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CASPOFUNGIN DIAMED 50MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CASPOFUNGIN / CASPOFUNGIN / CASPOFUNGIN

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Package Leaflet: Information for the user
Caspofungin Diamed 50 mg powder for concentrate for solution for infusion
Caspofungin
Read all of this leaflet carefully before you or your child are given this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor, nurse or pharmacist.
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Caspofungin Diamed is and what it is used for
2.
What you need to know before you are given Caspofungin Diamed
3.
How to use Caspofungin Diamed
4.
Possible side effects
5.
How to store Caspofungin Diamed
6.
Contents of the pack and other information

1.

What Caspofungin Diamed is and what it is used for

What Caspofungin Diamed is
Caspofungin Diamed contains the active substance caspofungin. This belongs to a group of medicines
called antifungals.
What Caspofungin Diamed is used for
Caspofungin Diamed is used to treat the following infections in children, adolescents and adults:
serious fungal infections in your tissues or organs (called “invasive candidiasis”). This infection
is caused by fungal (yeast) cells called Candida.
People who might get this type of infection include those who have just had an operation or
those whose immune systems are weak. Fever and chills that do not respond to an antibiotic are
the most common signs of this type of infection.
fungal infections in your nose, nasal sinuses or lungs (called “invasive aspergillosis”) if other
anti-fungal treatments have not worked or have caused side effects. This infection is caused by a
mould called Aspergillus.
People who might get this type of infection include those having chemotherapy, those who have
had a transplant and those whose immune systems are weak.
suspected fungal infections if you have a fever and a low white cell count that have not
improved on treatment with an antibiotic. People who are at risk of getting a fungal infection
include those who have just had an operation or those whose immune systems are weak.
How Caspofungin Diamed works
Caspofungin Diamed makes fungal cells fragile and stops the fungus from growing properly. This
stops the infection from spreading and gives the body’s natural defences a chance to completely get rid
of the infection.

2.

What you need to know before you are given Caspofungin Diamed

Do not use Caspofungin Diamed
if you are allergic to caspofungin or any of the other ingredients of this medicine (listed in
section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before you are given your medicine.
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Warnings and precautions
Talk to your doctor, nurse or pharmacist before you are given Caspofungin Diamed if:
you are allergic to any other medicines
you have ever had liver problems - you might need a different dose of this medicine
you are already taking cyclosporin (used to help prevent organ transplant rejection or to
suppress your immune system) – as your doctor may need to run extra blood tests during your
treatment.
if you have ever had any other medical problem.
If any of the above applies to you (or you are not sure), talk to your doctor, nurse or pharmacist before
you are given Caspofungin Diamed.
Other medicines and Caspofungin Diamed
Please 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 Diamed can affect the way some other medicines work. Also some other
medicines can affect the way Caspofungin Diamed works.
Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
cyclosporin or tacrolimus (used to help prevent organ transplant rejection or to suppress your
immune system) as your doctor may need to run extra blood tests during your treatment
some HIV medicines such as efavirenz or nevirapine
phenytoin or carbamazepine (used for the treatment of seizures)
dexamethasone (a steroid used e.g. for the treatment of inflammations)
rifampicin (an antibiotic).
If any of the above apply to you (or you are not sure), talk to your doctor, nurse or pharmacist before
you are given Caspofungin Diamed.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding or think
you are pregnant.
-

Caspofungin Diamed has not been studied in pregnant women. It should be used in pregnancy
only if the potential benefit justifies the potential risk to the unborn baby.
Women given Caspofungin Diamed should not breast-feed.

Driving and using machines
There is no information to suggest that Caspofungin Diamed affects your ability to drive or operate
machinery.
Caspofungin Diamed contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodiumfree”.

3.

How to use Caspofungin Diamed

Caspofungin Diamed will always be prepared and given to you by a healthcare professional.
You will be given Caspofungin Diamed:
once each day
by slow injection into a vein (intravenous infusion)
over about 1 hour.

