Label: information for the user

Mycamine 50mg powder for concentrate for solution for infusion

Mycamine 100mg powder for concentrate for solution for infusion

micafungina

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What you need to know before starting to use Mycamine

1. How to use Mycamine

1. Possible adverse effects

1. Storage of Mycamine

1. Contents of the package and additional information

Mycamine contains the active ingredient micafungin. Mycamine is an antifungal medication as it is used to treat infections caused by fungal cells.

Mycamine is used to treat fungal infections caused by fungal cells or yeasts called Candida..Mycamine is effective in the treatment of systemic infections (those that have penetrated the body). It interferes with the production of a part of the fungal cell wall.

When no other antifungal treatment is available, your doctor will prescribe Mycamine in the following circumstances (see section 2):

• To treat a severe fungal infection in adults, adolescents, and children, including newborns, called invasive candidiasis (infection that has penetrated the body).
• To treat adults and adolescents ≥ 16 years with a fungal infection in the esophagus in which intravenous treatment is appropriate.

To prevent Candida infection in patients undergoing a bone marrow transplant or who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.

Do not use Mycamine

• If you are allergic to micafungin, other echinocandins (Ecalta or Cancidas), or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Mycamine

• If you are allergic to any medication.

• If you have hemolytic anemia (anemia caused by the breakdown of red blood cells) or hemolysis (breakdown of red blood cells).

• If you have kidney problems (renal failure or abnormal kidney function test results). In this case, your doctor may decide to closely monitor your kidney function.

Micafungin may also cause severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other medications and Mycamine

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is especially important to inform your doctor if you are using amphotericin B desoxicolate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant), or nifedipine (a calcium channel blocker used to treat high blood pressure). Your doctor may decide to adjust the dose of these medications.

Use of Mycamine with food and drinks

Since Mycamine is administered intravenously (into a vein), there are no restrictions on food or drinks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Mycamine should not be used during pregnancy unless it is clearly necessary. If you use Mycamine, do not breastfeed.

Driving and operating machinery

It is unlikely that micafungin will affect your ability to drive or operate machinery. However, some people may feel dizzy when taking this medication, and if this happens to you, do not drive or operate any machinery or equipment. Please inform your doctor if you experience any effects that may cause you problems driving or operating machinery.

Mycamine contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Micafungin should be prepared and administered by a doctor or other healthcare professional. Micafungin should be administered by slow intravenous infusion (into a vein), once a day. Your doctor will determine the daily dose of Micafungin that you will receive.

Use in adults, adolescents ≥ 16 years and elderly patients

• The usual dose to treat invasive Candida infection is 100 mg per day for patients weighing 40 kg or more, and 2 mg/kg per day for patients weighing 40 kg or less.

• The dose to treat esophageal Candida infection is 150 mg for patients weighing more than 40 kg, and 3 mg/kg per day for patients weighing 40 kg or less.

• The usual dose to prevent invasive Candida infections is 50 mg per day for patients weighing more than 40 kg, and 1 mg/kg per day for patients weighing 40 kg or less.

Use in children > 4 months of age and adolescents <16years

• The usual dose to treat invasive Candida infection is 100 mg per day for patients weighing 40 kg or more, and 2 mg/kg per day for patients weighing 40 kg or less.

• The usual dose to prevent invasive Candida infections is 50 mg per day for patients weighing more than 40 kg, and 1 mg/kg per day for patients weighing 40 kg or less.

Use in children and newborns <

• The usual dose to treat invasive Candida infection is 4-10 mg/kg per day.
• The usual dose to prevent invasive Candida infections is 2 mg/kg per day.

If you receive more Micafungin than you should

Your doctor will monitor your response and the state of your disease to determine the necessary dose of Micafungin. However, if you are concerned that you have received too much Micafungin, contact your doctor or another healthcare professional immediately.

If you miss your Micafungin dose

Your doctor will monitor your response and the state of your disease to determine the appropriate treatment with Micafungin. However, if you are concerned that you have missed a dose of Micafungin, contact your doctor or another healthcare professional immediately.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience an allergic attack, or a severe skin reaction (e.g. blistering of the skin and peeling of the skin), you must inform your doctor or nurse immediately.

