DAPTOMICINA 350 mg Powder For Injectable Solution

Зміст інструкції

1. Daptomicina Hikma 500 mg powder for injectable solution/for infusion
   1. What is Daptomicina Hikma and what is it used for
   2. What you need to know before you are given Daptomicina Hikma.
   3. How Daptomicina Hikma is administered
   4. Possible side effects
   5. How to store Daptomicina Hikma
   6. Contents of the pack and other information
2. Daptomicina Hikma 350 mg powder for injectable solution/for infusion
   1. What is Daptomicina Hikma and what is it used for
   2. What you need to know before you are given Daptomicina Hikma.
   3. How Daptomicina Hikma is administered
   4. Possible side effects
   5. How to store Daptomicina Hikma
   6. Contents of the pack and other information

Daptomicina Hikma 500 mg powder for injectable solution/for infusion

daptomicina

“Generic medicine”

Read 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 questions, ask your doctor or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is Daptomicina Hikma and what is it used for

The active substance of Daptomicina Hikma powder for solution for injection or for infusion is daptomycin.
Daptomycin is an antibacterial that can stop the growth of certain bacteria.
Daptomicina Hikma is used in adults and in children and adolescents (age from 1 to 17 years) for
treating skin and subcutaneous tissue infections (under the skin). It is also used in adults for
the treatment of infections of the tissues lining the inside of the heart (including heart valves)
caused by a bacterium called Staphyloccocus aureusand for the treatment of blood infections caused by the same bacterium when they are associated with skin or heart infections.
Depending on the type of infection(s) you have, your doctor may also prescribe other
antibacterials during treatment with Daptomicina Hikma.

2. What you need to know before you are given Daptomicina Hikma.

You must not be given Daptomicina Hikma
If you are allergic to daptomycin or sodium hydroxide or to any of the other ingredients of
this medicine (listed in section 6).
If this is the case, tell your doctor or nurse. If you think you may be allergic, consult your
doctor or nurse.

Warnings and precautions
Talk to your doctor or nurse before you are given Daptomicina Hikma.

• If you have or have had kidney problems in the past. Your doctor may need to adjust the dose of Daptomicina Hikma (see section 3 of this leaflet).
• Patients treated with daptomycin sometimes experience suffering, pain or weakness.

If this happens, tell your doctor. The doctor will ensure that you undergo a blood test and
advise you whether to continue or not with the administration of Daptomicina Hikma. The symptoms, usually, disappear within a few days after stopping Daptomicina Hikma.

• If you are overweight. It is possible that levels of daptomycin in the blood may be higher than those observed in people of average weight, so you may need to be monitored more closely for side effects.

If you fall into any of these categories, tell your doctor or nurse before you are given
Daptomicina Hikma.

Tell your doctor immediately if any of the following symptoms occur:

• Serious, acute allergic reactions have been observed in patients treated with almost all antibacterial medicines, including daptomycin. Tell your doctor or nurse immediately if you experience symptoms that may suggest an allergic reaction such as wheezing, difficulty breathing, swelling of the face, neck and throat, rashes

information).

• Unusual tingling or numbness in the hands or feet, loss of sensation or difficulty moving. If this happens, tell your doctor who will decide whether to continue treatment.
• Diarrhoea, especially if you notice the presence of blood or mucus or if the diarrhoea becomes severe or persistent.
• Onset or worsening of fever, cough, difficulty breathing. These may be signs of a rare but serious lung disease called eosinophilic pneumonia. The doctor will check the condition of the lungs and decide whether to continue or stop treatment with Daptomicina Hikma.

Daptomicina Hikma can interfere with laboratory tests performed to measure blood coagulation.
The results may suggest a difficulty in blood coagulation, even if in
reality there is no problem. It is therefore important that your doctor is aware that you are
taking Daptomicina Hikma.
Tell your doctor that you are being treated with Daptomicina Hikma.
The doctor will perform blood tests to check the condition of the muscles both before
starting treatment and frequently during treatment with Daptomicina Hikma.

Children and adolescents
Daptomicina Hikma should not be given to children under one year of age
as studies conducted on animals have indicated that serious adverse effects may occur in this age group.

Use in the elderly
People over 65 years of age can take the same dose as adults, provided
they have normal kidney function.

