CASPOFUNGIN 50 mg Порошок И Раствор Для Инфузионного Раствора

Содержание инструкции

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

Caspofungin SUN 50 mg powder for concentrate for infusion solution, 70 mg powder for concentrate for infusion solution

Generic medicine

Read this leaflet carefully before you are given this medicine 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 you get any side effects, even those not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Caspofungin SUN and what is it used for

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

What is Caspofungin SUN used for
Caspofungin SUN 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 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 had surgery or those whose immune system is weak.

How Caspofungin SUN works
Caspofungin SUN 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 SUN

You must not be given Caspofungin SUN

• 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, nurse or pharmacist before you are given Caspofungin SUN:

• if you are allergic to any other medicines
• if you have ever had problems with your liver - you may need a different dose of this medicine
• if you are already taking ciclosporin (used to help prevent organ rejection or suppress the immune system) - as your doctor may need to perform further blood tests during treatment.
• if 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 Caspofungin SUN.
Caspofungin SUN can also cause severe skin reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

Other medicines and Caspofungin SUN
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you get without a prescription, including herbal medicines.
This is because Caspofungin SUN can affect the way some other medicines work. Also, some other medicines can affect the way Caspofungin SUN 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 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 not sure), talk to your doctor, nurse or pharmacist before you are given Caspofungin SUN.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.

• Caspofungin SUN 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 SUN should not breastfeed.

Driving and using machines
There is no information to suggest that Caspofungin SUN affects your ability to drive or operate machinery.
Caspofungin SUN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially ‘sodium-free’

3. How Caspofungin SUN is administered

Caspofungin SUN must always be prepared and administered by a healthcare professional.
Caspofungin SUN 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 SUN 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 are given too much Caspofungin SUN
The doctor will decide the daily amount of Caspofungin SUN you need and the duration of
treatment. If you are concerned that you have been given too much Caspofungin SUN, 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 everybody gets them.
manifest them.

Seek immediate medical attention or contact your nurse if you notice any of the following side effects, as 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 in 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):
decrease in hemoglobin (the substance in the blood that carries oxygen has decreased),
decrease in white blood cells;

• decrease in blood albumin (a type of protein) in the blood, 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 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):

• changes in some blood test values (including blood coagulation disease, platelets, red blood cells and white blood cells);
• loss of appetite, increased amount of body fluids, salt imbalance 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 levels of acids 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 part of the abdomen, abdominal distension, 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 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 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 of general malaise, general pain, swelling of the face, swelling of the ankles, hands or feet, edema, hypersensitivity, feeling of fatigue.

Additional 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;
• tachycardia;
• 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, talk to 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.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Caspofungin SUN

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 vial after Exp.
The expiry date refers to the last day of that month.
Closed vials: store in a refrigerator at 2°C - 8°C.
Chemical and physical stability during use has been demonstrated for up to 24 hours at a temperature equal to or less than
25°C and at 5 ± 3°C when reconstituted with water for injectable preparation. From a
microbiological point of view, unless the opening/reconstitution/dilution method excludes the risk of
microbial contamination, the medicine must be used immediately.
This is because it does not contain components that can prevent the growth of bacteria. If not used
immediately, the storage times during use and the storage conditions before use are
the responsibility of the operator.
The chemical and physical stability during use of the diluted intravenous infusion solution for the patient is
demonstrated for 48 hours if stored at 2 - 8°C and at room temperature (25°C), when diluted with a
sodium chloride 9 mg/ml (0.9 %), 4.5 mg/ml (0.45 %), or 2.25 mg/ml
(0.225 %) intravenous infusion solution, or with a Ringer's lactate solution.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times during use and the storage conditions before use are
the responsibility of the operator and should normally not exceed 24 hours at 2 – 8°C, unless the
reconstitution and dilution have taken place under controlled and validated aseptic conditions.
Only a qualified healthcare professional who has read the complete instructions should prepare the medicine
(see below "Instructions on how to reconstitute and dilute Caspofungin SUN").
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. Contents of the pack and other information

What Caspofungin SUN contains

• The active substance is caspofungin. Each 50 mg vial contains caspofungin (as acetate). Each 70 mg vial contains caspofungin (as acetate). After reconstitution in 10.5 ml of water for injectable preparation, 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 SUN and contents of the pack
Caspofungin SUN is a sterile, white to off-white lyophilized powder.
Each pack contains one vial (10 ml) of powder.

