CASPOFUNGINA DEMO 70 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

2. What you need to know before you use Caspofungin Demo

Do not use caspofungin

• 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, pharmacist, or nurse before you start using your medicine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using caspofungin if:

• you are allergic to any other medicine
• you have ever had liver problems; you may need a different dose of this medicine
• you are already taking cyclosporin (which is used to prevent organ transplant rejection or to suppress your immune system), as your doctor will probably need to do extra blood tests during your treatment
• you have ever had any other medical problem.

If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist, or nurse before you start using caspofungin.

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

Other medicines and Caspofungin Demo

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because caspofungin can affect how other medicines work. Also, other medicines can affect how caspofungin works.

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

• cyclosporin or tacrolimus (which are used to prevent organ transplant rejection or to suppress your immune system), as your doctor will probably need to do extra blood tests during your treatment
• certain anti-HIV medicines such as efavirenz or nevirapine
• phenytoin or carbamazepine (which are used to treat seizures)
• dexamethasone (a steroid)
• rifampicin (an antibiotic).

If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist, or nurse before you start using caspofungin.

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 using this medicine.

• Caspofungin has not been studied in pregnant women. It should only be used during pregnancy if the potential benefit justifies the potential risk to the unborn baby.
• Women using caspofungin should not breastfeed.

Driving and using machines

There is no information to suggest that this medicine affects your ability to drive or use machines.

3. How to use Caspofungin Demo

Caspofungin will always be prepared and given to you by a healthcare professional. You will be given caspofungin:

• once a day.
• by slow injection into a vein (intravenous infusion).
• over about 1 hour.

Your doctor will decide how long you should be treated with caspofungin and how much caspofungin you should be given each day. Your doctor will monitor whether the effect of the medicine is adequate. If you weigh more than 80 kg, you may need a different dose.

Use in children and adolescents

The dose for children and adolescents may be different from the dose in adults.

If you use more caspofungin than you should

Your doctor will decide how much caspofungin you need and for how long each day. If you are worried that you have been given too much caspofungin, tell your doctor or nurse straight away.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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

4. Possible side effects

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

Tell your doctor or nurse straight away if you notice any of the following side effects – you may need urgent medical treatment:

• rash, itching, feeling of warmth, swelling of your face, lips or throat or difficulty breathing: you may be having a histamine reaction to the medicine.
• difficulty breathing with wheezing or worsening of a rash that you already have: you may be having an allergic reaction to the medicine.
• cough, severe breathing difficulties: if you are an adult and have invasive aspergillosis, you may get a serious breathing problem that could lead to respiratory failure.
• rash, skin peeling, blisters on the mucous membrane, hives, large areas of skin peeling

As with any prescription medicine, 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 people:

• decrease in hemoglobin (decrease in the substance that carries oxygen in the blood), decrease in white blood cells.
• decrease in albumin (a type of protein) in your blood, decrease in potassium or low potassium levels in the blood.
• headache.
• vein inflammation.
• shortness of breath.
• diarrhea, nausea, or vomiting.
• changes in some laboratory blood tests (such as increased values of some liver tests).
• itching, rash, redness of the skin or more sweating than usual.
• joint pain.
• chills, fever.
• itching at the injection site.

Uncommon: may affect up to 1 in 100 people:

• changes in some laboratory blood tests (including blood clotting disorders, platelets, red blood cells, and white blood cells).
• loss of appetite, increase in body fluid, imbalance of body salts, high blood sugar, low calcium levels in the blood, high calcium levels in the blood, low magnesium levels in the blood, increase in the level of medicines you are taking that weaken your immune system.
• disorientation, feeling nervous, inability to sleep.
• feeling dizzy, decreased sensations or sensitivity (especially in the skin), agitation, feeling sleepy, change in the way things taste, tingling or numbness.
• blurred vision, increased tears, swollen eyelid, yellowing of the white part of the eyes.
• feeling of rapid or irregular heartbeats, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure.
• flushing, hot flashes, high blood pressure, low blood pressure, redness along a vein that is very sensitive to touch.
• tightness in the muscle bands around the airways leading to wheezing or cough, rapid breathing rate, waking up short of breath, lack of oxygen in the blood, abnormal breathing sounds, crackling sounds in the lungs, wheezing, nasal congestion, cough, sore throat.
• abdominal pain, upper abdominal pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, gas, stomach upset, bloating due to fluid accumulation around the abdomen.
• decrease in bile flow, increase in liver size, yellowing of the skin and/or the white part of the eyes, liver injury caused by a medicine or chemical, liver disorder.
• abnormal skin tissue, generalized itching, hives, rash of varying appearance, abnormal skin, red spots, often with itching, on arms and legs and sometimes on the face and the rest of the body.
• back pain, pain in an arm or leg, bone pain, muscle pain, muscle weakness.
• loss of kidney function, sudden loss of kidney function.
• pain at the catheter site, symptoms at the injection site (redness, hard lump, pain, swelling, irritation, rash, hives, leakage of fluid from the catheter into the tissue), vein inflammation at the injection site.
• increase in blood pressure and changes in some laboratory blood tests (such as kidney electrolyte tests and coagulation tests), increase in levels of medicines you are taking that weaken your immune system.
• chest discomfort, chest pain, feeling of change in body temperature, feeling unwell, general pain, swelling of the face, swelling of the ankles, hands, or feet, swelling, pain when touched

Other side effects in children and adolescents

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

• fever.

Common: may affect up to 1 in 10 people:

• headache.
• rapid heartbeat.
• flushing, low blood pressure.
• changes in some laboratory blood tests (increased values of some liver tests).
• itching, rash.
• pain at the catheter site.
• chills.
• changes in some laboratory blood tests.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Caspofungin Demo

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 on the vial after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C). Also, keep below 25°C for 1 month.

Once Caspofungin Demo has been prepared, it should be used immediately. This is because it does not contain any ingredient to prevent the growth of bacteria. Only a trained healthcare professional who has read the complete instructions should prepare the medicine (see “Instructions for reconstituting and diluting Caspofungin Demo” below).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Caspofungin Demo.

• The active ingredient is caspofungin. Each vial of this medication contains 70 mg of caspofungin (in the form of acetate). The concentration of the reconstituted vial will be 7.2 mg/ml.

• The other components are sucrose, mannitol, acetic acid, and sodium hydroxide (see section 2: What you need to know before taking Caspofungin Demo).

Appearance of the Product and Container Content

This medication is a compact, sterile, white to off-white powder, contained in a 10 ml capacity transparent and colorless glass vial (type I), closed with a rubber stopper and sealed with an aluminum cap.

Each container contains one vial of powder.

Marketing Authorization Holder and Manufacturer

DEMO S.A. PHARMACEUTICAL INDUSTRY

21st Km National Road Athens-Lamia.

14568 Greece

T:+30 210 8161802, F:+30 210816158

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Cyprus: Caspofungin DEMO 70 mg Πούδρα για πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση

Germany: Caspofungin DEMO 70 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Greece: Caspofungin DEMO 70 mg Πούδρα για πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση

Ireland: Caspofungin 70 mg powder for concentrate for solution for infusion

United Kingdom: Caspofungin 70 mg powder for concentrate for solution for infusion

Netherlands: Caspofungine DEMO 70 mg poeder voor concentraat voor oplossing voor infusie

Spain: Caspofungina DEMO 70 mg polvo para concentrado para solución para perfusión EFG

Romania: Caspofungina DEMO 70 mg pulbere pentru concentrat pentru solutie perfuzabila

Czech Republic: Caspofungin DEMO

Slovakia: Caspofungin DEMO 70 mg prášok na koncentrát na infúzny roztok

Hungary: Caspofungin DEMO 70 mg por oldatos infúzióhoz való koncentrátumhoz

Finland: Caspofungin Demo S.A. 70 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 70 mg

Italy: Caspofungin DEMO 70 mg

Date of the last revision of this prospectus: 10/2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Instructions for reconstituting and diluting Caspofungina Demo:

Reconstitution of Caspofungina Demo

DO NOT USE DILUENTS CONTAINING GLUCOSE, as Caspofungina Demo is not stable in diluents containing glucose. DO NOT MIX OR PERFUSE Caspofungina Demo WITH ANY OTHER MEDICATION, as there is no data available on the compatibility of caspofungina with other substances, additives, or pharmaceutical specialties for intravenous use. The infusion solution should be visually inspected for particulate matter or a change in color.

