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DAPTOMYCIN STADA ARZNEIMITTEL AG 350 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): DAPTOMYCIN / DAPTOMYCIN

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Package leaflet: Information for the patient
Daptomycin STADA Arzneimittel AG 350 mg Powder for solution for injection or
infusion
Daptomycin STADA Arzneimittel AG 500 mg Powder for solution for injection or
infusion
Daptomycin
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or nurse.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Daptomycin STADA Arzneimittel AG is and what it is used for
2. What you need to know before you are given Daptomycin STADA Arzneimittel AG
3. How Daptomycin STADA Arzneimittel AG is given
4. Possible side effects
5. How to store Daptomycin STADA Arzneimittel AG
6. Contents of the pack and other information

1. What Daptomycin STADA Arzneimittel AG is and what it is used for
The active substance in Daptomycin STADA Arzneimittel AG powder for solution for injection
or infusion is daptomycin. Daptomycin is an antibiotic that can stop the growth of certain
bacteria.
What is it used for?
Daptomycin STADA Arzneimittel AG is used in adults and in children and adolescents (age
from 1 to 17 years) to treat infections of the skin and the tissues below the skin. It is also
used in adults to treat infections in the tissues that line the inside of the heart (including heart
valves) which are caused by a bacterium called Staphylococcus aureus and to treat
infections in the blood caused by the same bacterium when associated with skin or heart
infection.
Depending on the type of infection(s) that you have, your doctor may also prescribe other
antibiotics while you are receiving treatment with Daptomycin STADA Arzneimittel AG.

2. What you need to know before you are given Daptomycin STADA Arzneimittel AG
You must not be given Daptomycin STADA Arzneimittel AG
 if you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients
of this medicine (listed in section 6)
If this applies to you, tell your doctor or nurse. If you think you may be allergic, ask your
doctor or nurse for advice.
Warnings and precautions
Talk to your doctor or nurse before you are given Daptomycin STADA Arzneimittel AG:
 if you have, or have previously had kidney problems. Your doctor may need to change the
dose of Daptomycin STADA Arzneimittel AG (see section 3 of this leaflet)
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 occasionally, patients receiving Daptomycin STADA Arzneimittel AG may develop tender
or aching muscles or muscle weakness (see section 4 of this leaflet for more information).
If this happens tell your doctor. Your doctor will make sure you have a blood test and will
advise whether or not to continue with Daptomycin STADA Arzneimittel AG. The
symptoms generally go away within a few days of stopping Daptomycin STADA
Arzneimittel AG
 if you are very overweight. There is a possibility that your blood levels of Daptomycin
STADA Arzneimittel AG could be higher than those found in persons of average weight
and you may need careful monitoring in case of side effects
If any of these applies to you, tell your doctor or nurse before you are given Daptomycin
STADA Arzneimittel AG.
Tell your doctor straight away if you develop any of the following symptoms:
 serious, acute allergic reactions have been observed in patients treated with nearly all
antibacterial agents, including daptomycin. Tell a doctor or a nurse straight away if you
experience symptoms suggestive of allergic reaction, such as wheezing, difficulty
breathing, swelling of the face, neck and throat, rashes and hives, fever (see section 4 of
this leaflet for more information)
 any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with
movements. If this happens, tell your doctor who will decide whether you should continue
the treatment
 diarrhoea, especially if you notice blood or mucus, or if diarrhoea becomes severe or
persistent
 new or worsening fever, cough or difficulty breathing. These may be signs of a rare but
serious lung disorder called eosinophilic pneumonia. Your doctor will check the condition
of your lungs and decide whether or not you should continue Daptomycin STADA
Arzneimittel AG treatment
Blood tests
Daptomycin STADA Arzneimittel AG may interfere with laboratory tests that measure how
well your blood is clotting. The results can suggest poor blood clotting when, in fact, there is
no problem. Therefore it is important that your doctor takes into account that you are
receiving Daptomycin STADA Arzneimittel AG. Please inform your doctor that you are on
treatment with Daptomycin STADA Arzneimittel AG.
Your doctor will perform blood tests to monitor the health of your muscles both before you
start treatment and frequently during treatment with Daptomycin STADA Arzneimittel AG.
Children and adolescents
Daptomycin STADA Arzneimittel AG should not be administered to children below one year
of age as studies in animals have indicated that this age group may experience severe side
effects.
Use in elderly
People over the age of 65 can be given the same dose as other adults, provided their
kidneys are working well.
Other medicines and Daptomycin STADA Arzneimittel AG
Tell your doctor or nurse if you are taking, have recently taken or might take any other
medicines. It is particularly important that you mention the following:
 medicines called statins or fibrates (to lower cholesterol) or ciclosporin (a medicinal
product used in transplantation to prevent organ rejection or for other conditions, e.g.
rheumatoid arthritis or atopic dermatitis). It is possible that the risk of side effects affecting
the muscles may be higher when any of these medicines (and some others that can affect
muscles) is taken during treatment with Daptomycin STADA Arzneimittel AG. Your doctor
may decide not to give you Daptomycin STADA Arzneimittel AG or to stop the other
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medicine for a while
 pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2
inhibitors (e.g. celecoxib). These could interfere with the effects of Daptomycin STADA
Arzneimittel AG in the kidney
 oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting. It
may be necessary for your doctor to monitor your blood clotting times
Pregnancy and breast-feeding
Daptomycin STADA Arzneimittel AG is not usually given to pregnant women. If you are
pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before you are given this medicine.
Do not breast-feed if you are receiving Daptomycin STADA Arzneimittel AG, because it may
pass into your breast milk and could affect the baby.
Driving and using machines
Daptomycin STADA Arzneimittel AG has no known effects on the ability to drive or use
machines.
Daptomycin STADA Arzneimittel AG contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially
‘sodium- free’.

