemically and physically stable for 96 hours at 25°C, provided it is protected from light and diluted as instructed above. 5. The infusion solution bottle (bag) should be gently turned to ensure thorough mixing of the diluted solution and SHOULD NOT BE SHAKEN to avoid foaming. The solution should not be administered if it is cloudy or contains precipitate. 6. The bottle (bag) containing the diluted solution should be placed in a closed, non-transparent cover to protect it from light. 7. Only a clear and colorless solution without particles should be used.

Preparation of the infusion solution

Standard infusion solution (after dilution to

100 ml)

Final concentration

50 1 x 50 5 ml approximately 5 ml (10 mg/ml) 0.5 mg/ml 100 1 x 100 5 ml approximately 5 ml (20 mg/ml) 1.0 mg/ml 150 1 x 100 + 1 x 50 5 ml approximately 10 ml 1.5 mg/ml 200 2 x 100 5 ml approximately 10 ml 2.0 mg/ml After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour.

Dose (mg)

Number of Micafungin Zentiva vials to use

Micafungin Zentiva (mg/vial)

Volume of sodium chloride (0.9%) or glucose (5%) solution to add to the vial

that should be added to the vial

Volume (concentration) of the reconstituted powder