Daptomycin Hospira: detailed information

Patient Information Leaflet

Daptomycin Hospira 350 mg powder for solution for injection or infusion

daptomycin
Please read this leaflet carefully before 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.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

What Daptomycin Hospira is and what it is used for
What you need to know before being given Daptomycin Hospira
How Daptomycin Hospira is administered
Possible side effects
How to store Daptomycin Hospira
Contents of the pack and other information

1. What Daptomicin Hospira is and what it is used for

The active substance of Daptomicin Hospira powder for injectable or infusion solution is
daptomycin. Daptomycin is an antibacterial agent that can stop the growth of certain bacteria.
Daptomicin Hospira is used in adults and in children and adolescents (aged 1 to 17 years) for the
treatment of skin and soft tissue infections. It is also used to treat bloodstream infections when associated with skin infections.
Daptomicin Hospira 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 type of bacterium called Staphylococcus aureus. It is also used to treat bloodstream infections caused by the same type of bacterium when associated with heart infections.
Depending on the type(s) of infection you have, your doctor may also prescribe other antibacterial agents during treatment with Daptomicin Hospira.

2. What you should know before being given Daptomycin Hospira

Do not be given Daptomycin Hospira 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 applies to you, inform 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 being given Daptomycin Hospira.

If you have or have previously had kidney problems. Your doctor may need to adjust the dose of Daptomycin Hospira (see section 3 of this leaflet).
Patients treated with daptomycin sometimes experience muscle pain, weakness, or muscle damage (see section 4 of this leaflet for more information). If this occurs, inform your doctor. Your doctor will arrange for you to have a blood test and will advise whether you should continue or stop treatment with Daptomycin Hospira. Symptoms usually resolve within a few days after stopping Daptomycin Hospira.
If you have previously developed a severe skin reaction, skin peeling, blistering rash, and/or mouth ulcers or serious kidney problems after taking daptomycin.
If you are overweight. Daptomycin blood levels may be higher than those observed in individuals of average weight, so you may need to be monitored more closely for adverse effects.

If any of these apply to you, inform your doctor or nurse before being given
Daptomycin Hospira.

Inform your doctor or nurse 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. Symptoms may include wheezing, difficulty breathing, swelling of the face, neck, and throat, skin rash, hives, or fever.
Serious skin disorders have been reported with the use of Daptomycin Hospira. Symptoms associated with these skin disorders may include:
- onset or worsening of fever,
- raised or fluid-filled red spots on the skin that may appear under the arms or in the chest or groin areas and may spread over large areas of the body,
- blisters or sores in the mouth or on the genitals.
A serious kidney problem has been reported with the use of Daptomycin Hospira. Symptoms may include fever and skin rash.
Unusual tingling or numbness in the hands or feet, loss of sensation, or difficulty moving. If this occurs, inform your doctor, who will decide whether treatment should continue.
Diarrhea, especially if you notice blood or mucus, or if diarrhea becomes severe or persistent.
Onset or worsening of fever, cough, or difficulty breathing. These may be signs of a rare but serious lung disease called eosinophilic pneumonia. Your doctor will check your lung function and decide whether you should continue treatment with Daptomycin Hospira.

Daptomycin may interfere with laboratory tests measuring blood coagulation. Test results may suggest a blood clotting problem even when none exists. It is therefore important that your doctor knows you are receiving daptomycin. Inform your doctor that you are being treated with Daptomycin Hospira.
Your doctor will perform blood tests to monitor your muscle condition both before starting treatment and regularly during treatment with Daptomycin Hospira.

Children and adolescents
Daptomycin must not be given to children under one year of age, as animal studies have shown that serious adverse effects may occur in this age group.

Use in the elderly
People over 65 years of age can receive the same dose as adults, provided their kidneys are functioning properly.

Other medicines and Daptomycin Hospira
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
It is particularly important to inform your doctor if you are taking:

Medicines called statins or fibrates (used to lower cholesterol) or cyclosporine (a medicine used in organ transplantation to prevent organ rejection or in other conditions such as rheumatoid arthritis or atopic dermatitis). If you take these medicines (and others that may cause muscle effects) during daptomycin therapy, the risk of muscle-related adverse effects may be increased. Your doctor may decide not to prescribe
Daptomycin Hospira or may temporarily discontinue the other medicines.
Painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These may interfere with the renal effects of daptomycin.
Oral anticoagulants (e.g. warfarin), which are medicines that prevent blood from clotting. Your doctor may need to monitor your clotting time.

