CASPOFUNGIN 50 mg Порошок Для Приготовления Концентрата Для Инфузионного Раствора

Содержание инструкции

1. Caspofungin Sandoz GmbH50 mg powder for concentrate for infusion solution
   1. What is Caspofungin Sandoz GmbH and what is it used for
2. Caspofungin Sandoz GmbH makes fungal cells fragile and prevents the fungus from growing
   1. What you need to know before you are given Caspofungin Sandoz GmbH
   2. How to use Caspofungin Sandoz GmbH
   3. Possible side effects
   4. How to store Caspofungin Sandoz GmbH
   5. Contents of the pack and other information
3. Caspofungin Sandoz GmbH is a white to off-white compact powder, sterile, for
4. Caspofungin Sandoz GmbH70 mg powder for concentrate for solution for infusion
   1. What is Caspofungin Sandoz GmbH and what is it used for
5. Caspofungin Sandoz GmbH is used to treat the following infections in children, adolescents
   1. What you need to know before you are given Caspofungin Sandoz GmbH
6. Caspofungin Sandoz GmbH can also cause serious adverse skin reactions such as
   1. How to use Caspofungin Sandoz GmbH
   2. Possible side effects
   3. How to store Caspofungin Sandoz GmbH
   4. Contents of the pack and other information

Caspofungin Sandoz GmbH50 mg powder for concentrate for infusion solution

Generic medicine

Read this leaflet carefully before this medicine is administered to you
or to 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 any side effects occur, including any not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

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

What is Caspofungin Sandoz GmbH 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 contract this type of infection include those who have recently had surgery or those whose immune system is weakened. Fever and chills that do not respond to an antibiotic 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 unwanted effects. This infection is caused by a mould called Aspergillus. People who may contract this type of infection include those undergoing chemotherapy, those who have undergone transplantation and those whose immune system is weakened.
• suspected fungal infections: if you have a fever and a low number of white blood cells without any improvement after antibiotic therapy. People who are at risk of developing a fungal infection include those who have recently had surgery or those whose immune system is weakened.

How Caspofungin Sandoz GmbH works

Caspofungin Sandoz GmbH makes fungal cells fragile and prevents the fungus from growing

correctly. This stops the spread of the infection and gives 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 not sure, ask your doctor, nurse or pharmacist before you are given this medicine.

Warnings and precautions
Ask your doctor, pharmacist or nurse before you are given Caspofungin Sandoz GmbH if:

• you are allergic to any other medicines
• you have ever had liver problems - you may need a different dose of this medicine
• if you are already taking cyclosporine (used to help prevent organ rejection after transplantation or suppress the immune system) - as your doctor may need further blood tests during treatment
• you have ever had any other medical problems.

If any of the above conditions apply to you (or if you are not sure), ask your doctor, nurse or pharmacist before you are given this medicine.
Caspofungin Sandoz GmbH can also cause serious skin 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 can interfere with the way some other medicines work. Also, some other medicines can 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 rejection after transplantation or suppress the immune system) as your doctor may need further blood tests during treatment
• some medicines for HIV such as efavirenz or nevirapine
• phenytoin or carbamazepine (used to treat seizures)
• dexamethasone (a steroid used e.g. in the treatment of inflammation)
• rifampicin (an antibiotic).

If any of the above conditions apply to you (or if you are not sure), ask 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, ask your doctor for advice before taking any medicine.

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

Driving and using machines
There is no information to suggest that Caspofungin Sandoz GmbH has an effect on the ability to drive or operate 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 administered to you:

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

The doctor will determine the duration of treatment and the amount of Caspofungin Sandoz GmbH
that will be administered to you daily. The doctor will monitor the effect that the
medicine has on you. If your body weight is more than 80 kg, you may need a
different dose.

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

If you have been given too much Caspofungin Sandoz GmbH
The 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, ask your doctor, nurse or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• skin rash, itching, feeling of heat, swelling of the face, lips or throat or difficulty breathing - this could be a histamine reaction to the medicine.
• difficulty breathing with wheezing or a skin rash that gets worse - this could be an allergic reaction to the medicine.
• cough, severe difficulty breathing - if you are an adult and have invasive aspergillosis, you may be experiencing a serious breathing problem that could lead to respiratory failure.
• skin rash, skin peeling, sores on the mucous membranes, hives, widespread areas of skin peeling.

