Caspofungin demo

Package leaflet: Information for the user

Caspofungin DEMO 50 mg powder for concentrate for solution for infusion
Caspofunginum
Please read all of this leaflet carefully before this medicine is administered to you or your child,
as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of the leaflet

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

1. What Caspofungin DEMO is and what it is used for

What Caspofungin DEMO is
Caspofungin DEMO contains a medicine called caspofungin, which belongs to a group of
antifungal medicines.
What Caspofungin DEMO is used for
Caspofungin DEMO is used to treat the following infections in children, adolescents and adults:

• Serious fungal infections of tissues and organs (called "invasive candidiasis"). This infection is caused by fungal cells (yeasts) called Candida. Patients who may develop this type of infection include those who have recently undergone surgery or have a weakened immune system. The most common symptoms of this type of infection are fever and chills that do not resolve with antibiotic treatment.
• Fungal infections of the nose, sinuses or lungs (called "invasive aspergillosis"), when other antifungal medicines have not worked or have caused side effects. These infections are caused by a mould fungus called Aspergillus. Patients who may develop such infections include those receiving chemotherapy, organ transplant recipients, and patients with weakened immune systems.
• Suspected fungal infection in patients with fever and low white blood cell count whose condition has not improved after antibiotic treatment. Patients at risk of developing fungal infection include those who have recently undergone surgery or have a weakened immune system.

How Caspofungin DEMO works
Caspofungin DEMO weakens fungal cells and inhibits their normal growth. This prevents the spread of infection and allows the body's natural defence mechanisms to eliminate the infection completely.

2. Important information before using Caspofungin DEMO

When not to use Caspofungin DEMO

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

If in doubt about whether to administer the medicine, consult a doctor, pharmacist, or nurse.
Warnings and precautions
Before starting treatment with Caspofungin DEMO, discuss this with a doctor, nurse,
or pharmacist:

• if the patient is allergic to any medicines;
• if the patient has ever had liver function disorders – an alternative dose of the medicine may be necessary;
• if the patient is taking cyclosporine (a medicine used to prevent transplant rejection or to suppress immune system responses), as the doctor may order additional blood tests during treatment;
• if the patient has ever had any other health problems.

If any of the above statements apply to the patient (or are suspected),
consult a doctor, pharmacist, or nurse before using Caspofungin DEMO.
Caspofungin DEMO may also cause severe skin reactions, such as
Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Caspofungin DEMO and other medicines
Tell your doctor, nurse, or pharmacist about all medicines the patient is currently taking,
has recently taken, or plans to take, including over-the-counter and herbal remedies, as Caspofungin DEMO
may affect how other medicines work. Likewise, certain other medicines may affect how Caspofungin DEMO works.
If the patient is taking any of the following medicines, inform the doctor, nurse, or pharmacist:

• cyclosporine or tacrolimus (medicines used to prevent transplant rejection or to suppress immune system responses), as the doctor may order additional blood tests during treatment;
• certain antiviral medicines used for HIV infection, such as efavirenz or nevirapine;
• phenytoin or carbamazepine (used to treat seizures);
• dexamethasone (a steroid medicine);
• rifampicin (an antibiotic).

If any of the above statements apply to the patient (or are suspected),
inform the doctor, nurse, or pharmacist before using Caspofungin DEMO.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.

• No studies have been conducted on the use of Caspofungin DEMO in pregnant women. This medicine should be used during pregnancy only if the potential benefits outweigh the potential risks to the unborn child.
• Women receiving Caspofungin DEMO should not breastfeed.

Driving and operating machinery
There is no information indicating that this medicine may affect the ability to drive or
operate machinery.

3. How to use Caspofungin DEMO

Caspofungin DEMO will always be prepared and administered by medical personnel.
Caspofungin DEMO will be given:

• once daily;
• by slow intravenous infusion (intravenous infusion);
• over approximately 1 hour.

