Label: information for the user

Caspofungina Tevagen50 mg powder for concentrate for solution for infusion EFG

Caspofungina Tevagen 70 mg powder for concentrate for solution for infusion EFG

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this label. See section 4.

5Storage of Caspofungina Tevagen

6.Contents of the package and additional information

What is caspofunginaTevagen

Caspofungina powder for concentrate for solution for infusion contains a medicine called caspofungina. This belongs to a group of medicines called antifungals.

How is Caspofungina Tevagen usedCaspofungina Tevagen

Caspofungina is used to treat the following fungal infections in children, adolescents and adults:

•severe fungal infections in their tissues or organs (designated “invasive candidiasis”). This infection is caused by fungal cells (yeast) called Candida. People who may suffer from this type of infection include those who have recently undergone surgery or those whose immune system is weakened. Fever and chills that do not respond to antibiotic treatment are the most common symptoms of this type of infection.

•fungal infections in their nose, nasal sinuses or lungs (designated “invasive aspergillosis”) if other antifungal treatments have not worked or have caused side effects. This infection is caused by molds called Aspergillus.

People who may suffer from this type of infection include those undergoing chemotherapy, those who have undergone a transplant and those whose immune system is weakened.

•presumed fungal infections if they have fever and a low white blood cell count, which have not improved with antibiotic treatment. People who are at risk of suffering from a fungal infection include those who have recently undergone surgery or those whose immune system is weakened.

How Caspofungina Tevagen works

Caspofungina makes fungal cells fragile and prevents the fungus from growing properly. This prevents the infection from spreading and gives the body's natural defenses the opportunity to completely get rid of the infection.

No use Caspofungina Tevagen

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

If you are unsure, consult your doctor, pharmacist, or nurse before starting to use your medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Caspofungin powder for concentrate for solution for infusion if:

• you are allergic to any other medication.
• you have ever had liver problems; you may need a different dose of this medication.
• you are already taking ciclosporin (used to prevent organ transplant rejection or to cause immunosuppression), as your doctor may need to perform additional blood tests during treatment.
• you have ever had any other medical condition.

If any of the above points apply to you (or you are unsure), consult your doctor, pharmacist, or nurse before starting to use Caspofungin.

Caspofungin may also cause severe skin reactions, such as Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (TEN).

Use of Caspofungina Tevagen with other medications

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication. This includes medications obtained without a prescription, including herbal remedies.

This is because Caspofungin may affect the way other medications work. Other medications may also affect the way Caspofungin works.

Inform your doctor, pharmacist, or nurse if you are taking any of the following medications:

• ciclosporin or tacrolimus (used to prevent organ transplant rejection or to cause immunosuppression), as your doctor may need to perform additional blood tests during treatment.
• some HIV medications such as efavirenz or nevirapina.
• phenytoin or carbamazepine (used to treat seizures).
• dexamethasone (a steroid).
• rifampicin (an antibiotic).

If any of the above points apply to you (or you are unsure), consult your doctor, pharmacist, or nurse before starting to use Caspofungin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

• Caspofungin has not been studied in pregnant women. It should only be used during pregnancy if the potential benefits justify the possible risks to the developing fetus.
• Women using Caspofungin should not breastfeed.

Driving and operating machinery

There is no information to suggest that Caspofungin affects the ability to drive or operate machinery.

Caspofungina Tevagen contains sodium

This medication contains less than 23 mgof sodium (1 mmol) per vial; this is, essentially “sodium-free”

Caspofungina will always be prepared and administered by a healthcare professional. Caspofungina will be administered:

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

Your doctor will determine the duration of treatment and the amount of Caspofungina to be administered each day.Your doctorwill monitoriftheeffectofthemedicationisadequate.If you weigh more than 80kg,it is possible that you will need a different dose.

Use in children and adolescents

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

If you use more Caspofungina Tevagen than you should

Your doctorwill decide how much Caspofungina you need and for how long each day.Ifyou are concerned that you may have been given too much Caspofungina,informyour doctoror nurse immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication,askyour doctor, pharmacist, ornurse.