Pregnancy and breastfeeding
Daptomycin is generally not given to pregnant women. If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before receiving this medicine.
Do not breastfeed while taking daptomycin, as Daptomycin Hospira may pass into breast milk and could therefore affect the infant.

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

Daptomycin Hospira contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How Daptomicina Hospira is administered

Daptomicina Hospira is generally administered by a doctor or nurse.
Adults (aged 18 years and older)
The dose administered depends on your body weight and the type of infection being treated. In adults, the usual dose is 4 mg per kilogram (kg) of body weight, given once daily for skin infections, or 6 mg per kg of body weight given once daily for heart infection or bloodstream infection associated with skin or heart infection. In adult patients, this dose is injected directly into the bloodstream (into a vein) either as an infusion lasting approximately 30 minutes or as an injection lasting approximately 2 minutes. The same dose is recommended for individuals over 65 years of age, provided their kidneys are functioning properly.
If your kidneys are not functioning properly, you may receive daptomycin less frequently, for example every other day. If you are undergoing dialysis and your next dose of daptomycin is to be given on the same day as dialysis, daptomycin will generally be administered after completion of dialysis.
Children and adolescents (from 1 to 17 years of age)
The dose for children and adolescents (from 1 to 17 years of age) depends on the patient's age and the type of infection being treated. This dose is injected directly into the bloodstream (into a vein) as an infusion lasting approximately 30–60 minutes.
Generally, for skin infections, a treatment course lasts from 1 to 2 weeks. For bloodstream or heart infections and skin infections, your doctor will decide how long your treatment should continue.
Detailed instructions for use and handling are provided at the end of this 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 listed below:
Serious side effects with unknown frequency (frequency cannot be estimated from the available data)

In some cases, hypersensitivity reactions (severe allergic reactions including anaphylaxis and angioedema) have been reported during administration of daptomycin. This severe allergic reaction requires immediate medical intervention. Immediately inform your doctor or nurse if any of the following symptoms occur:
Chest pain or tightness,
Rash or hives,
Swelling around the throat,
Rapid or weak heartbeat,
Wheezing,
Fever,
Chills or tremors,
Flushing,
Dizziness,
Fainting,
Metallic taste.

If you notice unexplained muscle pain, tenderness or weakness, inform your doctor immediately. Muscle problems can be serious, including destruction of muscle tissue (rhabdomyolysis), which may lead to kidney damage.
Other serious side effects reported with the use of Daptomicina Hospira are:

A rare but potentially serious lung disease called eosinophilic pneumonia, usually occurring after more than 2 weeks of treatment. Symptoms may include difficulty breathing, new or worsening cough, or new or worsening fever.
Severe skin disorders. Symptoms may include:
New or worsening fever,
Raised red skin lesions or fluid-filled blisters, which may appear under the arms or in the chest or groin areas and may spread over a large area of the body,
Blisters or sores in the mouth or on the genitals.
A serious kidney problem. Symptoms may include fever and rash. If you experience these symptoms, inform your doctor or nurse immediately. Your doctor will perform further tests to make a diagnosis.

The more frequently reported side effects are listed below:
Common: may affect up to 1 in 10 people

Fungal infections such as oral candidiasis,
Urinary tract infection,
Decrease in the number of red blood cells (anaemia),
Dizziness, anxiety, difficulty sleeping,
Headache,
Fever, weakness (asthenia),
High or low blood pressure,
Constipation, abdominal pain,
Diarrhoea, feeling unwell (nausea or vomiting),
Flatulence,
Abdominal swelling or bloated stomach,
Skin rash 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 during treatment with daptomycin are listed below:
Uncommon: may affect up to 1 in 100 people

Blood disorders (such as increased number of small particles called platelets, which may increase the tendency for blood to clot, 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 rhythm, hot flushes,
Indigestion (dyspepsia), inflammation of the tongue,
Skin rash associated with itching,
Muscle pain, cramps or weakness, inflammation of the muscles (myositis), joint pain,
Kidney problems,
Vaginal inflammation and irritation,
Generalised pain or weakness, tiredness (fatigue),
Blood tests showing increased levels of blood sugar, serum creatinine, myoglobin or lactate dehydrogenase (LDH), prolonged bleeding time or electrolyte imbalance,
Itching of the eyes.

