Micafungin Pharmazac

Leaflet accompanying the packaging: information for the user

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

infusion solution

Micafungin Pharmazac, 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 or pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Micafungin Pharmazac contains the active substance micafungin. Micafungin Pharmazac is called an antifungal medicine because it is used to treat infections caused by fungi.
Micafungin Pharmazac is used to treat fungal infections caused by fungi or yeasts called Candida. Micafungin Pharmazac is effective in treating systemic infections (those that have entered 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 Pharmazac damages the cell wall, preventing further development and growth of fungi.
The doctor will prescribe Micafungin Pharmazac 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 (generalized body infection);
• treatment of adults and adolescents over 16 years of age with fungal infection of the esophagus, where intravenous administration of the medicine is justified (intravenous treatment);
• prevention of Candida infections in patients undergoing allogeneic hematopoietic stem cell transplantation or in patients who are expected to develop neutropenia (decrease in the number of neutrophils; a type of white blood cell) lasting 10 or more days.

2. Important information before using Micafungin Pharmazac

When not to use Micafungin Pharmazac

• 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 Pharmazac. 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 Pharmazac, you should discuss it with your doctor or pharmacist

• if the patient is allergic to any medicine;
• if the patient has hemolytic anemia (anemia caused by red blood cell breakdown) or hemolysis (red blood cell breakdown);
• if the patient has kidney disease (e.g., kidney failure and abnormal kidney function test results). In such cases, the doctor may order closer monitoring of kidney function.

Micafungin may cause severe skin and mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Micafungin Pharmazac and other medicines

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

Micafungin Pharmazac with food and drink

Since Micafungin Pharmazac is administered intravenously, 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 using this medicine.
Micafungin Pharmazac should not be used during pregnancy unless it is absolutely necessary.
While using Micafungin Pharmazac, you should not breastfeed.

Driving and using machines

It is unlikely that micafungin will affect your ability to drive vehicles or operate machinery. However, some patients may experience dizziness while taking the medicine, and in such cases, you should not drive or operate machinery. You should inform your doctor if you experience any effects that may cause difficulties in driving or operating machinery.

Micafungin Pharmazac contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially sodium-free.

3. How to use Micafungin Pharmazac

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

Use in adults, adolescents over 16 years of age, and elderly patients

• In the treatment of invasive Candida infection, a dose of 100 mg per day is usually used for patients with a body weight of 40 kg or more, and 2 mg/kg per day for patients with a body weight of 40 kg or less.

in the treatment of Candida esophagitis, the daily dose is 150 mg for patients with a body weight over 40 kg, and 3 mg/kg per day for patients with a body weight of 40 kg or less.

• In the prevention of invasive Candida infections, a dose of 50 mg per day is usually used for patients with a body weight over 40 kg, and 1 mg/kg 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 Candida infection, a dose of 100 mg per day is usually used for patients with a body weight of 40 kg or more, and 2 mg/kg per day for patients with a body weight of 40 kg or less.
• In the prevention of invasive Candida infections, a dose of 50 mg per day is usually used for patients with a body weight over 40 kg, and 1 mg/kg 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 Candida infection, a dose of 4 mg/kg per day to 10 mg/kg per day is usually used.
• In the prevention of invasive Candida infections, a dose of 2 mg/kg per day is usually used.

Use of a higher than recommended dose of Micafungin Pharmazac

The doctor will determine the correct dose of Micafungin Pharmazac based on the patient's response to treatment and health status. If there are any doubts about whether too high a dose of Micafungin Pharmazac has been used, you should immediately contact a doctor or other medical personnel.

Missing a dose of Micafungin Pharmazac

The doctor will decide whether treatment with Micafungin Pharmazac is necessary based on the patient's response to treatment and health status. If there are any doubts about whether a dose of Micafungin Pharmazac has been missed, you should immediately contact a doctor or other medical personnel.
In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Micafungin Pharmazac 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 Pharmazac may cause the following other side effects:

Common (may occur in less than 1 in 10 patients)

• abnormal blood test results (decrease in the number of white blood cells [leukopenia; neutropenia]); decrease in the number of red blood cells (anemia)
• decrease in potassium levels in the blood (hypokalemia); decrease in magnesium levels in the blood (hypomagnesemia); decrease in 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 less than 1 in 100 patients)

• abnormal blood test results (decrease in the number of blood cells [pancytopenia]); decrease in the number of platelets (thrombocytopenia); increase in the number of a certain type of white blood cells (eosinophils); decrease in albumin levels in the blood (hypoalbuminemia)
• hypersensitivity
• increased sweating
• decrease in sodium levels in the blood (hyponatremia); increase in potassium levels in the blood (hyperkalemia); decrease in phosphate levels in the blood (hypophosphatemia); anorexia (loss of appetite)
• insomnia (sleep problems); anxiety; confusion
• drowsiness (drowsiness); tremors; dizziness; taste disorders
• rapid heartbeat; stronger heartbeat; irregular heartbeat
• high or low blood pressure; skin redness
• shortness of breath
• indigestion; constipation
• 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; liver enlargement; hepatitis
• itchy rash (hives); itching; skin redness (flushing)
• abnormal kidney function test results (increased creatinine levels in the blood; increased urea levels in the blood); worsening of kidney failure
• increased activity of the enzyme lactate dehydrogenase
• vein thrombosis 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)