As with any other prescription medicine, some side effects can be serious. For more information, contact your doctor. Other side effects in adults include:

Common(may affect up to 1 in 10 people):

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

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

• changes in some values in blood tests (including blood coagulation disease, platelets, red blood cells and white blood cells)
• loss of appetite, increased amount of body fluids, imbalance of salt in the body, high blood sugar, low calcium levels in the blood, increased calcium levels in the blood, low magnesium levels in the blood, increased acid levels in the blood
• disorientation, feeling of nervousness, inability to sleep
• feeling of dizziness, decreased sensation or sensitivity (especially at the skin level), tremor, feeling of drowsiness, altered taste, tingling or numbness
• blurred vision, increased tearing, swollen eyelid, yellowing of the white part of the eyes
• feeling of a fast or irregular heartbeat, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure
• flushing, hot flashes, 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 dyspnea or cough, rapid breathing, shortness of breath that wakes the patient, decreased oxygen in the blood, abnormal breathing sounds, rubbing sounds in the lungs, dyspnea, nasal congestion, cough, sore throat
• abdominal pain, pain in the upper abdomen, bloating, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, bloating caused by fluid buildup in the abdomen
• decreased bile flow, enlargement of the liver, yellowing of the skin and/or the white part of the eyes, liver damage caused by a medicine or chemical causes, liver disorder
• abnormal skin tissue, generalized itching, hives, various types of skin rash, abnormal skin, red spots often itchy on the arms and legs and sometimes on the face and the rest of the body
• back pain, pain in the arms or legs, bone pain, muscle pain, muscle weakness
• loss of kidney function, sudden loss of kidney function
• pain at the catheter site, discomfort at the injection site (redness, small hard lump, pain, swelling, irritation, rash, hives, leakage of fluid from the catheter into the tissue), inflammation of the vein at the injection site
• increased blood pressure and changes in some values in blood tests (including kidney electrolytes and coagulation parameters) increased levels of medicines you are taking that weaken the immune system
• chest discomfort, chest pain, perception of change in body temperature, general feeling of unwellness, general pain, swelling of the face, swelling of the ankles, hands or feet, edema, 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 some values in blood tests (increased values of some tests related to the liver)
• itching, rash
• pain at the catheter site
• chills
• changes in some values in blood tests.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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

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 which is stated on the pack and on the
vial (the first two numbers are the month, the following four numbers are the year). The expiry
date refers to the last day of that month.
Store in a 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 stop the growth of bacteria. Only a qualified
healthcare professional, who has read the complete instructions, should prepare this
medicine (see below “Instructions on how to reconstitute and dilute Caspofungin Sandoz
GmbH”).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Caspofungin Sandoz GmbH contains

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

Description of the appearance of Caspofungin Sandoz GmbH and contents of the pack

Caspofungin Sandoz GmbH is a white to off-white compact powder, sterile, for

concentrate for solution for infusion.
Each pack contains one vial of powder.

Marketing Authorisation Holder
MAH: Sandoz GmbH, Biochemiestrasse, 10, 6250 Kundl, Austria
Legal Representative in Italy: Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)
(Italy)

Manufacturer
PharmIdea SIA
4 RupnicuStr.
2114Olaine
Latvia
LekPharmaceuticalsd.d.
Verovškovaulica57
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

The following information is intended exclusively for physicians or healthcare professionals:
Instructions on how to reconstitute and dilute CaspofunginSandoz GmbH:

Reconstitution of CaspofunginSandoz GmbH
DO NOT USE DILUENTS CONTAINING GLUCOSE as CaspofunginSandoz GmbH is not
stable in diluents containing glucose. DO NOT MIX OR ADMINISTER CASPOFUNGIN SANDOZ GMBH WITH ANY OTHER MEDICINAL PRODUCT
VIA THE SAME INTRAVENOUS LINE, as there are no data available on the compatibility of CaspofunginSandoz GmbH with other
substances, additives or medicinal products for intravenous use. Visually inspect the infusion solution for
the presence of particles or colour changes.

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 compact white to off-white lyophilized powder must be completely dissolved.
Mix gently until a clear solution is obtained. Reconstituted
solutions must be visually inspected for the presence of particles or changes in
colour. This reconstituted solution can be stored for up to 24 hours at temperatures
equal to or below 25°C.

Step 2 Addition of reconstituted CaspofunginSandoz GmbH to the infusion solution for
the patient
Diluents for the final infusion solution are: sodium chloride injection solution, or Ringer’s lactate solution. The infusion solution is prepared
by aseptically adding the appropriate amount of the reconstituted concentrate (as
shown in the table below) to a 250 ml infusion bag or bottle. If
medically necessary, reduced infusion volumes of 100 ml can 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 IN ADULTS

* 10.5 ml should be used to reconstitute all vials.

INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS

Calculation of Body Surface Area (BSA) for paediatric dosage
Before preparing the infusion, calculate the patient’s body surface area (BSA) using the following formula (Mosteller’s Formula):

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

• 1. Determine the appropriate loading dose to use in paediatric patients 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 dose calculated for the patient.
• 2. Bring the refrigerated Caspofungin Sandoz GmbH vial to room temperature.
• 3. Aseptically add 10.5 ml of water for injection. This reconstituted solution can be stored for up to 24 hours at a temperature equal to or below 25°C. This will provide a final concentration of caspofungin in the vial of 5.2 mg/ml.
• 4. Take from the vial the volume of medicine corresponding to the calculated loading dose (step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Sandoz GmbH into an intravenous (IV) bag or bottle containing 250 ml of 0.9%, 0.45% or 0.225% sodium chloride injection solution, or Ringer’s lactate injection solution. Alternatively, the volume (ml) of reconstituted Caspofungin Sandoz GmbH can be added to a reduced volume of 0.9%, 0.45% or 0.225% sodium chloride injection solution, or Ringer’s lactate injection solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature equal to or below 25°C or within 48 hours if stored in a refrigerated environment between 2 and 8°C.

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

• 1. Determine the appropriate daily maintenance dose to use in the paediatric 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 dose calculated for the patient.
• 2. Bring the refrigerated Caspofungin Sandoz GmbH vial to room temperature.
• 3. Aseptically add 10.5 ml of water for injection. This reconstituted solution can be stored for up to 24 hours at a temperature equal to or below 25°C. This will provide a final concentration of caspofungin in the vial of 5.2 mg/ml.
• 4. Take from the vial the volume of medicine corresponding to the calculated daily maintenance dose (step 1). Aseptically transfer this volume (ml) of

Caspofungin Sandoz GmbH reconstituted into an intravenous (IV) bag or bottle
containing 250 ml of 0.9 %, 0.45 % or 0.225 % sodium chloride injection solution,
or Ringer’s lactate injection solution. Alternatively, the volume (ml) of
reconstituted Caspofungin Sandoz GmbH can be added to a reduced volume of
0.9 %, 0.45 % or 0.225 % sodium chloride injection solution, or Ringer
lactate injection solution, without exceeding a final concentration of 0.5
mg/ml. This infusion solution must be used within 24 hours if stored at
a temperature equal to or below 25°C or within 48 hours if stored in a refrigerated
environment between 2 and 8°C.

Notes for preparation:

• a. The white to off-white compound will dissolve completely. Mix gently until the solution becomes clear.
• b. Visually inspect the reconstituted solution for particles or colour changes during reconstitution and before infusion. Do not use if the solution is not clear or contains precipitates.
• c. Caspofungin Sandoz GmbH is formulated to provide the full dosage indicated on the label (50 mg) when 10 ml are drawn from the vial.

Caspofungin Sandoz GmbH70 mg powder for concentrate for solution for infusion

Generic medicine

Read this leaflet carefully before this medicine is administered to you
or to 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 any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

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

What is Caspofungin Sandoz GmbH 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 contract this type of infection include those who have recently had surgery or those whose immune system is weak. Fever and chills that do not respond to an antibiotic 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 unwanted effects. This infection is caused by a mold called Aspergillus. People who may contract this type of infection include those undergoing chemotherapy, those who have had a transplant, and those whose immune system is weak.
• suspected fungal infections: if you have a fever and a low number of white blood cells without any improvement after antibiotic therapy. People who are at risk of developing a fungal infection include those who have recently had surgery or those whose immune system is weak.

How does Caspofungin Sandoz GmbH work
Caspofungin Sandoz GmbH makes fungal cells fragile and prevents the fungus from growing
correctly. This stops the spread of the infection and gives the body’s natural
defenses the chance 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 not sure, ask 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 medicines
• 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 rejection after a transplant or to suppress the immune system) - as your doctor may need to carry out further blood tests during treatment
• you have ever had any other medical problems.

If any of the above conditions apply to you (or if you are not sure), talk to your doctor, nurse or pharmacist before you are given this medicine.