Other medicines and Daptomicina Hikma
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicine.
It is particularly important that you tell them if you are taking:

• Medicines called statins or fibrates (to lower cholesterol) or cyclosporine (a medicine used in transplants to prevent organ rejection or in other conditions such as rheumatoid arthritis or atopic dermatitis). If you take these medicines (and others that can cause effects on the muscles) during therapy with Daptomicina Hikma, the risk of adverse effects on the muscles may be higher. The doctor may decide not to prescribe Daptomicina Hikma or to stop the use of the other medicines for a certain period of time.
• Pain relievers called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These may interfere with the effects of Daptomicina Hikma on the kidneys.
• Oral anticoagulants (e.g. warfarin) which are medicines that prevent blood from clotting. Your doctor may need to check your bleeding time. Pregnancy and breastfeeding

Daptomycin is not usually given to pregnant women. If you are pregnant or
breastfeeding, if you suspect or are planning a pregnancy, ask your
doctor or pharmacist for advice before you are given this medicine.
Do not breastfeed if you are taking Daptomicina Hikma, as Daptomicina Hikma can pass into breast milk
and, consequently, may have effects on the baby.

Driving and using machines
Daptomycin has no known effects on the ability to drive and operate machinery.

3. How Daptomicina Hikma is administered

Daptomicina Hikma is usually administered by a doctor or nurse.
The dose administered depends on your weight and the type of infection to be treated. In adults, the normal dose is 4 mg per kilogram (kg) of body weight, administered once a day for skin infections or 6 mg per kg of body weight administered once a day for a heart infection or a blood infection associated with skin or heart infection. In adult patients, this dose is injected directly into the bloodstream (into the vein) or as an infusion lasting approximately 30 minutes or as an injection lasting approximately 2 minutes. The same dose is recommended for people over 65 years of age, provided they have normal kidney function.

Children and adolescents (from 1 to 17 years)
The dose for children and adolescents (from 1 to 17 years) to be used for the treatment of skin infections depends on the patient's age. The recommended doses based on age are shown in the table below:

If you have impaired kidney function, you may take Daptomicina Hikma less frequently, e.g. on alternate days. If you are on dialysis and the next dose of Daptomicina Hikma needs to be administered on the same day as dialysis, you will usually be given Daptomicin Hikma after the end of dialysis.
Usually, for skin infections, a treatment cycle lasts from 1 to 2 weeks. For blood or heart infections and skin infections, the doctor will decide how long you need to be treated.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The more serious side effects are described below:

Very rare serious side effects(may affect up to 1 in 10,000 people)
In some cases, a hypersensitivity reaction (a severe allergic reaction including anaphylaxis, angioedema, drug reaction with eosinophilia and systemic symptoms (DRESS)) has been reported during the administration of daptomycin. This severe allergic reaction requires
immediate medical attention. Tell your doctor or nurse immediately if you experience any of the
following symptoms:

• Chest pain or feeling of tightness,
• Skin rash (of the skin) with blistering that, sometimes, affects the mouth and genitals,
• Swelling around the throat,
• Fast or weak heartbeat,
• Wheezing,
• Fever,
• Chills or tremors,
• Hot flushes,
• Dizziness,
• Fainting,
• Metallic taste in the mouth.

If you notice the onset of unexplained muscle pain, tenderness or weakness, tell your doctor
immediately. In very rare cases (reported in less than 1 in 10,000 patients) muscle problems
can be severe, including muscle destruction (rhabdomyolysis) which can cause kidney damage.

Serious side effects with frequency not known(frequency cannot be estimated based on
available data)
A rare but potentially serious lung disease, called eosinophilic pneumonia, has been reported
in patients who received daptomycin, in most cases after more than 2
weeks of treatment. Symptoms may include difficulty breathing, onset or worsening of
cough, or onset or worsening of fever. If you experience these symptoms, tell your doctor or
nurse immediately.
If you experience raised, blistering or fluid-filled skin lesions over a large area of your body, tell
your doctor or nurse immediately.
The most frequently reported side effects are described below:

Common side effects(may affect up to 1 in 10 people)

• Fungal infections such as oral candidiasis,
• Urinary tract infections,
• Reduced number of red blood cells (anemia),
• Dizziness, anxiety, difficulty sleeping,
• Headache,
• Fever, weakness (asthenia),
• High or low blood pressure,
• Constipation, abdominal pain,
• Diarrhoea, feeling sick or vomiting,
• Flatulence,
• Abdominal bloating or distension,
• Skin rash (of the skin) or itching,
• Pain, itching or redness at the infusion site,
• Arm or leg pain,
• Increased levels of liver enzymes or creatine phosphokinase (CPK) shown in blood tests. Other side effects that may occur following treatment with daptomycin are described below:

