Micafungin sandoz

Package leaflet: Information for the patient

Micafungin Sandoz, 50 mg, powder for solution for infusion concentrate
Micafungin Sandoz, 100 mg, powder for solution for infusion concentrate
Micafunginum
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Micafungin Sandoz is and what it is used for
2. Important information before using Micafungin Sandoz
3. How to use Micafungin Sandoz
4. Possible side effects
5. How to store Micafungin Sandoz
6. Contents of the pack and other information

1. What Micafungin Sandoz is and what it is used for

Micafungin Sandoz contains the active substance micafungin. Micafungin Sandoz is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin Sandoz is used to treat fungal infections caused by fungi or yeast-like organisms called Candida.
Micafungin Sandoz is effective in treating systemic infections (those that have spread into the body). It acts on the process of forming a component of the fungal cell wall.
An intact cell wall is essential for the normal development and growth of fungal cells. Micafungin Sandoz damages the cell wall, causing fungi to become unable to grow and develop further.
Your doctor may prescribe Micafungin Sandoz in the following cases, when no other appropriate antifungal treatment is available (see section 2):

• treatment of adults, adolescents, and children, including newborns, with a serious fungal infection called invasive candidiasis (an infection that penetrates the body);
• treatment of adults and adolescents aged ≥ 16 years with fungal infection of the oesophagus (oesophagitis) where intravenous administration (into the vein) is indicated;
• prevention of Candida infections in patients undergoing allogeneic haematopoietic stem cell transplantation or in patients expected to develop neutropenia (reduction in neutrophils, a type of white blood cell) lasting for 10 or more days.

2. Important information before using Micafungin Sandoz

When not to use Micafungin Sandoz

• if the patient is allergic to micafungin, other echinocandins (Cancidas or Ecalta), or any of the other components of this medicine (listed in section 6).

Warnings and precautions
Long-term treatment with micafungin in rats has led to liver damage and subsequently to liver tumours. The potential risk of developing liver tumours in humans is unknown; the doctor will assess the benefits and risks of using this medicine before starting treatment.
Tell your doctor if you have severe liver disease (e.g. liver failure or hepatitis) or if abnormal liver function test results have been observed. Liver function will be closely monitored during treatment.
Before starting Micafungin Sandoz, discuss the following with your doctor or pharmacist:

• if the patient is allergic to any medicine;
• if the patient has haemolytic anaemia (anaemia caused by the breakdown of red blood cells) or haemolysis (breakdown of red blood cells);
• if the patient has kidney disease (e.g. kidney failure or abnormal kidney function test results). In such cases, the doctor may recommend closer monitoring of kidney function.

Micafungin may also cause a severe inflammatory condition and (or) skin and mucosal rashes
(Stevens-Johnson syndrome, toxic epidermal necrolysis [Lyell's syndrome]).
Micafungin Sandoz and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
It is especially important to inform your doctor if the patient is taking amphotericin B deoxycholate or
itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant), or nifedipine
(calcium channel blocker used in the treatment of hypertension). The doctor may decide
to adjust the dose of these medicinal products.
Micafungin Sandoz with food and drink
Since Micafungin Sandoz is administered intravenously (into a vein), there are no restrictions
regarding the use of this medicine with food and drink.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult her doctor or pharmacist before using this medicine.
Micafungin Sandoz should not be used during pregnancy unless absolutely necessary, as determined by the doctor. Breastfeeding should not be undertaken during treatment with Micafungin Sandoz.
Driving and operating machinery
It is unlikely that micafungin will affect the ability to drive or operate machinery. However, some patients may experience dizziness while receiving the medicine, and in such cases, the patient should not drive or operate any tools or machinery. Inform your doctor if any adverse effects occur that may impair the ability to drive or operate machinery.
Micafungin Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Micafungin Sandoz

Micafungin Sandoz must be prepared and administered by a doctor or other medical personnel.
Micafungin Sandoz should be given once daily as a slow intravenous infusion (into a vein). The daily dose will be determined by your doctor.

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

• For the treatment of invasive Candida infection, the usual dose is 100 mg once daily for patients weighing more than 40 kg and 2 mg/kg body weight once daily for patients weighing 40 kg or less.
• For the treatment of oesophageal Candida infection, the daily dose is 150 mg for patients weighing more than 40 kg and 3 mg/kg body weight once daily for patients weighing 40 kg or less.
• For prophylaxis of invasive Candida infections, the usual dose is 50 mg once daily for patients weighing more than 40 kg and 1 mg/kg body weight once daily for patients weighing 40 kg or less.

