MICAFUNGINA TEVA 50 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Micafungina Teva

Do not use Micafungina Teva

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

Warnings and precautions

In rats, long-term treatment with micafungin produced liver damage and subsequent liver tumors. The potential risk of developing liver tumors in humans is unknown; and your doctor will advise you on the benefits and risks of treatment with Micafungina Teva before starting to use it. You should inform your doctor if you have severe liver problems (e.g., liver failure or hepatitis) or have had abnormal liver function tests. Your liver function will be closely monitored during treatment.

Talk to your doctor or pharmacist before starting to use Micafungina Teva

• if you are allergic to any medicine
• if you have hemolytic anemia (anemia due to the 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 happens, your doctor may decide to closely monitor your kidney function.

Micafungina may also cause severe skin and mucous membrane inflammation/eruption (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other medicines and Micafungina Teva

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

It is especially important that you tell your doctor if you are using amphotericin B desoxycholate 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.

Micafungina Teva with food and drinks

Since Micafungina Teva is administered intravenously (in the vein), there are no restrictions on food or drinks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Micafungina Teva should not be used during pregnancy unless clearly necessary. If you use Micafungina Teva, you should 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 use any tools or machines. Please inform your doctor if you experience any effect that may cause problems with driving or using other machinery.

Micafungina Teva contains sodium

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

3. How to use Micafungina Teva

Micafungina Teva must be prepared and administered by a doctor or other healthcare professional. This medicine must be administered once a day by slow intravenous infusion (in 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 treating an invasive Candida infection is 100 mg per day for patients who weigh more than 40 kg and 2 mg/kg per day for patients who weigh 40 kg or less.
• The dose for treating a Candida infection in the esophagus is 150 mg for patients who weigh more than 40 kg and 3 mg/kg per day for patients who weigh 40 kg or less.
• The usual dose for preventing an invasive Candida infection is 50 mg per day for patients who weigh more than 40 kg and 1 mg/kg per day for patients who weigh 40 kg or less.

Use in children ≥ 4 months and adolescents < 16 years

• The usual dose for treating an invasive Candida infection is 100 mg per day for patients who weigh more than 40 kg and 2 mg/kg per day for patients who weigh 40 kg or less.
• The usual dose for preventing an invasive Candida infection is 50 mg per day for patients who weigh more than 40 kg and 1 mg/kg per day for patients who weigh 40 kg or less.

Use in children and newborns < 4 months

• The usual dose for treating an invasive Candida infection is 4-10 mg/kg per day.
• The usual dose for preventing an invasive Candida infection is 2 mg/kg per day.

If you receive more Micafungina Teva than you should

Your doctor will monitor your response and disease to determine what dose of micafungin is necessary. However, if you are concerned that you have received too much medicine, consult your doctor or other healthcare professional immediately.

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

If you miss a dose of Micafungina Teva

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

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

4. Possible side effects

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

If you suffer an allergic reaction or a severe skin reaction (e.g., blisters and skin peeling), you should inform your doctor or nurse immediately.

Micafungina Teva can cause the following side effects:

Common (may affect up to 1 in 10 people)

• abnormal blood test results (decrease in the number of white blood cells [leukopenia; neutropenia]); decrease in the number of red blood cells (anemia)
• decrease in potassium in the blood (hypokalemia); decrease in magnesium in the blood (hypomagnesemia); decrease in calcium in the blood (hypocalcemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (feeling sick); vomiting (being sick); diarrhea; abdominal pain
• abnormal liver function tests (increase in alkaline phosphatase; increase in aspartate aminotransferase, increase in alanine aminotransferase)
• increase in bilirubin in the blood (hyperbilirubinemia)
• rash
• fever
• chills

Uncommon (may affect up to 1 in 100 people)

• abnormal blood test results (decrease in the number of blood cells [pancytopenia]); decrease in the number of platelets (thrombocytopenia); increase in a certain type of white blood cell called eosinophils; decrease in albumin in the blood (hypoalbuminemia)
• hypersensitivity
• increased sweating
• decrease in sodium in the blood (hyponatremia); increase in potassium in the blood (hyperkalemia); decrease in phosphate in the blood (hypophosphatemia); anorexia (eating disorder)
• insomnia (difficulty sleeping); anxiety, confusion
• drowsiness (somnolence); tremors, dizziness, altered taste
• increased heart rate; stronger heartbeat; irregular heartbeat
• high or low blood pressure; flushing of the skin
• shortness of breath
• indigestion; constipation
• liver failure; increase in liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or the whites of the eyes caused by liver or blood problems); decrease in bile that reaches the intestine (cholestasis); enlarged liver; liver inflammation
• urticaria (hives); itching; red skin
• abnormal kidney function tests (increase in creatinine in the blood; increase in urea in the blood); worsening kidney failure
• increase in lactate dehydrogenase enzyme
• clot formation 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 1,000 people)

• anemia due to the breakdown of red blood cells (hemolytic anemia), breakdown of white blood cells (hemolysis)

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 side effects in children and adolescents

The following reactions have been reported more frequently in pediatric 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
• increase in bilirubin in the blood (hyperbilirubinemia); enlarged liver
• acute kidney failure; increase in urea in the blood

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's online platform: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micafungina Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial and carton, after EXP. The expiry date is the last day of the month stated.

The unopened medicine does not require any special storage conditions.

Reconstituted concentrate in the vial

Chemical and physical stability in use 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.

Infusion solution for dilution

Chemical and physical stability in use has been demonstrated for up to 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 point of view, the reconstituted and diluted solutions should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not be greater than 24 hours at 2-8°C, unless the reconstitution and dilution have taken place in a controlled and validated aseptic environment.

Only a healthcare professional who has read the instructions completely and correctly can prepare this medicine for use.

Do not use the infusion solution if you notice it is cloudy or if a precipitate has formed.

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

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

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

6. Container Content and Additional Information

Composition ofMicafunginTeva

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

Appearance ofMicafunginTeva and Container Content

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 container containing one vial.

Marketing Authorization Holder

Teva B.V.

Swensweg 5, 2031 GA Haarlem

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

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108, Alcobendas, Madrid (Spain)

Date of the last 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 only for healthcare professionals:

Micafungin Teva should not be mixed or infused simultaneously with other medicinal products except those mentioned below. Micafungin is reconstituted and diluted using aseptic techniques at room temperature, as follows:

1. The plastic cap should be removed from the vial and the stopper should be disinfected with alcohol.
2. 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) should be slowly and aseptically injected into each vial along the side of the inner wall. Although the concentrate will foam, special care should be taken to minimize the amount of foam generated. A sufficient number of Micafungin Teva vials should be reconstituted to obtain the necessary dose in mg (see the table below).
3. The vial should be gently rotated. IT SHOULD NOT BE SHAKEN. The powder will dissolve completely. The concentrate should be used immediately. The vial is for single use. Therefore, any unused reconstituted concentrate should be discarded immediately.
4. All reconstituted concentrate should be removed from each vial and returned to the infusion bottle/bag from which it was initially taken. The diluted solution for infusion should be used immediately. Chemical and physical stability has been demonstrated for 96 hours when stored at 25°C, protected from light, and the dilution is performed as described above.
5. The infusion bottle/bag should be carefully inverted to disperse the diluted solution but SHOULD NOT BE SHAKEN to avoid foam formation. The solution should not be used if it is turbid or if a precipitate has formed.
6. The bottle/bag containing the diluted solution for infusion should be placed in an opaque bag with a seal to protect it from light.

Preparation of the Solution for Infusion

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