Marketing Authorisation Holder
Sun Pharma France
31 Rue des Poissonniers
92 200 Neuilly-sur-Seine
France

Local Representative for Italy:
Sun Pharma Italia S.r.l.
Viale Giulio Richard 3
20143 Milan
Italy

Manufacturers
Pharmathen S.A.
6, Dervenakion str.
153 51 Pallini, Attiki
Greece
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
For any information relating to this medicine, contact the Legal Representative for Italy of the
Marketing Authorisation Holder.

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Denmark: Caspofungin SUN 50 mg powder for concentrate for infusion solution, solution
Caspofungin SUN 70 mg powder for concentrate for infusion solution, solution
Spain: Caspofungin SUN 50 mg powder for concentrate for solution for perfusion EFG
Caspofungin SUN 70 mg powder for concentrate for solution for perfusion EFG
France: Caspofungine SUN 50 mg, powder for solution for dilution for perfusion
Caspofungine SUN 70 mg, powder for solution for dilution for perfusion
Italy: Caspofungin SUN
Germany: Caspofungin SUN 50 mg Pulver für ein Konzentrat zur Herstellung einer
Infusionslösung
Caspofungin SUN 70 mg Pulver für ein Konzentrat zur Herstellung einer
Infusionslösung
United Kingdom: Caspofungin 50 mg powder for concentrate for solution for infusion
Caspofungin 70 mg powder for concentrate for solution for infusion
Romania Caspofungina Terapia 50mg powder for concentrate for solution for infusion
Caspofungina Terapia 70mg powder for concentrate for solution for infusion
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The following information is intended exclusively for healthcare professionals or healthcare operators:
Instructions on how to reconstitute and dilute Caspofungin SUN:

Reconstitution of Caspofungin SUN
DO NOT USE DILUENTS CONTAINING GLUCOSE because Caspofungin SUN is not stable in
diluents containing glucose. DO NOT MIX OR ADMINISTER Caspofungin SUN IN THE
SAME INTRAVENOUS LINE WITH ANY OTHER MEDICINE, because compatibility data for Caspofungin SUN with other substances, additives or intravenous medicines are not available.
Visually inspect the intravenous infusion solution for the presence of particles or
color changes.

Caspofungin SUN 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 injectable preparation. 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 checked
for the presence of particles or color changes. 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 °C.

Step 2 Addition of reconstituted Caspofungin SUN to the infusion solution for the patient
Diluents for the final infusion solution are: sodium chloride solution for injectable preparation, or
Ringer's lactate solution. The infusion solution is prepared by aseptically adding the appropriate amount of the 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 is cloudy or contains precipitates.

PREPARATION OF THE SOLUTION FOR INTRAVENOUS INFUSION IN ADULTS
DOSE*Volume of
Caspofungin
SUN reconstituted for
transfer to the
bag or bottle
for intravenous
solution
Standard
Preparation
(Caspofungin
SUN reconstituted
added to 250 ml)
final concentration

Reduced
infusion volume(Caspofungin
SUN reconstituted
added to 100 ml)
final concentration
50 mg 10 ml 0.20 mg/ml -
50 mg reduced
volume
10 ml - 0.47 mg/ml
35 mg for
moderate hepatic
impairment
(from 1 vial of
50 mg)
7 ml 0.14 mg/ml -
35 mg for
moderate hepatic
impairment
(from 1 vial of
50 mg) reduced
7 ml - 0.34 mg/ml
volume

*10.5 ml must 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)
𝐵𝑆𝐴 (𝑚²) = √𝐻𝑒𝑖𝑔ℎ𝑡 (𝑐𝑚)𝑥 𝑊𝑒𝑖𝑔ℎ𝑡 (𝑘𝑔)
3600

