Micafungin Teva 50 mg powder for concentrate for infusion solution EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Micafungina Teva 50 mg powder for concentrate for solution for infusion EFG

Micafungina Teva 100 mg powder for concentrate for solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Micafungina Teva is and what it is used for
2. What you need to know before using Micafungina Teva
3. How to use Micafungina Teva
4. Possible adverse effects
5. How to store Micafungina 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. Micafungin Teva is an antifungal medicine, as it is used to treat infections caused by fungal cells.

Micafungin Teva is used to treat fungal infections caused by fungal or yeast cells called Candida.

Micafungin Teva is effective in the treatment of systemic infections (those that have spread into the body). It interferes with the production of a component of the fungal cell wall. An intact cell wall is necessary for fungi to continue growing and surviving. Micafungin Teva causes defects in the fungal cell wall, preventing the fungus from growing and surviving.

Your doctor has prescribed Micafungin Teva when no other antifungal treatment is available, in the following circumstances (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 ≥ 16 years of age with a fungal infection of the throat (esophagus) when intravenous (IV) treatment is appropriate.
• To prevent Candida infections in patients undergoing bone marrow transplantation or in those expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or longer.

2. What you need to know before using Micafungin Teva

Do not use Micafungin Teva

• if you are allergic to micafungin, 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 caused liver damage and subsequent liver tumors. The potential risk of developing liver tumors in humans is unknown; your doctor will advise you on the benefits and risks of treatment with Micafungin Teva before you start using it. You must 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.

Consult your doctor or pharmacist before starting to use Micafungin Teva

• 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 applies, your doctor may decide to monitor your kidney function more closely.

Micafungin may also cause severe inflammation/skin rash and mucosal membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other medicines and Micafungin Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you inform your doctor if you are using 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.

Micafungin Teva with food and drinks

Since Micafungin Teva is administered intravenously (into the vein), there are no restrictions regarding food or drinks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Micafungin Teva must not be used during pregnancy unless clearly necessary. If you are using Micafungin Teva, you must not breastfeed.

Driving and using machines

It is unlikely that micafungin will affect your ability to drive or use machines. However, some people may feel dizzy when taking this medicine, and if this happens to you, do not drive or operate any tools or machinery. Please inform your doctor if you experience any side effect that could cause problems with driving or operating other machinery.

Micafungin Teva contains sodium

Micafungin Teva contains less than 23 mg of sodium (1 mmol) per vial; this is essentially “sodium-free”.

3. How to use Micafungin Teva

Micafungin Teva must be prepared and administered by a doctor or other healthcare professional. This medicine must be given once daily by slow intravenous infusion (into the vein). Your doctor will determine how much micafungin you will receive each day.

Use in adults, adolescents ≥ 16 years and elderly patients

• The usual dose for the treatment of invasive Candida infection is 100 mg per day for patients weighing more than 40 kg and 2 mg/kg per day for patients weighing 40 kg or less.
• The dose for the treatment of esophageal Candida infection is 150 mg per day for patients weighing more than 40 kg and 3 mg/kg per day for patients weighing 40 kg or less.
• The usual dose for the prevention of invasive Candida infection 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 and adolescents < 16 years

• The usual dose for the treatment of invasive Candida infection is 100 mg per day for patients weighing more than 40 kg and 2 mg/kg per day for patients weighing 40 kg or less.
• The usual dose for the prevention of invasive Candida infection 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

• The usual dose for the treatment of invasive Candida infection is 4–10 mg/kg per day.
• The usual dose for the prevention of invasive Candida infection is 2 mg/kg per day.

If you receive more Micafungin Teva than you should

Your doctor will monitor your response and condition to determine the appropriate dose of micafungin. However, if you are concerned that you have received too much medicine, contact your doctor or another healthcare professional immediately.

If you think you have suffered an overdose, inform your doctor immediately. You may also call the Toxicology Information Service at Tel. 91 562 04 20.

If you miss a dose of Micafungin Teva

Your doctor will monitor your response and condition to determine whether treatment with micafungin is necessary. However, if you are concerned that you have missed a dose, contact your doctor or another healthcare professional immediately.