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

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

• eruption, itching, feeling of heat, swelling of your face, lips, or throat, or difficulty breathing: you may be having a histamine reaction to the medicine.
• difficulty breathing with wheezing or worsening of an existing eruption: you may be having an allergic reaction to the medicine.
• cough, severe breathing difficulties: if you are an adult and have invasive aspergillosis, you may experience a severe respiratory problem that could lead to respiratory failure.
• eruption, skin peeling, mucous membrane lesions, rashes, large areas of skin peeling

As with any prescription medication, some side effects can be serious. Ask your doctor for more information.

Other side effects in adults include:

Frequent: can affect up to 1 in 10 people:

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

Rare: can affect up to 1 in 100 people:

• changes in some laboratory blood tests (including blood clotting disorders, platelets, red blood cells, and white blood cells).
• loss of appetite, increase in body fluid, electrolyte imbalance, high blood sugar levels, low calcium levels in the blood, high calcium levels in the blood, low magnesium levels in the blood, high levels of acid in the blood.
• disorientation, feeling of nerves, inability to sleep.
• feeling of dizziness, decreased sensations or sensitivity (especially in the skin), agitation, feeling of sleepiness, change in the way things taste, tingling or numbness.
• blurred vision, increased tearing, swollen eyelid, yellow discoloration of the white part of the eyes.
• feeling of rapid or irregular heartbeats, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure.
• flushing, hot flashes, high blood pressure, low blood pressure, redness along a vein that is very sensitive to the touch.
• tension in the bands of muscle around the airways that leads to wheezing or coughing, rapid breathing, shortness of breath that wakes you up, lack of oxygen in the blood, abnormal respiratory sounds, crepitant sounds in the lungs, wheezing, nasal congestion, cough, sore throat.
• abdominal pain, upper abdominal pain, swelling, constipation, difficulty swallowing, dry mouth, indigestion, gas passing, stomach discomfort, swelling due to fluid accumulation around the abdomen.
• decreased bile flow, enlarged liver, yellow discoloration of the skin and/or white part of the eyes, liver damage caused by a drug or chemical compound, liver disorder.
• abnormal skin tissue, generalized itching, rashes, varied appearance eruption, abnormal skin, red patches, often with itching, on arms and legs and sometimes on the face and rest of the body.
• back pain, pain in an arm or leg, bone pain, muscle pain, muscle weakness.
• loss of kidney function, sudden loss of kidney function.
• pain at the catheter site, symptoms at the injection site (redness, hard lump, pain, swelling, irritation, eruption, rashes, leakage of fluid from the catheter into the tissue), inflammation of the vein at the injection site.
• increase in blood pressure and alterations in some laboratory blood tests (such as kidney function tests and coagulation tests), increase in levels of medications you are taking that weaken the immune system.
• chest discomfort, chest pain, feeling of change in body temperature, feeling generally unwell, general pain, swelling of the face, swelling of the ankles, hands, or feet, swelling, pain on palpation, feeling of fatigue

Side effects in children and adolescents

Frequent: can affect more than 1 in 10 people:

• fever.

Frequent: can affect up to 1 in 10 people:

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

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and vial after CAD. The expiration date is the last day of the month indicated.

Unopened vial: store in refrigerator between 2°C and 8°C.

Stability data have shown that the concentrate for infusion solution can be stored for up to 24 hours when the vial is stored at a temperature equal to or less than 25 °C and at 5 ± 3 °C when reconstituted with water for injectable preparations. From a microbiological point of view, unless the opening/reconstitution/dilution method prevents the risk of microbiological contamination, the product should be used immediately.

This is because it does not contain any component to prevent bacterial growth. If not used immediately, the storage times in use and conditions before use are the responsibility of the user.

