Micafungin Mylan 50 mg powder for concentrate for solution for infusion
mikafungin
What Micafungin Mylan is and what it is used for
Micafungin Mylan contains the active substance micafungin. Micafungin Mylan is an antifungal drug and is used to treat infections caused by fungal cells.
Micafungin Mylan is used to treat fungal infections caused by fungal or yeast cells called Candida. Micafungin Mylan 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. Micafungin Mylan 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 Micafungin Mylan for you for any of the following reasons when there is no other suitable antifungal treatment 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.
Micafungin contained in Micafungin Mylan 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 Micafungin Mylan
Do not use Micafungin Mylan
- 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 micafungin treatment before using your medicine. Tell your doctor if you have severe liver problems (eg liver failure or hepatitis) or if you have had abnormal liver function tests before. During treatment, your liver function will be monitored more closely. |
Talk to your doctor or pharmacist before using Micafungin Mylan
- 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 Micafungin Mylan
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.
Micafungin Mylan with food and drink
Because Micafungin Mylan is given intravenously (into a vein), no special food or drink measures are required.
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.
Micafungin Mylan should not be used during pregnancy unless necessary. If you are taking Micafungin Mylan, 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.
Micafungin Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
How to use Micafungin Mylan
Micafungin Mylan must be prepared and given to you by a doctor or other healthcare professional. Micafungin Mylan is given once daily by slow intravenous (into a vein) infusion. Your doctor will decide how much Micafungin Mylan you should receive 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 Micafungin Mylan than you should
Your doctor will monitor your condition and how you react to the treatment to determine which dose of Micafungin Mylan you need. If you are still worried that you may have received too much Micafungin Mylan, talk to your doctor or other healthcare professionals immediately.
If you forget to use Micafungin Mylan
Your doctor will monitor your condition and how you react to the treatment to determine which dose of Micafungin Mylan 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 get an allergic reaction or a serious skin reaction (such as blisters and scaling of the skin), you must tell your doctor or nurse immediately.
Micafungin Mylan 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 number of alkaline phosphatases, 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 counts (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 Micafungin Mylan
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 carton and vial. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light. The drug can withstand direct exposure to light for up to 60 days (2 months).
The reconstituted concentrate and diluted infusion solution should be used immediately as it does not contain any preservatives to prevent bacterial contamination. 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 precipitation.
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, discard unused, prepared concentrate immediately.
Contents of the package and other information
Content declaration
- The active substance is mikafungin (as sodium salt). One vial contains 50 mg or 100 mg of micafungin (as sodium salt).
- The other ingredients are lactose monohydrate , citric acid (for pH adjustment) and sodium hydroxide (for pH adjustment) (see section 2).
What the medicine looks like and contents of the pack
Micafungin Mylan 50 mg and 100 mg powder for concentrate for solution for infusion are lyophilized white to off-white powder.
Micafungin Mylan is supplied in cartons containing a 10 ml clear glass vial (type I), closed with an isobutylene-isoprene gray rubber stopper and an aluminum seal with a blue plastic flip-off lid for Micafungin Mylan 50 mg and a red flip-off lid of plastic for Micafungin Mylan 100 mg. The bottle is wrapped in a film that protects against UV light.
Marketing Authorisation Holder
Marketing Authorisation Holder
Mylan AB
Box 23033
10435 Stockholm
Manufacturer
BAG Health Care GmbH
Amtsgerichtsstrasse 1 – 5
35423 Lich, Hesse (Germany)
Galenicum Health, SL
Avda. Cornellá 144, 7º-1ª, Edificio Lekla
Esplugues de Llobregat, 08950, Barcelona (Spain)
SAG MANUFACTURING, SLU
Ctra. NI, km 36
28750 San Agustín del Guadalix
Madrid (Spain)
Paradox Health, SL
KW20A Kordin Industrial Park
Paola PLA3000, Malta