Micafungin Sandoz

Leaflet accompanying the package: patient information

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

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

Micafungin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• If the patient experiences any side effects, including any 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 Sandoz and what is it used for
• 2. Important information before using Micafungin Sandoz
• 3. How to use Micafungin Sandoz
• 4. Possible side effects
• 5. How to store Micafungin Sandoz
• 6. Contents of the package and other information

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

Micafungin Sandoz contains the active substance micafungin. Micafungin Sandoz is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin Sandoz is used to treat fungal infections caused by fungal cells or yeast called Candida.
Micafungin Sandoz 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 Sandoz damages the cell wall, making the fungi unable to grow and develop further
The doctor will prescribe Micafungin Sandoz 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 it is intended to administer the medicine into a vein (intravenous administration);
• 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 Sandoz

When not to use Micafungin Sandoz

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

Warnings and precautions

Prolonged 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 this medicine.

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 monitored more closely.

Before starting Micafungin Sandoz, discuss with your doctor or pharmacist:

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

Micafungin can also cause severe inflammation and (or) skin and mucous membrane rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Micafungin Sandoz and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans 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). The doctor may decide to adjust the dose of these medicinal products.

Micafungin Sandoz with food and drink

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Micafungin Sandoz should not be used during pregnancy unless, in the doctor's opinion, it is absolutely necessary. During treatment with Micafungin Sandoz, breastfeeding should be avoided.

Driving and using machines

It is unlikely that micafungin will affect the ability to drive and use machines. However, some patients may experience dizziness while taking the medicine, and in this case, the patient should not drive or operate any tools or machines. If any side effects occur that may cause difficulties in driving and using machines, the doctor should be informed.

Micafungin Sandoz contains sodium

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

3. How to use Micafungin Sandoz

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

Use in adults, adolescents aged 16 years and older, 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 over 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 Candida esophagitis, the daily dose is 150 mg for patients with a body weight over 40 kg and 3 mg/kg body weight 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 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 Candida infection, a dose of 100 mg per day is usually used for patients with a body weight over 40 kg and 2 mg/kg body weight 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 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 Candida infection, a dose of 4 mg/kg body weight per day to 10 mg/kg body weight per day is usually used.
• In the prevention of invasive Candida infections, a dose of 2 mg/kg body weight per day is usually used.

Using a higher dose of Micafungin Sandoz than recommended

The doctor will determine the correct dose of Micafungin Sandoz based on the patient's response to treatment and health condition. If there is any doubt that too high a dose of Micafungin Sandoz has been used, the doctor or other medical staff should be contacted immediately.

Missing a dose of Micafungin Sandoz

The doctor will decide whether treatment with Micafungin Sandoz is necessary based on the patient's response to treatment and health condition. If there is any doubt that a dose of Micafungin Sandoz has been missed, the doctor or other medical staff should be contacted immediately.
In case of any further doubts about using this medicine, the doctor or pharmacist should be consulted.

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, the doctor or nurse should be informed immediately.
Micafungin Sandoz may cause the following other side effects:

• Frequent (may occur in up to 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 (vomiting); 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 (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); loss of appetite (eating disorders)
• insomnia (sleep disorders); anxiety; confusion
• drowsiness (drowsiness); tremors; dizziness; taste disorders
• rapid heartbeat; stronger heartbeat; irregular heartbeat
• high or low blood pressure; flushing
• 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 up to 1 in 1,000 patients)

• anemia caused by the breakdown of red blood cells (hemolytic anemia), breakdown of red blood cells (hemolysis)

Unknown (frequency cannot be estimated from available data)

• blood clotting disorders
• anaphylactic shock (allergic)
• liver cell damage, including fatal cases
• kidney problems; acute kidney failure

Additional side effects occurring in children and adolescents

The following side effects have been observed more frequently in pediatric patients than in adult patients:
Frequent (may occur in up to 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 any side effects occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Micafungin Sandoz

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial. The expiry date refers to the last day of the month.
Store in the original package to protect from light. The product is resistant to direct light for up to 60 days (2 months).
The prepared concentrate and diluted solution for infusion should be used immediately, as they do not contain any preservatives to protect against bacterial contamination.
This medicine may only be prepared for use by a qualified healthcare professional after proper familiarization with the entire instructions.
Do not use the diluted solution if it is cloudy or contains precipitated sediment.
To protect from light, the bottle (bag) containing the diluted solution should be placed in a sealed, non-transparent cover.

