Mycamine

Package leaflet: Information for the user

Mycamine 50 mg powder for concentrate for solution for infusion, 100 mg powder for concentrate for solution for infusion

micafungin
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Mycamine is and what it is used for
  2. What you need to know before using Mycamine
  3. How to use Mycamine
  4. Possible side effects
  5. How to store Mycamine
  6. Contents of the pack and other information

1. What Mycamine is and what it is used for

Mycamine contains the active substance micafungin. Mycamine is described as an antifungal medicine because it is used to treat infections caused by fungal cells.
Mycamine is used to treat infections caused by fungal or yeast cells called Candida.
Mycamine is effective in treating systemic infections (infections that have spread within the body). It interferes with the production of a component of the fungal cell wall. An intact cell wall is essential for the survival and growth of fungi.
Mycamine causes defects in the fungal cell wall, rendering the fungus unable to survive and grow.
Your doctor has prescribed Mycamine under the following circumstances, when no other appropriate antifungal treatments are available (see section 2):

• To treat adults, adolescents, and children including newborns who have a serious fungal infection called invasive candidiasis (an infection that has spread into the body).
• To treat adults and adolescents aged 16 years and older who have a fungal infection in the throat (in the oesophagus) for which intravenous (endovenous) treatment is appropriate.
• To prevent Candida infections in patients undergoing bone marrow transplantation or in patients expected to develop neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or longer.

2. What you need to know before using 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 In rats, long-term treatment with micafungin leads to liver damage and subsequent liver tumors. The potential risk of tumor development in humans is unknown, and your doctor will evaluate the benefits and risks of treatment with Mycamine before you start taking the medicine. Inform 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 function will be monitored more closely.
Ask your doctor or pharmacist before using Mycamine

• if you are allergic to any medicine
• if you have hemolytic anemia (anemia due to breakdown of red blood cells) or hemolysis (breakdown of red blood cells)
• if you have kidney problems (e.g. renal failure or abnormal kidney function tests). If this occurs, your doctor may decide to monitor your kidney function more closely.

Micafungin may also cause severe inflammation/rash of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Other medicines and Mycamine
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you inform your doctor if you are being treated with deoxycholate amphotericin B 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.
Mycamine with food and drink
Since Mycamine is administered intravenously (into a vein), there are no restrictions on food or drink intake.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Mycamine must not be used during pregnancy unless absolutely necessary. You must not breastfeed during treatment with Mycamine.
Driving and using machines
It is unlikely that micafungin will affect your ability to drive or operate machinery. However, some people may experience dizziness when taking this medicine, and if this happens to you, you should not drive or use tools or machines. Inform your doctor if you experience any side effect that could cause problems while driving or operating machinery.
Mycamine contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Mycamine

Mycamine must be prepared and administered by a doctor or other healthcare professional.
Mycamine is given once daily as a slow intravenous infusion (into a vein).
Your doctor will determine the daily dose of Mycamine you require.

Use in adults, adolescents aged 16 years and older, and elderly patients

• The usual dose for treating invasive Candida infection is 100 mg daily for patients weighing more than 40 kg and 2 mg/kg daily for patients weighing 40 kg or less.
• The usual dose for treating Candida oesophagitis is 150 mg daily for patients weighing more than 40 kg and 3 mg/kg daily for patients weighing 40 kg or less.
• The usual dose for preventing invasive Candida infections is 50 mg daily for patients weighing more than 40 kg and 1 mg/kg daily for patients weighing 40 kg or less.

Use in children from 4 months of age and adolescents under 16 years of age

• The usual dose for treating invasive Candida infection is 100 mg daily for patients weighing more than 40 kg and 2 mg/kg daily for patients weighing 40 kg or less.
• The usual dose for preventing invasive Candida infections is 50 mg daily for patients weighing more than 40 kg and 1 mg/kg daily for patients weighing 40 kg or less.

Use in children and neonates under 4 months of age

• The usual dose for treating invasive Candida infection is 4–10 mg/kg daily.
• The usual dose for preventing invasive Candida infections is 2 mg/kg daily.

If you receive more Mycamine than you should
Your doctor will monitor your response to the medicine and your overall health to determine the appropriate dose of Mycamine. However, if you are concerned that you have received too high a dose of Mycamine, speak to your doctor or another healthcare professional immediately.