Stability data of the diluted solution for patient infusion have shown that the product can be used within 48 hours between 2 to 8 °C and at room temperature (25 °C) when diluted in 9 mg/ml (0.9%), 4.5 mg/ml (0.45%), or 2.25 mg/ml (0.225%) of sodium chloride infusion solution, or with lactated Ringer's solution.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times in use and conditions before use are the responsibility of the user and should not exceed 24 hours between 2 and 8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.

Only a trained healthcare professional who has read the complete instructions should prepare the medication (see later "Instructions for reconstituting and diluting Tevagen Caspofungin").

Medications should not be disposed of through drains or trash. Dispose of containers and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. In this way, you will help protect the environment.

Composition of Caspofungin Tevagen

Caspofungin Tevagen50 mg powder for concentrate for solution for infusion EFG

• The active ingredient is caspofungin. Each vial contains 50 mg of caspofungin (as acetate). After reconstitution in 10.5 ml, each ml of concentrate contains 5.2 mg of caspofungin.
• The other components are sucrose, mannitol, glacial acetic acid, and sodium hydroxide.

Caspofungin Tevagen70 mg powder for concentrate for solution for infusion EFG

• The active ingredient is caspofungin. Each vial contains 70 mg of caspofungin (as acetate). After reconstitution in 10.5 ml, each ml of concentrate contains 7.2 mg of caspofungin.
• The other components are sucrose, mannitol, glacial acetic acid, and sodium hydroxide.

Aspect of the product and content of the package

Caspofungin Tevagen is a white to off-white lyophilized powder.

Each package contains a vial (10 ml) of powder.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas Madrid

Spain

Responsible for manufacturing

Pharmathen S.A.

Dervenakion str., Pallini, Attiki

153 51, Greece

O

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park, Paola

PLA 3000, Malta

O

Merckle GmbH

Ludwig-Merckle-Street 3, Blaubeuren

Baden-Wuerttemberg

89143 Germany

O

Teva Pharma B.V.

Swensweg 5

Haarlem

2031GA Netherlands

O

ELPEN PHARMACEUTICAL CO,.

Marathonos Ave. 95, Pikermi Attiki,

19009 Greece

This medicinal product is authorized in the Member States of the EEA under the following names:

Austria Caspofungin ratiopharm GmbH 50 mg Powder for a concentrate for the preparation of an infusion solution

Caspofungin ratiopharm GmbH 70 mg Powder for a concentrate for the preparation of an infusion solution

Belgium Caspofungin Teva Generics 50 mg powder for concentrate for solution for infusion / poudre pour solution à diluer for perfusion / Powder for a concentrate for the preparation of an infusion solution

Caspofungin Teva Generics 70 mg powder for concentrate for solution for infusion / poudre pour solution à diluer for perfusion / Powder for a concentrate for the preparation of an infusion solution

CroatiaKaspofungin Pliva 50 mg powder for concentrate for solution for infusion

Kaspofungin Pliva 70 mg powder for concentrate for solution for infusion

DenmarkCaspofungin Teva B.V.

EstoniaCaspofungin Teva Generics

FranceCaspofungine Teva Sante 50mg powder for solution for infusion

Caspofungine Teva Sante 70mg powder for solution for infusion

GermanyCaspofungin-ratiopharm 50 mg Powder for a concentrate for the preparation of an infusion solution

Caspofungin-ratiopharm 70 mg Powder for a concentrate for the preparation of an infusion solution

GreeceCaspofungin/Teva 50 mgκ?νιςγιαπυκν?δι?λυμαγιαπαρασκευ?διαλ?ματοςπρος?γχυση

Caspofungin/Teva70mgκ?νις για πυκν? δι?λυμα για παρασκευ? διαλ?ματος προς ?γχυση

HungaryíaCaspofunginratiopharm50mgporoldatosinfúzióhozvalókoncentrátumhoz

Caspofunginratiopharm70mgporoldatosinfúzióhozvalókoncentrátumhoz

ItalyCaspofungin Teva Italia

LithuaniaCaspofungin Teva Generics50 mg milteliai infuzinio tirpalo koncentratui

Caspofungin Teva Generics70 mg milteliai infuzinio tirpalo koncentratui

Netherlands Caspofungine 50 mg Teva, powder for concentrate for solution for infusion

