50 mg  powder for concentrate for solution for infusion 
caspofungin

Read all of this leaflet carefully before you or your child receive this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, nurse, or pharmacist.
  • If you get any side effects, talk to your doctor, nurse, or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Caspofungin Mylan is and what it is used for 
2. What you need to know before you are given Caspofungin Mylan 
3. How Caspofungin Mylan is used 
4. Possible side effects 
5. How to store Caspofungin Mylan 
6. Contents of the packaging and other information 

What Caspofungin Mylan is and what it is used for

What Caspofungin Mylan is

Caspofungin Mylan belongs to a group of medicines called antifungals ( antifungals ).

What Caspofungin Mylan is used for

Caspofungin Mylan is used to treat the following infections in children, adolescents, and adults:

  • Severe fungal infections of tissues or organs (called “invasive candidiasis”). Infection is caused by fungal (yeast) cells called Candida. People who can get this type of infection include newly operated patients or those with a weakened immune system. Fever and chills that do not go away with antibiotic treatment are the most common symptoms of this type of infection.
  • Fungal infections of the nose, sinuses, or lungs (called “invasive aspergillosis”) if other antifungal agents have not had the expected effect or have caused side effects. This infection is caused by an organism called Aspergillus. People who can get this type of infection include those treated with chemotherapy, those who have undergone a transplant, and those with a weakened immune system.
  • Suspected fungal infections if you have a fever and low white blood cell count that does not go away with antibiotic treatment. People at risk of getting a fungal infection include those who have recently undergone surgery or those with a weakened immune system.

How Caspofungin Mylan works

Caspofungin Mylan makes fungal cells fragile and prevents the fungus from growing properly. This prevents infection one from spreading and gives the body’s natural defenses a chance to completely get rid of infection one.

Caspofungin contained in Caspofungin Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you get Caspofungin Mylan

Do not use Caspofungin Mylan 

  • if you are allergic to caspofungin or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, talk to your doctor, nurse, or pharmacist before taking your medicine.

Warnings and cautions

Talk to your doctor, nurse, or pharmacist before receiving Caspofungin Mylan:

  • if you are allergic to any other medicines
  • if you have ever had liver problems – you may need another dose of this medicine
  • if you are already taking ciclosporin (helps prevent transplant rejection or suppress the immune system) – as your doctor may need to take additional blood samples during your treatment
  • if you have ever had other medical problems.

If any of the above apply to you (or you are not sure), talk to your doctor, nurse or pharmacist before taking Caspofungin Mylan.

Caspofungin Mylan can also cause serious skin side effects such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

Other medicines and Caspofungin Mylan 

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription or herbal medicines. This is because Caspofungin Mylan may affect the way other medicines work. Other medicines may also affect the way Caspofungin Mylan works.

Tell your doctor, nurse, or pharmacist if you are taking any of the following medicines:

  • ciclosporin or tacrolimus (helps prevent transplant rejection or suppress the immune system) as your doctor may need to take additional blood samples during your treatment
  • certain anti- HIV medicines like efavirenz or nevirapine
  • phenytoin or carbamazepine (used to treat seizures)
  • dexamethasone (cortisone preparation)
  • rifampicin (an antibiotic ).

If any of the above apply to you (or you are not sure), talk to your doctor, nurse or pharmacist before taking Caspofungin Mylan.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding or think you may be pregnant, ask your doctor for advice before taking this medicine.

  • Caspofungin Mylan has not been studied in pregnant women. It should only be used during pregnancy if the potential benefit outweighs the potential risk to the unborn baby.
  • Women receiving Caspofungin Mylan should not breast-feed.

Driving and using machines

There is no information to suggest that Caspofungin Mylan affects your ability to drive or use 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.

Caspofungin Mylan contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, ie essentially ‘sodium-free’.

How to use Caspofungin Mylan

Caspofungin Mylan is always prepared and given by professional healthcare professional. You will receive Caspofungin Mylan:

  • Once a day
  • with slow injection into a vein (intravenous infusion)
  • for about 1 hour.

Your doctor will determine the duration of treatment and how much Caspofungin Mylan you will receive per day. Your doctor will check how well the medicine works for you. If you weigh more than 80 kg, you may need another dose.

Children and young people

The dose for children and adolescents may differ from dose one to adults.

If you take more Caspofungin Mylan than you should

Your doctor will decide how much Caspofungin Mylan you need and the length of treatment per day. If you are concerned that you have been given too much Caspofungin Mylan, talk to a doctor or nurse immediately.

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

4. Possible side effects

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

If you get any of the following side effects, talk to your doctor or nurse immediately – you may need urgent medical attention:

  • rash, itching, feeling hot, swelling of the face, lips, or throat, or difficulty breathing – you may have had a histamine reaction to the medicine.
  • difficulty breathing with wheezing or worsening of existing rash – you may have had an allergic reaction to the medicine.
  • cough, severe breathing difficulties – if you are an adult and have invasive aspergillosis, you may have a serious breathing problem that may result in respiratory failure.
  • skin rash, flaky skin, sore mucous membranes, hives, large areas of flaky skin.

As with all prescription drugs, some side effects can be serious. Ask your doctor for more information.

Other side effects in adults include:

Common:  may affect up to 1 in 10 users:

  • decreased hemoglobin (decreased amount of oxygen-transporting substance in the blood), decreased number of white blood cells
  • decreased albumin (a type of protein) in the blood, decreased potassium or low potassium levels in the blood
  • headache
  • inflammation of the vein
  • respiratory distress
  • diarrhea, nausea, or vomiting
  • changed values ​​for certain blood tests (also applies to elevated values ​​on certain liver samples)
  • itching, rash, reddening of the skin, or increased sweating
  • joint pain
  • chills, fever
  • itching at the injection site.

