Caspofungin Sandoz GmbH: detailed information

Package leaflet: Information for the user

Caspofungin Sandoz GmbH 70 mg powder for concentrate for solution for infusion

Generic medicine
Please read this leaflet carefully before this medicine is administered to you or your child because it contains important information for you.

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

Contents of this leaflet:

What Caspofungin Sandoz GmbH is and what it is used for
What you need to know before Caspofungin Sandoz GmbH is administered to you
How to use Caspofungin Sandoz GmbH
Possible side effects
How to store Caspofungin Sandoz GmbH
Contents of the pack and other information

1. What Caspofungin Sandoz GmbH is and what it is used for

What Caspofungin Sandoz GmbH is
Caspofungin Sandoz GmbH contains an active substance called caspofungin. This belongs to a group of medicines known as antifungals.

What Caspofungin Sandoz GmbH is used for
Caspofungin Sandoz GmbH is used to treat the following infections in children, adolescents, and adults:

Serious fungal infections in tissues and organs (called "invasive candidiasis"). This infection is caused by fungal cells (yeasts) called Candida. People who may develop this type of infection include those who have recently undergone surgery or those with a weakened immune system. Fever and chills that do not respond to antibiotics are the most common signs of this type of infection.
Fungal infections of the nose, sinuses, or lungs (called "invasive aspergillosis") when other antifungal treatments have not worked or have caused undesirable effects. This infection is caused by a mold called Aspergillus. People who may develop this type of infection include those receiving chemotherapy, those who have undergone organ transplantation, and those with a weakened immune system.
Suspected fungal infections: when you have fever and a low white blood cell count without improvement after antibiotic therapy. People at risk of developing a fungal infection include those who have recently undergone surgery or those with a weakened immune system.

How Caspofungin Sandoz GmbH works
Caspofungin Sandoz GmbH weakens fungal cells and prevents the fungus from growing properly. This stops the spread of the infection and allows the body's natural defenses the opportunity to completely eliminate the infection.

2. What you need to know before you are given Caspofungin Sandoz GmbH

Do not use Caspofungin Sandoz GmbH

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

If you are unsure, consult your doctor, nurse, or pharmacist before this medicine is administered to you.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given Caspofungin Sandoz GmbH 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 cyclosporine (used to help prevent organ transplant rejection or to suppress the immune system) – because your doctor may need additional blood tests during treatment
you have ever had any other medical condition.

If any of the above conditions apply to you (or if you are unsure), consult your doctor, nurse, or pharmacist before this medicine is administered to you.

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

Other medicines and Caspofungin Sandoz GmbH

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

This is because Caspofungin Sandoz GmbH may interfere with the way some other medicines work. Likewise, some other medicines may interfere with the way Caspofungin Sandoz GmbH works.

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

cyclosporine or tacrolimus (used to help prevent organ transplant rejection or to suppress the immune system) – because your doctor may need additional blood tests during treatment
certain HIV medicines such as efavirenz or nevirapine
phenytoin or carbamazepine (used to treat seizures)
dexamethasone (a steroid)
rifampicin (an antibiotic).

If any of the above conditions apply to you (or if you are unsure), consult your doctor, nurse, or pharmacist before this medicine is administered to you.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, or are breastfeeding, ask your doctor for advice before taking any medicine.

Caspofungin Sandoz GmbH has not been studied in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn child.
Women receiving Caspofungin Sandoz GmbH must not breastfeed.

Driving and using machines

There is no information suggesting that Caspofungin Sandoz GmbH has an effect on the ability to drive or use machinery.

Caspofungin Sandoz GmbH contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is practically "sodium-free".

3. How to use Caspofungin Sandoz GmbH

Caspofungin Sandoz GmbH must always be prepared and administered by a healthcare professional.
Caspofungin Sandoz GmbH will be given to you:

once daily
by slow injection into a vein (intravenous infusion)
over approximately 1 hour.