Caspofungine 70 mg Teva, powder for concentrate for solution for infusion

PolandCaspofungin Teva Pharmaceuticals

PortugalCaspofungina Teva

Slovenia Kaspofungin Teva 50 mg mg powder for concentrate for solution for infusion

Kaspofungin Teva 70 mg mg powder for concentrate for solution for infusion

Slovakia Caspofungin Teva B.V. 50 mg

Caspofungin Teva B.V. 70 mg

SpainCaspofungina Tevagen 50 & 70 mg powder for concentrate for solution for infusion EFG

United KingdomCaspofungin Teva 50 mg & 70 mg Powder For Concentrate For Solution For Infusion

Last review date of this leaflet: April 2020

Lainformation detailed and updated on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for doctors or healthcare professionals:

Instructions for reconstituting and diluting Caspofungin Tevagen:

Reconstitution of Caspofungin Tevagen

DO NOT USE DILUENTS CONTAINING GLUCOSE, as CASPOFUNGINA TEVAGEN is not stable in diluents containing glucose. DO NOT MIX OR INFUSE CASPOFUNGINA TEVAGEN CONCURRENTLY WITH ANY OTHER MEDICAMENT, as there are no data on the compatibility of CASPOFUNGINA TEVAGEN with other substances, additives, or intravenous pharmaceutical specialties. The infusion solution must be visually inspected for the presence of solid particles or a change in color.

Caspofungin Tevagen 50 mg powder for concentrate for solution for infusion EFG

Instructions for use in adult patients

Step 1 Reconstitution of vials

To reconstitute the powder, bring the vial to room temperature and add asetically 10.5 ml of water for injection. The concentration of the reconstituted vial will be 5.2 mg/ml.

The white to off-white lyophilized powder will completely dissolve. Gently mix until a transparent solution is obtained. The reconstituted solutions must be visually inspected for the presence of solid particles or a change in color. The reconstituted solution can be stored for a maximum of 24 hours at a temperature equal to or less than 25°C or at 5 ± 3°C.

Step 2 Addition of reconstituted Caspofungin Tevagen to the patient's infusion solution

The diluents for the final infusion solution are: sodium chloride injection or Ringer lactate solution. The infusion solution is prepared by adding the appropriate amount of the reconstituted concentrate (as shown in the following table) to a 250 ml infusion bag or bottle. Infusions of reduced volume in 100 ml may be used if medically necessary for doses of 50 mg or 35 mg. Do not use if the solution is turbid or has precipitated.

PREPARATION OF THE INFUSION SOLUTION IN ADULT PATIENTS

*10.5 ml must be used for the reconstitution of all vials

Instructions for use in pediatric patients

Calculation of body surface area (SC) for pediatric dosing

Before preparing the infusion, calculate the patient's body surface area (SC) using the following formula: (Mosteller formula)

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

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

SC (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.

1. Wait for the refrigerated vial of Caspofungin Tevagen to reach room temperature.
2. Asetically add 10.5 ml of water for injectiona. This reconstituted solution can be stored for up to 24 hours at a temperature equal to or less than 25°C or at 5 ± 3°Cb. This will result in a final concentration of caspofungin in the vial of 5.2 mg/ml.
3. Extract the appropriate volume of the medication from the vial equal to the calculated loading dose (Step 1). Transfer this volume (ml)cof reconstituted Caspofungin Tevagen to an IV bag or bottle containing 250 ml of sodium chloride injection (0.9%, 0.45%, or 0.225%) or Ringer lactate solution. Alternatively, the volume (ml)cof reconstituted Caspofungin Tevagen can be added to a reduced volume of sodium chloride injection (0.9%, 0.45%, or 0.225%) or Ringer lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).