Uncommon:  may affect up to 1 in 100 people:

  • altered values ​​for certain blood tests (including blood coagulation disorders, platelets, red blood cells, and white blood cells )
  • decreased appetite, increased amount of body fluid, imbalance in the body’s salt content, high blood sugar levels in the blood, low calcium levels in the blood, elevated calcium levels in the blood, low magnesium levels in the blood, increased acid levels in the blood
  • confusion, nervous feeling, inability to sleep
  • a feeling of dizziness, decreased sensation and sensitivity (especially in the skin), tremors, feeling of tiredness, change in taste, tingling or numbness
  • blurred vision, increased amount of tears, swollen eyelids, yellowing of the whites of the eyes
  • a feeling of fast or irregular heartbeat, fast heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure
  • hot flashes, hot flashes, high blood pressure, low blood pressure, redness along a vein that is also extremely tender to the touch
  • tightening of the muscles around the airways that results in wheezing or coughing, rapid breathing, shortness of breath that wakes you up, lack of oxygen in the blood, abnormal breathing sounds, creaking sounds in the lungs, wheezing, nasal congestion, cough, sore throat
  • abdominal pain, upper abdominal pain, flatulence, constipation, difficulty swallowing, dry mouth, indigestion, gas, stomach upset, swelling due to accumulation of fluid around the abdomen
  • decreased bile flow, liver enlargement, yellowing of the skin and/or whites of the eyes, liver damage caused by drugs or chemicals, liver disorders
  • abnormal skin tissue, general itching, hives, various types of rash, abnormal skin, red and often itchy spots on the arms and legs and sometimes on the face and on the rest of the body
  • back pain, pain in an arm or leg, bone tissue pain, muscle pain, muscle weakness
  • renal impairment, sudden renal impairment
  • catheter entry pain, injection site problems ( redness, hardening, pain, swelling, irritation, rash, hives, fluid leakage from the catheter into tissue one), inflammation in the vein at the injection site
  • elevated blood pressure and altered values ​​for certain blood tests (including kidney electrolytes and coagulation tests), elevated levels of the drug you are taking which weakens the immune system
  • chest discomfort, chest pain, feeling of changing body temperature, general malaise, general pain, swelling of face, swelling of ankles, hands or feet, swelling, tenderness, feeling of tiredness.

Side effects in children and adolescents

Very common:  may affect more than 1 user in 10:

  • fever.

Common:  may affect up to 1 in 10 users:

  • headache
  • fast pulse
  • hemorrhage, low blood pressure
  • altered values ​​for certain blood tests (elevated values ​​on certain liver samples)
  • itching, rash
  • pain at the catheter area
  • overindulge
  • changed values ​​for certain blood tests.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Caspofungin Mylan

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

Use before the expiry date which is stated on the carton and bottle (the first two digits indicate the month, the last four digits indicate the year). The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C to 8 ° C).

As soon as Caspofungin Mylan is completed, it should be used immediately. This is because it does not contain any substances that stop bacterial growth. Only trained healthcare professionals who have read the entire instructions for use should complete this medicine (see below “Instructions for dissolving and diluting Caspofungin Mylan”).

If the infusion solution is not used immediately, it can be used within 24 hours when stored at 25 ° C or lower, or within 48 hours when the intravenous infusion bag (bottle) is refrigerated (2 ° C to 8 ° C) and diluted with sodium chloride 9 mg/ml (0.9%), 4.5 mg/ml (0.45%) or 2.25 mg/ml (0.225%) for infusion or lactated Ringer’s solution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ° C to 8 ° C, unless reconstitution and dilution have been performed under controlled and validated aseptic conditions.

Do not use the solution if it is cloudy or has a precipitate.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is caspofungin. One bottle of Caspofungin Mylan contains 50 mg of caspofungin (as acetate).
  • The other ingredients are sucrose, mannitol, concentrated hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), carbon dioxide (for adjustment).

What the medicine looks like and the contents of the pack

Caspofungin Mylan is a sterile, white to off-white, compact powder. The finished solution is ready.

Caspofungin Mylan is available in 10 ml glass vials with a bromobutyl stopper and an aluminum seal with a red plastic flip-off lid.

Each pack contains 1 vial of powder.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder 

Mylan Ireland Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate, Dublin 13

Ireland

Manufacturer

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park

Paola

PLA 3000

Malta

or

SAG Manufacturing SLU

Ctra. NI, Km 36. San Agustín de Guadalix

28750, Madrid 
Spain

or

Galenicum Health SL

Avda. Cornellà 144 7º, 1ª

Lekla Edification, 08950

Llobregat jobs

Barcelona 
Spain

or

Mylan SAS

117 Allée des Parcs

69800 Saint-Priest

France

or

Mylan Germany GmbH

Branch release Bad Homburg vd Hoehe

Benzstrasse 1

Bad Homburg vd Hoehe

Hessen, 61352

Germany

or

Hikma Italia SPA

Viale Certosa, 10

27100, Pavia (PV)

Italy

or

Mylan UK Healthcare Limited

Building 20, Station close

EN6 1T L, Potters Bar

Great Britain

Further information on this medicine can be obtained from the representative of the marketing authorization holder:

Muhammad Nadeem

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