Rare: may affect up to 1 in 1,000 people

Yellowing of the skin and eyes,
Prolongation of prothrombin time.

Frequency not known: frequency cannot be estimated from the available data
Antibiotic-associated colitis, including pseudomembranous colitis (severe and persistent diarrhoea containing blood and/or mucus, associated with abdominal pain or fever), easy bruising, bleeding gums or nosebleeds.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Daptomycin Hospira

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 “Exp.”. The expiry date refers to the last day of that month.
Do not store above 30 °C.

6. Package contents and other information

What Daptomicina Hospira contains

The active substance is daptomycin. One vial of powder contains 350 mg of daptomycin.
The other components are sodium hydroxide and citric acid.

What Daptomicina Hospira looks like and contents of the pack
Daptomicina Hospira powder for solution for injection or infusion is supplied as a lyophilisate or
light yellow to light brown powder in a glass vial. Before administration, it is mixed with a solvent to form a liquid.
Daptomicina Hospira is available in packs containing 1 vial or 5 vials.

Marketing Authorization Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Service Company BV
Hoge Wei 10
1930 Zaventem
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer NV/SA Tel: + 370 5 251 4000
Tél/Tel: + 32 (0)2 554 62 11

България Magyarország
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Тел.: + 359 2 970 4333 Tel.: + 36 1 488 37 00

Česká republika Malta
Pfizer, spol. s r.o. Drugsales Ltd
Tel: +420 283 004 111 Tel: + 356 21419070/1/2

Danmark Nederland
Pfizer ApS Pfizer bv
Tlf: + 45 44 20 11 00 Tel: + 31 (0)800 63 34 636

Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel: + 49 (0)30 550055-51000 Tlf: + 47 67 52 61 00

Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel: + 372 666 7500 Tel: + 43 (0)1 521 15-0

Ελλάδα Polska
Pfizer Ελλάς A.E. Pfizer Polska Sp. z o.o.
Τηλ.: + 30 210 6785800 Tel.: + 48 22 335 61 00

España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel: + 34 91 490 99 00 Tel: + 351 21 423 5500

France România
Pfizer Pfizer Romania S.R.L.
Tél: + 33 (0)1 58 07 34 40 Tel: + 40 (0) 21 207 28 00

Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: + 385 1 3908 777 Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)1 52 11 400

Ireland Slovenská republika
Pfizer Healthcare Ireland Pfizer Luxembourg SARL, organizačná zložka
Tel: + 1800 633 363 (toll free) Tel: + 421 2 3355 5500
Tel: + 44 (0)1304 616161

Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Sími: + 354 540 8000 Puh/Tel: +358 (0)9 430 040

Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: + 39 06 33 18 21 Tel: + 46 (0)8 550 520 00

Κύπρος United Kingdom (Northern Ireland)
Pharmaceutical Trading Co Ltd Pfizer Limited
Τηλ: + 357 24656165 Tel: + 44 (0) 1304 616161

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals

Important: Refer to the product characteristics summary before prescribing.
Instructions for use and handling
350 mg powder for injectable solution or for infusion:
In adults, daptomycin may be administered intravenously either as a 30-minute infusion or as a 2-minute injection. Unlike adults, daptomycin must not be administered as a 2-minute injection in pediatric patients. In pediatric patients aged 7 to 17 years, daptomycin should be administered by infusion over 30 minutes. In pediatric patients under 7 years of age receiving a dose of 9–12 mg/kg, daptomycin must be administered over at least 60 minutes. Preparation of the infusion solution requires further dilution, as described below.

Daptomycin Hospira administered as a 30- or 60-minute intravenous infusion
A concentration of 50 mg/mL of Daptomycin Hospira for infusion is obtained by reconstituting the lyophilized powder with 7 mL of 9 mg/mL (0.9%) sodium chloride injectable solution.
The fully reconstituted medicinal product is clear, and there may be some bubbles or foam around the edges of the vial.
To prepare Daptomycin Hospira for intravenous infusion, follow the instructions below:
Throughout the entire reconstitution process of Daptomycin Hospira lyophilized powder, aseptic technique must be used.
To avoid foam formation, AVOID vigorous shaking or agitation of the vial during or after reconstitution.

