Caspofungin Sun

Package leaflet: Information for the user

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

Generic medicine
Please read this leaflet carefully before you are given this medicine because 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, talk to your doctor, nurse or pharmacist. This includes any side effects not listed in this leaflet. 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 administered
4. Possible side effects
5. How to store Caspofungin SUN
6. Contents of the pack and other information

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

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

What Caspofungin SUN is 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 develop this type of infection include those who have recently undergone surgery or those with a weakened immune system. Fever and chills that do not respond to antibiotics 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 side effects. This infection is caused by a mould called Aspergillus. People who may develop this type of infection include those receiving chemotherapy, those who have undergone organ transplantation, and those with a weakened immune system.
• Suspected fungal infections: if you have fever and a low white blood cell count without improvement after antibiotic therapy. People at risk of developing a fungal infection include those who have recently undergone surgery or those with a weakened immune system.

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 allows the body's natural defences the opportunity to eliminate the infection completely.

2. What you need to know before you are given Caspofungin SUN

Caspofungin SUN must not be administered to you

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

If you are unsure, consult your doctor, nurse, or pharmacist before being administered this medicine.

Warnings and precautions

Talk to your doctor, nurse, or pharmacist before being administered Caspofungin SUN:

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

If any of the above conditions apply to you (or if you are unsure), consult your doctor, nurse, or pharmacist before being administered Caspofungin SUN.

Caspofungin SUN may 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 obtained without a prescription, including herbal medicines.

This is because Caspofungin SUN may interfere with the way some other medicines work. Likewise, some other medicines may interfere with the way Caspofungin SUN works.

Tell your doctor, nurse, or pharmacist if you are taking any of the following medicines:

• cyclosporine or tacrolimus (used to help prevent organ transplant rejection or suppress the immune system) – as your doctor may need additional blood tests during treatment
• certain HIV medicines 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), consult your doctor, nurse, or pharmacist before being administered Caspofungin SUN.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, 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 be used during pregnancy only if the potential benefit justifies the potential risk to the unborn child.
• Women receiving Caspofungin SUN must not breastfeed.

Driving and using machines

There is no information suggesting that Caspofungin SUN has an effect on the ability to drive or use machines.

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 given to you:
 once daily

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

Your doctor will determine the duration of treatment and the amount of Caspofungin SUN you will receive daily. Your doctor will monitor the effect of the medicine on you. If your body weight is over 80 kg, you may require a different dose.
Use in children and adolescents
The dose for children and adolescents may differ from that for adults.
If you are given more Caspofungin SUN than you should have been
Your 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 how to use this medicine, consult your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor or nurse immediately if you notice any of the following side effects because you may need urgent medical treatment:

• rash, itching, feeling of warmth, swelling of the face, lips or throat, or breathing difficulties – you may be experiencing a histamine reaction to the medicine;
• breathing difficulties with wheezing or a worsening rash – you may be experiencing an allergic reaction to the medicine;
• cough, severe breathing difficulties – if you are an adult with invasive aspergillosis, you may be experiencing a serious respiratory problem that could lead to respiratory failure;
• rash, skin peeling, sores in the mucous membranes, hives, extensive areas of skin peeling.

As with any other prescription medicine, some side effects can be serious. For further information, please consult your doctor.
Other side effects in adults include:
Common (may affect up to 1 in 10 people):
decrease in haemoglobin (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 blood potassium levels;
• headache;
• inflammation of the vein;
• shortness of breath;
• diarrhoea, nausea, vomiting;
• changes in certain blood test values (including increased values of certain liver parameters);
• itching, rash, skin redness, or excessive sweating;
• joint pain;
• chills, fever; itching at the injection site.