Your doctor will determine the duration of treatment and the amount of Caspofungin Sandoz GmbH you will receive daily. Your doctor will monitor the effect of the medicine on you. If your body weight is over 80 kg, you may require a different dose.
Children and adolescents
The dose for children and adolescents may differ from that for adults.
If you have been given more Caspofungin Sandoz GmbH than you should have
Your doctor will decide the daily amount of Caspofungin Sandoz GmbH you need and the duration of treatment. If you are concerned that you have been given too much Caspofungin Sandoz GmbH, inform your doctor or nurse immediately.
If you have any doubts about how to use this medicine, consult your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor or nurse immediately if you notice any of the following side effects – you may
need urgent medical treatment:

rash, itching, feeling of warmth, swelling of the face, lips or throat, or difficulty breathing – you may be experiencing a histamine reaction to the medicine.
difficulty breathing with wheezing or a rash that worsens – you may be experiencing an allergic reaction to the medicine.
cough, severe breathing difficulties – if you are an adult with invasive aspergillosis, you may be experiencing a serious respiratory problem that could lead to respiratory failure.
rash, skin peeling, mouth mucosa sores, hives, extensive areas of skin peeling.

As with any other prescription medicine, some side effects may be serious. For further information, consult your doctor.
Other side effects in adults include:
Common (may affect up to 1 in 10 people):

decreased haemoglobin (reduction in the substance in the blood that carries oxygen), decreased white blood cells
decreased blood albumin (a type of protein) in the blood, decreased potassium or low potassium levels in the blood
headache
inflammation of the vein
shortness of breath
diarrhoea, nausea, vomiting
changes in certain blood test values (including increased liver test parameters)
itching, rash, skin redness or excessive sweating
joint pain
chills, fever
itching at the injection site.

Uncommon (may affect up to 1 in 100 people):

changes in certain blood test values (including blood coagulation disorders, platelets, red blood cells and white blood cells)
loss of appetite, increased body fluid, electrolyte imbalance, high blood sugar, low blood calcium, increased blood calcium, low blood magnesium, increased blood acid levels
disorientation, feeling nervous, inability to sleep
dizziness, decreased sensation or sensitivity (especially skin-related), tremor, drowsiness, altered taste, tingling or numbness
blurred vision, increased tear production, swollen eyelid, yellowing of the whites of the eyes
sensation of rapid or irregular heartbeat, fast heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure
hot flushes, flushing, high blood pressure, low blood pressure, redness of a vein that is extremely painful upon pressure
narrowing of the muscle bands in the airways causing shortness of breath or cough, rapid breathing, shortness of breath waking the patient, reduced oxygen in the blood, abnormal breathing sounds, lung friction rub, dyspnoea, nasal congestion, cough, sore throat
abdominal pain, upper abdominal pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, swelling due to fluid accumulation in the abdomen
decreased bile flow, enlarged liver, yellowing of the skin and/or whites of the eyes, liver damage caused by a medicine or chemical agents, liver disorder
abnormal skin tissue, generalized itching, hives, various types of skin rash, abnormal skin, red spots often itchy on arms and legs and sometimes on the face and other parts of the body
back pain, arm or leg pain, bone pain, muscle pain, muscle weakness
loss of kidney function, sudden loss of kidney function
pain at catheter site, discomfort at injection site (redness, small hard lump, pain, swelling, irritation, rash, hives, leakage of fluid from catheter into tissue), inflammation of the vein at injection site
increased blood pressure and changes in certain blood test values (including renal electrolytes and coagulation parameters), increased levels of medicines you are taking that suppress the immune system
chest discomfort, chest pain, sensation of body temperature change, feeling of general malaise, general pain, facial swelling, swelling of ankles, hands or feet, swelling, hypersensitivity, feeling of fatigue.

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
fast heartbeat
flushing, low blood pressure
changes in certain blood test values (increased values in certain liver tests)
itching, rash
pain at catheter site
chills
changes in certain blood test values.