Remove the polypylene overcap to expose the center portion of the rubber stopper. Wipe the top of the rubber stopper with an alcohol-impregnated swab or other antiseptic solution and allow it to dry (perform the same procedure for the sodium chloride solution vial, if applicable). After cleaning, do not touch the rubber stopper or allow it to contact any other surface. Using a syringe and a sterile transfer needle with a gauge of 21 or smaller, or a needle-free device, withdraw 7 mL of 9 mg/mL (0.9%) sodium chloride injectable solution, insert the needle into the center of the rubber stopper, and inject the solution SLOWLY into the vial, directing the stream onto the powder.
Release the syringe plunger and wait for pressure equalization before removing the syringe from the vial.
Hold the vial by the neck, tilt it, and rotate the contents until the medicinal product is completely reconstituted.
Before use, carefully inspect the reconstituted solution to ensure complete dissolution of the product and visually check for absence of particulate matter. The color of the reconstituted Daptomycin Hospira solution may vary from pale yellow to light brown.
Slowly withdraw the reconstituted liquid (50 mg of daptomycin/mL) from the vial using a sterile needle with a gauge of 21 or smaller.
Invert the vial to allow the solution to flow toward the stopper. Using a new syringe, insert the needle into the inverted vial. While holding the vial inverted, keep the needle tip at the bottom of the solution as the solution is aspirated into the syringe. Before removing the needle from the vial, pull back the plunger to the end of the syringe barrel to aspirate all solution from the inverted vial.
Replace the needle with a new needle for intravenous infusion.
Expel air, large bubbles, and excess solution to achieve the required dose.
Transfer the reconstituted solution into an infusion bag containing 9 mg/mL (0.9%) sodium chloride solution (typical volume 50 mL).
The reconstituted and diluted solution should then be administered slowly by intravenous infusion over 30 or 60 minutes.

Daptomycin Hospira is physically or chemically incompatible with glucose-containing solutions. The following agents have been shown to be compatible when added to infusion solutions containing Daptomycin Hospira: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.
The total storage period (reconstituted solution in the vial and diluted solution in the infusion bag) must not exceed 12 hours at 25 °C (24 hours if refrigerated).
The stability of the diluted solution in the infusion bag is 12 hours at 25 °C or 24 hours if stored refrigerated at 2 °C–8 °C.

Daptomycin Hospira administered as a 2-minute intravenous injection (adult patients only)
Water must not be used for reconstitution of Daptomycin Hospira for intravenous injection.
Daptomycin Hospira must be reconstituted only with 9 mg/mL (0.9%) sodium chloride injectable solution.
A concentration of 50 mg/mL of Daptomycin Hospira for injection is obtained by reconstituting the lyophilized powder with 7 mL of 9 mg/mL (0.9%) sodium chloride injectable solution.
The fully reconstituted medicinal product is clear, and there may be some bubbles or foam around the edges of the vial.
To prepare Daptomycin Hospira for intravenous injection, follow the instructions below:
Throughout the entire reconstitution process of Daptomycin Hospira lyophilized powder, aseptic technique must be used.
To avoid foam formation, AVOID vigorous shaking or agitation of the vial during or after reconstitution.

Remove the polypylene overcap to expose the center portion of the rubber stopper. Wipe the top of the rubber stopper with an alcohol-impregnated swab or other antiseptic solution and allow it to dry (perform the same procedure for the sodium chloride solution vial, if applicable). After cleaning, do not touch the rubber stopper or allow it to contact any other surface. Using a syringe and a sterile transfer needle with a gauge of 21 or smaller, or a needle-free device, withdraw 7 mL of 9 mg/mL (0.9%) sodium chloride injectable solution, insert the needle into the center of the rubber stopper, and inject the solution SLOWLY into the vial, directing the stream onto the powder.
Release the syringe plunger and wait for pressure equalization before removing the syringe from the vial.
Hold the vial by the neck, tilt it, and rotate the contents until the medicinal product is completely reconstituted.
Before use, carefully inspect the reconstituted solution to ensure complete dissolution of the product and visually check for absence of particulate matter. The color of the reconstituted Daptomycin Hospira solution may vary from pale yellow to light brown.
Slowly withdraw the reconstituted liquid (50 mg of daptomycin/mL) from the vial using a sterile needle with a gauge of 21 or smaller.
Invert the vial to allow the solution to flow toward the stopper. Using a new syringe, insert the needle into the inverted vial. While holding the vial inverted, keep the needle tip at the bottom of the solution as the solution is aspirated into the syringe. Before removing the needle from the vial, pull back the plunger to the end of the syringe barrel to aspirate all solution from the inverted vial.
Replace the needle with a new needle for intravenous injection.
Expel air, large bubbles, and excess solution to achieve the required dose.
The reconstituted solution should then be administered slowly by intravenous injection over 2 minutes.