Uncommon side effects(may affect up to 1 in 100 people)

• Changes in blood (such as increased number of small particles called platelets, which may increase the tendency to blood clotting or increased levels of certain types of white blood cells),
• Loss of appetite,
• Tingling or numbness in the hands or feet, altered taste,
• Tremor,
• Changes in heart rate, hot flushes,
• Indigestion (dyspepsia), inflammation of the tongue,
• Skin rash (of the skin) associated with itching,
• Muscle pain or weakness, muscle inflammation (myositis), joint pain,
• Kidney problems,
• Vaginal inflammation and irritation,
• General pain or weakness, fatigue,
• Blood tests showing increased levels of blood sugar, serum creatinine, myoglobin or lactate dehydrogenase (LDH), prolonged bleeding time or electrolyte imbalance. Rare side effects(may affect up to 1 in 1,000 people)
• Yellowing of the skin and eyes,
• Prolonged prothrombin time.

Frequency not known(frequency cannot be estimated based on the available data) Antibiotic
associated colitis, including pseudomembranous colitis (severe and persistent diarrhoea
containing blood and/or mucus, associated with abdominal pain or fever).

Reporting of side effects
If you get any side effect, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. 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 Daptomicina Hikma

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the package and label after Scad. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C - 8°C). After reconstitution: the chemical and physical stability in use 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.

After dilution: the chemical and physical stability of the diluted solution in infusion bags is established
for 12 hours at 25° C or for 24 hours at 2° C – 8° C.
For the 30-minute intravenous infusion, the total storage time (reconstituted solution
in the vial and diluted solution in the infusion bag; see paragraph 6.6) 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 (see paragraph 6.6) at 25° C must not exceed 12 hours (or 48 at 2° C – 8° C).
From a microbiological point of view, the product must be used immediately. If not
used immediately, the storage times and conditions in use are the responsibility
of the user and should normally not be longer than 24 hours at 2 ° C – 8 ° C.
Do not use Daptomicina Hikma if you notice any change in the appearance of the product (signs
of moisture or the presence of particles with a different color in the powder, or the presence of particles,
turbidity or precipitate when the solution is reconstituted).
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 Daptomicina Hikma contains

• The active substance is daptomycin. One vial of powder contains 500 mg of daptomycin. One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9%) solution.
• The other component is sodium hydroxide.

Description of the appearance of Daptomicina Hikma and contents of the pack
Daptomicina Hikma powder for solution for injection or for infusion is supplied as
lyophilized or powder of a light yellow to light brown color in a glass vial. Before
administration, it is mixed with a solvent to form a liquid.
Daptomicina Hikma is available in packs containing 1 vial or 5 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Hikma Italia SpA
Viale Certosa 10
27100 Pavia
Italy

Manufacturer
Medichem, S.A.
Mossèn Jacint Verdaguer 67A
08970 Sant Joan Despí (Barcelona)
Spain
Hikma Italia SpA
Viale Certosa 10
27100 Pavia
Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany:
Daptomycin-ratiopharm 350 mg Pulver zur Herstellung einer Injektions-/Infusionslösung
Italy:
Daptomicina Hikma

The following information is intended exclusively for healthcare professionals
Important: Consult the Summary of Product Characteristics before prescribing
Instructions for use and handling
500 mg vial:
Daptomycin can be administered intravenously as an infusion lasting 30 or 60
minutes or as an injection lasting 2 minutes. Preparation of the solution for infusion
requires further dilution, as described below.

Administration of Daptomicina Hikma as an intravenous infusion lasting 30 or 60
minutes
A concentration of 50 mg/ml of Daptomicina Hikma for infusion is obtained by
reconstituting the lyophilized powder with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Approximately 15 minutes are required to dissolve the lyophilized powder. The fully
reconstituted medicine has a clear appearance and some bubbles or foam may be present around the edges
of the vial.
To prepare Daptomicina Hikma for intravenous infusion, follow these
instructions: During the entire reconstitution process of Daptomicina Hikma lyophilized powder, an aseptic technique must be used.

