100 mg powder for solution for infusion
mikafungin
What Mikafungin Teva is and what it is used for
Mikafungin Teva contains the active substance mikafungin. Mikafungin Teva is an antifungal drug and is used to treat infections caused by fungal cells.
Mikafungin Teva is used to treat fungal infections caused by fungal or yeast cells called Candida. Mikafungin Teva is effective in treating systemic fungal infections (fungal infections inside the body). It interferes with the production of a component in the cell wall of the fungus. An intact cell wall is necessary for the fungus to continue to live and grow. Mikafungin Teva creates defects in the cell wall of the fungus and thus makes it impossible for the fungus to live and grow.
Your doctor has prescribed Mikafungin Teva for any of the following reasons when there is no other suitable antifungal agent available (see section 2):
- To treat adults, adolescents and children including newborns who have a severe fungal infection called invasive candidiasis (fungal infection inside the body).
- To treat adults and adolescents ≥ 16 years of age who have a fungal infection of the esophagus (esophagus) where administration of the drug via a vein ( intravenous treatment) is appropriate.
- To prevent Candida infection in patients undergoing bone marrow transplantation or patients who are expected to have neutropenia (low level of neutrophils , a type of white blood cell) for 10 days or more.
Mikafungin contained in Mikafungin Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Mikafungin Teva
Do not use Mikafungin Teva
- if you are allergic to mikafungin, other echinocandins (Ecalta or Cancidas) or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
| In rats, long-term treatment with mikafungin caused liver damage and subsequent liver tumors. The potential risk for humans from developing liver tumors is unknown and your doctor will make a benefit/risk assessment of the treatment with Mikafungin Teva before using your medicine. Tell your doctor if you have severe liver problems (eg liver failure or hepatitis ) or if you have previously had abnormal liver function tests. During treatment, your liver function will be monitored more closely. |
Talk to your doctor or pharmacist before using Mikafungin Teva
- if you are allergic to any medicine
- if you have haemolytic anemia ( anemia due to red blood cell breakdown ) or hemolysis ( red blood cell breakdown )
- if you have kidney problems (eg kidney failure and abnormal kidney function values). If this happens, your doctor may monitor your kidney function more closely.
Micafungin can also cause severe inflammation/rash on the skin and mucous membranes ( Stevens-Johnson syndrome, toxic epidermal necrolysis ).
Other medicines and Mikafungin Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to tell your doctor if you are taking amphotericin B deoxycholate 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 one of these medicines.
Mikafungin Teva with food and drink
Because Mikafungin Teva is given intravenously (into a vein), no special measures are required about food and drink.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Mikafungin Teva should not be used during pregnancy unless necessary. If you are taking Mikafungin Teva, you should not breastfeed.
Driving and using machines
Micafungin is unlikely to affect the ability to drive or use machines. However, some people may get dizzy when taking this medicine, and should it happen to you, do not drive, use any tools or machines. Tell your doctor if you experience any effects that may lead to problems with driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Mikafungin Teva contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.
How to use Mikafungin Teva
Mikafungin Teva must be prepared and given to you by a doctor or other healthcare professional. Micafungin is given once daily by slow intravenous (into a vein) infusion. Your doctor will decide how much micafungin to take each day.
Use in adults, adolescents ≥ 16 years and older
- The usual dose for the treatment of invasive Candida infection is 100 mg per day for patients weighing 40 kg or more and 2 mg / kg per day for patients weighing 40 kg or less.
- The dose to treat a Candida infection in the esophagus is 150 mg for patients weighing more than 40 kg and 3 mg / kg per day for patients weighing 40 kg or less.
- The usual dose to prevent the development of 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 40 kg or more and 2 mg / kg per day for patients weighing 40 kg or less.
- The usual dose to prevent the development of 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 treating invasive Candida infection is 4-10 mg / kg per day.
- The usual dose to prevent the development of Candida infection is 2 mg / kg per day.
If you use more Mikafungin Teva than you should
Your doctor will monitor your condition and how you react to the treatment to determine which dose of Mikafungin Teva you need. If you are still worried that you may have received too much Mikafungin Teva, talk to your doctor or another healthcare professional immediately.
If you forget to use Mikafungin Teva
Your doctor will monitor your condition and how you react to the treatment to determine which dose of Mikafungin Teva you need. If you are still worried that you may have forgotten to take a dose, talk to a doctor or other healthcare professional immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have an allergic attack or a severe skin reaction (eg blisters and scaling of the skin), you must inform your doctor or nurse immediately.