Reporting of side effects
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Caspofungin Sandoz GmbH

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 vial (the first two digits indicate the month, the following four digits the year). The expiry date refers to the last day of that month.
Store in the refrigerator (from 2°C to 8°C).
Once Caspofungin Sandoz GmbH has been prepared, it must be used immediately. This is because it does not contain ingredients to prevent bacterial growth. Only a healthcare professional who has read the complete instructions should prepare this medicine (see below “Instructions for reconstitution and dilution of Caspofungin Sandoz GmbH”).
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Caspofungin Sandoz GmbH contains

The active substance is caspofungin. Each vial of Caspofungin Sandoz GmbH contains 70 mg of caspofungin (as acetate). After reconstitution, each ml of concentrate for infusion solution contains 7.2 mg of caspofungin.
The other excipients are sucrose, mannitol, glacial acetic acid, and sodium hydroxide 3.9% (to adjust pH).

Description of the appearance of Caspofungin Sandoz GmbH and contents of the pack
Caspofungin Sandoz GmbH is a sterile, compact white to off-white powder for concentrate for infusion solution.
Each pack contains one vial of powder.

Marketing Authorization Holder
Marketing Authorization Holder: Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Legal representative in Italy: Sandoz S.p.A., Viale Luigi Sturzo, 43 – 20154 Milano, Italy

Manufacturers
PharmIdea SIA
4 Rupnicu Str.
2114 Olaine
Latvia
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, Sachsen-Anhalt
39179, Barleben
Germany
BAG Health Care GmbH
Amtsgerichtsstraße 1-5
35423 Lich
Germany
Lyocontract GmbH
Pulverwiese 1
38871 Ilsenburg
Germany
LABORATORIOS ALCALÁ FARMA, S.L.
Avenida de Madrid, 82,
Alcalá de Henares, 28802
Madrid, Spain

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for reconstituting and diluting Caspofungin Sandoz GmbH:

Reconstitution of Caspofungin Sandoz GmbH
DO NOT USE DILUENTS CONTAINING DEXTROSE because Caspofungin Sandoz GmbH is not stable in diluents containing glucose. DO NOT MIX OR ADMINISTER CASPOFUNGIN SANDOZ GMBH IN THE SAME INTRAVENOUS LINE WITH ANY OTHER MEDICINAL PRODUCT, as compatibility data with other substances, additives, or intravenous drugs are not available. Visually inspect the infusion solution for presence of particles or discoloration.

INSTRUCTIONS FOR USE IN ADULT PATIENTS
Step 1: Reconstitution of standard vials
To reconstitute the powder, allow the vial to reach room temperature and aseptically add 10.5 ml of water for injection. The concentration of the reconstituted vial will be 7.2 mg/ml.
The white to off-white lyophilized powder must be completely dissolved. Gently swirl until a clear solution is obtained. Reconstituted solutions should be visually inspected for presence of particles or discoloration. The reconstituted solution may be stored for up to 24 hours at temperatures not exceeding 25°C.

Step 2: Adding reconstituted Caspofungin Sandoz GmbH to the patient’s infusion solution
The diluents for the final infusion solution are: sodium chloride solution for injection or lactated Ringer’s solution. The infusion solution is prepared by aseptically adding the appropriate volume of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. Medically, if necessary, reduced infusion volumes down to 100 ml may be used for daily doses of 50 mg or 35 mg. Do not use if the solution is cloudy or contains precipitates.

PREPARATION OF THE INFUSION SOLUTION FOR ADULTS

DOSE*	Volume of reconstituted Caspofungin Sandoz GmbH to be transferred into the intravenous bag or bottle	Standard preparation (reconstituted Caspofungin Sandoz GmbH added to 250 ml) final concentration	Reduced infusion volume (reconstituted Caspofungin Sandoz GmbH added to 100 ml) final concentration
70 mg	10 ml	0.28 mg/ml	Not recommended
70 mg (from 2 vials of 50 mg each)**	14 ml	0.28 mg/ml	Not recommended
35 mg in case of moderate hepatic impairment (from 1 vial of 70 mg)	5 ml	0.14 mg/ml	0.34 mg/ml