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

• changes in certain blood test values (including blood clotting disorders, platelets, red blood cells, and white blood cells);
• loss of appetite, increased body fluid, electrolyte imbalance, high blood sugar, low blood calcium, increased blood calcium, low blood magnesium, increased blood acid levels;
• disorientation, feeling nervous, inability to sleep;
• dizziness, decreased sensation or sensitivity (especially skin-related), tremor, drowsiness, altered taste, tingling or numbness;
• blurred vision, increased tearing, swollen eyelid, yellowing of the whites of the eyes;
• sensation of rapid or irregular heartbeat, fast heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure;
• hot flushes, flushing, high blood pressure, low blood pressure, redness of a vein that is extremely painful to touch;
• narrowing of the muscle bands in the airways causing shortness of breath or cough, rapid breathing, shortness of breath waking the patient, reduced oxygen in the blood, abnormal breathing sounds, rubbing noise in the lungs, dyspnoea, nasal congestion, cough, sore throat;
• abdominal pain, upper abdominal pain, abdominal distension, constipation, difficulty swallowing, dry mouth, indigestion, gas, stomach discomfort, swelling due to fluid accumulation in the abdomen;
• decreased bile flow, enlarged liver, yellowing of the skin and/or whites of the eyes, liver damage due to medicine or chemical causes, liver disorder;
• abnormal skin tissue, generalized itching, hives, various types of skin rash, abnormal skin, red spots often itchy on arms and legs and sometimes on the face and other parts of the body;
• back pain, pain in arms or legs, bone pain, muscle pain, muscle weakness;
• loss of kidney function, sudden loss of kidney function;
• pain at catheter site, discomfort at injection site (redness, small hard lump, pain, swelling, irritation, rash, hives, leakage of fluid from catheter into tissue), inflammation of the vein at injection site;
• increased blood pressure and changes in certain blood test values (including renal electrolytes and coagulation parameters), increased levels of medicines you are taking that suppress the immune system;
• chest discomfort, chest pain, sensation of body temperature change, feeling of general malaise, general pain, facial swelling, swelling of ankles, hands or feet, swelling, 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 certain blood test values (increased values of certain liver tests);
• itching, rash;
• pain at catheter site;
• chills;
• changes in certain blood test values.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, nurse or pharmacist. You can also report side effects directly via 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 stated on the carton and vial after Exp.
The expiry date refers to the last day of that month.
Closed vials: store refrigerated at 2°C - 8°C.
Chemical and physical in-use stability has been demonstrated for up to 24 hours at temperatures equal to or below 25°C and at 5 ± 3°C when reconstituted with water for injection.
From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbiological contamination, the medicine should be used immediately.
This is because it does not contain components that prevent bacterial growth. If not used immediately, the storage times during use and storage conditions prior to use are the responsibility of the user.
Chemical and physical in-use stability of the diluted intravenous infusion solution for the patient has been demonstrated for 48 hours when stored at 2 - 8°C and at room temperature (25°C), when diluted with an intravenous infusion solution of sodium chloride 9 mg/ml (0.9%), 4.5 mg/ml (0.45%), or 2.25 mg/ml (0.225%), or with Ringer lactate solution.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage times and storage conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2 – 8°C, unless 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 this medicine (see below "Instructions for reconstitution and dilution of Caspofungin SUN").
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 injections, 1 ml of concentrate contains 5.2 mg or 7.2 mg of caspofungin.
• The other components 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 Authorization 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 regarding this medicinal product, please contact the Legal Representative in Italy of the Marketing Authorization Holder.

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Denmark: Caspofungin SUN 50 mg powder for concentrate for infusion solution
Caspofungin SUN 70 mg powder for concentrate for infusion solution
Spain: Caspofungin SUN 50 mg powder for concentrate for perfusion solution EFG
Caspofungin SUN 70 mg powder for concentrate for perfusion solution EFG
France: Caspofungine SUN 50 mg, powder for solution to be diluted for infusion
Caspofungine SUN 70 mg, powder for solution to be diluted for infusion
Italy: Caspofungin SUN
Germany: Caspofungin SUN 50 mg powder for concentrate for infusion solution
Caspofungin SUN 70 mg powder for concentrate for infusion solution
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 perfusion solution
Caspofungina Terapia 70mg powder for concentrate for perfusion solution

The following information is intended exclusively for medical professionals or healthcare providers:
Instructions for reconstitution and dilution of Caspofungin SUN:

Reconstitution of Caspofungin SUN
DO NOT USE DILUENTS CONTAINING GLUCOSE, as Caspofungin SUN is not stable in diluents containing glucose.
DO NOT MIX OR ADMINISTER Caspofungin SUN IN THE SAME INTRAVENOUS LINE AS ANY OTHER MEDICINAL PRODUCT, as compatibility data with other substances, additives, or intravenous drugs are not available.
Visually inspect the intravenous infusion solution for presence of particles or discoloration.