• 1. Remove the polypropylene cap, exposing the center of the rubber stopper. Clean the top of the rubber stopper with a swab soaked in alcohol or another antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper and do not allow it to touch any other surface. Using a sterile transfer needle of 21 gauge or smaller, or a needle-free device, draw 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe and slowly inject it into the vial, inserting the needle into the center of the rubber stopper with the tip directed towards the wall of the vial.
• 2. Gently rotate the vial to ensure that the product is completely wetted by the liquid, then let it stand for 10 minutes.
• 3. Finally, gently rotate the vial for a few minutes until a clear reconstituted solution is obtained. Avoid shaking or vigorously swirling the vial to prevent foam formation.
• 4. Before use, the reconstituted solution must be carefully checked to ensure that the product is completely dissolved and inspected visually for the presence of particulate matter. The color of the reconstituted solution of Daptomicina Hikma may range from pale yellow to light brown.
• 5. Slowly remove the reconstituted liquid (50 mg of daptomycin/ml) from the vial using a sterile needle of 21 gauge or smaller.
• 6. The reconstituted solution must then be diluted with intravenous infusion of sodium chloride 9 mg/ml (0.9%) (typical volume 50 ml).
• 7. Invert the vial to allow the solution to flow towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, position the tip of the needle at the bottom of the solution while aspirating the solution into the syringe. Before removing the needle from the vial, pull back the plunger to the end of the syringe body to aspirate all the solution from the inverted vial.
• 8. Replace the needle with a new needle for intravenous infusion.
• 9. Expel air, large bubbles and excess solution to obtain the required dose.
• 10. The reconstituted and diluted solution must then be administered by intravenous infusion over 30 or 60 minutes. Daptomicina Hikma is physically and chemically incompatible with solutions containing glucose. The following agents have been shown to be compatible when added to infusion solutions containing daptomycin: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.

The overall storage period (reconstituted solution in the vial and diluted solution in the
infusion bag) should not exceed 12 hours at 25°C (24 hours if stored in a refrigerator).
The stability of the diluted solution in the infusion bag is 12 hours at 25°C or 24 hours if stored
in a refrigerator at 2°C – 8°C.

Administration of Daptomicina Hikma by intravenous injection lasting 2 minutes
Water should not be used for the reconstitution of Daptomicina Hikma for intravenous injection.
Daptomicina Hikma must only be reconstituted with sodium chloride 9 mg/ml (0.9%).
A concentration of 50 mg/ml of Daptomicina Hikma for injection is obtained by
reconstituting the lyophilized powder with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Approximately 15 minutes are required to dissolve the lyophilized powder. The fully
reconstituted medicine has a clear appearance and some bubbles or foam may be present around the edges
of the vial.
To prepare Daptomicina Hikma for intravenous injection, follow these
instructions: During the entire reconstitution process of Daptomicina Hikma lyophilized powder, an aseptic technique must be used.

• 1. Remove the polypropylene cap, exposing the center of the rubber stopper. Clean the top of the rubber stopper with a swab soaked in alcohol or another antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper and do not allow it to touch any other surface. Using a sterile transfer needle of 21 gauge or smaller, or a needle-free device, draw 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe and slowly inject it into the vial, inserting the needle into the center of the rubber stopper with the tip directed towards the wall of the vial.
• 2. Gently rotate the vial to ensure that the product is completely wetted by the liquid, then let it stand for 10 minutes.
• 3. Finally, gently rotate the vial for a few minutes until a clear reconstituted solution is obtained. Avoid shaking or vigorously swirling the vial to prevent foam formation.
• 4. Before use, the reconstituted solution must be carefully checked to ensure that the product is completely dissolved and inspected visually for the presence of particulate matter. The color of the reconstituted solution of Daptomicina Hikma may range from pale yellow to light brown.
• 5. Slowly remove the reconstituted liquid (50 mg of daptomycin/ml) from the vial using a sterile needle of 21 gauge or smaller.
• 6. Invert the vial to allow the solution to flow towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, position the tip of the needle at the bottom of the solution while aspirating the solution into the syringe. Before extracting the needle from the vial, pull back the plunger to the end of the syringe body to aspirate all the solution from the inverted vial.
• 7. Replace the needle with a new needle for intravenous injection.
• 8. Expel air, large bubbles and excess solution to obtain the required dose.
• 9. The reconstituted solution must then be injected slowly intravenously over 2 minutes. The physicochemical stability during use of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours if stored in a refrigerator (2°C – 8°C). However, from a microbiological point of view, the medicine must be used immediately. If not, the user is responsible for the period of storage during use, which, as a rule, should not exceed the times mentioned above for chemical and physical stability in use. The medicine must not be mixed with other products except those mentioned above. The vials of Daptomicina Hikma are for single use only. Any unused solution remaining in the vial must be discarded.