6. Contents of the package and other information

What Micafungin Sandoz 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 (to adjust pH), and sodium hydroxide (to adjust pH), see section 2.

What Micafungin Sandoz looks like and contents of the package

Micafungin Sandoz 50 mg or 100 mg, powder for concentrate for solution for infusion, is a white or off-white lyophilized powder.
Micafungin Sandoz is available in packages containing 1 vial of 10 ml of clear glass type I, with a gray rubber stopper and an aluminum seal with a blue plastic flip-off cap (Micafungin Sandoz, 50 mg) or a red plastic flip-off cap (Micafungin Sandoz, 100 mg). The vial is wrapped in a protective foil to protect against UV radiation.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
BAG Health Care GmbH
Amtsgerichtsstrasse 1 - 5
35423 Lich, Hessen
Germany D-35423
Galenicum Health S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla,
Esplugues de Llobregat 08950 Barcelona
Spain
SAG MANUFACTURING, S.L.U.
Ctra. N-I, km 36
28750 San Agustín del Guadalix Madrid –
Spain
Lek Pharmaceuticals d.d
Verovskova ulica 57
1526 Ljubljana
Slovenia

To obtain more detailed information about this medicine, please contact

the local representative of the marketing authorization holder:Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

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

Malta
Micafungin Sandoz
Austria
Micafungin Sandoz 50 mg – Powder for concentrate for solution for infusion.
Micafungin Sandoz 100 mg – Powder for concentrate for solution for infusion.
Germany
Micafungin HEXAL 50 mg, Powder for concentrate for solution for infusion.
Micafungin HEXAL 100 mg Powder for concentrate for solution for infusion.
Spain
Micafungina Sandoz 50 mg powder for concentrate for solution for infusion EFG
Micafungina Sandoz 100 mg powder for concentrate for solution for infusion
Finland
Micafungin Sandoz 50 mg infuusiokuiva-aine, konsentrattia varten
Micafungin Sandoz 100 mg infuusiokuiva-aine, konsentrattia varten
Croatia
Mikafungin Sandoz 50 mg prašak za koncentrat za otopinu za infuziju
Mikafungin Sandoz 100 mg prašak za koncentrat za otopinu za infuziju
Poland
Micafungin Sandoz
Sweden
Micafungin Sandoz 50 mg powder for concentrate for solution for infusion
Micafungin Sandoz 100 mg powder for concentrate for solution for infusion
Slovenia
Mikafungin Sandoz 50 mg, prašek za koncentrat za raztopino za infundiranje
Mikafungin Sandoz 100 mg prašek za koncentrat za raztopino za infundiranje
(logo of the marketing authorization holder)
Date of last revision of the leaflet:
The following information is intended for healthcare professionals only:
Instructions for use, see also section 3. How to use Micafungin Sandoz.
Micafungin Sandoz should be prepared and diluted as follows:

• 1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
• 2. Under aseptic conditions, slowly inject 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) 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 of Micafungin Sandoz (see the table below).
• 3. Gently rotate the vial 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 but unused concentrate should be discarded immediately.
• 4. Transfer the entire contents of the prepared concentrate from the vials to the infusion solution bottle (bag) from which the solution was initially taken. The diluted solution for infusion should be administered immediately. The prepared solution is chemically and physically stable for 24 hours at 25°C, provided it is protected from light and diluted according to the instructions above.
• 5. Gently turn the infusion solution bottle (bag) upside down to ensure thorough mixing of the diluted solution and DO NOT SHAKE, to avoid foaming. The solution should not be administered if it is cloudy or contains precipitated sediment.
• 6. Place the bottle (bag) with the diluted solution in a sealed, non-transparent cover to protect it from light.

Preparation of the infusion solution