Use in children aged > 4 months and adolescents aged < 16 years

• For the treatment of invasive Candida infection, the usual dose is 100 mg once daily for patients weighing more than 40 kg and 2 mg/kg body weight once daily for patients weighing 40 kg or less.
• For prophylaxis of invasive Candida infections, the usual dose is 50 mg once daily for patients weighing more than 40 kg and 1 mg/kg body weight once daily for patients weighing 40 kg or less.

Use in children and neonates aged < 4 months

• For the treatment of invasive Candida infection, the usual dose ranges from 4 mg/kg body weight to 10 mg/kg body weight once daily.
• For prophylaxis of invasive Candida infections, the usual dose is 2 mg/kg body weight once daily.

Use of a higher than recommended dose of Micafungin Sandoz
Your doctor will determine the appropriate dose of Micafungin Sandoz based on the patient's response to treatment and overall health condition. If there is any doubt whether too high a dose of Micafungin Sandoz has been administered, contact your doctor or other medical personnel immediately.

Missed dose of Micafungin Sandoz
Your doctor will decide on the need for continued treatment with Micafungin Sandoz based on the patient's response to treatment and health status. If there is any doubt whether a dose of Micafungin Sandoz has been missed, contact your doctor or other medical personnel immediately.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience an allergic reaction or a severe skin reaction (e.g. blistering and peeling of the skin), inform your doctor or nurse immediately.
Micafungin Sandoz may cause the following other adverse reactions:

Common (may occur in up to 1 in 10 patients):

• abnormal blood test results (decreased white blood cell count [leukopenia; neutropenia]); decreased red blood cell count (anaemia)
• decreased blood potassium levels (hypokalaemia); decreased blood magnesium levels (hypomagnesaemia); decreased blood calcium levels (hypocalcaemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (feeling sick); vomiting; diarrhoea; abdominal pain
• abnormal liver function test results (increased alkaline phosphatase activity, increased aspartate aminotransferase activity, increased alanine aminotransferase activity)
• increased blood bilirubin levels (hyperbilirubinaemia)
• rash
• fever
• chills

Uncommon (may occur in up to 1 in 100 patients):

• abnormal blood test results (decreased blood cell counts [pancytopenia]); decreased platelet count (thrombocytopenia); increased number of a certain type of white blood cells (eosinophils); decreased blood albumin levels (hypoalbuminaemia)
• hypersensitivity
• increased sweating
• decreased blood sodium levels (hyponatraemia); increased blood potassium levels (hyperkalaemia); decreased blood phosphate levels (hypophosphataemia); loss of appetite (feeding disorders)
• insomnia (sleep problems); anxiety; confusion
• drowsiness (somnolence); tremor; dizziness; taste disturbance
• rapid heartbeat; stronger heartbeat; irregular heartbeat
• high or low blood pressure; skin flushing
• shortness of breath
• indigestion; constipation
• liver failure; increased liver enzyme activity (gamma-glutamyl transferase); jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders); bile flow obstruction before reaching the intestine (cholestasis); enlarged liver; hepatitis
• itchy rash (urticaria); itching; skin redness (erythema)
• abnormal kidney function test results (increased blood creatinine levels; increased blood urea levels); worsening of kidney failure
• increased activity of an enzyme called lactate dehydrogenase
• vein thrombosis at injection site; inflammation at injection site; pain at injection site; fluid retention in the body

Rare (may occur in up to 1 in 1,000 patients):

• anaemia caused by destruction of red blood cells (haemolytic anaemia), breakdown of red blood cells (haemolysis)

Unknown frequency (frequency cannot be estimated from available data):

• blood coagulation disorder
• shock (allergic)
• liver cell damage, including cases resulting in death
• kidney problems; acute kidney failure

Additional adverse reactions observed in children and adolescents
The following adverse reactions have been observed more frequently in paediatric patients than in adults:
Common (may occur in up to 1 in 10 patients):

• decreased platelet count (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increased blood bilirubin levels (hyperbilirubinaemia); enlarged liver
• acute kidney failure; increased blood urea levels

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Micafungin Sandoz

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light. The product is resistant to direct light exposure for up to 60 days (2 months).
The prepared concentrate and diluted infusion solution should be used immediately, as they contain no preservatives to protect against bacterial contamination.
This medicine may be prepared for use only by a qualified healthcare professional who has read the entire instruction carefully.
Do not use the diluted solution if it becomes cloudy or if a precipitate has formed.
To protect from light, the bottle (bag) containing the diluted solution should be placed in a closed, opaque cover.
The vial is intended for single use only. Any unused prepared concentrate should be discarded immediately.