If a dose of Mycamine has not been administered
Your doctor will assess your response to the medicine and your overall health to determine the appropriate treatment with Mycamine. However, if you are concerned that a dose of Mycamine has been missed, speak to your doctor or another healthcare professional immediately.

If you have any questions about the use of Mycamine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have an allergic reaction, or a severe skin reaction (e.g. blistering and peeling of the skin), inform your doctor or nurse immediately.
Mycamine may cause the following additional side effects:

Common (may affect up to 1 in 10 people)

• Blood test abnormalities (reduction in white blood cells [leucopenia; neutropenia]); reduction in red blood cells (anaemia)
• Low potassium levels in the blood (hypokalaemia); low magnesium levels in the blood (hypomagnesaemia); low calcium levels in the blood (hypocalcaemia)
• Headache
• Inflammation of the vein wall (at the injection site)
• Nausea (feeling unwell); vomiting (being unwell); diarrhoea; abdominal pain
• Abnormal liver function tests (increased alkaline phosphatase; increased aspartate aminotransferase; increased alanine aminotransferase)
• Increased blood bile pigment (hyperbilirubinaemia)
• Rash
• Fever
• Chills (shivering)

Uncommon (may affect up to 1 in 100 people)

• Blood test abnormalities (reduction in the number of blood cells [pancytopenia]); reduced platelet count (thrombocytopenia); increase in a certain type of white blood cell called eosinophils; reduced albumin in the blood (hypoalbuminaemia)
• Hypersensitivity
• Increased sweating
• Low sodium levels in the blood (hyponatraemia); high potassium levels in the blood (hyperkalaemia); low phosphate levels in the blood (hypophosphataemia); anorexia (eating disorder)
• Insomnia; anxiety; confusion
• Drowsiness; tremors; dizziness; taste disturbances
• Increased heart rate; increased force of 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 due to liver or blood problems); reduced bile flow to the intestine (cholestasis); enlarged liver; liver inflammation
• Itchy rash (urticaria); itching; skin redness (erythema)
• Abnormal kidney function tests (increased blood creatinine; increased blood urea levels); worsening of kidney failure
• Increase in an enzyme called lactate dehydrogenase
• Blood clots 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 1000 people)

• Anaemia caused by destruction of red blood cells (haemolytic anaemia); destruction of red blood cells (haemolysis)

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

• Disorders of the blood clotting system
• Shock (allergic)
• Liver cell damage, including death
• Kidney problems; acute kidney failure

Additional side effects in children and adolescents
The following reactions have been reported more frequently in paediatric patients than in adult patients:

Common (may affect up to 1 in 10 people)

• Reduced platelet count in the blood (thrombocytopenia)
• Increased heart rate (tachycardia)
• High or low blood pressure
• Increased bile pigments in the blood (hyperbilirubinaemia); enlarged liver
• Acute kidney failure; increased blood urea concentration

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

5. How to store Mycamine

Keep Mycamine out of the sight and reach of children.
Do not use Mycamine after the expiry date stated on the vial and on the outer carton,
following the term “Exp”. The expiry date refers to the last day of the month.
The unopened vial does not require any special storage conditions. The reconstituted concentrate and the diluted infusion solution must be used immediately, as they contain no preservatives to prevent bacterial contamination. Only a healthcare professional who has thoroughly read the instructions may prepare this medicine for use.
Do not use the diluted infusion solution if it appears cloudy or contains precipitates.
The infusion bag containing the diluted infusion solution must be placed inside an opaque, closable bag to protect it from light.
The vial is for single use only. Therefore, any unused reconstituted concentrate should be immediately discarded.

6. Package contents and other information

What Mycamine contains
The active substance is micafungin (as sodium salt).
Each vial contains 50 mg or 100 mg of micafungin (as sodium salt).
The other components are lactose monohydrate, anhydrous citric acid and sodium hydroxide.

Description of the appearance of Mycamine and contents of the pack
Mycamine 50 mg and 100 mg powder for concentrate for solution for infusion is a white, compact lyophilized powder.
Mycamine is supplied in packs containing 1 vial.

