CASPOFUNGIN 50 mg Порошок Для Приготовления Концентрата Для Инфузионного Раствора

Содержание инструкции

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

Caspofungin Laboratorios Lorien 50 mg powder for concentrate for solution for infusion, 70 mg powder for concentrate for solution for infusion

Caspofungin

Equivalent medicinal product

Read this leaflet carefully before this medicine is administered to you or your child, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Caspofungin Laboratorios Lorien is and what it is used for

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

What Caspofungin Laboratorios Lorien is used for
Caspofungin Laboratorios Lorien 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 mould called Aspergillus. People who may contract this type of infection include those who are 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 Caspofungin Laboratorios Lorien works
Caspofungin Laboratorios Lorien 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 Laboratorios Lorien

Do not use Caspofungin Laboratorios Lorien

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Caspofungin Laboratorios Lorien if:

• you are allergic to any other medicines;
• you have ever had problems with your liver - you may need a different dose of this medicine;
• you are already taking ciclosporin (used to help prevent organ rejection or 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.

Caspofungin Laboratorios Lorien can cause serious skin reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

Other medicines and Caspofungin Laboratorios Lorien
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 Laboratorios Lorien can interfere with the way some other medicines work. Also, some other medicines can interfere with the way Caspofungin Laboratorios Lorien works.
Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:

• ciclosporin or tacrolimus (used to help prevent organ rejection or suppress the immune system) as your doctor may need to carry out 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 not sure), talk to your doctor, nurse or pharmacist before you are given Caspofungin Laboratorios Lorien.

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 or pharmacist for advice before you are given this medicine.

• Caspofungin Laboratorios Lorien 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 Laboratorios Lorien should not breastfeed.

Driving and using machines
There is no information to suggest that Caspofungin Laboratorios Lorien affects the ability to drive or operate machinery.

3. How to use Caspofungin Laboratorios Lorien

Caspofungin Laboratorios Lorien must always be prepared and administered by a healthcare professional.
Caspofungin Laboratorios Lorien 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 Laboratorios Lorien 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 Laboratorios Lorien
The doctor will decide the daily amount of Caspofungin Laboratorios Lorien you need and
the duration of treatment. If you are worried that you have been given too much Caspofungin
Laboratorios Lorien, tell 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 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 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 mucous membranes, hives, large areas of flaky skin. 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 blood test values (including increased values 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:

• changes in some blood test values (including blood coagulation disease, 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, 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
• 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 build-up 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 by chemical causes, liver disorder
• abnormal skin tissue, generalized itching, hives, various types of 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 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, feeling generally unwell, 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:

• fever

Common: may affect up to 1 in 10:

• 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 get any side effects, even those 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.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Caspofungin Laboratorios Lorien

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 package and vial after
EXP. The expiry date refers to the last day of that month.
Store and transport in a refrigerator (from 2°C to 8°C).
Once Caspofungin Laboratorios Lorien 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 Laboratorios Lorien”).
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 Laboratorios Lorien contains

• The active ingredient is caspofungin. Each vial of Caspofungin Laboratorios Lorien 50 mg contains 50 mg of caspofungin. Each vial of Caspofungin Laboratorios Lorien 70 mg contains 70 mg of caspofungin. After reconstitution, each ml of concentrate contains 5.2 mg of caspofungin. After reconstitution, each ml of concentrate contains 7.2 mg of caspofungin.
• The other excipients are sucrose, mannitol (E421), succinic acid (E363) and sodium hydroxide (for pH adjustment) (E524).

Description of the appearance of Caspofungin Laboratorios Lorien and contents of the pack
Caspofungin Laboratorios Lorien is a compact white to off-white powder.
Each pack contains one vial of powder.

Marketing Authorisation Holder
Laboratorios Lorien S.L, C/ Séneca 10, bajos 2ª, 08006 Barcelona, Spain

Manufacturer
Laboratori Fundació DAU, C/ C, 12-14 Pol. Ind. Zona Franca, 08040 Barcelona, Spain

The following information is intended exclusively for healthcare professionals:
Instructions on how to reconstitute and dilute Caspofungin Laboratorios Lorien 50 mg:
Reconstitution of Caspofungin Laboratorios Lorien
DO NOT USE DILUENTS CONTAINING GLUCOSE as Caspofungin Laboratorios Lorien is not
stable in diluents containing glucose. DO NOT MIX OR ADMINISTER VIA THE
SAME INTRAVENOUS ROUTE CASPOFUNGIN LABORATORIOS LORIEN WITH ANY
OTHER MEDICINAL PRODUCT, as there is no data available on the compatibility of Caspofungin
Laboratorios Lorien with other substances, additives, or medicinal products for intravenous use. Visually
inspect the infusion solution to check for particles or colour changes.

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 injections. The concentration of the reconstituted vials will be 5.2 mg/ml.
The compact, white to off-white lyophilised powder must be completely dissolved.
Gently swirl until a clear, colourless to slightly yellow solution is obtained. Reconstituted
solutions must be visually inspected to check for particles or colour changes. This reconstituted
solution can be stored for up to 24 hours at a temperature equal to or below 25°C.

