CASPOFUNGIN 50 mg Powder For Concentrate For Infusion Solution

Зміст інструкції

1. Caspofungin Teva Italia 50 mg powder for concentrate for solution for infusion, 70 mg powder for concentrate for solution for infusion
   1. What Caspofungin Teva Italia is and what it is used for
   2. What you need to know before you are given Caspofungin Teva Italia
   3. How to use Caspofungin Teva Italia
   4. Possible side effects
   5. How to store Caspofungin Teva Italia
   6. Content of the pack and other information

Caspofungin Teva Italia 50 mg powder for concentrate for solution for infusion, 70 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, nurse or pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Caspofungin Teva Italia is and what it is used for

What Caspofungin Teva Italia is
Caspofungin Teva Italia contains a medicine called caspofungin. This belongs to a group of
medicines called antifungals.

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

• serious fungal infections in tissues or 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 undergone 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”) if other antifungal treatments have not worked or have caused side 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 undergone transplantation 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 undergone surgery or those whose immune system is weak.

How Caspofungin Teva Italia works
Caspofungin Teva Italia makes fungal cells fragile and prevents the fungus from growing properly.
This stops the spread of the infection and gives the body’s natural defenses the chance to eliminate
the infection completely.

2. What you need to know before you are given Caspofungin Teva Italia

You must not be given Caspofungin Teva Italia

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

If you have any doubts, ask your doctor, nurse or pharmacist before you are given this medicine.

Warnings and precautions
Talk to your doctor, nurse or pharmacist before you are given Caspofungin Teva Italia:

• if you are allergic to any other medicines;
• if you have had problems with your liver - you may need a different dose of this medicine;
• if 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 perform further blood tests during treatment;
• if you have had any other medical problems.

If any of the above conditions apply to you (or if you are unsure), ask your doctor, nurse or pharmacist before you are given Caspofungin Teva Italia.
Caspofungin Teva Italia may also cause serious skin reactions, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

Other medicines and Caspofungin Teva Italia
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 Teva Italia can interfere with the way some other medicines work. Also, some other medicines can affect the way Caspofungin Teva Italia 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 a transplant or to suppress the immune system), as your doctor may need to perform further blood tests during treatment;
• some medicines for HIV 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), ask your doctor, nurse or pharmacist before you are given Caspofungin Teva Italia.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor, nurse or pharmacist for advice before using this medicine.

• Caspofungin Teva Italia has not been studied in pregnant women. It should only be used in pregnancy if the potential benefit justifies the potential risk to the fetus.
• Women receiving Caspofungin Teva Italia should not breastfeed.

Driving and using machines
There is no data to suggest that Caspofungin Teva Italia affects your ability to drive or operate machinery.

3. How to use Caspofungin Teva Italia

Caspofungin Teva Italia must always be prepared and administered by a healthcare professional.
You will be administered Caspofungin Teva Italia:

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

The doctor will determine the duration of treatment and the amount of Caspofungin Teva Italia that will be
administered to you daily. The doctor will monitor the effect that the medicine has on you. If your
body weight is greater 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 for adults.

If you have been given too much Caspofungin Teva Italia
The doctor will decide the daily amount of Caspofungin Teva Italia you need and the duration of
treatment. If you are concerned that you have been given too much Caspofungin Teva Italia, 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 gets them.
manifest them.

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

• skin rash, itching, feeling of warmth, 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, large 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):

• decreased hemoglobin (decreased substance in the blood that carries oxygen), decreased white blood cells;
• decreased blood albumin (a type of protein), decreased potassium or low potassium levels in the blood;
• headache;
• inflammation of the veins;
• shortness of breath;
• diarrhea, nausea or vomiting;
• changes in some blood test values (including increased levels of some liver parameters);
• itching, 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 disorder, platelets, red blood cells and white blood cells);
• loss of appetite, increased body fluids, imbalance of salts 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 nervous, inability to sleep, feeling dizzy, decreased sensation or sensitivity (especially at the skin level), tremor, feeling sleepy, 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;
• redness, hot flashes, high blood pressure, low blood pressure, redness along a vein that is extremely painful to the touch;
• narrowing of the muscle bands in the airways causing wheezing or coughing, rapid breathing, shortness of breath leading to waking up, decreased oxygen in the blood, abnormal breathing sounds, crackling noise in the lungs, wheezing, nasal congestion, cough, sore throat;
• abdominal pain, pain in the upper abdomen, abdominal distension, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, swelling caused by fluid accumulation in the abdomen;
• decreased bile flow, enlarged liver, yellowing of the skin and/or the white of the eyes, liver damage caused by a medicine or chemical substance, 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 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 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, swelling, tenderness, feeling tired.

Additional side effects that occur 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 blood test values (increased levels of some liver parameters);
• itching, rash;
• pain at the catheter site;
• chills;
• changes in some blood test values.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your
doctor, nurse or pharmacist. You can also report side effects directly through
the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.Reporting side effects can help provide more information on the safety of
this medicine.