Caspofungin SUN 50 mg powder for concentrate for solution for infusion
INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1: Reconstitution of standard 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 vial will be 5.2 mg/ml.
The white to off-white compact lyophilized powder must be completely dissolved. Gently swirl until a clear solution is obtained. The reconstituted solution should be visually inspected for presence of particles or discoloration. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5 ± 3°C.

Step 2: Addition of reconstituted Caspofungin SUN to the patient's infusion solution
Suitable diluents for the final infusion solution are: sodium chloride solution for injection or lactated Ringer's solution. The infusion solution is prepared by aseptically adding the appropriate volume of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. From a medical standpoint, if necessary, reduced infusion volumes of 100 ml may be used for daily doses of 50 mg or 35 mg.
Do not use if the solution is cloudy or contains precipitates.

PREPARATION OF THE INTRAVENOUS INFUSION SOLUTION IN ADULTS

| Dose* | Reconstituted Caspofungin SUN for transfer to IV bag/bottle | Standard Preparation (Reconstituted Caspofungin SUN added to 250 ml) Final Concentration | Reduced Volume (Reconstituted Caspofungin SUN 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 (moderate hepatic impairment) (from one 50 mg vial) | 7 ml | 0.14 mg/ml | – | | 35 mg (moderate hepatic impairment) (from one 50 mg vial) (reduced volume) | 7 ml | – | 0.34 mg/ml |

* 10.5 ml must be used to reconstitute all vials

INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS

Calculation of Body Surface Area (BSA) for Pediatric Dosing
Before preparing the infusion, calculate the patient's body surface area (BSA) using the following formula: (Mosteller Formula)
𝐵𝑆𝐴 (𝑚²) = √𝐻𝑒𝑖𝑔ℎ𝑡 (𝑐𝑚) × 𝑊𝑒𝑖𝑔ℎ𝑡 (𝑘𝑔)

Preparation of 70 mg/m² Infusion for Pediatric Patients Aged >3 Months (Using a 50 mg Vial)

1. Determine the appropriate loading dose to be used in pediatric patients using the patient’s BSA (as calculated above) and the following equation:
   BSA (m²) × 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. Allow the refrigerated Caspofungin SUN vial to reach room temperature.
3. Aseptically add 10.5 mL of Water for Injections. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5 ± 3°C. This will yield a final concentration of caspofungin in the vial of 5.2 mg/mL.
4. Withdraw from the vial the volume of medication 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 0.9%, 0.45%, or 0.225% Sodium Chloride Solution for Injection or Lactated Ringer's Solution for Injection. Alternatively, the volume (mL) of reconstituted Caspofungin SUN may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Solution for Injection or Lactated Ringer's Solution for Injection, provided the final concentration does not exceed 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 50 mg/m² Infusion for Pediatric Patients Aged >3 Months (Using a 50 mg Vial)

1. Determine the appropriate daily maintenance dose to be used in the pediatric patient using the patient’s BSA (as calculated above) and the following equation:
   BSA (m²) × 50 mg/m² = Daily Maintenance Dose
   The daily maintenance dose must not exceed 70 mg, regardless of the calculated dose for the patient.
2. Allow the refrigerated Caspofungin SUN vial to reach room temperature.
3. Aseptically add 10.5 mL of Water for Injections. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5 ± 3°C. This will yield a final concentration of caspofungin in the vial of 5.2 mg/mL.
4. Withdraw from the vial the volume of medication 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 0.9%, 0.45%, or 0.225% Sodium Chloride Solution for Injection or Lactated Ringer's Solution for Injection. Alternatively, the volume (mL) of reconstituted Caspofungin SUN may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Solution for Injection or Lactated Ringer's Solution for Injection, provided the final concentration does not exceed 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 Notes:
a. The white to off-white powder will dissolve completely. Gently swirl until the solution becomes clear.
b. Visually inspect the reconstituted solution for particles or discoloration during reconstitution and before administration. Do not use if the solution is not clear or contains precipitates.
c. Caspofungin SUN is formulated to deliver the full labeled dose (50 mg) when 10 mL is withdrawn from the vial.