Mycamine may cause these other side effects:

Frequent (may affect up to 1 in 10 people)

• Abnormal results in blood tests (reduction in the number of white blood cells [leucopenia; neutropenia]); reduction in the number of red blood cells (anemia)

• Reduction of potassium in the blood (hypokalemia); reduction of magnesium in the blood (hypomagnesemia); reduction of calcium in the blood (hypocalcemia)

• Headache

• Phlebitis (inflammation in the vein wall) (at the injection site)

• Nausea (feeling of sickness); vomiting; diarrhea, abdominal pain

• Abnormal results in liver tests (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)

• Increased bilirubin in the blood (hyperbilirubinemia)

• Rash

• Fever

• Chills

Less frequent (may affect up to 1 in 100 people)

• Abnormal results in blood tests (reduction in the number of blood cells [pancytopenia]); reduction in the number of platelets (thrombocytopenia); increase in the number of a certain type of white blood cell, called eosinophils; reduction in albumin in the blood (hypoalbuminemia)

• Hypersensitivity

• Increased sweating

• Reduction of sodium in the blood (hyponatremia); increase of potassium in the blood (hyperkalemia); reduction of phosphate in the blood (hypophosphatemia); anorexia (eating disorder)

• Insomnia (difficulty sleeping); anxiety; confusion

• Drowsiness; tremors, dizziness; alteration of taste

• Increased heart rate; stronger heartbeat; irregular heartbeat

• High or low blood pressure; redness

• Shortness of breath

• Indigestion; constipation

• Liver failure; increase in liver enzymes (gamma-glutamyltransferase); jaundice (skin or white part of the eyes turns yellow due to liver or blood problems); reduction of bile that reaches the intestine (cholestasis); enlargement of the liver; inflammation of the liver

• Rash with itching (urticaria); pruritus; redness (erythema)

• Abnormal results in kidney function tests (increase in creatinine in the blood; increase in urea in the blood); worsening of kidney failure

• Increased lactate dehydrogenase enzyme

• Formation of blood clots at the injection site; inflammation at the injection site; pain at the injection site; accumulation of fluid in the body

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

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

Not known (frequency cannot be estimated from available data)

• Blood clotting disorders

• Shock (allergic)

• Liver cell damage including death

• Renal alterations; acute kidney failure

Other side effects in children and adolescents

The following reactions have been described more frequently in pediatric patients than in adults:

Frequent (may affect up to 1 in 10 people)

• Reduction of platelets in the blood (thrombocytopenia)

• Increased heart rate (tachycardia)

• High or low blood pressure

• Increased bilirubin in the blood (hyperbilirubinemia); enlargement of the liver

• Acute kidney failure; increase of urea in the blood

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Mycamine after the expiration date that appears on the vial and on the packaging. The expiration date is the last day of the month indicated.

The intact vial (not opened) does not require special storage conditions.

The reconstituted concentrate and the diluted solution for infusion must be used immediately, as they do not contain preservatives to prevent bacterial contamination. Only a properly trained healthcare professional who has read the instructions correctly can prepare this medication for use.

Do not use the diluted solution for infusion if you observe that it is cloudy or if a precipitate has formed.

To protect the diluted solution for infusion from light, the bottle/bag containing it must be introduced into an opaque bag with a seal.

The vial has a single use. Therefore, the unused reconstituted concentrate must be discarded immediately.

Composition ofMycamine

• The active ingredient is micafungin (as sodium salt).

1 vial contains 50mg or 100mg of micafungin (as sodium salt).

• The other components are lactose monohydrate, anhydrous citric acid, and sodium hydroxide.

Appearance of the product and contents of the container

Mycamine 50mg or 100mg powder for concentrate solution for infusion is a white, compact, lyophilized powder. Mycamine is supplied in a pack containing 1 vial.

Marketing Authorization Holder

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57

1000 Liubliana

Eslovenia

Responsible Person

Astellas Ireland Co., Ltd.

Killorglin, County Kerry

Irlanda

Haupt Pharma Wolfratshausen GmbH

Pfaffenrieder Straβe 5

82515 Wolfratshausen

Alemania

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics: {MM/AAAA}

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

Mycamine should not be mixed or infused simultaneously with other medicinal products except those mentioned below. Mycamine is reconstituted and diluted, using aseptic techniques at room temperature, as described below:

1. The plastic cap must be removed from the vial and the stopper must be disinfected with alcohol.

1. 5 ml of sodium chloride 9mg/ml (0.9%) for infusion or glucose 50mg/ml (5%) for infusion (taken from a 100ml bottle/bag) must be slowly and aseptically injected into each vial along the inner wall. Although the concentrate will foam, special care must be taken to minimize the amount of foam generated. A sufficient number of vials of Mycamine must be reconstituted to obtain the required dose in mg (see table below).

1. The vial must be gently rotated. DO NOT SHAKE. The powder will dissolve completely. The concentrate must be used immediately. The vial is for single use only. Therefore, the unused reconstituted concentrate must be discarded immediately.

1. All the reconstituted concentrate must be removed from each vial and returned to the infusion bag from which it was taken initially. The diluted infusion solution must be used immediately. It has been demonstrated that the chemical and physical stability allows the use of the medicinal product for 96 hours, when kept at 25°C, provided it is protected from light, and the dilution is performed as described above.

1. The infusion bag must be carefully inverted to disperse the diluted solution but NOT shaken, to avoid foam formation. The solution must not be used if it is turbid or if a precipitate has formed.

1. The infusion bag containing the diluted infusion solution must be introduced into an opaque bag with a seal to protect it from light.

Preparation of the infusion solution