5. How to store Caspofungin Teva Italia

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 vial after SCAD.
The expiry date refers to the last day of that month.
Closed vial: store in a refrigerator (from 2 ° C to 8 ° C).
The chemical-physical stability in use has been demonstrated for up to 24 hours at a temperature equal to or less than 25°C
and at 5 ± 3°C, in case of reconstitution with water for injectable preparation. From a
microbiological point of view, unless the opening/reconstitution/dilution method excludes the risk of
microbiological contamination, the medicine must be used immediately.
This is because it does not contain ingredients to stop the growth of bacteria.
If not used immediately, the storage times and conditions in use are the responsibility
of the user.
The chemical-physical stability in use of the diluted infusion solution for the patient has been demonstrated for 48
hours at 2-8°C and at room temperature (25°C), in case of dilution in sodium chloride infusion solution
9 mg/ml (0.9%), 4.5 mg/ml (0.45%) or 2.25 mg/ml (0.225%) or in Ringer lactate solution.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times and conditions before use are the responsibility
of the user and normally do not exceed 24 hours at 2-8°C, unless the solution has been
reconstituted/diluted in controlled and validated aseptic conditions.
Only a qualified healthcare professional who has read the complete instructions should prepare the
medicine (please see below “Instructions for reconstitution and dilution of Caspofungina Teva Italia”).
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Caspofungin Teva Italia contains

• The active substance is caspofungin.
• Each 50 mg vial contains 50 mg of caspofungin (as acetate).
• Each 70 mg vial contains 70 mg of caspofungin (as acetate).
• After reconstitution in 10.5 ml of water for injection, 1 ml of concentrate contains 5.2 mg or 7.2 mg of caspofungin.
• The other ingredients are sucrose, mannitol, glacial acetic acid and sodium hydroxide.

Description of the appearance of Caspofungin Teva Italia and contents of the pack
Caspofungin Teva Italia is a sterile, lyophilized powder, white to off-white in color.
Each pack contains one vial (10 ml) of powder.

Marketing authorization holder and manufacturer
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milan

Manufacturer:
Pharmathen S.A.
Dervenakion str., 6
153 51 - Pallini, Attiki
Greece
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
PLA 3000 - Paola
Malta
Merckle GmbH
Ludwig-Merckle-Strasse, 3 - Blaubeuren

• 89143 - Baden-Wuerttemberg Germany

Teva Pharma B.V.
Swensweg, 5
2031GA - Haarlem
Netherlands
Teva Operations Poland Sp. z.o.o.
ul. Mogilska, 80
31-546 Kraków
Poland
For any information on this medicine, please contact the local representative of the marketing authorization holder.

This medicinal product is authorized in the Member States of the European Economic Area with the following
denominations:
Denmark Caspofungin Teva B.V.
Germany Caspofungin-ratiopharm 50 mg Powder for a concentrate for solution for infusion
Caspofungin-ratiopharm 70 mg Powder for a concentrate for solution for infusion
Estonia Caspofungin Teva Pharma
Greece Caspofungin/Teva 50 mg powder for dense solution for preparation of solution for
infusion
Caspofungin/Teva 70 mg powder for dense solution for preparation of solution for
infusion
Spain Caspofungina Tevagen 50 & 70 mg powder for concentrate for solution for
infusion EFG
France Caspofungine Teva Sante 50mg powder for solution to be diluted for perfusion
Caspofungine Teva Sante 70mg powder for solution to be diluted for perfusion
Croatia Kaspofungin Pliva 50 mg powder for concentrate for solution for infusion
Kaspofungin Pliva 70 mg powder for concentrate for solution for infusion
Hungary Caspofungin ratiopharm 50 mg powder for concentrate for infusion
Caspofungin ratiopharm 70 mg powder for concentrate for infusion
Italy Caspofungin Teva Italia
Lithuania Caspofungin Teva Pharma 50 mg powder for concentrate for infusion solution
Caspofungin Teva Pharma 70 mg powder for concentrate for infusion solution
Poland Caspofungin Teva Pharmaceuticals
Portugal Caspofungina Teva
Romania Caspofungină ratiopharm 50 mg powder for concentrate for perfusable solution
Caspofungină ratiopharm 70 mg powder for concentrate for perfusable solution
United Kingdom Caspofungin Teva 50 mg & 70 mg Powder For Concentrate For Solution For
Infusion
<----------------------------------------------------------------------------------------------------------------------------->

The following information is intended for healthcare professionals only:
Instructions on how to reconstitute and dilute Caspofungin Teva Italia:
Reconstitution of Caspofungin Teva Italia
DO NOT USE DILUENTS CONTAINING GLUCOSE as Caspofungin Teva Italia is unstable in
diluents containing glucose. DO NOT MIX OR ADMINISTER Caspofungin Teva Italia WITH
ANY OTHER MEDICINE, as there is no data available on the compatibility of Caspofungin
Teva Italia with other additives, substances or medicines for intravenous use. Visually inspect
the infusion solution for the presence of particles or colour changes.