Caspofungin SUN 70 mg Powder for Concentrate for Solution for Infusion
INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of Standard Vials
To reconstitute the powder, allow the vial to reach room temperature and aseptically add 10.5 mL of Water for Injections. The concentration of the reconstituted vial will be 7.2 mg/mL. The white to off-white lyophilized compact powder must be completely dissolved. Gently swirl until a clear solution is obtained. Reconstituted solutions should be visually inspected for particles or discoloration. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5 ± 3°C.

Step 2 Addition of Reconstituted Caspofungin SUN to Intravenous Infusion Solution for the Patient
The diluents for the final intravenous infusion solution are: Sodium Chloride Solution for Injection or Lactated Ringer's Solution for Injection. The intravenous infusion solution is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 mL infusion bag or bottle. From a medical standpoint, reduced infusion volumes down to 100 mL may be used for daily doses of 50 mg or 35 mg, if necessary.
Do not use if the solution is cloudy or contains precipitates.

PREPARATION OF INFUSION SOLUTION IN ADULTS

| Dose* | Standard Preparation | Reduced Volume Preparation | Final Concentration | |------------|--------------------------|-------------------------------|--------------------------| | | Volume of Reconstituted Caspofungin SUN added to 250 mL | Volume of Reconstituted Caspofungin SUN added to 100 mL | Final Concentration | | 70 mg | 10 mL | — | 0.28 mg/mL | Not recommended | | 70 mg (from two 50 mg vials)** | 14 mL | — | 0.28 mg/mL | Not recommended | | 35 mg (in moderate hepatic impairment) (from one 70 mg vial) | 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 may be prepared from two 50 mg vials.

INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS

Calculation of Body Surface Area (BSA) for Pediatric Dosing
Before preparing the infusion, calculate the patient's body surface area (BSA) using the following formula: (Mosteller Formula)
𝐵𝑆𝐴 (𝑚²) = √𝐻𝑒𝑖𝑔ℎ𝑡 (𝑐𝑚) × 𝑊𝑒𝑖𝑔ℎ𝑡 (𝑘𝑔)

Preparation of 70 mg/m² Infusion for Pediatric Patients Aged >3 Months (Using a 70 mg Vial)

1. Determine the appropriate loading dose to be used in pediatric patients using the patient’s BSA (as calculated above) and the following equation:
   BSA (m²) × 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. Allow the refrigerated Caspofungin SUN vial to reach room temperature.
3. Aseptically add 10.5 mL of Water for Injections. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5 ± 3°C. This will yield a final concentration of caspofungin in the vial of 7.2 mg/mL.
4. Withdraw from the vial the volume of medication 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 0.9%, 0.45%, or 0.225% Sodium Chloride Solution for Injection or Lactated Ringer's Solution for Injection. Alternatively, the volume (mL) of reconstituted Caspofungin SUN may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Solution for Injection or Lactated Ringer's Solution for Injection, provided the final concentration does not exceed 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 50 mg/m² Infusion for Pediatric Patients Aged >3 Months (Using a 70 mg Vial)

1. Determine the appropriate daily maintenance dose to be used in the pediatric patient using the patient’s BSA (as calculated above) and the following equation:
   BSA (m²) × 50 mg/m² = Daily Maintenance Dose
   The daily maintenance dose must not exceed 70 mg, regardless of the calculated dose for the patient.
2. Allow the refrigerated Caspofungin SUN vial to reach room temperature.
3. Aseptically add 10.5 mL of Water for Injections. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5 ± 3°C. This will yield a final concentration of caspofungin in the vial of 7.2 mg/mL.
4. Withdraw from the vial the volume of medication 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 0.9%, 0.45%, or 0.225% Sodium Chloride Solution for Injection or Lactated Ringer's Solution for Injection. Alternatively, the volume (mL) of reconstituted Caspofungin SUN may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Solution for Injection or Lactated Ringer's Solution for Injection, provided the final concentration does not exceed 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 Notes:
a. The white to off-white powder will dissolve completely. Gently swirl until the solution becomes clear.
b. Visually inspect the reconstituted solution for particles or discoloration during reconstitution and before administration. Do not use if the solution is not clear or contains precipitates.
c. Caspofungin SUN is formulated to deliver the full labeled dose (70 mg) when 10 mL is withdrawn from the vial.