* 10.5 ml must be used to reconstitute all vials.
** If the 70 mg vial is not available, the 70 mg dose can be prepared using 2
50 mg vials.
INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS
Calculation of Body Surface Area (BSA) for pediatric dosing
Before preparing the infusion, calculate the patient's body surface area (BSA)
using the following formula: (Mosteller Formula)

Mathematical formula for calculating body surface area BSA in square meters equal to the square root of height in cm multiplied by weight in kg divided by 3600

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

Determine the appropriate loading dose to be used in pediatric patients using the patient's BSA (calculated as above) and the following equation: BSA (m²) × 70 mg/m² = Loading Dose. The maximum loading dose on Day 1 must not exceed 70 mg, regardless of the calculated dose for the patient.
Allow the refrigerated Caspofungin Sandoz GmbH vial to reach room temperature.
Aseptically add 10.5 ml of Water for Injections. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C. This will provide a final caspofungin concentration of 7.2 mg/ml in the vial.
Withdraw from the vial the volume of medication corresponding to the calculated loading dose (step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Sandoz GmbH

into an IV infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride for Injection, or Lactated Ringer's for Injection. Alternatively, the volume (ml) of reconstituted Caspofungin Sandoz GmbH may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride for Injection, or Lactated Ringer's for Injection, provided that the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if refrigerated at 2–8°C.
Preparation of the 50 mg/m² infusion for pediatric patients aged >3 months (using a
70 mg vial)

Determine the appropriate daily maintenance dose for the pediatric patient using the patient's BSA (calculated as above) and the following equation: BSA (m²) × 50 mg/m² = Daily Maintenance Dose. The daily maintenance dose must not exceed 70 mg, regardless of the calculated dose for the patient.
Allow the refrigerated Caspofungin Sandoz GmbH vial to reach room temperature.
Aseptically add 10.5 ml of Water for Injections. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C. This will provide a final caspofungin concentration of 7.2 mg/ml in the vial.
Withdraw from the vial the volume of medication corresponding to the calculated daily maintenance dose (step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Sandoz GmbH into an IV infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride for Injection, or Lactated Ringer's for Injection. Alternatively, the volume (ml) of reconstituted Caspofungin Sandoz GmbH may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride for Injection, or Lactated Ringer's for Injection, provided that the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if refrigerated at 2–8°C.

Notes for preparation:
a. The white to off-white powder will dissolve completely. Gently swirl until the solution becomes clear.
b. Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and before infusion. Do not use if the solution is not clear or contains precipitates.
c. Caspofungin Sandoz GmbH is formulated to deliver the full labeled dose (70 mg) when 10 ml are withdrawn from the vial.

Package leaflet: Information for the user

Caspofungin Sandoz GmbH 50 mg powder for concentrate for solution for infusion

Generic medicine
Please read this leaflet carefully before this medicine is administered to you or your child as it contains important information for you.

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

Contents of this leaflet:

What Caspofungin Sandoz GmbH is and what it is used for
What you need to know before you are given Caspofungin Sandoz GmbH
How to use Caspofungin Sandoz GmbH
Possible side effects
How to store Caspofungin Sandoz GmbH
Contents of the pack and other information

1. What Caspofungin Sandoz GmbH is and what it is used for

What Caspofungin Sandoz GmbH is
Caspofungin Sandoz GmbH contains an active substance called caspofungin. This belongs to
a group of medicines known as antifungals.
What Caspofungin Sandoz GmbH is used for
Caspofungin Sandoz GmbH is used to treat the following infections in children, adolescents and adults:

severe fungal infections in tissues and organs (called 'invasive candidiasis'). This infection is caused by fungal cells (yeasts) called Candida. People who may get this type of infection include those who have recently undergone surgery or those with a weakened immune system. Fever and chills that do not respond to antibiotics are the most common signs of this type of infection.
fungal infections of the nose, sinuses or lungs (called 'invasive aspergillosis') when other antifungal treatments have not worked or have caused undesirable effects. This infection is caused by a mould called Aspergillus. People who may get this type of infection include those undergoing chemotherapy, those who have had a transplant, and those with a weakened immune system.
suspected fungal infections: if you have fever and a low white blood cell count without improvement after antibiotic therapy. People at risk of developing a fungal infection include those who have recently undergone surgery or those with a weakened immune system.