6. Contents of the pack and other information

What Micafungin Sandoz contains

• The active substance is micafungin (as the sodium salt). Each vial contains 50 mg or 100 mg of micafungin (as the sodium salt).
• Other components are: monohydrate lactose, citric acid (for pH adjustment), and sodium hydroxide (for pH adjustment), see section 2.

What Micafungin Sandoz looks like and contents of the pack
Micafungin Sandoz 50 mg or 100 mg, powder for concentrate for solution for infusion is a white or off-white lyophilized powder.
Micafungin Sandoz is available in packs containing 1 vial of 10 ml made of clear type I glass, with a grey butyl-isoprene rubber stopper and an aluminium seal with a blue plastic flip-off cap (Micafungin Sandoz, 50 mg) or a red plastic flip-off cap (Micafungin Sandoz, 100 mg). The vial is wrapped in a protective foil against UV radiation.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers
BAG Health Care GmbH
Amtsgerichtsstrasse 1 - 5
35423 Lich, Hessen
Germany D-35423
Galenicum Health S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla,
Esplugues de Llobregat 08950 Barcelona
Spain
SAG MANUFACTURING, S.L.U.
Ctra. N-I, km 36
28750 San Agustín del Guadalix Madrid –
Spain
Lek Pharmaceuticals d.d
Verovskova ulica 57
1526 Ljubljana
Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Malta Micafungin Sandoz
Austria Micafungin Sandoz 50 mg – Powder for a concentrate for solution for infusion.
Micafungin Sandoz 100 mg – Powder for a concentrate for solution for infusion.
Germany Micafungin HEXAL 50 mg, powder for concentrate for solution for infusion.
Micafungin HEXAL 100 mg, powder for concentrate for solution for infusion.
Spain Micafungina Sandoz 50 mg powder for concentrate for perfusion solution EFG
Micafungina Sandoz 100 mg powder for concentrate for perfusion solution EFG
Finland Micafungin Sandoz 50 mg for infusion concentrate, powder
Micafungin Sandoz 100 mg for infusion concentrate, powder
Croatia Mikafungin Sandoz 50 mg powder for concentrate for infusion solution
Mikafungin Sandoz 100 mg powder for concentrate for infusion solution
Poland Micafungin Sandoz
Sweden Micafungin Sandoz 50 mg powder for concentrate for infusion solution
Micafungin Sandoz 100 mg powder for concentrate for infusion solution
Slovenia Mikafungin Sandoz 50 mg, powder for concentrate for infusion solution
Mikafungin Sandoz 100 mg, powder for concentrate for infusion solution

(logo of the Marketing Authorisation Holder)

The following information is intended for healthcare professionals only:
Instructions for use, see also section 3. How to use Micafungin Sandoz.
Micafungin Sandoz must be prepared and diluted as follows:

1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
2. Under aseptic conditions, slowly inject 5 ml along the inner wall of the vial, either of 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion (taken from a 100 ml bottle/bag). Although foaming may occur, every effort should be made to minimize foam formation. To obtain the correct dose in mg, prepare the concentrate using the appropriate number of vials of Micafungin Sandoz medicinal product (see table below).
3. Gently rotate the vial along its long axis. DO NOT SHAKE! The powder will dissolve completely. The prepared concentrate should be used immediately. The vial is for single use only. Any prepared but unused concentrate must be discarded immediately.
4. Transfer the entire volume of the prepared concentrate from the vial(s) into the infusion bottle (bag) from which the diluent was originally withdrawn. The diluted infusion solution should be administered immediately. The prepared solution remains chemically and physically stable for 24 hours at 25°C, provided it is protected from light and has been diluted according to the instructions above.
5. Gently invert the infusion bottle (bag) to ensure thorough mixing of the diluted solution and DO NOT SHAKE to avoid foaming. Do not administer the solution if it is cloudy or contains a precipitate.
6. Place the bottle (bag) containing the diluted solution into a closed, opaque container to protect it from light.

Preparation of the infusion solution