Daptomicina Hikma 350 mg powder for injectable solution/for infusion

daptomicina

“Generic medicine”

Read this leaflet carefully before you start using 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 or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is Daptomicina Hikma and what is it used for

The active ingredient of Daptomicina Hikma powder for injectable or infusion solution is
daptomycin. Daptomycin is an antibacterial that can stop the growth of certain bacteria.
Daptomicina Hikma is used in adults and children and adolescents (age 1 to 17 years) for
treating skin and subcutaneous tissue infections (under the skin). It is also used in adults for
the treatment of infections of the tissues lining the inside of the heart (including heart valves)
caused by a bacterium called Staphylococcus aureusand for the treatment of blood infections caused by the same bacterium when they are associated with skin and heart infections.
Depending on the type of infection(s) you have, your doctor may also prescribe other
antibacterials during treatment with Daptomicina Hikma.

2. What you need to know before you are given Daptomicina Hikma.

You must not be given Daptomicina Hikma
If you are allergic to daptomycin or sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6).
If this is the case, tell your doctor or nurse. If you think you may be allergic, consult your doctor or nurse.

Warnings and precautions
Talk to your doctor or nurse before you are given Daptomicina Hikma.

• If you have or have had kidney problems. Your doctor may need to adjust the dose of Daptomicina Hikma (see section 3 of this leaflet).
• Patients treated with daptomycin sometimes experience suffering, pain or weakness.

If this happens, tell your doctor. The doctor will ensure that you undergo a blood test and will advise you whether to continue or not with the administration of Daptomicina Hikma. The symptoms usually disappear within a few days after stopping Daptomicina Hikma.

• If you are overweight. It is possible that levels of daptomycin in the blood may be higher than those observed in people of average weight, so you may need to be monitored more closely for side effects.

If you fall into any of these categories, tell your doctor or nurse before you are given Daptomicina Hikma.

Tell your doctor immediately if any of the following symptoms occur:

• Severe, acute allergic reactions have been observed in patients treated with almost all antibacterial medicines, including daptomycin. Tell your doctor or nurse immediately if you experience symptoms that may suggest an allergic reaction such as wheezing, difficulty breathing, swelling of the face, neck and throat, rashes.

(further information).

• Unusual tingling or numbness in the hands or feet, loss of sensation or difficulty moving. If this happens, tell your doctor who will decide whether to continue treatment.
• Diarrhoea, especially if you notice the presence of blood or mucus or if the diarrhoea becomes severe or persistent.
• Onset or worsening of fever, cough, difficulty breathing. These may be signs of a rare but serious lung disease called eosinophilic pneumonia. The doctor will check the condition of the lungs and decide whether to continue or stop treatment with Daptomicina Hikma.

Daptomicina Hikma may interfere with laboratory tests performed to measure blood coagulation.
The results may suggest a difficulty in blood coagulation, even if in reality there is no problem. It is therefore important that your doctor is aware that you are taking Daptomicina Hikma.
Tell your doctor that you are being treated with Daptomicina Hikma.
The doctor will perform blood tests to check the condition of the muscles both before starting treatment and frequently during treatment with Daptomicina Hikma.

Children and adolescents
Daptomicina Hikma should not be given to children under one year of age because studies conducted on animals have indicated that serious adverse effects may occur in this age group.

Use in the elderly
People over the age of 65 can take the same dose as adults, provided they have normal kidney function.

Other medicines and Daptomicina Hikma
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
It is particularly important that you tell them if you are taking:

• Medicines called statins or fibrates (to lower cholesterol) or cyclosporine (a medicine used in transplants to prevent organ rejection or in other conditions such as rheumatoid arthritis or atopic dermatitis). If you take these medicines (and others that can cause effects on the muscles) during therapy with Daptomicina Hikma, the risk of adverse effects on the muscles may be increased. The doctor may decide not to prescribe Daptomicina Hikma or to stop the use of the other medicines for a certain period of time.
• Pain relievers called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These may interfere with the effects of Daptomicina Hikma on the kidneys.
• Oral anticoagulants (e.g. warfarin) which are medicines that prevent blood from clotting. Your doctor may need to check your bleeding time. Pregnancy and breastfeeding

Daptomycin is not generally given to pregnant women. If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before you are given this medicine.
Do not breastfeed if you are taking Daptomicina Hikma, as Daptomicina Hikma may pass into breast milk and, consequently, may have effects on the baby.

