MICAFUNGINA 50 mg Powder For Intravenous Infusion Solution

Зміст інструкції

1. MICAFUNGINA TEVA 50 mg powder for concentrate for infusion solution, 100 mg powder for concentrate for infusion solution
   1. What is Micafungina Teva and what is it used for
   2. What you need to know before you use Micafungina Teva
   3. How to use Micafungina Teva
   4. Possible side effects
   5. How to store Micafungina Teva
   6. Contents of the pack and other information

MICAFUNGINA TEVA 50 mg powder for concentrate for infusion solution, 100 mg powder for concentrate for infusion solution

micafungin

Read this leaflet carefully before you use 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Micafungina Teva contains the active ingredient micafungin. Micafungina Teva is defined as an
antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungina Teva is used to treat infections caused by fungal or yeast cells called

Candida.
Micafungina Teva is effective in the treatment of systemic infections (those infections that have
penetrated inside the body). It interferes with the production of a part of the fungal cell wall. An intact cell wall is essential for the fungus to continue to live and to
grow. Micafungina Teva causes defects in the fungal cell wall, making the fungus
unable to live and grow.
Your doctor has prescribed Micafungina Teva in the following circumstances, when no other suitable antifungal treatments are available (see section 2):

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

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

Do not use Micafungina Teva

• 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
liver. The potential risk of tumor development in humans is unknown, and the doctor will assess the
benefits and risks of treatment with Micafungina Teva before you start taking the medicine.
Tell your doctor if you have severe liver problems (e.g. liver impairment or hepatitis) or have
presented altered liver function tests. During treatment, your liver function will
be monitored more closely.
Consult your doctor or pharmacist before using Micafungina Teva

• if you are allergic to any medicine
• if you suffer from hemolytic anemia (anemia due to the breakdown of red blood cells) or hemolysis (breakdown of red blood cells)
• if you suffer from kidney problems (e.g. kidney impairment and abnormal kidney function tests). If this should happen, the doctor may decide to monitor your kidney function more closely.

Micafungin can also cause a severe inflammation/rash of the skin and mucous membranes
(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 medicine.
It is particularly important that you inform your doctor if you are being treated with amphotericin B deoxycholate
or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant) or nifedipine (a calcium channel blocker
used to treat high blood pressure). The doctor may decide to
adjust the dose of these medicines.

Micafungina Teva with food and drink
Since Micafungina Teva is administered intravenously (in a vein), there are no
restrictions on food and drink intake.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Micafungina Teva should not be used during pregnancy unless strictly
necessary. Do not breastfeed during treatment with Micafungina Teva.

Driving and using machines
It is unlikely that micafungin will affect driving or using machines. However,
some people may experience dizziness when taking this medicine and if this happens to you,
do not drive vehicles or use tools or machinery. Tell your doctor if you experience any
effect that may cause you problems with driving or using machinery.

Micafungina Teva contains sodium
Micafungina Teva contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially
“sodium-free”.

3. How to use Micafungina Teva

Micafungina Teva must be prepared and administered by a doctor or another healthcare professional.
Micafungina Teva must be administered once daily by slow intravenous (into a vein) infusion.
The doctor will determine the daily dose of Micafungina Teva needed for you.

Use in adults, adolescents from 16 years of age and the elderly

• The commonly used dose for treating an invasive Candidainfection is 100 mg per day for patients with a body weight greater than 40 kg and 2 mg/kg per day for patients with a body weight equal to or less than 40 kg.
• The commonly used dose for treating an Candidainfection of the esophagus is 150 mg for patients with a body weight greater than 40 kg and 3 mg/kg per day for patients with a body weight equal to or less than 40 kg.
• The commonly used dose for preventing invasive Candidainfections is 50 mg per day for patients with a body weight greater than 40 kg and 1 mg/kg per day for patients with a body weight equal to or less than 40 kg.

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

• The commonly used dose for treating an invasive Candidainfection is 100 mg per day for patients with a body weight greater than 40 kg and 2 mg/kg per day for patients with a body weight equal to or less than 40 kg.
• The commonly used dose for preventing invasive Candidainfections is 50 mg per day for patients with a body weight greater than 40 kg and 1 mg/kg per day for patients with a body weight equal to or less than 40 kg.

Use in children and infants under 4 months of age

• The commonly used dose for treating an invasive Candidainfection is 4-10 mg/kg per day.
• The commonly used dose for preventing invasive Candidainfections is 2 mg/kg per day.

If you take more Micafungina Teva than you should
To determine the dose of Micafungina Teva needed, the doctor will check your response to the
medicine and your health conditions. However, if you are concerned that you have received an excessive
dose of Micafungina Teva, talk to your doctor or another healthcare professional immediately.

