MYCAMINE 50 mg POWDER FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Mycamine 50mg powder for concentrate for solution for infusion

Mycamine 100mg powder for concentrate for solution for infusion

micafungin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Mycamine and what is it used for

1. What you need to know before you use Mycamine

1. How to use Mycamine

1. Possible side effects

1. Storage of Mycamine

1. Contents of the pack and other information

1. What is Mycamine and what is it used for

Mycamine contains the active substance micafungin. Mycamine is an antifungal medicine 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 treating systemic infections (those that have penetrated the body). It interferes with the production of a part of the fungal cell wall. The fungus needs an intact cell wall to live and grow. Mycamine causes defects in the fungal cell wall, preventing the fungus from growing and living.

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

• To treat a serious 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 where it is appropriate to apply treatment by intravenous route.

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

2. What you need to know before you use Mycamine

Do not use Mycamine

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Mycamine

• if you are allergic to any medicine.

• 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 (kidney failure or abnormal kidney function tests). In this case, your doctor may decide to monitor your kidney function more closely.

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

Other medicines and Mycamine

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is especially important that you tell your doctor if you are using amphotericin B desoxycholate 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 medicines.

Using Mycamine with food and drinks

Since Mycamine is given by intravenous route (in a vein), there are no restrictions on food or drinks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

Driving and using machines

It is unlikely that micafungin will affect your ability to drive or use machines. However, some people may feel dizzy when taking this medicine, and if this happens to you, do not drive or use any machine or tool. Please tell your doctor if you experience any effect that may affect your ability to drive or use machinery.

Mycamine contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to use Mycamine

Mycamine must be prepared and administered by a doctor or other healthcare professional. Mycamine must be administered by slow intravenous infusion (in a vein), once a day. Your doctor will determine the dose of Mycamine you will receive each day.

Use in adults, adolescents ≥ 16 years, and elderly patients

• The usual dose for treating an 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 for treating a Candida esophagus 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 for preventing 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 <16 years< strong>

• The usual dose for treating an 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 for preventing 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 infants <4 months of age< strong>

• The usual dose for treating an invasive Candida infection is 4-10 mg/kg per day.
• The usual dose for preventing invasive Candida infections is 2 mg/kg per day.

If you receive more Mycamine than you should

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

If you miss a dose of Mycamine

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you suffer an allergic reaction or a severe skin reaction (e.g. blistering of the skin and peeling of the skin), you should tell your doctor or nurse immediately.

Mycamine can cause these other side effects:

Common (may affect up to 1 in 10 people)

• abnormal blood test results (reduction in the number of white blood cells [leukopenia; neutropenia]); reduction in the number of red blood cells (anemia)

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

• headache

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

• nausea (feeling sick); vomiting; diarrhea; abdominal pain

• abnormal liver function tests (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)

• increase in bilirubin in the blood (hyperbilirubinemia)

• rash

• fever

• chills

Uncommon (may affect up to 1 in 100 people)

• abnormal blood test results (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 cells called eosinophils; reduction of albumin in blood (hypoalbuminemia)

• hypersensitivity

• increased sweating

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

• insomnia (difficulty sleeping); anxiety; confusion

• feeling sleepy (somnolence); tremors; dizziness; alteration of taste

• increase in heart rate; stronger heartbeat; irregular heartbeat

• high or low blood pressure; flushing

• shortness of breath

• indigestion; constipation

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

• rash with itching (urticaria); itching; flushing (erythema)

• abnormal kidney function tests (increase in creatinine in blood; increase in urea in blood); worsening of kidney failure

• increase in an enzyme called lactate dehydrogenase

• clot formation at the injection site; inflammation at the injection site; pain at the injection site; fluid accumulation 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 the available data)

• blood clotting disorders

• allergic shock

• liver cell damage including death

• kidney problems; acute kidney failure

Other side effects in children and adolescents

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

Common (may affect up to 1 in 10 people)

• reduction of platelets in blood (thrombocytopenia)

• increase in heart rate (tachycardia)

• high or low blood pressure

• increase in bilirubin in blood (hyperbilirubinemia); increase in liver size

• acute kidney failure; increase in urea in blood

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mycamine

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

Do not use Mycamine after the expiry date which is stated on the vial and carton. The expiry date is the last day of the month stated.

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

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

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

To protect the bottle/bag containing the diluted solution for infusion from light, it should be placed in an opaque bag with a seal.

The vial is for single use only. Therefore, any unused reconstituted concentrate should be discarded immediately.

6. Container Content and Additional Information

Composition ofMycamine

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

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

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

Appearance of the Product and Container Content

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

Marketing Authorization Holder

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57

1000 Ljubljana

Slovenia

Manufacturer

Astellas Ireland Co., Ltd.

Killorglin, County Kerry

Ireland

Haupt Pharma Wolfratshausen GmbH

Pfaffenrieder Straße 5

82515 Wolfratshausen

Germany

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

Date of Last Revision of this Leaflet: {MM/YYYY}

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

This information is intended only 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 follows:

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

1. 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 and aseptically injected into each vial along the inner wall. Although the concentrate will foam, care should be taken to minimize the amount of foam generated. A sufficient number of Mycamine vials should be reconstituted to obtain the required dose in mg (see the table below).

1. The vial should be gently rotated. IT SHOULD NOT BE SHAKEN. The powder will dissolve completely. The concentrate should be used immediately. The vial is for single use. Therefore, any unused reconstituted concentrate should be discarded immediately.

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

1. The infusion bottle/bag should be carefully inverted to disperse the diluted solution but SHOULD NOT BE SHAKEN to avoid foam formation. The solution should not be used if it is turbid or if a precipitate has formed.

1. The infusion bottle/bag containing the diluted solution for infusion should be placed in an opaque bag with a seal to protect it from light.

Preparation of the Infusion Solution