Caspofungin Teva Italia 50 mg powder for concentrate for solution for infusion
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 colour changes. This reconstituted solution can be stored for up
to 24 hours at a temperature equal to or below 25°C or at 5 ± 3°C.

Step 2 Addition of reconstituted Caspofungin Teva Italia 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 reconstituted concentrate (as shown in the following table) to a bag or bottle for
infusion of 250 ml. 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 shows opacity or precipitate.

PREPARATION OF THE INFUSION SOLUTION IN ADULTS
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 over 3 months of age (using a
50 mg vial)

• 1. Determine the appropriate loading dose to be used in the paediatric patient using the patient's BSA Height(cm) X Weight(kg) ) BSA(m  3600

(as calculated above) and the following equation:
BSA (m ) X 70 mg/m = Loading Dose
The maximum loading dose on Day 1 should not exceed 70 mg regardless of the patient's calculated dose.

• 2. Bring the refrigerated Caspofungin Teva Italia 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 or at 5 ± 3°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 Teva Italia into an IV infusion 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 Teva Italia 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 48 hours if stored in a refrigerator between 2 and 8°C or at room temperature (25°C).

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

• 1. Determine the appropriate daily maintenance dose to be used in the paediatric patient using the patient's BSA (as calculated above) and the following equation: BSA (m ) X 50 mg/m = Daily maintenance dose

The daily maintenance dose should not exceed 70 mg regardless of the patient's calculated dose.

• 2. Bring the refrigerated Caspofungin Teva Italia 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 or at 5 ± 3°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 reconstituted Caspofungin Teva Italia into an IV infusion 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 Teva Italia 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 48 hours if stored in a refrigerator between 2 and 8°C or at room temperature (25°C).

Caspofungin Teva Italia 70 mg powder for concentrate for solution for infusion
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 7.2 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 colour changes. This reconstituted solution can be stored for up
to 24 hours at a temperature equal to or below 25°C or at 5 ± 3°C.

Step 2 Addition of reconstituted Caspofungin Teva Italia 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 reconstituted concentrate (as shown in the following table) to a bag or bottle for
infusion of 250 ml. 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 shows opacity or precipitate.

PREPARATION OF THE INFUSION SOLUTION IN ADULTS

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/m infusionfor pediatric patients aged >3 months (using a 70 mg vial)

• 1. Determine the appropriate loading dose to use in the pediatric patient using the patient's BSA Height(cm) X Weight(kg) ) BSA(m  3600

(as calculated above) and the following equation:
BSA (m ) X 70 mg/m = Loading Dose
The maximum loading dose on Day 1 should not exceed 70 mg regardless of the patient's calculated dose.

• 2. Bring the refrigerated Caspofungin Teva Italia vial to room temperature.
• 3. Aseptically add 10.5 ml of water for injection. This reconstituted solution may be stored for up to 24 hours at a temperature equal to or less than 25°C or at 5 ± 3°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 Teva Italia into an IV infusion bag (or bottle) containing 250 ml of 0.9%, 0.45% or 0.225% sodium chloride injectable solution, or Ringer's lactate injectable solution. Alternatively, the volume (ml) of reconstituted Caspofungin Teva Italia may be added to a reduced volume of 0.9%, 0.45% or 0.225% sodium chloride injectable solution, or Ringer's lactate injectable solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 48 hours if stored in a refrigerated environment between 2 and 8°C or at room temperature (25°C).

Preparation of the 50 mg/m infusionfor pediatric patients aged >3 months (using a 70 mg vial)

• 1. Determine the appropriate daily maintenance dose to use in the pediatric patient using the patient's BSA (as calculated above) and the following equation: BSA (m ) X 50 mg/m = Daily maintenance dose. The daily maintenance dose should not exceed 70 mg regardless of the patient's calculated dose.
• 2. Bring the refrigerated Caspofungin Teva Italia vial to room temperature.
• 3. Aseptically add 10.5 ml of water for injection. This reconstituted solution may be stored for up to 24 hours at a temperature equal to or less than 25°C or at 5 ± 3°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 Teva Italia into an IV infusion bag (or bottle) containing 250 ml of 0.9%, 0.45% or 0.225% sodium chloride injectable solution, or Ringer's lactate injectable solution. Alternatively, the volume (ml) of reconstituted Caspofungin Teva Italia may be added to a reduced volume of 0.9%, 0.45% or 0.225% sodium chloride injectable solution, or Ringer's lactate injectable solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 48 hours if stored in a refrigerated environment between 2 and 8°C or at room temperature (25°C).