Preparation of the diluted solution before infusion

Caspofungina Demo can be administered in the following infusion solutions:

• Sodium chloride 0.9%
• Sodium chloride 0.45%
• Sodium chloride 0.225%
• Ringer's lactate

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of the vials

To reconstitute the powder, bring the vial to room temperature and add aseptically 10.5 ml of water for injectable preparations. The concentration of the reconstituted vial will be 7.2 mg/ml.

The compact, lyophilized, white to off-white powder will dissolve completely. Mix gently until a clear solution is obtained. The reconstituted solutions should be visually inspected for particulate matter or a change in color. The reconstituted solution can be stored for a maximum of 24 hours at a temperature equal to or below 25 °C.

Step 2 Addition of reconstituted Caspofungina Demo to the patient's infusion solution

The diluents for the final infusion solution are: sodium chloride injection solution or Ringer's lactate solution. The infusion solution is prepared by adding aseptically the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. Reduced-volume infusions of 100 ml can be used if medically necessary for daily doses of 50 mg or 35 mg. Do not use if the solution is cloudy or has precipitated.

PREPARATION OF THE INFUSION SOLUTION FOR ADULTS

*10.5 ml should be used for the reconstitution of all vials.

**If the 70 mg vial is not available, the 70 mg dose can be prepared from two 50 mg vials.

INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS

Calculation of body surface area (BSA) for pediatric dosing

Before preparing the infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller formula[1])

BSA (m2) =

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

Preparation of the 70 mg/m2 infusion for pediatric patients over 3 months (using a 70 mg vial)

1. Determine the actual loading dose to be used in the pediatric patient using the patient's BSA (as calculated above) and the following equation:

BSA (m2) X 70 mg/m2 = loading dose

The maximum loading dose on day 1 should not exceed 70 mg, regardless of the calculated dose for the patient.

1. Wait for the refrigerated vial of caspofungina to reach room temperature.
2. Add aseptically 10.5 ml of water for injectable preparations. This reconstituted solution can be stored for up to 24 hours at a temperature equal to or below 25 °C. This will result in a final concentration of caspofungina in the vial of 7.2 mg/ml.
3. Withdraw from the vial a volume of the medication equal to the calculated loading dose (Step 1). Transfer aseptically this volume (ml) of reconstituted caspofungina to an intravenous bag or bottle containing 250 ml of sodium chloride injection solution 0.9%, 0.45%, or 0.225%, or Ringer's lactate solution. Alternatively, the volume (ml) of reconstituted caspofungina can be added to a reduced volume of sodium chloride injection solution 0.9%, 0.45%, or 0.225%, or Ringer's lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution should be used within 24 hours if stored at a temperature equal to or below 25 °C or within 48 hours if stored refrigerated between 2 °C and 8 °C.

Preparation of the 50 mg/m2 infusion for pediatric patients over 3 months (using a 70 mg vial)

1. Determine the actual daily maintenance dose to be used in the pediatric patient using the patient's BSA (as calculated above) and the following equation:

BSA (m2) X 50 mg/m2 = daily maintenance dose

The daily maintenance dose should not exceed 70 mg, regardless of the calculated dose for the patient.

1. Wait for the refrigerated vial of caspofungina to reach room temperature.
2. Add aseptically 10.5 ml of water for injectable preparations. This reconstituted solution can be stored for up to 24 hours at a temperature equal to or below 25 °C. This will result in a final concentration of caspofungina in the vial of 7.2 mg/ml.
3. Withdraw from the vial a volume of the medication equal to the calculated daily maintenance dose (Step 1). Transfer aseptically this volume (ml) of reconstituted caspofungina to an intravenous bag or bottle containing 250 ml of sodium chloride injection solution 0.9%, 0.45%, or 0.225%, or Ringer's lactate solution. Alternatively, the volume (ml) of reconstituted caspofungina can be added to a reduced volume of sodium chloride injection solution 0.9%, 0.45%, or 0.225%, or Ringer's lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution should be used within 24 hours if stored at a temperature equal to or below 25 °C or within 48 hours if stored refrigerated between 2 °C and 8 °C.

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