Driving and operating machinery
Daptomycin has no known effects on the ability to drive and operate machinery.

3. How Daptomicina Hikma is administered

Daptomicina Hikma is usually administered by a doctor or nurse.
The dose administered depends on your weight and the type of infection to be treated. In adults, the normal
dose is 4 mg per kilogram (kg) of body weight, administered once daily for
skin infections or 6 mg per kg of body weight administered once daily for
a heart infection or a blood infection associated with skin or heart infection. In
adult patients, this dose is injected directly into the bloodstream (into the vein) or as
an infusion lasting approximately 30 minutes or as an injection lasting approximately 2 minutes. The same dose
is recommended for people over 65 years of age, provided they have normal
kidney function.

Children and adolescents (from 1 to 17 years)
The dose for children and adolescents (from 1 to 17 years) to be used for the treatment of skin
infections depends on the patient's age. The recommended doses based on age are shown in the
table below:

If you have impaired kidney function, you may take Daptomicina Hikma less frequently,
e.g. on alternate days. If you are on dialysis and the next dose of Daptomicina Hikma needs to be
administered on the same day as dialysis, you will usually be given Daptomicina Hikma after
the end of dialysis.
Usually, for skin infections, a treatment cycle lasts from 1 to 2 weeks. For
blood or heart infections and skin infections, the doctor will decide how long you should
be treated.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The more serious side effects are described below:

Very rare serious side effects(may affect up to 1 in 10,000 people)
In some cases, a hypersensitivity reaction (a severe allergic reaction including anaphylaxis, angioedema, drug reaction with eosinophilia and systemic symptoms (DRESS)) has been reported during the administration of daptomycin. This severe allergic reaction requires
immediate medical attention. Tell your doctor or nurse immediately if you experience any of the
following symptoms:

• Chest pain or a feeling of tightness in the chest,
• Skin rash (of the skin) with blistering that, sometimes, affects the mouth and genitals,
• Swelling around the throat,
• Rapid or weak heartbeat,
• Wheezing,
• Fever,
• Chills or tremors,
• Hot flushes,
• Dizziness,
• Fainting,
• Metallic taste in the mouth.

If you notice the onset of unexplained muscle pain, tenderness or weakness, tell your doctor
immediately. In very rare cases (reported in less than 1 in 10,000 patients) muscle problems
can be serious, including muscle destruction (rhabdomyolysis) which can cause kidney damage.

Serious side effects with unknown frequency(frequency cannot be estimated on the basis of
available data)
A rare but potentially serious lung disease, called eosinophilic pneumonia, has been reported
in patients who received daptomycin, in most cases after more than 2
weeks of treatment. Symptoms may include difficulty breathing, onset or worsening of
cough, or onset or worsening of fever. If you experience these symptoms, tell your doctor or
nurse immediately.
If you notice raised or fluid-filled spots on a large area of your body, tell your doctor or
nurse immediately.
The more frequently reported side effects are described below:

Common side effects(may affect up to 1 in 10 people)

• Fungal infections such as oral candidiasis,
• Urinary tract infections,
• Reduced number of red blood cells (anemia),
• Dizziness, anxiety, difficulty sleeping,
• Headache,
• Fever, weakness (asthenia),
• High or low blood pressure,
• Constipation, abdominal pain,
• Diarrhea, feeling sick or vomiting,
• Flatulence,
• Abdominal bloating or distension,
• Skin rash (of the skin) or itching,
• Pain, itching or redness at the infusion site,
• Pain in the arms or legs,
• Increased levels of liver enzymes or creatine phosphokinase (CPK) shown in blood tests. Other side effects that may occur following treatment with daptomycin are described below:

Uncommon side effects(may affect up to 1 in 100 people)