Caspofungin Sandoz GmbH can also cause serious adverse skin 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
may take any other medicines. This includes medicines obtained without
a prescription, including herbal medicines.
This is because Caspofungin Sandoz GmbH can interfere with the action of some other
medicines. Also, some other medicines can interfere with the action of
Caspofungin Sandoz GmbH.
Tell your doctor, nurse or pharmacist if you are taking any of the following
medicines:

• cyclosporine or tacrolimus (used to help prevent organ rejection after transplantation or suppress the immune system) as your doctor may need to perform additional blood tests during treatment
• some medicines for HIV such as efavirenz or nevirapine
• phenytoin or carbamazepine (used to treat seizures)
• dexamethasone (a steroid used, for example, in the treatment of inflammation)
• rifampicin (an antibiotic).

If any of the above conditions apply to you (or if you are not sure), talk to 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 with breast
milk, ask your doctor for advice before taking any medicine.

• Caspofungin Sandoz GmbH 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 child.
• Women receiving Caspofungin Sandoz GmbH should not breastfeed.

Driving and using machines
There is no information to suggest that Caspofungin Sandoz GmbHhas an
effect on the ability to drive or operate machines.

Caspofungin Sandoz GmbH contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, which 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 administered to you:

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

The doctor will determine the duration of treatment and the amount of Caspofungin Sandoz GmbH
that will be administered to you daily. The doctor will monitor the effect that the
medicine has on you. If your body weight is over 80 kg, you may need a
different dose.

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

If you have been given too much Caspofungin Sandoz GmbH
The doctor will decide the daily amount of Caspofungin Sandoz GmbH that 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 questions about the use of this medicine, ask your doctor, nurse or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Seek immediate medical attention or contact your nurse if you notice any of the following side effects – you may need urgent medical treatment:

• skin rash, itching, feeling of heat, swelling of the face, lips or throat or difficulty breathing - this could be a histamine reaction to the medicine.
• difficulty breathing with wheezing or a skin rash that worsens - this could be an allergic reaction to the medicine.
• cough, severe difficulty breathing - if you are an adult and have invasive aspergillosis, you may be experiencing a serious breathing problem that could lead to respiratory failure.
• skin rash, peeling of the skin, sores on the mucous membranes, hives, extensive areas of skin peeling.

As with any other prescription medicine, some side effects can be serious. For more information, consult your doctor. Other side effects in adults include:

Common(may affect up to 1 in 10 people):

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

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

• changes in some blood test values (including blood coagulation disorders, platelets, red blood cells and white blood cells)
• loss of appetite, increased body fluids, imbalance of salt in the body, high blood sugar, low calcium levels in the blood, increased calcium levels in the blood, low magnesium levels in the blood, increased acid levels in the blood
• disorientation, feeling of nervousness, inability to sleep
• feeling of dizziness, decreased sensation or sensitivity (especially at the skin level), tremor, feeling of drowsiness, altered taste, tingling or numbness
• blurred vision, increased tearing, swollen eyelid, yellowing of the white part of the eyes
• feeling of a fast or irregular heartbeat, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure
• flushing, hot flashes, high blood pressure, low blood pressure, redness of a vein that is extremely painful to the touch
• constriction of the muscle bands in the airways causing dyspnea or cough, rapid breathing, shortness of breath that wakes the patient, reduced oxygen in the blood, abnormal breathing sounds, rubbing sounds in the lungs, dyspnea, nasal congestion, cough, sore throat
• abdominal pain, pain in the upper abdomen, bloating, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, bloating caused by fluid buildup in the abdomen
• decreased bile flow, enlargement of the liver, yellowing of the skin and/or the white part of the eyes, liver damage caused by a medicine or chemical causes, liver disorder
• abnormal skin tissue, generalized itching, hives, various types of skin rash, abnormal skin, red spots often itchy on the arms and legs and sometimes on the face and the rest 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 the catheter site, discomfort at the injection site (redness, small hard lump, pain, swelling, irritation, rash, hives, leakage of fluid from the catheter into the tissue), inflammation of the vein at the injection site
• increased blood pressure and changes in some blood test values (including kidney electrolytes and coagulation parameters) increased levels of medicines you are taking that weaken the immune system
• chest discomfort, chest pain, perception of change in body temperature, general feeling of unwellness, general pain, swelling of the face, swelling of the ankles, hands or feet, edema, 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 some blood test values (increased values of some tests related to the liver)
• itching, rash
• pain at the catheter site
• chills
• changes in some blood test values.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the pack and the
vial (the first two numbers are the month, the following four numbers are the year). The expiry
date refers to the last day of that month.
Store in a 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 stop the growth of bacteria. Only a qualified
healthcare professional, who has read the complete instructions, should prepare this
medicine (see below “Instructions on how to reconstitute and dilute Caspofungin Sandoz
GmbH”).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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 solution for infusion contains 7.2 mg of caspofungin. The other excipients are sucrose, mannitol, glacial acetic acid and 3.9% sodium hydroxide (to adjust the pH).