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 if refrigerated (2 °C–8 °C).
However, from a microbiological standpoint, the medicinal product should be used immediately. Otherwise, the user is responsible for the in-use storage period, which under normal circumstances must not exceed 24 hours at 2 °C–8 °C, unless reconstitution/dilution was performed under controlled and validated aseptic conditions.
This medicinal product must not be mixed with other medicinal products except those mentioned above.
Daptomycin Hospira vials are for single use only. Any unused solution remaining in the vial must be discarded.

Package leaflet: Information for the patient

Daptomycin Hospira 500 mg powder for solution for injection or infusion

daptomycin
Please read this leaflet carefully before 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.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of this leaflet

What Daptomycin Hospira is and what it is used for
What you need to know before being given Daptomycin Hospira
How Daptomycin Hospira is administered
Possible side effects
How to store Daptomycin Hospira
Contents of the pack and other information

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

The active substance of Daptomicina Hospira powder for injectable solution or infusion is
daptomycin. Daptomycin is an antibacterial agent that can stop the growth of certain bacteria.
Daptomicina Hospira is used in adults and in children and adolescents (aged 1 to 17 years) for the
treatment of skin and soft tissue infections. It is also used to treat bloodstream infections when they are
associated with skin infections.
Daptomicina Hospira 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 type of bacterium called Staphylococcus aureus. It is
also used to treat bloodstream infections caused by the same type of bacterium when they are
associated with heart infections.
Depending on the type of infection(s) you have, your doctor may also prescribe other antibacterial agents
during treatment with Daptomicina Hospira.

2. What you should know before being given Daptomicin Hospira

Do not be given Daptomicin Hospira
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 applies to you, inform 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 Daptomicin Hospira.

If you have or have previously had kidney problems. Your doctor may need to adjust the dose of Daptomicin Hospira (see section 3 of this leaflet).
Patients treated with daptomycin may sometimes experience muscle pain, weakness, or muscle damage (see section 4 of this leaflet for more information). If this occurs, inform your doctor. Your doctor will arrange for you to have a blood test
and will advise whether you should continue or stop treatment with Daptomicin Hospira. Symptoms
usually resolve within a few days after stopping Daptomicin Hospira.
If you have developed a severe skin reaction, skin peeling, blistering rash, and/or mouth ulcers or serious kidney problems after taking daptomycin.
If you are overweight. Daptomycin blood levels may be higher than those observed in people of average weight, so you may need to be monitored more closely for adverse effects. If any of these situations apply to you, inform your doctor or nurse before being given Daptomicin Hospira.

Inform your doctor or nurse 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. Symptoms may include wheezing, difficulty breathing, swelling of the face, neck, and throat, skin rash, hives, or fever.
Serious skin disorders have been reported with the use of Daptomicin Hospira. Symptoms associated with these skin disorders may include:
onset or worsening of fever,
raised red or fluid-filled spots on the skin that may appear under the arms or in chest or groin areas and may spread over large areas of the body,
blisters or sores in the mouth or on the genitals.
A serious kidney problem has been reported with the use of Daptomicin Hospira. Symptoms may include fever and rash.
Unusual tingling or numbness in the hands or feet, loss of sensation, or difficulty moving. If this occurs, inform your doctor, who will decide whether to continue treatment.
Diarrhea, especially if you notice blood or mucus, or if diarrhea becomes severe or persistent.
Onset or worsening of fever, cough, or difficulty breathing. These may be signs of a rare but serious lung disease called eosinophilic pneumonia. Your doctor will check your lung condition and decide whether you should continue treatment with Daptomicin Hospira.