The duration of treatment and the daily dose of Caspofungin DEMO will be determined by the physician. The physician will monitor the effectiveness of the medicine in the patient. In patients with body weight above 80 kg, a different dose may be required.
Use in children and adolescents
The dose intended for children and adolescents may differ from that used in adults.
Use of a higher than recommended dose of Caspofungin DEMO
The physician will decide what daily dose of Caspofungin DEMO the patient requires and how long the treatment should last. If there is any doubt whether the patient has received too high a dose of Caspofungin DEMO, consult the attending physician or nurse immediately.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any of the following adverse reactions, you should
contact your doctor or nurse immediately, as immediate
medical assistance may be required:

• Rash, itching, feeling of warmth, swelling of the face, lips or throat, or difficulty breathing – possible occurrence of a histamine reaction to the medicine;
• Difficulty breathing with wheezing or worsening rash – possible occurrence of an allergic reaction to the medicine;
• Cough, severe breathing problems – in adults with invasive aspergillosis, severe breathing problems may occur, which may progress to respiratory failure;
• Rash, skin peeling, mucosal ulceration, urticaria, extensive skin peeling.

As with all prescription medicines, some of the adverse reactions may
be serious. Please consult your treating physician for additional information.
Other adverse reactions observed in adults include:
Common: may occur in no more than 1 in 10 people:

• Decreased hemoglobin concentration (reduced concentration in blood of the substance transporting oxygen), decreased white blood cell count
• Decreased albumin concentration (a type of protein) in blood, decreased potassium concentration or low potassium levels in blood
• Headache
• Phlebitis (inflammation of veins)
• Dyspnea (shortness of breath)
• Diarrhea, nausea or vomiting
• Changes in results of certain blood laboratory tests (including increased values in certain liver function tests)
• Itching, rash, skin redness, or excessive sweating more than usual
• Joint pain
• Chills, fever
• Itching at injection site.

Uncommon: may occur in no more than 1 in 100 people:

• Changes in results of certain blood laboratory tests (including blood coagulation, platelet count, red blood cells, and white blood cells)
• Loss of appetite, increased body fluid volume, electrolyte imbalance, high blood sugar, low blood calcium, increased blood calcium, low blood magnesium, increased blood acidity
• Disorientation, feeling of nervousness, inability to sleep
• Dizziness, reduced sensation or sensitivity (especially of the skin), tremor, drowsiness, altered taste, tingling or numbness sensations
• Blurred vision, increased tear production, eyelid swelling, yellowing of the sclera (whites of the eyes)
• Sensation of rapid or irregular heartbeat, tachycardia, irregular heartbeat, abnormal heart rhythm, heart failure
• Facial flushing, hot flushes, high blood pressure, low blood pressure, redness along the vein, skin hypersensitivity to touch
• Bronchospasm causing wheezing or cough, rapid breathing, dyspnea causing awakening from sleep, hypoxemia (low blood oxygen), abnormal breath sounds, crackles in lungs, wheezing, nasal congestion, cough, sore throat
• Abdominal pain, epigastric pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, flatulence, stomach discomfort, swelling due to fluid accumulation in the abdominal cavity (ascites)
• Reduced bile flow, enlarged liver, jaundice (yellowing of the skin and/or sclera), chemical or drug-induced liver injury, liver function disorders
• Abnormal skin changes, generalized itching, urticaria, polymorphic rash, abnormal skin appearance, presence of red, often itchy spots on hands and legs, and sometimes on the face and other body parts
• Back pain, pain in arms or legs, bone pain, muscle pain, muscle weakness
• Worsening of kidney function, sudden deterioration of kidney function
• Pain at catheter site, injection site reactions (redness, induration, pain, swelling, irritation, rash, urticaria, leakage of fluid from catheter into tissues), phlebitis at injection site
• Elevated blood pressure and changes in results of certain blood laboratory tests (including tests assessing kidney function, electrolytes, and blood coagulation), increased concentrations of immunosuppressive drugs
• Feeling of discomfort in the chest, chest pain, sensation of body temperature change, general malaise, generalized pain, facial swelling, ankle, hand or foot swelling, edema, tenderness, feeling of fatigue.

Adverse reactions in children and adolescents
Very common: may occur in more than 1 in 10 people:

• Fever.