How Caspofungin Sandoz GmbH works
Caspofungin Sandoz GmbH weakens fungal cells and prevents the fungus from growing
properly. This stops the spread of the infection and allows the body's natural defences the
opportunity to completely eliminate the infection.

2. What you need to know before you are given Caspofungin Sandoz GmbH

Do not use Caspofungin Sandoz GmbH

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

If you are unsure, consult your doctor, nurse, or pharmacist before you are given this medicine.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Caspofungin Sandoz GmbH 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 cyclosporine (used to help prevent rejection of a transplanted organ or to suppress the immune system) – because your doctor may need additional blood tests during treatment
you have ever had any other medical condition.

If any of the conditions listed above apply to you (or if you are unsure), consult your doctor, nurse, or pharmacist before you are given this medicine.
Caspofungin Sandoz GmbH may also cause serious skin reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Other medicines and Caspofungin Sandoz GmbH
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
This is because Caspofungin Sandoz GmbH may interfere with the way some other medicines work. Likewise, some other medicines may interfere with the way Caspofungin Sandoz GmbH works.
Inform your doctor, nurse, or pharmacist if you are taking any of the following medicines:

cyclosporine or tacrolimus (used to help prevent rejection of a transplanted organ or to suppress the immune system) – because your doctor may need additional blood tests during treatment
certain HIV medicines such as efavirenz or nevirapine
phenytoin or carbamazepine (used to treat seizures)
dexamethasone (a steroid)
rifampicin (an antibiotic).

If any of the conditions listed above apply to you (or if you are unsure), consult your doctor, nurse, or pharmacist before you are given this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are breastfeeding, consult your doctor before taking any medicine.

Caspofungin Sandoz GmbH has not been studied in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn child.
Women being administered Caspofungin Sandoz GmbH should not breastfeed.

Driving and using machines
There is no information suggesting that Caspofungin Sandoz GmbH has an effect on the ability to drive or use machines.
Caspofungin Sandoz GmbH contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is practically “sodium-free”.

3. How to use Caspofungin Sandoz GmbH

Caspofungin Sandoz GmbH must always be prepared and administered by a healthcare professional.
Caspofungin Sandoz GmbH will be given to you:

once daily
by slow injection into a vein (intravenous infusion)
over approximately 1 hour.

Your doctor will determine the duration of treatment and the amount of Caspofungin Sandoz GmbH you will receive each day. Your doctor will monitor the effect of the medicine on you. If your body weight is over 80 kg, you may require a different dose.

Children and adolescents
The dose for children and adolescents may differ from that for adults.

If you have been given more Caspofungin Sandoz GmbH than you should have
Your doctor will decide the daily amount of Caspofungin Sandoz GmbH you need and the duration of treatment. If you are concerned that you have been given too much Caspofungin Sandoz GmbH, inform your doctor or nurse immediately.

If you have any doubts about the use of this medicine, consult your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or nurse immediately if you notice any of the following side effects – you may
need urgent medical treatment:

rash, itching, feeling of warmth, swelling of the face, lips or throat, or difficulty breathing – you may be experiencing a histamine reaction to the medicine.
difficulty breathing with wheezing or a worsening rash – you may be experiencing an allergic reaction to the medicine.
cough, severe breathing difficulties – if you are an adult and have invasive aspergillosis, you may be experiencing a serious respiratory problem that could lead to respiratory failure.
rash, skin peeling, mouth sores, hives, extensive areas of skin peeling.

decreased hemoglobin (reduction in the substance in the blood that carries oxygen), decreased white blood cells
decreased blood albumin (a type of protein) in the blood, decreased potassium or low potassium levels in the blood
headache
inflammation of the vein
shortness of breath
diarrhea, nausea, vomiting
changes in certain blood test values (including increased values of certain liver parameters)
itching, rash, skin redness, or excessive sweating
joint pain
chills, fever
itching at the injection site.