Daptomycin may interfere with laboratory tests used to measure blood clotting. Test results may suggest a blood clotting problem even when none exists. It is therefore important that your doctor is aware that you are receiving daptomycin. Inform your doctor that you are being treated with Daptomicin Hospira.
Your doctor will perform blood tests to monitor your muscle condition both before starting treatment and regularly during treatment with Daptomicin Hospira.

Children and adolescents
Daptomycin must not be given to children under one year of age, as animal studies have shown that serious adverse effects may occur in this age group.

Use in the elderly
People over 65 years of age may receive the same dose as adults, provided their kidneys are functioning properly.

Other medicines and Daptomicin Hospira
Inform 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 (used to lower cholesterol) or cyclosporine (a medicine used in organ transplantation to prevent organ rejection or in other conditions such as rheumatoid arthritis or atopic dermatitis). If you take these medicines (and others that may affect muscles) during daptomycin therapy, the risk of muscle-related adverse effects may be increased. Your doctor may decide not to prescribe
Daptomicin Hospira or to temporarily discontinue the other medicines.
Painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These may interfere with the renal effects of daptomycin.
Oral anticoagulants (e.g. warfarin), which are medicines that prevent blood from clotting. Your doctor may need to monitor your bleeding time.

Pregnancy and breastfeeding
Daptomycin is generally not given to pregnant women. If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before this medicine is administered.
Do not breastfeed while taking daptomycin, as Daptomicin Hospira may pass into breast milk and could therefore affect the baby.

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

Daptomicin Hospira contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How Daptomicina Hospira is administered

Daptomicina Hospira is generally administered by a doctor or nurse.
Adults (aged 18 years and older)
The dose administered depends on your body weight and the type of infection being treated. In adults, the usual dose is 4 mg per kilogram (kg) of body weight, given once daily for skin infections, or 6 mg per kg of body weight given once daily for heart infection or bloodstream infection associated with skin or heart infection. In adult patients, this dose is injected directly into the bloodstream (into a vein) either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes. The same dose is recommended for people over 65 years of age, provided their kidneys are functioning well.
If your kidneys are not working properly, you may receive daptomycin less frequently, for example every other day. If you are undergoing dialysis and your next dose of daptomycin is to be given on the same day as dialysis, daptomycin will generally be administered after completion of dialysis.
Children and adolescents (from 1 to 17 years of age)
The dose for children and adolescents (from 1 to 17 years of age) depends on the patient's age and the type of infection being treated. This dose is injected directly into the bloodstream (into a vein) as an infusion lasting approximately 30–60 minutes.
Generally, for skin infections, a treatment course lasts from 1 to 2 weeks. For bloodstream or heart infections and skin infections, your doctor will decide how long your treatment should last.
Detailed instructions for use and handling are provided at the end of this package leaflet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most serious side effects are described below:
Serious side effects with unknown frequency (frequency cannot be estimated from the available data)
In some cases, hypersensitivity reactions (severe allergic reactions including anaphylaxis and angioedema) have been reported during administration of daptomycin. This severe allergic reaction requires immediate medical intervention. Immediately inform your doctor or nurse if any of the following symptoms occur:

Chest pain or tightness in the chest,
Skin rash or hives,
Swelling around the throat,
Rapid or weak heartbeat,
Wheezing,
Fever,
Chills or shivering,
Hot flushes,
Dizziness,
Fainting,
Metallic taste.

If you notice unexplained muscle pain, tenderness, or weakness, inform your doctor immediately. Muscle problems can be serious, including destruction of muscle tissue (rhabdomyolysis), which may lead to kidney damage. Other serious side effects reported with the use of Daptomycin Hospira include:

A rare but potentially serious lung disease called eosinophilic pneumonia, most often occurring after more than 2 weeks of treatment. Symptoms may include difficulty breathing, new or worsening cough, or new or worsening fever.
Severe skin disorders. Symptoms may include:
- new or worsening fever,
- raised or fluid-filled red spots on the skin, which may appear under the arms or in the chest or groin areas and may spread over a large area of the body,
- blisters or sores in the mouth or on the genitals.
A serious kidney problem. Symptoms may include fever and skin rash. If you experience these symptoms, inform your doctor or nurse immediately. Your doctor will perform further tests to make a diagnosis.