Common: may occur in no more than 1 in 10 people:

• Headache
• Rapid heartbeat
• Sudden facial flushing, low blood pressure
• Changes in results of certain blood laboratory tests (increased values in certain liver function tests)
• Itching, rash
• Pain at catheter site
• Chills
• Changes in results of certain blood laboratory tests.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms
not listed in this leaflet, you should inform your doctor, pharmacist, or
nurse. Adverse reactions can be reported directly to the Department
of Monitoring of Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Caspofungin DEMO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial label
(Exp). The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C to 8°C). It may also be stored below 25°C for up to 1 month.
After reconstitution, Caspofungin DEMO should be used immediately, as it contains no
antimicrobial preservatives. The medicine should be prepared only by trained healthcare
personnel who have read all instructions (see below “Instructions for reconstitution and
dilution of Caspofungin DEMO”).
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Caspofungin DEMO contains

• The active substance is caspofungin. Each vial contains 50 mg of caspofungin (as caspofungin acetate). The concentration in the vial after reconstitution will be 5.2 mg/mL.
• Other ingredients are: sucrose, mannitol, acetic acid and sodium hydroxide (see section 2 “Important information before using Caspofungin DEMO”).

What Caspofungin DEMO looks like and contents of the pack
This medicine is a sterile, white to almost white, lyophilized powder in a clear, colourless glass vial (type I) with a capacity of 10 mL, closed with a rubber stopper and sealed with an aluminium cap.
Each carton contains one vial of powder.
Marketing Authorisation Holder and Manufacturer
Demo S.A. Pharmaceutical Industry
21st Km National Road Athens-Lamia
14568 Krioneri
Greece
T: +30 210 8161802, F: +30 210816158
This medicine is authorised for marketing in the European Economic Area countries under the following names:
Cyprus: Caspofungin DEMO 50 mg Κόνις για πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση
Germany: Caspofungin DEMO 50 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Greece: Caspofungin DEMO 50 mg Κόνις για πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση
Ireland: Caspofungin 50 mg powder for concentrate for solution for infusion
United Kingdom: Caspofungin 50 mg powder for concentrate for solution for infusion
Netherlands: Caspofungin DEMO 50 mg poeder voor concentraat voor oplossing voor infusie
Spain: Caspofungina DEMO 50 mg polvo para concentrado para solución para perfusión EFG
Romania: Caspofungina DEMO 50 mg pulbere pentru concentrat pentru soluţie perfuzabilă
Czech Republic: Caspofungin DEMO
Slovakia: Caspofungin DEMO 50 mg prášok na koncentrát na infúzny roztok
Hungary: Caspofungin DEMO 50 mg por oldatos infúzióhoz való koncentrátumhoz
Finland: Caspofungin Demo S.A. 50 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos
Sweden: Caspofungin Demo S.A.
Denmark: Caspofungin Demo S.A.
Norway: Caspofungin Demo S.A.
Poland: Caspofungin DEMO
Italy: Caspofungin DEMO
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Information intended exclusively for professional medical personnel:

Instructions for reconstitution and dilution of Caspofungin DEMO:
Reconstitution of Caspofungin DEMO product
DO NOT USE ANY SOLUTIONS CONTAINING DEXTROSE, as
CASPOFUNGIN DEMO is not stable in solutions containing dextrose. DO NOT MIX OR
ADMINISTER IN THE SAME INFUSION WITH OTHER DRUGS, as there are no data
available on co-administration of CASPOFUNGIN DEMO with other intravenously administered active substances, excipients or medicinal products.
The infusion solution should be inspected visually for particulate matter and discoloration.

Preparation of diluted solution prior to infusion
Caspofungin DEMO may be administered in the following infusion solutions:

• Sodium chloride 0.9%
• Sodium chloride 0.45%
• Sodium chloride 0.225%
• Lactated Ringer's solution

INSTRUCTIONS FOR USE IN ADULT PATIENTS
Step 1 Reconstitution of the vial contents
To reconstitute the powder, bring the unopened vial to room temperature and then aseptically add 10.5 mL of water for injection. The concentration of the resulting concentrate will be 5.2 mg/mL.
Gently swirl the vial until a clear solution is obtained. The lyophilized powder is white or almost white, slightly viscous. The prepared solution should be inspected visually for particulate matter and discoloration. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C.