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Your doctor will determine the duration of your treatment and how much Caspofungin Diamed you
will be given each day. Your doctor will monitor how well the medicine works for you. If you weigh
more than 80 kg, you may need a different dose.
Children and adolescents
The dose for children and adolescents may differ from the adult dose.
If you have been given more Caspofungin Diamed than you should
Your doctor will decide how much Caspofungin Diamed you need and for how long each day. If you
are worried that you may have been given too much Caspofungin Diamed, tell your doctor or nurse
straight away.
If you have any further questions on 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.
Tell your doctor or nurse straight away if you notice any of the following side effects - you may
need urgent medical treatment:
rash, itching, feeling warm, 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 a rash that gets worse - you may be having an allergic
reaction to the medicine.
cough, serious breathing difficulties - if you are an adult and have invasive aspergillosis you
may be experiencing a serious respiratory problem that could result in respiratory failure.
As with any prescription medicine, some side effects may be serious. Ask your doctor for more
information.
Other side effects in adults include:
Common (may affect up to 1 in 10 people):
decreased haemoglobin (decreased oxygen carrying substance in the blood), decreased white
blood cells
decreased blood albumin (a type of protein) in your blood, decreased potassium or low
potassium levels in the blood
headache
inflammation of the vein
shortness of breath
diarrhoea, nausea or vomiting
changes in some laboratory blood tests (including increased values of some liver tests)
itching, rash, skin redness or sweating more than usual
joint pain
chills, fever
itching at the injection site.
Uncommon (may affect up to 1 in 100 people):
changes in some laboratory blood tests (including disease of blood clotting, platelets, red blood
cells and white blood cells)
loss of appetite, increase in amount of body fluid, imbalance of salt in the body, high sugar level
in the blood, low calcium level in the blood, low magnesium level in the blood, increase in acid
level in the blood
disorientation, feeling nervous, being unable to sleep
feeling dizzy, decreased feeling or sensitivity (especially in the skin), shaking, feeling sleepy,
change in the way things taste, tingling or numbness
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blurred vision, increase in tears, swollen eyelid, yellowing of the whites of the eyes
sensation of fast or irregular heart beats, rapid heart beat, irregular heart beat, abnormal heart
rhythm, heart failure
flushing, hot flush, high blood pressure, low blood pressure, redness along a vein which is
extremely tender when touched
tightening of the bands of muscle around the airways resulting in wheezing or coughing, fast
breathing rate, shortness of breath that wakes you up, shortage of oxygen in the blood, abnormal
breath sounds, crackling sounds in the lungs, wheezing, nasal congestion, cough, throat pain
belly pain, upper belly pain, bloating, constipation, difficulty swallowing, dry mouth,
indigestion, passing gas, stomach discomfort, swelling due to build-up of fluid around the belly
decreased flow of bile, enlarged liver, yellowing of the skin and/or whites of the eyes, liver
injury caused by a drug or chemical, liver disorder
abnormal skin tissue, generalised itching, hives, rash of varying appearance, abnormal skin, red
often itchy spots on your arms and legs and sometimes on the face and the 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
catheter site pain, injection site complaints (redness, hard lump, pain, swelling, irritation, rash,
hives, leaking of fluid from the catheter into the tissue), inflammation of vein at injection site
increased blood pressure and alterations in some laboratory blood tests (including kidney
electrolyte and clotting tests), increased levels of the medicines you are taking that weaken the
immune system
chest discomfort, chest pain, feeling of body temperature change, generally feeling unwell,
general pain, swelling of the face, swelling of the ankles, hands or feet, swelling, tenderness,
feeling tired.

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
fast heart beat
flushing, low blood pressure
changes in some laboratory blood tests (increased values of some liver tests)
itching, rash
catheter site pain
chills
changes in some laboratory blood tests.
Other side effects reported since this medicine has been on the market
Not known (frequency cannot be estimated):
liver problems
swelling of the ankles, hands or feet
increased calcium levels in the blood have been reported.
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on
the safety of this medicine.