3. How Daptomycin STADA Arzneimittel AG is given
Daptomycin STADA Arzneimittel AG will usually be given to you by a doctor or a nurse.
Method of administration
In adult patients, it is given directly into your blood stream (into a vein), either as an infusion
lasting about 30 minutes or as an injection lasting about 2 minutes.
Dosage
The dose will depend on how much you weigh and the type of infection being treated. The
usual dose for adults is:
 4 mg for every kilogram (kg) of body weight once daily for skin infections or
 6 mg for every kg of body weight once daily for a heart infection or a blood infection
associated with skin or heart infection
The same dose is recommended in people aged over 65 years provided their kidneys are
working well.
Children and adolescents (1 to 17 years of age)
The dose for children and adolescents (1 to 17 years of age) being treated for skin infection
will depend on the age of patient. The recommended doses based on age are shown in the
table below:
Age group
12 to 17 years
7 to 11 years
2 to 6 years
1 to < 2 years

Dosage
5 mg/kg once every 24 hours infused over
30 minutes
7 mg/kg once every 24 hours infused over
30 minutes
9 mg/kg once every 24 hours infused over
60 minutes
10 mg/kg once every 24 hours infused over
60 minutes
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Duration of treatment

Up to 14 days

If your kidneys do not work well, you may receive Daptomycin STADA Arzneimittel AG less
often, e.g. once every other day. If you are receiving dialysis, and your next dose of
Daptomycin STADA Arzneimittel AG is due on a dialysis day, you will be usually given
Daptomycin STADA Arzneimittel AG after the dialysis session.
Duration of use
A course of treatment usually lasts for 1 to 2 weeks for skin infections. For blood or heart
infections and skin infections your doctor will decide how long you should be treated.
Detailed instructions for use and handling are given at the end of the leaflet.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects are described below:
Very rare serious side effects (may affect up to 1 in 10,000 people)
A hypersensitivity reaction (serious allergic reaction including anaphylaxis, angioedema, drug
rash with eosinophilia and systemic symptoms (DRESS)) has been reported in some cases
during administration of daptomycin. This serious allergic reaction needs immediate medical
attention. Tell your doctor or nurse straight away if you experience any of the following
symptoms:












chest pain or tightness
rash with blistering, sometimes affecting the mouth and genitals
swelling around throat
rapid or weak pulse
wheezing
fever
shivering or trembling
hot flushes
dizziness
fainting
metallic taste