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 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 calculated dose for the patient.
• 2. Bring the refrigerated Caspofungin SUN vial to room temperature.
• 3. Aseptically add 10.5 ml of water for injectable preparation. 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°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 SUN into an intravenous (IV) bag (or bottle) containing 250 ml of 0.9%, 0.45% or 0.225% sodium chloride solution for injectable preparation, or Ringer's lactate solution for injectable preparation. Alternatively, the volume (ml) of reconstituted Caspofungin SUN can be added to a reduced volume of 0.9%, 0.45% or 0.225% sodium chloride solution for injectable preparation, or Ringer's lactate solution for injectable preparation, 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/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 (m²) X 50 mg/m² = Daily Maintenance Dose The daily maintenance dose must not exceed 70 mg regardless of the calculated dose for the patient.
• 2. Bring the refrigerated Caspofungin SUN vial to room temperature.
• 3. Aseptically add 10.5 ml of water for injectable preparation. 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°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 SUN into an intravenous (IV) bag (or bottle) containing 250 ml of 0.9%, 0.45% or 0.225% sodium chloride solution for preparation

injectable, or Ringer's lactate solution for injectable preparation. Alternatively, the volume (ml) of reconstituted Caspofungin SUN can be added to a reduced volume of
0.9%, 0.45% or 0.225% sodium chloride solution for injectable preparation, or Ringer's lactate solution for
injectable preparation, 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 of 25°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 color changes during reconstitution and before infusion. Do not use if the solution is not clear or contains precipitates.
• c.Caspofungin SUN is formulated to provide the full dosage indicated on the label (50 mg) when 10 ml are drawn from the vial.

Caspofungin SUN 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 injectable preparation. 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 checked
for the presence of particles or color changes. 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 °C.

Step 2 Addition of reconstituted Caspofungin SUN to the intravenous infusion solution for the patient
Diluents for the final intravenous infusion solution are: sodium chloride solution for injectable
preparation, or Ringer's lactate solution. The intravenous infusion solution is prepared
by aseptically adding the appropriate amount of the reconstituted concentrate (as shown in the table that
follows) 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 is cloudy or contains precipitates.

PREPARATION OF THE SOLUTION FOR INTRAVENOUS INFUSION IN ADULTS
DOSE*Volume of
Caspofungin
SUN reconstituted for
transfer to the
bag or bottle
for intravenous
solution
Standard
Preparation
(Caspofungin
SUN reconstituted
added to 250 ml)
final concentration

Reduced
infusion volume(Caspofungin
SUN reconstituted
added to 100 ml)
final concentration
70 mg 10 ml 0.28 mg/ml Not recommended
70 mg (from 2
vials of 50
mg)**
14 ml 0.28 mg/ml Not recommended
35 mg for
moderate hepatic
impairment
(from 1 vial of
70 mg)
5 ml 0.14 mg/ml 0.34 mg/ml

*10.5 ml must be used to reconstitute all vials.

**If the 70 mg vial is not available, the 70 mg dose can be prepared from two 50 mg
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)
𝐵𝑆𝐴 (𝑚²) = √𝐻𝑒𝑖𝑔ℎ𝑡 (𝑐𝑚)𝑥 𝑊𝑒𝑖𝑔ℎ𝑡 (𝑘𝑔)
3600

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

• 1. Determine the appropriate loading dose to use in pediatric 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 calculated dose for the patient.
• 2. Bring the refrigerated Caspofungin SUN 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. Withdraw from the vial the volume of medicine corresponding to the calculated loading dose (Step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin SUN into an IV infusion bag (or bottle) containing 250 ml of sodium chloride solution for injection 0.9%, 0.45% or 0.225%, or Ringer's lactate solution for injection. Alternatively, the volume (ml) of reconstituted Caspofungin SUN may be added to a reduced volume of sodium chloride solution for injection 0.9%, 0.45% or 0.225%, or Ringer's lactate solution for injection, 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/m² infusion for 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 calculated dose for the patient.

• 2. Bring the refrigerated Caspofungin SUN 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. 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 SUN into an IV infusion bag (or bottle) containing 250 ml of sodium chloride solution for injection 0.9%, 0.45% or 0.225%, or Ringer's lactate solution for injection. Alternatively, the volume (ml) of reconstituted Caspofungin SUN may be added to a reduced volume of sodium chloride solution for injection 0.9%, 0.45% or 0.225%, or Ringer's lactate solution for injection, 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 of 25°C.

Preparation Notes:

• a.The compound from white to off-white will dissolve completely. Gently swirl until the solution becomes clear.
• 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 not clear or contains precipitates.
• c.Caspofungin SUN is formulated to deliver the full dosage indicated on the label (70 mg) when 10 ml are drawn from the vial.