Step 2 Addition of reconstituted Caspofungin DEMO to the patient's infusion solution
The final infusion solution may be prepared using the following solutions: sodium chloride injection or lactated Ringer's solution. The infusion solution should be prepared by aseptically adding the appropriate volume of the reconstituted concentrate (as shown in the table below) to a 250 mL infusion bag or bottle. Reduced infusion volumes of 100 mL may be used when medically necessary for daily doses of 50 mg or 35 mg. Do not use if the solution is cloudy or contains precipitate.

PREPARATION OF INFUSION SOLUTION FOR ADULTS

* To dissolve the contents of each vial, use 10.5 mL of diluent.
INSTRUCTIONS FOR USE OF THE MEDICINAL PRODUCT IN CHILDREN AND ADOLESCENTS
Calculation of body surface area (BSA) for dose determination in children and adolescents
Before preparing the infusion, calculate the patient's body surface area using the following formula: (Mosteller formula)

Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17): 1098 (letter)

Preparation of intravenous infusion containing a dose of 70 mg/m BSA for children and adolescents aged
>3 months (using a vial containing 50 mg of product)

1. Determine the actual loading dose for children and adolescents based on body surface area (calculated as indicated above) using the following equation: BSA (m²) × 70 mg/m² = Loading dose. The maximum loading dose administered on Day 1 of therapy should not exceed 70 mg, regardless of the calculated dose for the individual patient.
2. Remove the Caspofungin DEMO vial from the refrigerator and allow it to warm to room temperature.
3. Under aseptic conditions, add 10.5 mL of water for injections. The resulting solution may be stored for no longer than 24 hours at a temperature not exceeding 25°C. This results in a final concentration of caspofungin of 5.2 mg/mL in the vial.
4. Withdraw from the vial the volume of medication corresponding to the calculated loading dose (step 1). Under aseptic conditions, transfer this volume (mL) of diluted Caspofungin DEMO into an intravenous infusion bag (or bottle) containing 250 mL of 0.9%, 0.45%, or 0.225% sodium chloride injection solution or lactated Ringer's injection solution. Alternatively, the specified volume (mL) of diluted Caspofungin DEMO may be added to a smaller volume of 0.9%, 0.45%, or 0.225% sodium chloride injection solution or lactated Ringer's injection solution, provided that the final concentration does not exceed 0.5 mg/mL. The prepared infusion solution must be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if stored refrigerated at 2 to 8°C.

Preparation of intravenous infusion containing a dose of 50 mg/m BSA for children and adolescents aged
>3 months (using a vial containing 50 mg of product)

1. Determine the actual daily maintenance dose for children and adolescents based on body surface area (calculated as indicated above) using the following equation: BSA (m²) × 50 mg/m² = Daily maintenance dose. The daily maintenance dose should not exceed 70 mg, regardless of the calculated dose for the individual patient.
2. Remove the Caspofungin DEMO vial from the refrigerator and allow it to warm to room temperature.
3. Under aseptic conditions, add 10.5 mL of water for injections. The resulting solution may be stored for no longer than 24 hours at a temperature not exceeding 25°C. This results in a final concentration of caspofungin of 5.2 mg/mL in the vial.
4. Withdraw from the vial the volume of medication corresponding to the calculated daily maintenance dose (step 1). Under aseptic conditions, transfer this volume (mL) of diluted Caspofungin DEMO into an intravenous infusion bag (or bottle) containing 250 mL of 0.9%, 0.45%, or 0.225% sodium chloride injection solution or lactated Ringer's injection solution. Alternatively, the specified volume (mL) of diluted Caspofungin DEMO may be added to a smaller volume of 0.9%, 0.45%, or 0.225% sodium chloride injection solution or lactated Ringer's injection solution, provided that the final concentration does not exceed 0.5 mg/mL. The prepared infusion solution must be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if stored refrigerated at 2 to 8°C.

Notes on preparation of the medicinal product:
a. The white or almost white compact substance should dissolve completely. Gently mix the contents until a clear solution is obtained.
b. The prepared solution should be inspected visually for particulate matter and discoloration prior to administration. If the solution is cloudy or contains precipitate, it should not be administered.
c. Caspofungin DEMO is formulated to allow complete recovery of the full dose stated on the vial label (50 mg) by withdrawing 10 mL of solution from the vial.