Mikafungin Teva can cause the following other side effects:
Common (may affect up to 1 in 10 people)
- abnormal blood counts (decreased white blood cell count [leukopenia; neutropenia ]); decreased number of red blood cells ( anemia )
- decreased blood potassium ( hypokalaemia ), decreased magnesium content in the blood ( hypomagnesaemia ), decreased blood calcium ( hypocalcaemia )
- headache
- inflammation of the vessel wall of the veins (at the injection site)
- nausea, vomiting, diarrhea, abdominal pain
- abnormal liver function tests (increased alkaline phosphatase levels, elevated AST , elevated ALT )
- increase in bile pigments in the blood (hyperbilirubinemia)
- rash
- fever
- stiffness (with chills).
Uncommon (may affect up to 1 in 100 people)
- abnormal blood levels (decreased number of blood cells [pancytopenia]), decreased number of platelets ( thrombocytopenia ), increase in certain types of white blood cells called eosinophils , decreased albumin content in the blood (hypoalbuminemia)
- hypersensitivity
- increased sweating
- decreased sodium levels in the blood ( hyponatremia ), increased potassium levels in the blood ( hyperkalaemia ), decreased levels of phosphatases in the blood ( hypophosphatemia ), anorexia (eating disorders)
- insomnia (difficulty sleeping), anxiety, confusion
- drowsiness ( somnolence ), tremors, dizziness, taste disturbances
- increased heart rate , stronger heartbeat, irregular heartbeat
- high or low blood pressure , reddening of the skin
- respiratory distress
- indigestion, constipation
- liver failure, elevated liver enzymes (gamma-glutamyltransferase), jaundice (yellowing of the skin or whites of the eyes due to liver or blood problems), decreased bile in the intestines (cholestasis), enlarged liver, hepatitis
- itchy rash ( urticaria ), itching , redness of the skin ( erythema )
- abnormal renal function values (increased blood creatinine, increased urea level in the blood), worsening renal failure
- increased levels of an enzyme called lactate dehydrogenase
- blood coagulation 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 1,000 people)
- anemia (anemia) due to red blood cell breakdown ( hemolytic anemia ), red blood cell breakdown ( hemolysis ).
Has been reported (occurs in an unknown number of users)
- disturbance in the blood’s ability to coagulate
- (allergic) shock
- liver cell damage including death
- kidney problems, acute renal failure .
Additional side effects in children and adolescents
The following reactions have been reported more frequently in children than in adults:
Common (may affect up to 1 in 10 people)
- decreased platelet count ( thrombocytopenia )
- increased heart rate ( tachycardia )
- high or low blood pressure
- elevated bile pigment levels in the blood (hyperbilirubinemia), enlarged liver
- acute renal failure , elevated urea in the blood.
How to store Mikafungin 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 carton after EXP. The expiration date is the last day of the specified month.
An unopened vial does not require any special storage instructions.
Reconstituted concentrate in the vial
Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25 ºC, when the powder is dissolved with sodium chloride solution for infusion, 9 mg/ml (0.9%) solution or glucose solution for infusion, 50 mg/ml (5%).
Diluted infusion solution
Chemical and physical in-use stability has been demonstrated for up to 96 hours at 25 ºC and in light protection, when the concentrate is diluted with sodium chloride solution for infusion, 9 mg/ml (0.9%) solution or glucose solution for infusion 50 mg/ml ( 5%).
From a microbiological point of view, dissolved and diluted solutions should be used immediately. If not used immediately, in-use storage times and conditions before administration are the responsibility of the user and should normally not be longer than 24 hours at 2 to 8 ºC, unless reconstitution and dilution have taken place under controlled and validated aseptic conditions.
Only trained healthcare professionals who have read the entire instructions for use properly can prepare this medicine before use.
Do not use the diluted infusion solution if it is cloudy or if there is a precipitate.
To protect the infusion bottle/bag containing the diluted infusion fluid from light, it should be tucked into a sealable opaque bag.
The vials are for single use only. Therefore, dispose of unused, dissolved concentrate immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is mikafungin (as sodium salt).1 vial contains 100 mg mikafungin.
- The other ingredients are sucrose, citric acid and sodium hydroxide.
What the medicine looks like and contents of the pack
Mikafungin Teva 100 mg powder for solution for infusion is a white to off-white powder.
Mikafungin Teva is supplied in cartons containing 1 vial.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Teva BV
Swensen 5
2031 GA Haarlem
Netherlands
Manufacturer
SC Sinden-Pharma SRL
11 Ion Mihalache Ave.
011171 Bucharest
Romania
or
Actavis Italy SpA
Via Pasteur 10
Nerviano
20014 Milano
Italy