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

Marketing Authorisation Holder
Marketing Authorisation Holder: Sandoz GmbH, Biochemiestrasse, 10, 6250 Kundl, Austria
Legal Representative for Italy: Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)
(Italy)

Manufacturer
PharmIdea SIA
4 RupnicuStr.
2114Olaine
Latvia
LekPharmaceuticalsd.d.
Verovškovaulica57
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

The following information is intended exclusively for doctors or healthcare professionals:
Instructions on how to reconstitute and dilute CaspofunginSandoz GmbH:

Reconstitution of CaspofunginSandoz GmbH
DO NOT USE DILUENTS CONTAINING GLUCOSE since CaspofunginSandoz GmbH is not
stable in diluents containing glucose. DO NOT MIX OR ADMINISTER CASPOFUNGIN SANDOZ GMBH WITH ANY OTHER MEDICINAL PRODUCT
via the same intravenous route, because there are no data available on the compatibility of CaspofunginSandoz GmbH with other
substances, additives or medicinal products for intravenous use. Visually inspect the infusion solution to check for particles or colour changes.

INSTRUCTIONS FOR USE IN ADULT PATIENTS
Step 1 Reconstitution of conventional vials
To reconstitute the powder, bring the vial to room temperature and add
aseptically 10.5 ml of water for injection. The concentration of the
reconstituted vial will be 7.2 mg/ml.
The compact, white to off-white lyophilised powder must be completely dissolved.
Mix gently until a clear solution is obtained. Reconstituted solutions
must be visually checked for the presence of particles or colour changes. This reconstituted solution can be stored for up to 24 hours at temperatures
equal to or below 25°C.

Step 2 Addition of reconstituted CaspofunginSandoz GmbH to the infusion solution for
the patient
Diluents for the final infusion solution are: sodium chloride injection solution, or Ringer’s lactate solution. The infusion solution is prepared
by aseptically adding the appropriate amount of the reconstituted concentrate (as
shown in the table below) to a 250 ml bag or bottle for infusion. If
medically necessary, reduced infusion volumes of 100 ml may be used for daily doses of 50 mg or 35 mg. Do not use if the solution is cloudy or
precipitates.

PREPARATION OF THE INFUSION SOLUTION IN ADULTS

* 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
with 2 vials of 50 mg

INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS

Calculation of the Body Surface Area (BSA) for paediatric dosage
Before preparing the infusion, calculate the patient’s body surface area (BSA) using the following formula (Mosteller’s Formula):

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

• 1. Determine the appropriate loading dose to use in paediatric patients 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 must not exceed 70 mg regardless of the dose calculated for the patient.
• 2. Bring the refrigerated Caspofungin Sandoz GmbH vial to room temperature.
• 3. Aseptically add 10.5 ml of water for injection. This reconstituted solution can be stored for up to 24 hours at a temperature equal to or below 25°C. This will provide a final concentration of caspofungin in the vial of 7.2 mg/ml.
• 4. Take from the vial the volume of medicine 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 Ringer’s lactate 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 Ringer’s lactate for injection, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature equal to or below 25°C or within 48 hours if stored in a refrigerator between 2 and 8°C.

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

• 1. Determine the appropriate daily maintenance dose to use in the paediatric 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 must not exceed 70 mg regardless of
the dose calculated for the patient.

• 2. Bring the refrigerated Caspofungin Sandoz GmbH vial to room temperature.
• 3. Aseptically add 10.5 ml of water for injection. This reconstituted solution can be stored for up to 24 hours at a temperature equal to or below 25°C. This will provide a final concentration of caspofungin in the vial of 7.2 mg/ml.
• 4. Take from the vial the volume of medicine 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 Ringer’s lactate 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 Ringer’s lactate for injection, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature equal to or below 25°C or within 48 hours if stored in a refrigerator between 2 and 8°C.

Notes for preparation:

• a. The white to off-white compound will dissolve completely. Mix gently until the solution becomes clear.
• b. Visually inspect the reconstituted solution for particles or colour changes during reconstitution and before infusion. Do not use if the solution is not clear or contains precipitates.
• c. Caspofungin Sandoz GmbH is formulated to provide the full dosage indicated on the label (70 mg) when 10 ml are drawn from the vial.