If you forget to take a dose of Micafungina Teva
To determine the type of treatment with Micafungina Teva needed, the doctor will check your
response to the medicine and your health conditions. However, if you are concerned that you have not
received a dose of Micafungina Teva, talk to your doctor or another healthcare professional immediately.
If you have any questions about using 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 have an allergic reaction, or a serious skin reaction (e.g. formation of blisters and
skin peeling), tell your doctor or nurse immediately.
Micafungina Teva may cause the following further side effects:

Common (may affect up to 1 in 10 people)

• alteration of blood values (decrease in white blood cells [leukopenia; neutropenia]); decrease in red blood cells (anemia)
• decrease in potassium in the blood (hypokalaemia); decrease in magnesium in the blood (hypomagnesaemia); decrease in calcium in the blood (hypocalcaemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (feeling unwell); vomiting (feeling unwell); diarrhoea; abdominal pain
• altered values in liver function tests (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)
• increase in bile pigment in the blood (hyperbilirubinaemia)
• skin rash
• fever
• chills (tremor)

Uncommon (may affect up to 1 in 100 people)

• alteration of blood values (decrease in the number of blood cells [pancytopenia]); decrease in the number of platelets (thrombocytopenia); increase in a certain type of white blood cells called eosinophils; decrease in albumin in the blood (hypoalbuminaemia)
• hypersensitivity
• increased sweating
• decrease in sodium in the blood (hyponatraemia); increase in potassium in the blood (hyperkalaemia); decrease in phosphates in the blood (hypophosphataemia); anorexia (eating disorder)
• insomnia (difficulty sleeping); anxiety; confusion
• drowsiness; tremors; dizziness; taste disturbances
• increased heart rate; increased heart beat force; irregular heartbeat
• high or low blood pressure; skin flushing
• shortness of breath
• indigestion; constipation
• liver failure; increase in liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems); decreased amount of bile reaching the intestine (cholestasis); enlarged liver; liver inflammation
• itchy skin rash (urticaria); itching; skin redness (erythema)
• alteration of values in renal function tests (increase in blood creatinine; increase in urea in the blood); worsening of renal insufficiency
• increase in an enzyme called lactate dehydrogenase
• blood clots in the veins 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)

• anemia caused by the destruction of red blood cells (hemolytic anemia); destruction of red blood cells (hemolysis)

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

• blood coagulation system disorders
• shock (allergic)
• damage to liver cells, including death
• kidney problems; acute renal failure

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

Common (may affect up to 1 in 10 people)

• decrease in blood platelets (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increase in bile pigments in the blood (hyperbilirubinaemia); enlarged liver
• acute renal failure; increase in urea concentration in the blood

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through the national reporting system
at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store 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 the outer packaging after
“Exp”. The expiry date refers to the last day of the month.
The unopened vial does not require any particular storage conditions.
Reconstituted concentrate in vial
Chemical and physical stability under usage conditions has been demonstrated for up to 48 hours at 25°C if
reconstituted with sodium chloride 9 mg/ml (0.9%) solution for infusion or with glucose 50 mg/ml (5%)
solution for infusion.
Diluted infusion solution
Chemical and physical stability under usage conditions has been demonstrated for up to 96 hours at 25°C if
stored protected from light and if diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or
with glucose 50 mg/ml (5%) solution for infusion.
From a microbiological point of view, diluted and reconstituted solutions must be used
immediately. If not used immediately, the storage times in use and the conditions
prior to use are the responsibility of the user and must not exceed 24 hours at temperatures of
2-8°C, unless the reconstitution and dilution have taken place under controlled and validated aseptic
conditions.
Only a healthcare professional who has read the instructions thoroughly can
prepare this medicine for its use.
Do not use the diluted solution for infusion if it appears cloudy or precipitated.
The vial/infusion bag containing the diluted solution for infusion must be placed in an
opaque bag with a closing mechanism to protect it from light.
The vial is for single use. Please therefore dispose of any unused reconstituted concentrate immediately.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Micafungina Teva contains

• The active substance is micafungin (as sodium salt). 1 vial contains micafungin sodium equivalent to 50 mg or 100 mg of micafungin.
• The other ingredients are sucrose, citric acid and sodium hydroxide.

Description of the appearance of Micafungina Teva and contents of the pack
Micafungina Teva 50 mg and 100 mg powder for concentrate for solution for infusion is a powder
of colour from white to off-white.
Micafungina Teva is supplied in packs of 1 vial.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
011171 Bucharest - Romania
---------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:
Micafungina Teva must not be mixed or infused with other products except those
indicated below. Micafungina Teva is reconstituted and diluted at room temperature and under aseptic
conditions as follows:

• 1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
• 2. Slowly inject into each vial, along the inner wall and under aseptic conditions, 5 ml of sodium chloride solution for infusion 9 mg/ml (0.9%) or glucose solution for infusion 50 mg/ml (5%) (taken from a 100 ml bottle/bag). Even if the concentrate develops foam, maximum care must be taken to minimize the amount of foam generated. A sufficient number of vials of Micafungina Teva 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. Therefore, any unused reconstituted concentrate must be discarded immediately.
• 4. Aspirate all the concentrate, once reconstituted, from each vial and transfer it to the bottle/bag for infusion from which it was originally taken. The diluted infusion solution must be used immediately. Chemical and physical stability in use of the solution has been demonstrated for 96 hours at 25°C if stored protected from light and if diluted as described previously.
• 5. Gently invert the bottle/bag for infusion to promote dispersion of the diluted solution but DO NOT shake to avoid foam formation. The solution must not be used if it appears cloudy or has precipitated.
• 6. Insert the bottle/bag for infusion containing the diluted infusion solution into an opaque bag with a closure to protect it from light.

Preparation of the solution for infusion
After reconstitution and dilution, the solution must be administered via intravenous
infusion approximately over 1 hour.