Mycamine 50 mg powder for concentrate for solution for infusion

Mycamine 100 mg powder for concentrate for solution for infusion

micafungin

Mycamine contains the active substance micafungin. Mycamine is called an antifungal medicine because it is used to treat infections caused by fungal cells.

Mycamine is used to treat fungal infections caused by fungal or yeast cells called Candida. Mycamine is effective in treating systemic infections (those that have penetrated within the body). It interferes with the production of a part of the fungal cell wall. An intact cell wall is necessary for the fungus to continue living and growing. Mycamine causes defects in the fungal cell wall, making the fungus unable to live and grow.

Your doctor has prescribed Mycamine for you in the following circumstances when there are no other suitable antifungal treatments available (see section 2):

• To treat adults, adolescents and children including neonates who have a serious fungal infection called invasive candidiasis (infection that has penetrated the body).
• To treat adults and adolescents ≥ 16 years of age who have a fungal infection in the gullet (oesophagus) where treatment into a vein (intravenous) is appropriate.
• To prevent infection with Candida in patients who are having a bone-marrow transplant or who are expected to have a neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.

Mycamine must be prepared and given to you by a doctor or another healthcare professional. Mycamine should be administered once daily by slow intravenous (into a vein) infusion. Your doctor will determine how much Mycamine you will receive each day.

Use in adults, adolescents ≥ 16 years of age and elderly

• The usual dose to treat 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 to treat a Candida infection of the oesophagus 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 < 16 years of age

• The usual dose to treat 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 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 < 4 months of age

• The usual dose to treat an 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 have any further questions on the use of this product, ask your doctor or pharmacist.

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

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

Mycamine may cause the following other side effects:

Common (may affect up to 1 in 10 people)

• abnormal blood tests (decreased white blood cells [leucopenia; neutropenia]); decreased red blood cells (anaemia)
• decreased potassium in the blood (hypokalaemia); decreased magnesium in the blood (hypomagnesaemia); decreased calcium in the blood (hypocalcaemia)
• headache
• inflammation of the vein wall (at injection-site)
• nausea (feeling sick); vomiting (being sick); diarrhoea; abdominal pain
• abnormal liver function tests (increased alkaline phosphatase; increased aspartate aminotransferase, increased alanine aminotransferase)
• increased bile pigment in the blood (hyperbilirubinaemia)
• rash
• fever
• rigors (shivering)

Uncommon (may affect up to 1 in 100 people)

• abnormal blood tests (decreased blood cells [pancytopenia]); decreased blood platelets (thrombocytopenia); increases in a certain type of white blood cells called eosinophils; decreased albumin in the blood (hypoalbuminaemia)
• hypersensitivity
• increased sweating
• decreased sodium in the blood (hyponatraemia); increased potassium in the blood (hyperkalaemia); decreased phosphates in the blood (hypophosphataemia); anorexia (eating disorder)
• insomnia (difficulty in sleeping); anxiety; confusion
• feeling lethargic (somnolence); trembling; dizziness; disturbed taste
• increased heart rate; stronger heartbeat; irregular heartbeat
• high or low blood pressure; skin flushing
• shortness of breath
• indigestion; constipation
• liver failure; increased liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems); reduced bile reaching the intestine (cholestasis); enlarged liver; liver inflammation
• itchy rash (urticaria); itching; skin flushing (erythema)
• abnormal kidney function tests (increased blood creatinine; increased urea in the blood); aggravated kidney failure
• increase in an enzyme called lactate dehydrogenase
• clotting in vein at injection-site; inflammation at injection-site; pain at injection-site; collection of fluid in your body

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

• anaemia due to breakdown of red blood cells (haemolytic anaemia); breakdown of red blood cells (haemolysis)

Not known (frequency cannot be estimated from the available data)

• disorder of blood clotting system
• (allergic) shock
• damage to liver cells including death
• kidney problems; acute kidney failure

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 on the carton. The expiry date refers to the last day of that month.

The unopened vial does not require any special storage conditions.

The reconstituted concentrate and the diluted infusion solution should be used immediately, because it does not contain any preservatives to prevent bacterial contamination. Only a trained healthcare professional who has read the complete directions properly can prepare this medicine for use.

Do not use the diluted infusion solution if it is cloudy or precipitated.

In order to protect the infusion bottle/bag containing the diluted infusion solution from light it should be inserted into a closable opaque bag.

The vial is for single use only. Therefore, please discard unused reconstituted concentrate immediately.