Uncommon (may affect up to 1 in 100 people):

changes in certain blood test values (including blood clotting disorders, platelets, red blood cells, and white blood cells)
loss of appetite, increased body fluid, imbalance of salts in the body, high blood sugar levels, low blood calcium levels, increased blood calcium levels, low blood magnesium levels, increased levels of acids in the blood
disorientation, feeling nervous, inability to sleep
dizziness, decreased sensation or sensitivity (especially skin-related), tremor, drowsiness, altered taste, tingling or numbness
blurred vision, increased tear production, swollen eyelid, yellowing of the whites of the eyes
sensation of rapid or irregular heartbeat, fast heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure
hot flushes, flushing, high blood pressure, low blood pressure, redness of a vein that is extremely painful to pressure
narrowing of the muscle bands in the airways causing shortness of breath or cough, rapid breathing, shortness of breath waking the patient, reduced oxygen in the blood, abnormal breathing sounds, rubbing noise in the lungs, dyspnea, nasal congestion, cough, sore throat
abdominal pain, upper abdominal pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, swelling due to fluid accumulation in the abdomen
decreased bile flow, enlarged liver, yellowing of the skin and/or whites of the eyes, liver damage caused by a medicine or chemical agents, liver disorder
abnormal skin tissue, generalized itching, hives, various types of skin rash, abnormal skin, red spots often itchy on arms and legs and sometimes on the face and other parts of the body
back pain, arm or leg pain, bone pain, muscle pain, muscle weakness
loss of kidney function, sudden loss of kidney function
pain at catheter site, discomfort at injection site (redness, small hard lump, pain, swelling, irritation, rash, hives, leakage of fluid from catheter into tissue), inflammation of the vein at injection site
increased blood pressure and changes in certain blood test values (including renal electrolytes and coagulation parameters), increased levels of medicines you are taking that suppress the immune system
chest discomfort, chest pain, sensation of body temperature changes, feeling of general malaise, general pain, facial swelling, swelling of ankles, hands or feet, swelling, hypersensitivity, feeling of fatigue.

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
fast heartbeat
redness, low blood pressure
changes in certain blood test values (increased values of certain liver tests)
itching, rash
pain at catheter site
chills
changes in certain blood test values.

Reporting of side effects
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Caspofungin Sandoz GmbH

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 vial (the first two digits indicate the month, the following four digits the year). The expiry date refers to the last day of that month.
Once Caspofungin Sandoz GmbH has been prepared, it must be used immediately. This is because it does not contain ingredients to prevent bacterial growth. Only a healthcare professional who has read the complete instructions should prepare this medicine (see below “Instructions for reconstitution and dilution of Caspofungin Sandoz GmbH”).
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Caspofungin Sandoz GmbH contains

The active substance is caspofungin. Each vial of Caspofungin Sandoz GmbH contains 50 mg of caspofungin (as acetate). After reconstitution, each ml of concentrate for infusion solution contains 5.2 mg of caspofungin.
The other excipients are sucrose, mannitol, glacial acetic acid, and sodium hydroxide 3.9% (to adjust pH).

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for reconstituting and diluting Caspofungin Sandoz GmbH:

Reconstitution of Caspofungin Sandoz GmbH
DO NOT USE DILUENTS CONTAINING DEXTROSE because Caspofungin Sandoz GmbH is not stable in diluents containing dextrose. DO NOT MIX OR ADMINISTER CASPOFUNGIN SANDOZ GMBH IN THE SAME INTRAVENOUS LINE WITH ANY OTHER MEDICINAL PRODUCT, as compatibility data with other substances, additives, or intravenous medicinal products are not available. Visually inspect the infusion solution for presence of particles or discoloration.

INSTRUCTIONS FOR USE IN ADULT PATIENTS
Step 1 Reconstitution of conventional vials
To reconstitute the powder, bring the vial to room temperature and aseptically add 10.5 ml of water for injection. The concentration of the reconstituted vial will be 5.2 mg/ml.
The white to off-white compact lyophilized powder must be completely dissolved. Gently swirl until a clear solution is obtained. Reconstituted solutions should be visually inspected for presence of particles or discoloration. This reconstituted solution may be stored for up to 24 hours at temperatures not exceeding 25°C.