• coagulation disorders
• anaphylactic shock (allergic)
• liver cell damage, which can also lead to death
• 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 less than 1 in 10 patients)

• decrease in the number of platelets (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 those not listed in the leaflet, you should inform your doctor. 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
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 Pharmazac

The medicine should be stored out of sight and reach of children.
Do not use Micafungin Pharmazac after the expiry date stated on the vial and carton.
The expiry date refers to the last day of the given month.
The closed vial does not need to be stored in special conditions.
The prepared concentrate and diluted infusion solution should be used immediately, as they do not contain any preservatives to protect against 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 protective cover.
The vial is for single use only. Any unused, prepared concentrate should be discarded immediately.

6. Contents of the packaging and other information

What Micafungin Pharmazac contains

• The active substance of the medicine is micafungin (as sodium salt). One vial contains 50 mg or 100 mg of micafungin (as sodium salt).
• The other ingredients are: lactose monohydrate, citric acid (E330), and sodium hydroxide.

What Micafungin Pharmazac looks like and contents of the pack

Micafungin Pharmazac 50 mg or 100 mg powder for concentrate for solution for infusion is a white or off-white solid.
Micafungin Pharmazac 50 mg or 100 mg powder for concentrate for solution for infusion is packaged in a 10R type I orange glass vial closed with a 20 mm bromobutyl rubber stopper and sealed with a single-part aluminum cap with a blue or red plastic flip-off cap (flip-off cap).
Micafungin Pharmazac is supplied in packs containing 1 vial.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmazac S.A.
31 Naousis Str., 104 47 Athens, Greece
tel.: +30 210 3418889-97

Manufacturer

S.C. ROMPHARM COMPANY S.R.L.
1A Eroilor Street, clădiri Rompharm 1 și Rompharm 2m, 075100 Otopeni, Ilfov County
Romania

This medicinal product is authorized in the Member States of the EEA under the following names:

Austria
Micafungin Pharmazac 50 mg powder for concentrate for solution for infusion
Micafungin Pharmazac 100 mg powder for concentrate for solution for infusion
Cyprus
Micafungin/Pharmazac 50 mg powder for concentrate for solution for infusion
Micafungin/Pharmazac 100 mg powder for concentrate for solution for infusion
Greece
Micafungin/Pharmazac 50 mg powder for concentrate for solution for infusion
Micafungin/Pharmazac 100 mg powder for concentrate for solution for infusion
Hungary
Micafungin Pharmazac 50 mg powder for concentrate for infusion solution
Micafungin Pharmazac 100 mg powder for concentrate for infusion solution
Poland
Micafungin Pharmazac 50 mg
Micafungin Pharmazac 100mg
Romania
Micafungin Pharmazac 50 mg powder for concentrate for infusion solution
Micafungin Pharmazac 100 mg powder for concentrate for infusion solution
Slovenia
Micafungin Pharmazac 50 mg powder for concentrate for infusion solution
Micafungin Pharmazac 100 mg powder for concentrate for infusion solution
Netherlands
Micafungine Pharmazac 50 mg powder for concentrate for infusion solution
Micafungine Pharmazac 100 mg powder for concentrate for infusion solution

Date of last revision of the leaflet:

Information intended for healthcare professionals only:
Micafungin Pharmazac should not be mixed or administered in infusion with other medicinal products, except for those listed below. In aseptic conditions and at room temperature, Micafungin Pharmazac should be prepared as follows:

• 1. The plastic cap should be removed from the vial and the stopper disinfected with alcohol.
• 2. In 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, every effort should be made 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 vials (see table below).
• 3. The vial should be gently rotated along its longer axis. DO NOT SHAKE! The powder will dissolve completely. The prepared concentrate should be used immediately. The vial is for single use only. Any prepared, unused concentrate should be discarded immediately.
• 4. The entire amount of the prepared concentrate should be transferred from the vials to the infusion solution bottle (bag) from which the solution was initially taken. The diluted infusion solution should be administered immediately. The diluted solution retains chemical and physical stability for 96 hours at 25°C, if protected from light and diluted according to the instructions above.

and

• 5. The infusion solution bottle (bag) should be gently turned over to ensure thorough mixing of the diluted solution and NOT shaken, to avoid foaming. The solution should not be administered if it is cloudy or contains precipitate.
• 6. The bottle (bag) with the diluted solution should be placed in a closed protective cover to protect it from light.

Preparation of the infusion solution