Marketing Authorisation Holder
Sandoz Pharmaceuticals d.d.
Verovškova ulica 57
1000, Ljubljana,
Slovenia

Manufacturer
Astellas Ireland Co. Ltd
Killorglin
County Kerry
Ireland
Haupt Pharma Latina S.r.l.
Strada Statale 156 Km 47,600
04100 Borgo San Michele,
Latina, Italy

For further information about Mycamine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d
Tél/Tel: +32 (0)2 722 97 97 Branch Office Lithuania
Upės g. 21-1
LT – 08128 Vilnius
Tel: +370 5 2636 037

България Luxembourg/Luxemburg
КЧТ Сандоз Sandoz nv/sa
България Tél/Tel: +32 (0)2 722 97 97
Teл.: +359 2 970 47 47

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 234 142 222 Bartók Béla út 43-47
H-1114 Budapest
Tel: +36 1 430 2890
[email protected]

Danmark Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf.: +45 63 95 10 00 (Slovenia)
Tel: +35699644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Industriestr. 25 Hospitaaldreef 29,
D-83607 Holzkirchen NL-1315 RC Almere
D: +49 8024 908 0 Tel: +31 36 5241600
E-Mail: [email protected] E-mail:[email protected]

Eesti Norge
Sandoz d.d. Eesti filiaal Sandoz A/S
Pärnu mnt 141 Tlf: +45 63 95 10 00
EE – 11314 Tallinn
Tel: +372 6652400

Ελλάδα Österreich
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz GmbH
Τηλ: +30 216 600 5000 Biochemiestr. 10
A-6250 Kundl
Tel: +43(0)1 86659-0

España Polska
BEXAL FARMACÉUTICA, S.A. Sandoz Polska Sp. z o.o.
Tel: +34 900 456 856 ul. Domaniewska 50 C
02 672 Warszawa
Tel.: +48 22 209 7000
[email protected]

France Portugal
Sandoz SAS Sandoz Farmacêutica Lda.
Tél: +33 1 49 64 48 00 Phone: +351 211 964 000

Hrvatska România
Sandoz d.o.o. Sandoz Pharmaceuticals SRL
Maksimirska 120 Tel: +40 21 407 51 60
10 000 Zagreb
Tel : +385 1 235 3111
[email protected]

Ireland Slovenija
Rowex Ltd., Lek farmacevtska družba d.d.
Bantry, Co. Cork, Verovškova ulica 57
Ireland, SI-1526 Ljubljana
P75 V009 Tel: +386 1 580 21 11
Tel: +353 27 50077 [email protected]
e-mail: [email protected]

Ísland Slovenská republika
Sandoz A/S Sandoz d.d. - organizačná zložka
Símí: +45 63 95 10 00 Žižkova 22B
811 02 Bratislava
Tel: +421 2 48 200 600
[email protected]

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 812 806 96 Puh/Tel: +358 10 6133 400

Κύπρος Sverige
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz A/S
(Ελλάδα) Tel: +45 63 95 10 00
Τηλ: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
K.Valdemāra 33 – 29
LV-1010 Rīga
Tel: +371 67892006

More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu/ .

The following information is intended exclusively for medical or healthcare professionals:
Mycamine must not be mixed or co-infused with other products except those specified below. Mycamine is reconstituted and diluted at room temperature under aseptic conditions as follows:

1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
2. Slowly inject, along the inner wall and under aseptic conditions, 5 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (drawn from a 100 ml infusion vial/bag) into each vial. Even though foam may form in the concentrate, care must be taken to minimize foam formation. A sufficient number of Mycamine vials must be reconstituted to obtain the required dose in mg (see table below).
3. Gently rotate the vial. DO NOT SHAKE. The powder will dissolve completely. The concentrate must be used immediately. The vial is for single use only. Therefore, any unused reconstituted concentrate must be discarded immediately.
4. Aspirate all of the reconstituted concentrate from each vial and transfer it into the infusion vial/bag from which the diluent was originally withdrawn. The diluted infusion solution must be used immediately. Chemical and physical in-use stability of the solution has been demonstrated for 96 hours at 25°C when protected from light and diluted as described above.
5. Gently invert the infusion vial/bag to aid dispersion of the diluted solution, but DO NOT SHAKE to avoid foaming. The solution must not be used if it is cloudy or contains precipitates.
6. Place the infusion vial/bag containing the diluted infusion solution into an opaque, closable bag to protect it from light.

Preparation of the infusion solution