• Changes in blood (such as increased number of small particles called platelets, which may increase the tendency to bleed or increased levels of certain types of white blood cells),
• Loss of appetite,
• Tingling or numbness in the hands or feet, altered taste,
• Tremor,
• Changes in heart rate, hot flushes,
• Indigestion (dyspepsia), inflammation of the tongue,
• Skin rash (of the skin) associated with itching,
• Muscle pain or weakness, muscle inflammation (myositis), joint pain,
• Kidney problems,
• Inflammation and irritation of the vagina,
• General pain or weakness, fatigue,
• Blood tests showing increased levels of blood sugar, serum creatinine, myoglobin or lactate dehydrogenase (LDH), prolonged bleeding time or salt imbalance. Rare side effects(may affect up to 1 in 1,000 people)
• Yellowing of the skin and eyes,
• Prolonged prothrombin time.

Frequency not known(frequency cannot be estimated on the basis of the available data) Antibiotic-associated colitis, including pseudomembranous colitis (severe and persistent diarrhea
containing blood and/or mucus, associated with abdominal pain or fever).

Reporting of side effects
If you get any side effect, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. 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 Daptomicina Hikma

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the package and on the label after Exp. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C - 8°C). After reconstitution: the chemical and physical stability in use 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.

After dilution: the chemical and physical stability of the diluted solution in infusion bags is established
for 12 hours at 25° C or for 24 hours at 2° C – 8° C.
For the 30-minute intravenous infusion, the combined overall storage time (reconstituted solution in the vial and diluted solution in the infusion bag; see paragraph 6.6) at 25° C
should 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 (see paragraph 6.6) at 25° C should not exceed 12 hours (or 48 at 2° C – 8° C).
From a microbiological point of view, the product must be used immediately. If not
used immediately, the storage times and conditions in use are the responsibility
of the user and should normally not be longer than 24 hours at 2 ° C – 8 ° C.
Do not use Daptomicina Hikma if you notice any change in the appearance of the product (signs
of moisture or the presence of particles with a different color in the powder), or the presence of particles,
turbidity or precipitate when the solution is reconstituted.
Do not dispose of any medicine in the drains 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 Daptomicina Hikma contains

• The active substance is daptomycin. One vial of powder contains 350 mg of daptomycin. One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution.
• The other component is sodium hydroxide.

Description of the appearance of Daptomicina Hikma and contents of the pack
Daptomicina Hikma powder for solution for injection or for infusion is supplied as
lyophilized or a powder of light yellow to light brown color in a glass vial. Before
administration it is mixed with a solvent to form a liquid.
Daptomicina Hikma is available in packs containing 1 vial or 5 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Hikma Italia SpA
Viale Certosa 10
27100 Pavia
Italy

Manufacturer
Medichem, S.A.
Mossèn Jacint Verdaguer 67A
08970 Sant Joan Despí (Barcelona)
Spain
Hikma Italia SpA
Viale Certosa 10
27100 Pavia
Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany:
Daptomycin-ratiopharm 350 mg Pulver zur Herstellung einer Injektions-/Infusionslösung
Italy:
Daptomicina Hikma

The following information is intended exclusively for healthcare professionals
Important: Consult the Summary of Product Characteristics before prescribing
Instructions for use and handling
350 mg vial:
Daptomycin can be administered intravenously as an infusion lasting 30 or 60
minutes or as an injection lasting 2 minutes. Preparing the solution for infusion
requires further dilution, as described below.

Administration of Daptomicina Hikma as an intravenous infusion lasting 30 or 60
minutes
A concentration of 50 mg/ml of Daptomicina Hikma for infusion is obtained by
reconstituting the lyophilized powder with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Approximately 15 minutes are required to dissolve the lyophilized powder. The fully
reconstituted medicine has a clear appearance and some bubbles or foam may be present around the edges
of the vial.
To prepare Daptomicina Hikma for intravenous infusion, follow these
instructions: Throughout the entire reconstitution process of Daptomicina Hikma lyophilized powder, aseptic technique must be used.