Step 2 Adding reconstituted Caspofungin Sandoz GmbH to the patient’s infusion solution
The diluents for the final infusion solution are: sodium chloride solution for injection or lactated Ringer’s solution. The infusion solution is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. From a medical standpoint, if necessary, infusion volumes may be reduced to 100 ml for daily doses of 50 mg or 35 mg. Do not use if the solution is cloudy or contains precipitates.

PREPARATION OF THE INFUSION SOLUTION FOR ADULTS

DOSAGE*	Volume of reconstituted Caspofungin Sandoz GmbH to be transferred into the intravenous bag or bottle	Standard preparation (reconstituted Caspofungin Sandoz GmbH added to 250 ml) final concentration	Reduced infusion volume (reconstituted Caspofungin Sandoz GmbH added to 100 ml) final concentration
50 mg	10 ml	0.20 mg/ml
50 mg reduced volume	10 ml		0.47 mg/ml
35 mg in case of moderate hepatic impairment (from one 50 mg vial)	7 ml	0.14 mg/ml
35 mg in case of moderate hepatic impairment (from one 50 mg vial) reduced volume	7 ml		0.34 mg/ml

* 10.5 ml must be used to reconstitute all vials.
INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS
Calculation of Body Surface Area (BSA) for Pediatric Dosing
Before preparing the infusion, calculate the patient's body surface area (BSA)
using the following formula: (Mosteller Formula)

Mathematical formula for calculating body surface area BSA in square meters equal to the square root of

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

Determine the appropriate loading dose to be used in pediatric patients using the patient’s BSA (calculated as above) and the following equation: BSA (m²) × 70 mg/m² = Loading Dose. The maximum loading dose on Day 1 must not exceed 70 mg, regardless of the calculated dose for the patient.
Allow the refrigerated Caspofungin Sandoz GmbH vial to reach room temperature.
Aseptically add 10.5 ml of water for injectable preparations. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C. This will yield a final caspofungin concentration of 5.2 mg/ml in the vial.
Withdraw from the vial the volume of medication corresponding to the calculated loading dose (step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Sandoz GmbH
into an intravenous infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% sodium chloride for injectable preparations, or lactated Ringer’s for injectable preparations. Alternatively, the volume (ml) of reconstituted Caspofungin Sandoz GmbH may be added to a reduced volume of 0.9%, 0.45%, or 0.225% sodium chloride for injectable preparations, or lactated Ringer’s for injectable preparations, provided that the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if refrigerated between 2 and 8°C.

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

Determine the appropriate daily maintenance dose for the pediatric patient using the patient’s BSA (calculated as above) and the following equation: BSA (m²) × 50 mg/m² = Daily Maintenance Dose. The daily maintenance dose must not exceed 70 mg, regardless of the calculated dose for the patient.
Allow the refrigerated Caspofungin Sandoz GmbH vial to reach room temperature.
Aseptically add 10.5 ml of water for injectable preparations. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C. This will yield a final caspofungin concentration of 5.2 mg/ml in the vial.
Withdraw from the vial the volume of medication corresponding to the calculated daily maintenance dose (step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Sandoz GmbH into an intravenous infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% sodium chloride for injectable preparations, or lactated Ringer’s for injectable preparations. Alternatively, the volume (ml) of reconstituted Caspofungin Sandoz GmbH may be added to a reduced volume of 0.9%, 0.45%, or 0.225% sodium chloride for injectable preparations, or lactated Ringer’s for injectable preparations, provided that the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if refrigerated between 2 and 8°C.

Notes for Preparation:
a. The white to off-white powder will dissolve completely. Gently swirl until the solution becomes clear.
b. Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and before administration. Do not use if the solution is not clear or contains precipitates.
c. Caspofungin Sandoz GmbH is formulated to deliver the full labeled dose (50 mg) when 10 ml are withdrawn from the vial.