Step 2 Addition of reconstituted CASPOFUNGIN LABORATORIOS LORIEN
to the infusion solution for the patient
The 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/day. Do not use if the solution is cloudy or contains
precipitates.

PREPARATION OF THE INFUSION SOLUTION IN ADULTS

*10.5 ml must be used to reconstitute all vials

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):
𝐵𝑆𝐴 (𝑚 ) = √𝐴𝑙𝑡𝑒𝑧𝑧𝑎 (𝑐𝑚)𝑥 𝑃𝑒𝑠𝑜 (𝑘𝑔)
3600

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

• 1. Determine the appropriate loading dose to be used in paediatric patients using the patient's BSA (as calculated above) and the following equation: BSA (m ) x 70 mg/m = 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 Laboratorios Lorien vial to room temperature.
• 3. Aseptically add 10.5 ml of water for injections. 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 Laboratorios Lorien 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 Laboratorios Lorien 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/minfusion for paediatric patients aged > 3 months
(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 must not exceed 70 mg regardless of the dose calculated for the patient.
• 2. Bring the refrigerated Caspofungin Laboratorios Lorien vial to room temperature.
• 3. Aseptically add 10.5 ml of water for injections. 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 reconstituted Caspofungin Laboratorios Lorien 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 Laboratorios Lorien 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.

Notes for preparation:

• a. The white to off-white compound will dissolve completely. Gently swirl until a clear, colourless to slightly yellow solution is obtained.
• b. Visually inspect the reconstituted solution for particles or colour changes during reconstitution and before infusion. Do not use if the solution is cloudy or contains precipitates.
• c. Caspofungin Laboratorios Lorien is formulated to provide the full dosage indicated on the label (50 mg) when 10 ml are drawn from the vial.

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

Instructions on how to reconstitute and dilute Caspofungin Laboratorios Lorien 70 mg:
Reconstitution of CASPOFUNGIN LABORATORIOS LORIEN
DO NOT USE DILUENTS CONTAINING GLUCOSE as CASPOFUNGIN
LABORATORIOS LORIEN is not stable in diluents containing glucose. DO NOT
MIX OR ADMINISTER VIA THE SAME INTRAVENOUS ROUTE
CASPOFUNGIN LABORATORIOS LORIEN WITH ANY OTHER
MEDICINAL PRODUCT, as there is no data available on the compatibility of CASPOFUNGIN
LABORATORIOS LORIEN 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 aseptically add
10.5 ml of water for injections. The concentration of the reconstituted vials will be 7.2 mg/ml.
The compact, white to off-white lyophilised powder must be completely dissolved.
Gently swirl until a clear, colourless to slightly yellow solution is obtained. Reconstituted
solutions must be visually inspected to check for particles or colour changes. This reconstituted
solution can be stored for up to 24 hours at a temperature equal to or below 25°C.

Step 2 Addition of reconstituted CASPOFUNGIN LABORATORIOS LORIEN
to the infusion solution for the patient
The 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/day. Do not use if the solution is cloudy or contains 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 50 mg vials

INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS

Calculation of the Body Surface Area (BSA) for paediatric dosage
Before preparing the infusion, calculate the body surface area (BSA)
of the patient using the following formula: (Mosteller's Formula)
𝐵𝑆𝐴 (𝑚 ) = √𝐴𝑙𝑡𝑒𝑧𝑧𝑎 (𝑐𝑚)𝑥 𝑃𝑒𝑠𝑜 (𝑘𝑔)
3600

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

• 1. Determine the appropriate loading dose to be used in paediatric patients using the patient's BSA (as calculated above) and the following equation: BSA (m ) x 70 mg/m = 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 Laboratorios Lorien vial to room temperature.
• 3. Aseptically add 10.5 ml of water for injections. 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 Laboratorios Lorien 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 Laboratorios Lorien 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/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 (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 Laboratorios Lorien vial to room temperature.
• 3. Aseptically add 10.5 ml of water for injectable preparations. This reconstituted solution can be stored for up to 24 hours at a temperature equal to or below 25°C. This will provide a final concentration of caspofungin in the vial of 7.2 mg/ml.
• 4. Withdraw from the vial the volume of medicine corresponding to the calculated daily maintenance dose (step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Laboratorios Lorien into an IV infusion bag (or bottle) containing 250 ml of 0.9 %, 0.45 % or 0.225 % sodium chloride for injectable preparations, or Ringer's lactate for preparations

injectable. Alternatively, the volume (ml) of reconstituted Caspofungin Laboratorios Lorien
can be added to a reduced volume of 0.9 %, 0.45 % or 0.225 % sodium chloride for
injectable preparations, or Ringer's lactate for
injectable preparations, 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 compound from white to white-whitish will dissolve completely. Gently mix until a clear solution from colorless to slightly yellow is obtained.
• b. Visually inspect the reconstituted solution for the presence of particles or color changes during reconstitution and before infusion. Do not use if the solution is opaque or contains precipitates.
• c. CASPOFUNGIN LORIEN is formulated to provide the full dosage indicated on the label (70 mg) when 10 ml are withdrawn from the vial.

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