• 11. Remove the polypropylene cap, exposing the center of the rubber stopper. Clean the top of the rubber stopper with a swab soaked in alcohol or another antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper and do not allow it to touch any other surface. Using a sterile transfer needle with a diameter of 21 gauge or less, or a needle-free device, draw 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe and slowly inject it into the vial, inserting the needle into the center of the rubber stopper with the tip directed towards the vial wall.
• 12. Gently rotate the vial to ensure that the product is completely wetted by the liquid, then let it stand for 10 minutes.
• 13. Finally, gently rotate the vial for a few minutes until a clear reconstituted solution is obtained. Avoid shaking or vigorously swirling the vial to prevent foam formation.
• 14. Before use, the reconstituted solution must be carefully checked to ensure that the product is completely dissolved and inspected visually for the presence of particulate matter. The color of the reconstituted solution of Daptomicina Hikma may range from pale yellow to light brown.
• 15. Slowly remove the reconstituted liquid (50 mg of daptomycin/ml) from the vial using a sterile needle with a diameter of 21 gauge or less.
• 16. The reconstituted solution must then be diluted with intravenous infusion of sodium chloride 9 mg/ml (0.9%) (typical volume 50 ml).
• 17. Invert the vial to allow the solution to flow towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, position the tip of the needle at the bottom of the solution while drawing the solution into the syringe. Before removing the needle from the vial, pull back the plunger to the end of the syringe body to aspirate all the solution from the inverted vial.
• 18. Replace the needle with a new needle for intravenous infusion.
• 19. Expel air, large bubbles and excess solution until the required dose is obtained.
• 20. The reconstituted and diluted solution must then be administered by intravenous infusion over 30 or 60 minutes. Daptomicina Hikma is physically and chemically incompatible with solutions containing glucose. The following agents have been shown to be compatible when added to infusion solutions containing daptomycin: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.

The overall shelf life (reconstituted solution in the vial and diluted solution in the
infusion bag) should not exceed 12 hours at 25°C (24 hours if stored in a refrigerator).
The stability of the diluted solution in the infusion bag is 12 hours at 25°C or 24 hours if stored
in a refrigerator at 2°C – 8°C.

Administration of Daptomicina Hikma by intravenous injection lasting 2 minutes
Water should not be used for the reconstitution of Daptomicina Hikma for intravenous injection.
Daptomicina Hikma must be reconstituted only with sodium chloride 9 mg/ml (0.9%).
A concentration of 50 mg/ml of Daptomicina Hikma for injection is obtained by
reconstituting the lyophilized powder with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Approximately 15 minutes are required to dissolve the lyophilized powder. The fully
reconstituted medicine has a clear appearance and some bubbles or foam may be present around the edges
of the vial.
To prepare Daptomicina Hikma for intravenous injection, follow these
instructions: Throughout the entire reconstitution process of Daptomicina Hikma lyophilized powder, aseptic technique must be used.

• 10. Remove the polypropylene cap, exposing the center of the rubber stopper. Clean the top of the rubber stopper with a swab soaked in alcohol or another antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper and do not allow it to touch any other surface. Using a sterile transfer needle with a diameter of 21 gauge or less, or a needle-free device, draw 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe and slowly inject it into the vial, inserting the needle into the center of the rubber stopper with the tip directed towards the vial wall.
• 11. Gently rotate the vial to ensure that the product is completely wetted by the liquid, then let it stand for 10 minutes.
• 12. Rotate the vial gently for a few minutes until a clear reconstituted solution is obtained. Avoid shaking or vigorously swirling the vial to prevent foam formation.
• 13. Before use, the reconstituted solution must be carefully checked to ensure that the product is completely dissolved and inspected visually for the presence of particulate matter. The color of the reconstituted solution of Daptomicina Hikma may range from pale yellow to light brown.
• 14. Slowly remove the reconstituted liquid (50 mg of daptomycin/ml) from the vial using a sterile needle with a diameter of 21 gauge or less.
• 15. Invert the vial to allow the solution to flow towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, position the tip of the needle at the bottom of the solution while drawing the solution into the syringe. Before extracting the needle from the vial, pull back the plunger to the end of the syringe body to aspirate all the solution from the inverted vial.
• 16. Replace the needle with a new needle for intravenous injection.
• 17. Expel air, large bubbles and excess solution until the required dose is obtained.
• 18. The reconstituted solution must then be injected slowly intravenously over 2 minutes. Chemical and physical stability during use of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours if stored in a refrigerator (2°C – 8°C). However, from a microbiological point of view, the medicine must be used immediately. If not, the user is responsible for the period of conservation during use which, as a rule, should not exceed the times mentioned above for chemical and physical stability in use. The medicine must not be mixed with other products except those mentioned above. The vials of Daptomicina Hikma are for single use only. Any unused solution remaining in the vial must be discarded.