Tell your doctor straight away if you experience unexplained muscle pain, tenderness, or
weakness. In very rare cases (reported in less than 1 in every 10,000 patients), muscle
problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in
kidney damage.
Serious side effects with frequency not known (frequency cannot be estimated from the
available data)
A rare but potentially serious lung disorder called eosinophilic pneumonia has been reported
in patients given daptomycin, mostly after more than 2 weeks of treatment. The symptoms
can include difficulty breathing, new or worsening cough, or new or worsening fever. If you
experience these symptoms, tell your doctor or nurse straight away.
If you experience raised or fluid-filled skin spots over a large area of your body, tell your
doctor or nurse straight away.
The most frequently reported side effects are described below:
Common side effects (may affect up to 1 in 10 people)
 fungal infections such as thrush
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urinary tract infection
decreased number of red blood cells (anaemia)
dizziness, anxiety, difficulty in sleeping
headache
fever, weakness (asthenia)
high or low blood pressure
constipation, abdominal pain
diarrhoea, feeling sick (nausea) or being sick (vomiting)
flatulence
abdominal swelling or bloating
skin rash or itching
pain, itchiness or redness at the site of infusion
pain in arms or legs
blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK)

Other side effects which may occur following Daptomycin STADA Arzneimittel AG treatment
are described below:
Uncommon side effects (may affect up to 1 in 100 people)
 blood disorders (e.g. increased number of small blood particles called platelets, which
may increase the tendency for blood clotting, or higher levels of certain types of white
blood cells)
 decreased appetite
 tingling or numbness of the hands or feet, taste disturbance
 trembling
 changes in heart rhythm, flushes
 indigestion (dyspepsia), inflammation of the tongue
 itchy rash of skin
 muscle pain or weakness, inflammation of the muscles (myositis), joint pain
 kidney problems
 inflammation and irritation of the vagina
 general pain or weakness, tiredness (fatigue)
 blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or
lactate dehydrogenase (LDH), prolonged blood clotting time or imbalance of salts
Rare side effects (may affect up to 1 in 1,000 people)
 yellowing of the skin and eyes
 prothrombin time prolonged
Frequency not known (frequency cannot be estimated from the available data)
Antibacterial-associated colitis, including pseudomembranous colitis (severe or persistent
diarrhoea containing blood and/or mucus, associated with abdominal pain or fever).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: 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 Daptomycin STADA Arzneimittel AG
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 carton and label after
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EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C-8 °C).
After reconstitution: Chemical and physical in-use stability of the reconstituted solution in the
vial has been demonstrated for 12 hours at 25 °C and up to 48 hours at 2 °C – 8 °C.
Chemical and physical stability of the diluted solution in infusion bags is established as
12 hours at 25 °C or 24 hours at 2 °C – 8 °C.
For the 30-minute intravenous infusion, the combined storage time (reconstituted solution in
vial and diluted solution in infusion bag at 25 °C must not exceed 12 hours (or 24 at 2 °C –
8 °C).
For the 2-minute intravenous injection, the storage time of the reconstituted solution in the
vial at 25°C must not exceed 12 hours (or 48 at 2 °C – 8 °C).
However, from a microbiological point of view the product should be used immediately. No
preservative or bacteriostatic agent is present in this product. If not used immediately, in-use
storage times are the responsibility of the user and would not normally be longer than
24 hours at 2 °C – 8 °C, unless reconstitution/dilution has taken place in controlled and
validated aseptic conditions.
Do not use this medicine if you notice visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6. Contents of the pack and other information
What Daptomycin STADA Arzneimittel AG contains
The active substance is daptomycin.
One vial of powder contains 350 mg daptomycin.
One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride
9 mg/ml (0.9 %) solution.
One vial of powder contains 500 mg daptomycin.
One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride
9 mg/ml (0.9 %) solution.
The other ingredient is sodium hydroxide.
What Daptomycin STADA Arzneimittel AG looks like and contents of the pack
Daptomycin STADA Arzneimittel AG powder for solution for injection or infusion is supplied
as a pale yellow to light brown cake or powder in a glass vial. It is mixed with a solvent to
form a liquid before it is administered.
Daptomycin STADA Arzneimittel AG is available in packs containing 1 vial or 5 vials.
Marketing Authorisation Holder and Manufacturer
STADA ARZNEIMITTEL AG
Stadastrasse 2-18
Bad Vilbel
D-61118
Germany

