Micafungin teva

Package leaflet: Information for the user

Micafungin Teva, 50 mg, powder for solution for infusion concentrate
Micafungin Teva, 100 mg, powder for solution for infusion concentrate
micafungin

Please read all of this leaflet carefully before this medicine is administered 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 leaflet

1. What Micafungin Teva is and what it is used for
2. What you need to know before you are given Micafungin Teva
3. How to use Micafungin Teva
4. Possible side effects
5. How to store Micafungin Teva
6. Contents of the pack and other information

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

Micafungin Teva contains the active substance micafungin. It is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin Teva is used to treat fungal infections caused by fungi or yeast called Candida. Micafungin Teva 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. The medicine damages the cell wall, thereby preventing further development and growth of fungi.
Your doctor will prescribe Micafungin Teva in the following cases, if 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 spreads into the body);
• Treatment of adults and adolescents aged ≥ 16 years with fungal infection of the oesophagus (oesophageal candidiasis) where intravenous treatment (treatment given directly into the vein) is appropriate;
• Prevention of Candida infections in patients undergoing allogeneic (i.e. from a donor) haematopoietic stem cell transplantation or in patients expected to have neutropenia (low levels of neutrophils; a type of white blood cell) lasting for 10 or more days.

2. Important information before using Micafungin Teva

When not to use Micafungin Teva:

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

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

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

Micafungin may cause severe inflammatory reactions/skin rashes and mucosal lesions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Micafungin Teva with other medicines
You must tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important to inform the doctor about the use of amphotericin B deoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressive medicine), or nifedipine (a calcium channel blocker used in the treatment of hypertension). The doctor may decide to adjust the dosage of these medicinal products.
Micafungin Teva with food and drink
Since Micafungin Teva is administered intravenously (into a vein), there are no restrictions regarding food and drink intake.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Micafungin Teva must not be used during pregnancy unless absolutely necessary.
Breastfeeding must be avoided during treatment with Micafungin Teva.
Driving and operating machinery
It is unlikely that micafungin will affect the ability to drive or operate machinery. However, dizziness may occur in some patients during treatment, and in such cases, the patient should not drive or operate tools or machinery. Inform your doctor if any side effects occur that may cause difficulties in driving or operating other equipment.
Micafungin Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".

3. How to use Micafungin Teva

Micafungin Teva must be prepared and administered by a doctor or other medical personnel.
Micafungin Teva should be given once daily as a slow intravenous infusion (into a vein). The daily dose
is determined by the treating physician.

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

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

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

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

Use in children and newborns under 4 months of age

• For treatment of invasive Candida infection, the usual dose ranges from 4 mg/kg body weight once daily 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.

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

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

If you have any further questions about 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 will experience 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 Teva may cause the following other adverse reactions:
Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

• abnormal blood test results [reduced number of blood cells (pancytopenia)]; reduced number of platelets (thrombocytopenia); increased number of a certain type of white blood cells (eosinophils); reduced blood albumin levels (hypoalbuminaemia)
• hypersensitivity
• increased sweating
• low blood sodium levels (hyponatraemia); high blood potassium levels (hyperkalaemia); low blood phosphate levels (hypophosphataemia); anorexia (loss of appetite)
• insomnia (sleep problems); anxiety; confusion
• drowsiness; 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 bile reaches the intestine (cholestasis); enlarged liver; hepatitis
• itchy rash (urticaria); itching; skin redness (erythema)
• abnormal kidney function tests (increased blood creatinine levels; increased blood urea levels); worsening of kidney failure
• increased activity of an enzyme called lactate dehydrogenase
• venous thrombosis at injection site; inflammation at injection site; pain at injection site; fluid retention in the body

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

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

Unknown (frequency cannot be estimated from available data)

• blood coagulation disorder
• shock (allergic)
• liver cell damage, which may also lead to death
• kidney problems; acute kidney failure

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

• reduced number of platelets (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, tell your doctor or pharmacist. 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 to provide more information on the safety of this medicine.

5. How to store Micafungin Teva

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and outer packaging. The expiry date refers to the last day of the specified month.
The unopened vial does not require storage under special conditions.

Concentrate prepared in the vial
The prepared concentrate maintains chemical and physical stability for 48 hours at 25°C when reconstituted with sodium chloride solution 9 mg/ml (0.9%) for infusion or glucose solution 50 mg/ml (5%) for infusion.

Diluted infusion solution
The prepared solution maintains chemical and physical stability for 96 hours at 25°C, provided it is protected from light and diluted with sodium chloride solution 9 mg/ml (0.9%) for infusion or glucose solution 50 mg/ml (5%) for infusion.

From a microbiological point of view, the prepared and diluted solutions should be administered immediately after preparation. If not administered immediately, the person administering the medicine is responsible for the storage conditions and duration. The storage time should not exceed 24 hours at a temperature of 2 to 8°C, unless reconstitution and dilution were carried out under controlled and validated aseptic conditions.

This medicine must be prepared for use only by trained healthcare personnel after carefully reading the entire instruction.

Do not use the diluted solution if it becomes cloudy or contains particulate matter.

To protect from light, the bottle (or bag) containing the diluted solution should be placed inside a closed protective covering.

The vial is intended for single use only. Any unused, prepared concentrate should be promptly discarded.

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

6. Contents of the pack and other information

What Micafungin Teva contains

• The active substance is micafungin (as micafungin sodium). One vial contains 50 mg or 100 mg of micafungin (as micafungin sodium).
• Other ingredients: sucrose, citric acid, and sodium hydroxide.

What Micafungin Teva looks like and contents of the pack
Micafungin Teva 50 mg or 100 mg, powder for concentrate for solution for infusion, is a white
or almost white powder.
Micafungin Teva is available in a pack containing 1 vial.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53, 00-113 Warsaw
Tel.: (22) 345 93 00

Manufacturer
S.C. Sindan-Pharma S.R.L.
11, Ion Mihalache Ave., the 1st district
011171 Bucharest
Romania

Merckle GmbH
Graf-Arco-Str. 3,
89079 Ulm
Germany

Information intended exclusively for medical professionals:

Micafungin Teva must not be mixed or administered simultaneously with other medicinal products, except those listed below. Under aseptic conditions and at room temperature, Micafungin Teva should be prepared 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 each vial of sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) 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 of the medicinal product in mg, prepare the concentrate using the appropriate number of vials (see table below).

3. Gently rotate the vial. 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 vials into the bottle (bag) containing the infusion solution from which the solution was originally withdrawn. The diluted infusion solution should be administered immediately. The prepared solution maintains chemical and physical stability for 96 hours at 25°C, provided it is protected from light and has been diluted according to the instructions above.

5. Gently invert the bottle (bag) containing the infusion solution to ensure thorough mixing, and DO NOT SHAKE to avoid foam formation. The solution must not be administered if it is cloudy or contains particulate matter.

6. The bag (bottle) containing the diluted solution should be placed in a closed container protecting it from light.

Preparation of the infusion solution

After reconstitution and dilution, the solution should be administered by slow intravenous infusion over approximately 1 hour.