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

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

SC (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.

1. Wait for the refrigerated vial of Caspofungin Tevagen to reach room temperature.
2. Asetically add 10.5 ml of water for injectiona. This reconstituted solution can be stored for up to 24 hours at a temperature equal to or less than 25°C or at 5 ± 3°Cb. This will result in a final concentration of caspofungin in the vial of 5.2 mg/ml.
3. Extract the appropriate volume of the medication from the vial equal to the calculated daily maintenance dose (Step 1). Transfer this volume (ml)cof reconstituted Caspofungin Tevagen to an IV bag or bottle containing 250 ml of sodium chloride injection (0.9%, 0.45%, or 0.225%) or Ringer lactate solution. Alternatively, the volume (ml)cof reconstituted Caspofungin Tevagen can be added to a reduced volume of sodium chloride injection (0.9%, 0.45%, or 0.225%) or Ringer lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).

Caspofungin Tevagen 70 mg powder for concentrate for solution for infusion EFG

Instructions for use in adult patients

Step 1 Reconstitution of vials

To reconstitute the powder, bring the vial to room temperature and add asetically 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 will completely dissolve. Gently mix until a transparent solution is obtained. The reconstituted solutions must be visually inspected for the presence of solid particles or a change in color. The reconstituted solution can be stored for a maximum of 24 hours at a temperature equal to or less than 25°C or at 5 ± 3°C.

Step 2 Addition of reconstituted Caspofungin Tevagen to the patient's infusion solution

The diluents for the final infusion solution are: sodium chloride injection or Ringer lactate solution. The infusion solution is prepared by adding the appropriate amount of the reconstituted concentrate (as shown in the following table) to a 250 ml infusion bag or bottle. Infusions of reduced volume in 100 ml may be used if medically necessary for doses of 50 mg or 35 mg. Do not use if the solution is turbid or has precipitated.

PREPARATION OF THE INFUSION SOLUTION IN ADULT PATIENTS

*10.5 ml must be used for the reconstitution of all vials

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

Instructions for use in pediatric patients

Calculation of body surface area (SC) for pediatric dosing

Before preparing the infusion, calculate the patient's body surface area (SC) using the following formula: (Mosteller formula)

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

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

SC (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.

1. Wait for the refrigerated vial of Caspofungin Tevagen to reach room temperature.
2. Asetically add 10.5 ml of water for injectiona. This reconstituted solution can be stored for up to 24 hours at a temperature equal to or less than 25°C or at 5 ± 3°Cb. This will result in a final concentration of caspofungin in the vial of 7.2 mg/ml.
3. Extract the appropriate volume of the medication from the vial equal to the calculated loading dose (Step 1). Transfer this volume (ml)cof reconstituted Caspofungin Tevagen to an IV bag or bottle containing 250 ml of sodium chloride injection (0.9%, 0.45%, or 0.225%) or Ringer lactate solution. Alternatively, the volume (ml)cof reconstituted Caspofungin Tevagen can be added to a reduced volume of sodium chloride injection (0.9%, 0.45%, or 0.225%) or Ringer lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).

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

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

SC (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.

1. Wait for the refrigerated vial of Caspofungin Tevagen to reach room temperature.
2. Asetically add 10.5 ml of water for injectiona. This reconstituted solution can be stored for up to 24 hours at a temperature equal to or less than 25°C or at 5 ± 3°Cb. This will result in a final concentration of caspofungin in the vial of 7.2 mg/ml.
3. Extract the appropriate volume of the medication from the vial equal to the calculated daily maintenance dose (Step 1). Transfer this volume (ml)cof reconstituted Caspofungin Tevagen to an IV bag or bottle containing 250 ml of sodium chloride injection (0.9%, 0.45%, or 0.225%) or Ringer lactate solution. Alternatively, the volume (ml)cof reconstituted Caspofungin Tevagen can be added to a reduced volume of sodium chloride injection (0.9%, 0.45%, or 0.225%) or Ringer lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).