50 mg, 70 mg powder for concentrate for infusion solution
kaspofungin
1. What Cancidas is and what it is used for
What Cancidas is
Cancidas contains a medicine called caspofungin. It belongs to a group of medicines called antifungals ( antifungals ).
What Cancidas is used for
Cancidas 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 Cancidas works
Cancidas make fungal cells fragile and prevent 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.
2. What you need to know before you get Cancidas
Do not use Cancidas
- 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 Cancidas about:
- 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) – your doctor may need additional blood tests 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 Cancidas.
Cancidas can also cause serious skin side effects such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Other medicines and Cancidas
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 Cancidas may affect the way other medicines work. Other medicines may also affect the way Cancidas 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 Cancidas.
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.
- Cancidas 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 Cancidas should not breast-feed.
Driving and using machines
There is no information to suggest that Cancidas affects your ability to drive or use machines
Cancidas contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.
How Cancidas is used
Cancidas is prepared and always given by professional healthcare professionals.
You will get Cancidas:
- 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 Cancidas 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
Dose one for children and adolescents may differ from dose one to adults.
If you take more Cancidas than you should
Your doctor will decide how much Cancidas you need and the duration of treatment per day. If you are concerned that you have received too much Cancidas, 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, 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 less than 1 user in 10:
- decreased hemoglobin (decreased amount of oxygen-transporting substance in the blood), decreased number of white blood cells
- low potassium in the blood
- 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 less than 1 user in 100:
- 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
- the 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
- the 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 skin 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.
Additional side effects are in children and adolescents
Very common: may affect more than 1 user in 10:
- fever
Common: may affect less than 1 user in 10:
- 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 Cancidas
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 bottle (the first two digits indicate the month, the following 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).
Once Cancidas 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 Cancidas”).
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.
Cancidas 50 mg powder for concentrate for solution for infusion
Each bottle of Cancidas contains 50 mg caspofungin.
Cancidas 70 mg powder for concentrate for solution for infusion
Each bottle of Cancidas contains 70 mg caspofungin.
- The other ingredients are sucrose, mannitol (E421), concentrated acetic acid, and sodium hydroxide (please see section 2 What you need to know before you take Cancidas).
What the medicine looks like and the contents of the pack
Cancidas is a sterile, off-white, compact powder.
Each pack contains a vial of powder.
Marketing Authorization Holder and Manufacturer
| Marketing Authorisation Holder | Manufacturer |
| Merck Sharp & Dohme BVWaarderweg 392031 BN HaarlemNetherlands | Merck Sharp & Dohme BVWaarderweg 392031 BN HaarlemNetherlands |
| or Laboratories Merck Sharp & Dohme- ChibretRoute of Marsat-RIOM63963 Clermont-Ferrand Cedex 9France |
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgique / België / BelgienMSD Belgium BVBA / SPRLTel: +32 (0) 27766211dpoc_belux@merck.com | LithuaniaUAB Merck Sharp & DohmeTel .: +370 5 278 02 47msd_lietuva@merck.com |
| BulgariaMark Harp and Doom Bulgaria BulgariaTel: +359 2 819 3737info-msdbg@merck.com | Luxembourg / LuxemburgMSD Belgium BVBA / SPRLTel: +32 (0) 27766211dpoc_belux@merck.com |
| Czech RepublicMerck Sharp & Dohme sroTel .: +420 233 010 111dpoc_czechslovak@merck.com | HungaryMSD Pharma Hungary Kft.Tel .: +36 1 888 5300hungary_msd@merck.com |
| DenmarkMSD Danmark ApSTel: +45 44 82 40 00dkmail@merck.com | MaltaMerck Sharp & Dohme Cyprus LimitedTel .: 8007 4433 (+ 356 99917558)malta_info@merck.com |
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| ΚύπροςMerck Sharp & Dohme Cyprus Limited.:Ηλ .: 800 00 673 (+357 22866700)cyprus _ info @ merck . com | |
| LatviaSIA Merck Sharp & Dohme LatvijaTel: +371 67364 224msd_lv@merck.com | United KingdomMerck Sharp & Dohme LimitedTel: +44 (0) 1992 467272medicalinformationuk@merck.com |