5.

How to store Caspofungin Diamed

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

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Do not use this medicine after the expiry date which is stated on the carton and the vial (the first two
numbers are the month; the next four numbers are the year). The expiry date refers to the last day of
that month.
Store in a refrigerator (2 °C to 8 °C).
Reconstituted concentrate should be used immediately. Stability data have shown that the concentrate
for solution for infusion can be stored for up to 24 hours when the vial is stored at 25 °C or less and
reconstituted with water for injection.
Diluted patient infusion solution should be used immediately. Stability data have shown that the
product can be used within 24 hours when stored at 25 °C or less, or within 48 hours when the
intravenous infusion bag (bottle) is stored refrigerated (2 to 8 °C) and diluted with sodium chloride
solution 9 mg/ml (0.9 %), 4.5 mg/ml (0.45 %), or 2.25 mg/ml (0.225 %) for infusion, or lactated
Ringer’s solution.
[Inventend Name] contains no preservatives. From a microbiological point of view, the product should
be used immediately. If not used immediately, in use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless
reconstitution and dilution have taken place in controlled validated aseptic conditions.
Once Caspofungin Diamed has been prepared, it should be used straight away. This is because it does
not contain any ingredients to stop the growth of bacteria. Only a trained healthcare professional who
has read the complete directions should prepare the medicine (please see below “Instructions of how
to reconstitute and dilute Caspofungin Diamed”).
Do not throw away any medicines via wastewater . Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Caspofungin Diamed contains
The active substance is caspofungin. Each vial of Caspofungin Diamed contains 50 mg
caspofungin (as acetate). After reconstitution each ml concentrate contains 5 mg caspofungin.
The other ingredients are sucrose, mannitol, glacial acetic acid and sodium hydroxide 3.9 % (to
adjust the pH) (please see section 2. “What you need to know before you are given Caspofungin
Diamed”).
What Caspofungin Diamed looks like and contents of the pack
Caspofungin Diamed is a sterile, white to off-white compact powder for concentrate for solution for
infusion.
Each pack contains one vial of powder.
Marketing Authorisation Holder
DiaMed Beratungsgesellschaft für pharmazeutische Unternehmen mbH
Am Mittelhafen 20
48155 Muenster
Germany
Manufacturer
PharmIdea SIA
4 Rupnicu Str.
2114 Olaine
Latvia

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This medicinal product is authorised in the Member States of the EEA under the following
names:
France
Germany
Italy
Spain
United Kingdom

Caspofungin Diamed 50 mg poudre pour solution à diluer pour perfusion
Caspofungin Diamed 50 mg Pulver für ein Konzentrat zur Herstellung einer
Infusionslösung
Caspofungin Diamed 50 mg polvere per concentrato per soluzione per
infusione
Caspofungin Diamed 50 mg polvo para concentrado para solución para
perfusión
Caspofungin Diamed 50 mg powder for concentrate for solution for infusion

This leaflet was last revised in 09/2016.

The following information is intended for healthcare professionals only:
Instructions of how to reconstitute and dilute Caspofungin Diamed:
Reconstitution of Caspofungin Diamed
DO NOT USE ANY DILUENTS CONTAINING GLUCOSE as CASPOFUNGIN DIAMED is not
stable in diluents containing glucose. DO NOT MIX OR CO-INFUSE CASPOFUNGIN DIAMED
WITH ANY OTHER MEDICINES, as there are no data available on the compatibility of Caspofungin
Diamed with other intravenous substances, additives, or medicinal products. Visually inspect the
infusion solution for particulate matter or discolouration.
INSTRUCTIONS FOR USE IN ADULT PATIENTS
Step 1 Reconstitution of conventional vials
To reconstitute the powder, bring the vial to room temperature and aseptically add 10.5 ml of water for
injection. The concentrations of the reconstituted vials will be 5.2 mg/ml.
The white to off-white compact lyophilised powder will dissolve completely. Mix gently until a clear
solution is obtained. Reconstituted solutions should be visually inspected for particulate matter or
discolouration. This reconstituted solution may be stored for up to 24 hours at or below 25 °C.
Step 2 Addition of reconstituted Caspofungin Diamed to patient infusion solution
Diluents for the final solution for infusion are: sodium chloride solution for injection, or lactated
Ringer’s solution. The solution for infusion 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. Reduced
volume infusions in 100 ml may be used, when medically necessary, for 50 mg or 35 mg daily doses.
Do not use if the solution is cloudy or has precipitated.
PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
DOSE*