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

4. Possible adverse effects

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

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

Micafungin Teva may cause the following adverse effects:

Common (may affect up to 1 in 10 people)

• abnormal blood test results (decrease in white blood cells [leucopenia; neutropenia]); decrease in red blood cells (anaemia)
• low potassium levels in blood (hypokalaemia); low magnesium levels in blood (hypomagnesaemia); low calcium levels in blood (hypocalcaemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (feeling unwell); vomiting (being sick); diarrhoea; abdominal pain
• abnormal liver function test results (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)
• increased biliary pigment in blood (hyperbilirubinaemia)
• rash
• fever
• chills

Uncommon (may affect up to 1 in 100 people)

• abnormal blood test results (decrease in blood cells [pancytopenia]); decrease in platelets (thrombocytopenia); increase in a certain type of white blood cells called eosinophils; decrease in albumin in blood (hypoalbuminaemia)
• hypersensitivity
• increased sweating
• low sodium levels in blood (hyponatraemia); high potassium levels in blood (hyperkalaemia); low phosphate levels in blood (hypophosphataemia); anorexia (eating disorder)
• insomnia (difficulty sleeping); anxiety, confusion
• drowsiness; tremor; dizziness; taste disturbance
• increased heart rate; stronger heartbeat; irregular heartbeat
• high or low blood pressure; skin redness
• shortness of breath
• indigestion; constipation
• liver failure; increased liver enzymes (gamma-glutamyl transferase); jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems); reduced bile flow to the intestine (cholestasis); enlarged liver; liver inflammation
• itchy rash (urticaria); itching; red skin (erythema)
• abnormal kidney function test results (increased creatinine in blood; increased urea in blood); worsened renal failure
• increased lactate dehydrogenase enzyme
• blood clot formation at injection site; inflammation at injection site; pain at injection site; fluid accumulation in the body

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

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

Frequency not known (frequency cannot be estimated from the available data)

• blood coagulation disorder
• anaphylactic shock
• liver cell damage including death
• kidney problems; acute kidney failure

Other adverse effects in children and adolescents

The following reactions have been reported more frequently in paediatric patients than in adults:

Common (may affect up to 1 in 10 people)

• decrease in platelets (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increased biliary pigment in blood (hyperbilirubinaemia); enlarged liver
• acute kidney failure; increased urea in blood

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Micafungin Teva

Keep this 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, after EXP. The expiry date refers to the last day of the month indicated.

The unopened medicine does not require special storage conditions.

Reconstituted concentrate in the vial

Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C when reconstituted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.

Diluted solution for infusion

Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light, when diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.

From a microbiological standpoint, reconstituted and diluted solutions should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours between 2 and 8°C, unless reconstitution and dilution have taken place under controlled and validated aseptic conditions.

Only a properly trained healthcare professional who has fully read and correctly followed the instructions should prepare this medicine for use.

Do not use the diluted solution for infusion if it appears cloudy or if a precipitate has formed.

To protect from light, the bottle/bag containing the diluted solution for infusion must be placed in an opaque bag with a seal.

The vial is for single use only. Therefore, any unused reconstituted concentrate must be immediately discarded.

Medicines must not be disposed of via wastewater or household waste. If in doubt, consult your pharmacist on how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Micafungin Teva

• The active substance is micafungin (as sodium salt).
• One vial contains sodium micafungin equivalent to 50 mg or 100 mg of micafungin.
• The other components are sucrose, citric acid, and sodium hydroxide.

Appearance of Micafungin Teva and contents of the pack

Micafungin Teva 50 mg or 100 mg powder for concentrate for solution for infusion is a white to off-white powder.

Micafungin Teva is supplied in a pack containing one vial.

Marketing Authorization Holder

Teva B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

Manufacturer

s.c. Sindan-Pharma S.R.L.

11, Ion Mihalache Ave.,

The 1st District

Bucharest 011171

Romania

or

Merckle GmbH

Graf-Arco-Str. 3,

89079 Ulm

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108, Alcobendas, Madrid (Spain)

Date of the most recent revision of this leaflet: August 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

This information is intended for healthcare professionals only:

Micafungin Teva must not be mixed or co-administered by infusion with other medicinal products except those mentioned below. Micafungin should be reconstituted and diluted using aseptic techniques at room temperature as described below:

1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
2. Slowly and aseptically inject 5 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) into each vial, along the side of the inner vial wall. Although foaming may occur, care should be taken to minimize the amount of foam generated. Reconstitute a sufficient number of Micafungin Teva vials to obtain the required dose in mg (refer to the table below).
3. Gently rotate the vial. DO NOT SHAKE. The powder will dissolve completely. The concentrate should be used immediately. The vial is for single use only. Therefore, any unused reconstituted concentrate must be discarded immediately.
4. Withdraw all of the reconstituted concentrate from each vial and return it to the infusion bottle/bag from which the diluent was initially taken. The diluted solution for infusion should be used immediately. Chemical and physical in-use stability has been demonstrated for 96 hours when stored at 25°C, provided it is protected from light and the dilution has been performed as described above.
5. Carefully invert the infusion bottle/bag to disperse the diluted solution, but DO NOT SHAKE, to avoid foam formation. Do not use the solution if it is cloudy or if a precipitate has formed.
6. The bottle/bag containing the diluted solution for infusion should be placed in an opaque sealed bag to protect it from light.

Preparation of the solution for infusion

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