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Mycamine (Micafungin)

What Mycamine is and what it is used for

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 tfie 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:

  • To treat adults, adolescents and children who have a serious fungal infection called invasive candidiasis (infection that has penetrated the body).
  • To treat adults and adolescents & 16 yeaTS of age who have a fungal infection in the gullet (oesophagus) where treatment into a vein (intravenous) is appropriate.
  • To treat adults, adolescents and children who are at risk of developing a Candida fungal infection that may penetrate the body.

Before you use Mycamine

Do not use Mycamine

  • if you are allergic (hypersensitive) to micafungin or any of the other ingredients of Mycamine.

Take special care with Mycamine

In rats, long-term treatment with micafungin led to liver damage and subsequent liver tumours. The potential risk o- developing Iiver tumours in humans is not known, and your doctor will assess the benefits and risks of Mycamine treatment before starting your medicine. Please tell your doctor if you have severe liver problems (e.g. liver failure or hepatitis) or have had abnormal liver function tests. During treatment your liver functions will be monitored more closely.

  • if you have haemolytic anaemia (anaemia due to breakdown of red blood cells) or haemolysis (breakdown of red blood cells).
  • if you have kidney problems (e.g. kidney failure and abnormal kidney function test). If this happens, your doctor may decide to monitor your kidney function more closely.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is especially important to inform your doctor if you are using amphotericin B desoxycholate or itraconazole (antifungal antibiotics], sirolimus (an immunosuppressant) or nifedipine (a calcium antagonist). Your doctor may decide to adjust the dose of these medicines.

Using Mycamine with food and drink

As Mycamine is given intravenously (into a vein], no restrictions on food or drink are required.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Mycamine should not be used during pregnancy unless clearly necessary. If you use Mycamine you should not breast-feed.

Driving and using machines

There is no information on the effect of Mycamine on the ability to drive or use machines. Please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery.

Important information about some of the ingredients of Mycamine

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to use Mycamine

Mycamine must be prepared and given to you by a doctor or another health care 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 irfection is 100 mg per day for patients weighing 40 kg or more and 1 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 (including newboms) and adolescents < 16 years of age

  • The usual dose to treat an invasive Candida irfection is 100 mg per day foT patients weighing 40 kg or more and 1 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.

If you receive more Mycamine than you should

Your doctor monitors yout response aid condition to determine what dose of Mycamine is needed. However, if you are concerned that you may have been given too much Mycamine, speak to your doctor or another health care professional immediately.

If you miss a dose of Mycamine

Your doctor monitors your response aid condition to determine what Mycamine treatment is needed. However, if you are concerned that you may have missed a dose, speak to your doctor or another health care professional immediately.

Effects when treatment with Mycamine is stopped There are no known withdrawal symptoms.

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

Possible side effects

Like all medicines, Mycamine can cause side effects, although not everybody get ttiem.

The safety of Mycamine has been assessed in clinical trials. Patients in these trials were critically ill, had a wide variety of other medical conditions, and required many other medicines.

Mycamine may cause the following side effects:

Common (affects 1 to 10 users in 100)

  • abnormal blood tests (decreased white blood cells [leucopenia; neutropenia]); decreased red blood cells [anaemia]
  • decreased potassium in the clood (hypokalaenie); 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)
  • ircreased bile pigment in the blood (hyperbilirubinaemia)
  • rash
  • fever
  • rigors (shivering)

Uncommon (affects 1 to 10 users in 1,000)

  • abnormal blood tests (decreased blood cells [pancytopenia]); decreased blood platelets (thrombocytopenis); increases in a certain type of white blood cells called eosinophils; decreased albumin in the blood (hypoalbuminaemia)
  • allergic attack (anaphylactic reaction I anaphylactoid shock); 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 flush ing
  • 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 faik ‘s
  • increase in an enzyme called lactate dehydrogenase
  • clotting in vein at injection-site; inflammation at injec:ior-site, pain at injection-site; collection of fluid in your body

Rare (affects 1 to 10 users in 10,000)

  • 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):

  • shock
  • damage to liver cells including death
  • severe skin reaction
  • kidney problems; acute kidney failure

The following reactions have been reported more often in paediatric patients than in adult patients:

Common (affects 1 to 10 users in 100)

  • decreased bloorj platelets (thrornbocytcpenia)
  • increased heart rate (tachycardia)
  • high or low blood pressure
  • increased bile pigment in the blood (hyperbilirubinaemia); enlarged liver
  • acute kidney failure; increased urea in the blood

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Mycamine

Keep out of the reach and sight of children.

Do not use Mycarnine 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.

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

In order to protect the infusion bottl-e / 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

Reconstituted Mycarnine should be used immediately because it does not contain any preservatives to prevent bacterial contamination. Only a trained health care professional who has read the complete directions properly can prepare this medicine for use.

Further Information

What Mycarnine contains

The active substance is micafungir sodium.

1 vial contains 50 mg or 100 mg micafungin (as sodium). – The other ingredients are lactose monohydrate, citric acid anhydrous and sodium hydroxide.

What Mycarnine looks like and contents of the pack

Mycarnine 50 mg or 100 mg powder for solution for infusion is a white compact freeze-dried powder. Mycarnine is supplied in a box containing 1 vial.

Preparation of the solution for infusion

Dose (mg) Mycamine uial to be used (mg/vial) Volume of sodium cloride (0.9%) or glucose (5%) to be added per vial Volume ;concentration) of reconstituted powder Standard infusion (added up to 100 ml) Final concentration
50 1×50 5 ml appro?;. 5 ml (lOmg/ml) 0.5 mgi’ml
100 1×100 5 ml appro?:. 5 ml (20 mg/ml) 1.0mg/ml
ISO 1×100 + 1×50 5 ml approx. 10 ml 1.5mgv’ml
200 2×100 5 ml approx. 10 ml 2.0 ma/ml
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