50 mg
50 mg at reduced
volume
35 mg for moderate
hepatic impairment
(from one 50 mg vial)
35 mg for moderate

Volume of
reconstituted
Caspofungin Diamed
for transfer to
intravenous bag or
bottle
10 ml
10 ml

Standard preparation
(reconstituted
Caspofungin Diamed
added to 250 ml) final
concentration

Reduced volume
infusion (reconstituted
Caspofungin Diamed
added to 100 ml) final
concentration

0.20 mg/ml
-

0.47 mg/ml

7 ml

0.14 mg/ml

-

-

0.34 mg/ml

7 ml
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hepatic impairment
(from one 50 mg vial)
at reduced volume
*
10.5 ml should be used for reconstitution of all vials
INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS
Calculation of Body Surface Area (BSA) for paediatric dosing
Before preparation of infusion, calculate the body surface area (BSA) of the patient using the
following formula: (Mosteller1 Formula)

Preparation of the 70 mg/m² infusion for paediatric patients >3 months of age (using a 50-mg vial)
1.
Determine the actual loading dose to be used in the paediatric patient by 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 patient’s
calculated dose.
2.
Equilibrate the refrigerated vial of Caspofungin Diamed to room temperature.
3.
Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up
to 24 hours at or below 25 °C.b This will give a final Caspofungin Diamed concentration in the
vial of 5.2 mg/ml.
4.
Remove the volume of medicinal product equal to the calculated loading dose (Step 1) from the
vial. Aseptically transfer this volume (ml)c of reconstituted Caspofungin Diamed to an IV bag
(or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or
Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted Caspofungin
Diamed can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride
Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/ml. This
infusion solution must be used within 24 hours if stored at or below 25 °C or within 48 hours if
stored refrigerated at 2 to 8 °C.
Preparation of the 50 mg/m2 infusion for paediatric patients >3 months of age (using a 50-mg vial)
1.
Determine the actual daily maintenance dose to be used in the paediatric patient by 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 patient’s calculated dose.
2.
Equilibrate the refrigerated vial of Caspofungin Diamed to room temperature.
3.
Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up
to 24 hours at or below 25 °C.b This will give a final Caspofungin Diamed concentration in the
vial of 5.2 mg/ml.
4.
Remove the volume of medicinal product equal to the calculated daily maintenance dose (Step
1) from the vial. Aseptically transfer this volume (ml)c of reconstituted Caspofungin Diamed to
an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride
Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted
Caspofungin Diamed can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium
Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of
0.5 mg/ml. This infusion solution must be used within 24 hours if stored at or below 25 °C or
within 48 hours if stored refrigerated at 2 to 8 °C.
Preparation notes:
a.
The white to off-white cake will dissolve completely. Mix gently until a clear solution is
obtained.
                                                            
1

 Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med. 1987 Oct 22; N317(17): p.1098 (letter) 
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b.

Visually inspect the reconstituted solution for particulate matter or discolouration during
reconstitution and prior to infusion. Do not use if the solution is cloudy or has precipitated.

c.

Caspofungin Diamed is formulated to provide the full labelled vial dose (50 mg) when 10 ml is
withdrawn from the vial.

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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