This leaflet was last revised in May 2017.
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The following information is intended for healthcare professionals only
Important: Please refer to the Summary of Product Characteristics before prescribing.
Instructions for use and handling
350 mg Powder for solution for injection or infusion
500 mg Powder for solution for injection or infusion
Daptomycin may be administered intravenously as an infusion over 30 or 60 minutes or as
an injection over 2 minutes. Preparation of the solution for infusion requires an additional
dilution step as detailed below.
Daptomycin STADA Arzneimittel AG given as an intravenous infusion over 30 or
60 minutes
A 50 mg/ml concentration of Daptomycin STADA Arzneimittel AG for infusion can be
achieved by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml
(0.9 %) solution for injection.
A 50 mg/ml concentration of Daptomycin STADA Arzneimittel AG for infusion can be
achieved by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml
(0.9 %) solution for injection.
The lyophilised product takes approximately 15 minutes to dissolve. The fully reconstituted
product will appear clear and may have a few small bubbles or foam around the edge of the
vial.
To prepare Daptomycin STADA Arzneimittel AG for intravenous infusion, please adhere to
the following instructions:
Aseptic technique should be used throughout to reconstitute lyophilised Daptomycin STADA
Arzneimittel AG.
1. The polypropylene flip off seal should be removed to expose the central portions of the
rubber stopper. Wipe the top of the rubber stopper with an alcohol swab or other
antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or
allow it to touch any other surface. Draw 7 ml of sodium chloride 9 mg/ml (0.9 %) solution
for injection into a syringe, using a sterile transfer needle that is 21 gauge or smaller in
diameter, or a needleless device, then slowly inject through the centre of the rubber
stopper into the vial pointing the needle towards the wall of the vial.
1. The polypropylene flip off seal should be removed to expose the central portions of the
rubber stopper. Wipe the top of the rubber stopper with an alcohol swab or other
antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or
allow it to touch any other surface. Draw 10 ml of sodium chloride 9 mg/ml (0.9 %)
solution for injection into a syringe, using a sterile transfer needle that is 21 gauge or
smaller in diameter, or a needleless device, then slowly inject through the centre of the
rubber stopper into the vial pointing the needle towards the wall of the vial.
2. The vial should be gently rotated to ensure complete wetting of the product and then
allowed to stand for 10 minutes.
3. Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a
clear reconstituted solution. Vigorous shaking/agitation should be avoided to prevent
foaming of the product.
4. The reconstituted solution should be checked carefully to ensure that the product is in
solution and visually inspected for the absence of particulates prior to use. Reconstituted
solutions of Daptomycin STADA Arzneimittel AG range in colour from pale yellow to light
brown.
7

5. Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile
needle that is 21 gauge or smaller in diameter:
Invert the vial in order to allow the solution to drain towards the stopper. Using the new
syringe, insert the needle into the inverted vial. Keeping the vial inverted, position the
needle tip at the very bottom of the solution in the vial when drawing the solution into the
syringe. Before removing the needle from the vial, pull the plunger all the way back to the
end of the syringe barrel in order to remove all of the solution from the inverted vial.
6. The reconstituted solution should then be diluted with sodium chloride 9 mg/ml (0.9 %)
(typical volume 50 ml).
7. Replace needle with a new needle for the intravenous infusion.
8. Expel air, large bubbles, and any excess solution in order to obtain the required dose.
9. The reconstituted and diluted solution should then be infused intravenously over 30 or
60 minutes.
Daptomycin STADA Arzneimittel AG is not physically or chemically compatible with glucosecontaining solutions.
The combined storage time (reconstituted solution in vial and diluted solution in infusion bag)
at 25 °C must not exceed 12 hours (24 hours if refrigerated).
Stability of the diluted solution in infusion bags is established as 12 hours at 25 °C or
24 hours if stored under refrigeration at 2 °C-8 °C.
Daptomycin STADA Arzneimittel AG given as 2-minute intravenous injection (adult
patients only)
Water should not be used for reconstitution of Daptomycin STADA Arzneimittel AG for
intravenous injection. Daptomycin STADA Arzneimittel AG should only be reconstituted with
sodium chloride 9 mg/ml (0.9 %).
A 50 mg/ml concentration of Daptomycin STADA Arzneimittel AG for injection is obtained by
reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9 %) solution
for injection.
A 50 mg/ml concentration of Daptomycin STADA Arzneimittel AG for injection is obtained by
reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9 %) solution
for injection.
The lyophilised product takes approximately 15 minutes to dissolve. The fully reconstituted
product will appear clear and may have a few small bubbles or foam around the edge of the
vial.
To prepare Daptomycin STADA Arzneimittel AG for intravenous injection, please adhere to
the following instructions:
Aseptic technique should be used throughout to reconstitute lyophilised Daptomycin STADA
Arzneimittel AG.
1. The polypropylene flip off seal should be removed to expose the central portions of the
rubber stopper. Wipe the top of the rubber stopper with an alcohol swab or other
antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or
allow it to touch any other surface. Draw 7 ml of sodium chloride 9 mg/ml (0.9 %) solution
for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller
diameter, or a needleless device, then slowly inject through the centre of the rubber
stopper into the vial pointing the needle towards the wall of the vial.
1. The polypropylene flip off seal should be removed to expose the central portions of the
rubber stopper. Wipe the top of the rubber stopper with an alcohol swab or other
antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or
8

2.
3.

4.

5.

6.
7.
8.

allow it to touch any other surface. Draw 10 ml of sodium chloride 9 mg/ml (0.9 %)
solution for injection into a syringe using a sterile transfer needle that is 21 gauge or
smaller diameter, or a needleless device, then slowly inject through the centre of the
rubber stopper into the vial pointing the needle towards the wall of the vial.
The vial should be gently rotated to ensure complete wetting of the product and then
allowed to stand for 10 minutes.
Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a
clear reconstituted solution. Vigorous shaking/agitation should be avoided to prevent
foaming of the product.
The reconstituted solution should be checked carefully to ensure that the product is in
solution and visually inspected for the absence of particulates prior to use. Reconstituted
solutions of Daptomycin STADA Arzneimittel AG range in colour from pale yellow to light
brown.
Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile
needle that is 21 gauge or smaller in diameter:
Invert the vial in order to allow the solution to drain towards the stopper. Using a new
syringe, insert the needle into the inverted vial. Keeping the vial inverted, position the
needle tip at the very bottom of the solution in the vial when drawing the solution into the
syringe. Before removing the needle from the vial, pull the plunger all the way back to the
end of the syringe barrel in order to remove all of the solution from the inverted vial.
Replace needle with a new needle for the intravenous injection.
Expel air, large bubbles, and any excess solution in order to obtain the required dose.
The reconstituted solution should then be injected intravenously slowly over 2 minutes.

Chemical and physical in-use stability on the reconstituted solution in the vial has been
demonstrated for 12 hours at 25 °C and up to 48 hours if stored under refrigeration
(2 °C-8 °C).
However, from a microbiological point of view the product should be used immediately. If not
used immediately, in-use storage times are the responsibility of the user and would normally
not be longer than 24 hours at 2 °C-8 °C unless reconstitution / dilution has taken place in
controlled and validated aseptic conditions.
Daptomycin STADA Arzneimittel AG vials are for single-use only. Any unused portion
remaining in the vial should be discarded.

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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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