If you notice raised or fluid-filled skin lesions spreading over a large area of your body, inform your doctor or nurse immediately.

The side effects reported most frequently are described below:
Common: may affect up to 1 in 10 people

Fungal infections such as oral candidiasis,
Urinary tract infection,
Decrease in the number of red blood cells (anaemia),
Dizziness, anxiety, difficulty sleeping,
Headache,
Fever, weakness (asthenia),
High or low blood pressure,
Constipation, abdominal pain,
Diarrhoea, feeling unwell (nausea or vomiting),
Flatulence,
Abdominal swelling or bloated stomach,
Skin rash or itching,
Pain, itching or redness at the infusion site,
Pain in arms or legs,
Increased levels of liver enzymes or creatine phosphokinase (CPK) in blood tests.

Other side effects that may occur during treatment with daptomycin are described below:
Uncommon: may affect up to 1 in 100 people

Blood disorders (such as increased number of small particles called platelets, which may increase the tendency for blood to clot, or increased levels of certain types of white blood cells),
Loss of appetite,
Tingling or numbness in hands or feet, altered taste,
Tremor,
Changes in heart rhythm, hot flushes,
Indigestion (dyspepsia), inflammation of the tongue,
Skin rash associated with itching,
Muscle pain, cramps or weakness, inflammation of muscles (myositis), joint pain,
Kidney problems,
Inflammation and irritation of the vagina,
Pain or generalised weakness, tiredness (fatigue),
Blood tests showing increased levels of blood sugar, serum creatinine, myoglobin or lactate dehydrogenase (LDH), prolonged bleeding time or electrolyte imbalance,
Itching of the eyes.

Rare: may affect up to 1 in 1,000 people

Yellowing of the skin and eyes,
Prolongation of prothrombin time.

Frequency not known: frequency cannot be estimated from the available data
Colitis associated with antibiotic use, including pseudomembranous colitis (severe and persistent diarrhoea containing blood and/or mucus, associated with abdominal pain or fever), easy bruising, bleeding gums, or nosebleeds.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Daptomycin Hospira

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 “Exp.”. The expiry date refers to the last day of that month.
Do not store above 30 °C.

6. Package contents and other information

What Daptomycin Hospira contains

The active substance is daptomycin. One vial of powder contains 500 mg of daptomycin.
The other components are sodium hydroxide and citric acid.

Description of the appearance of Daptomycin Hospira and contents of the pack
Daptomycin Hospira powder for solution for injection or infusion is supplied as a lyophilized cake or powder ranging in colour from light yellow to light brown, in a glass vial. Prior to administration, it is mixed with a solvent to form a liquid.
Daptomycin Hospira is available in packs containing 1 vial or 5 vials.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Service Company BV
Hoge Wei 10
1930 Zaventem
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer NV/SA Tel: + 370 5 251 4000
Tél/Tel: + 32 (0)2 554 62 11

България Magyarország
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Тел.: + 359 2 970 4333 Tel.: + 36 1 488 37 00

Česká republika Malta
Pfizer, spol. s r.o. Drugsales Ltd
Tel: +420 283 004 111 Tel: + 356 21419070/1/2

Danmark Nederland
Pfizer ApS Pfizer bv
Tlf: + 45 44 20 11 00 Tel: +31 (0)800 63 34 636

Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel:+ 49 (0)30 550055-51000 Tlf: +47 67 52 61 00

Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel: + 372 666 7500 Tel: + 43 (0)1 521 15-0

Ελλάδα Polska
Pfizer Ελλάς A.E. Pfizer Polska Sp. z o.o.
Τηλ.: + 30 210 6785800 Tel: + 48 22 335 61 00

España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel: + 34 91 490 99 00 Tel: + 351 21 423 5500

France România
Pfizer Pfizer România S.R.L.
Tél: + 33 (0)1 58 07 34 40 Tel: + 40 (0) 21 207 28 00

Ireland Slovenská republika
Pfizer Healthcare Ireland Pfizer Luxembourg SARL, organizačná zložka
Tel: + 1800 633 363 (toll free) Tel: + 421 2 3355 5500
Tel: + 44 (0)1304 616161

Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Sími: + 354 540 8000 Puh/Tel: +358 (0)9 430 040

Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: + 39 06 33 18 21 Tel: + 46 (0)8 550 520 00

Κύπρος United Kingdom (Northern Ireland)
Pharmaceutical Trading Co Ltd Pfizer Limited
Τηλ: + 357 24656165 Tel: + 44 (0) 1304 616161

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals

Important: Refer to the Summary of Product Characteristics before prescribing.
Instructions for use and handling
500 mg powder for solution for injection or infusion:
In adults, daptomycin may be administered intravenously either as a 30-minute infusion or as a 2-minute injection. Unlike adults, daptomycin must not be administered as a 2-minute injection in pediatric patients. In pediatric patients aged 7 to 17 years, daptomycin should be administered by infusion over 30 minutes. In pediatric patients under 7 years of age receiving a dose of 9–12 mg/kg, daptomycin should be administered over at least 60 minutes. Preparation of the infusion solution requires further dilution, as described below.

Daptomycin Hospira administered as a 30- or 60-minute intravenous infusion
A concentration of 50 mg/mL of Daptomycin Hospira for infusion is obtained by reconstituting the lyophilized powder with 10 mL of 9 mg/mL (0.9%) sodium chloride injectable solution.
The fully reconstituted medicinal product has a clear appearance, and there may be some bubbles or foam around the edges of the vial.
To prepare Daptomycin Hospira for intravenous infusion, follow the instructions below:
Throughout the entire reconstitution process of Daptomycin Hospira lyophilized powder, an aseptic technique must be used.
To avoid foam formation, DO NOT shake or vigorously agitate the vial during or after reconstitution.

Remove the polypropylene overcap to expose the central portion of the rubber stopper. Wipe the top of the rubber stopper with an alcohol-impregnated swab or other antiseptic solution and allow it to dry (perform the same procedure for the sodium chloride solution vial, if applicable). After cleaning, do not touch the rubber stopper or allow it to contact any other surface. Using a syringe and a sterile transfer needle with a gauge of 21 or smaller, or a needle-free device, withdraw 10 mL of 9 mg/mL (0.9%) sodium chloride injectable solution, insert the needle into the center of the rubber stopper, and inject the solution SLOWLY into the vial, directing the stream onto the product.
Release the syringe plunger and wait for pressure equalization before removing the syringe from the vial.
Hold the vial by the neck, tilt it, and gently rotate the contents until complete reconstitution of the medicinal product is achieved.
Before use, the reconstituted solution must be carefully inspected to ensure the product is fully dissolved and visually checked for particulate matter. The color of the reconstituted Daptomycin Hospira solution may range from pale yellow to light brown.
Slowly withdraw the reconstituted liquid (50 mg of daptomycin/mL) from the vial using a sterile needle with a gauge of 21 or smaller.
Invert the vial to allow the solution to flow toward the stopper. Using a new syringe, insert the needle into the inverted vial. While holding the vial inverted, keep the needle tip 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 barrel to aspirate all remaining solution from the inverted vial.

Replace the needle with a new needle for intravenous infusion.
Expel air, large bubbles, and excess solution until the required dose is obtained.
Transfer the reconstituted solution into an infusion bag containing 9 mg/mL (0.9%) sodium chloride solution (typical volume 50 mL).
The reconstituted and diluted solution should then be administered slowly by intravenous infusion over 30 or 60 minutes.

Daptomycin Hospira is physically or chemically incompatible with glucose-containing solutions. The following agents have been shown to be compatible when added to infusion solutions containing Daptomycin Hospira: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.
The total storage time (reconstituted solution in the vial and diluted solution in the infusion bag) must not exceed 12 hours at 25 °C (24 hours if refrigerated).
The stability of the diluted solution in the infusion bag is 12 hours at 25 °C or 24 hours if stored refrigerated at 2 °C–8 °C.

Daptomycin Hospira administered as a 2-minute intravenous injection (adults only)
Water must not be used for reconstitution of Daptomycin Hospira intended for intravenous injection.
Daptomycin Hospira must only be reconstituted with 9 mg/mL (0.9%) sodium chloride injectable solution.
A concentration of 50 mg/mL of Daptomycin Hospira for injection is obtained by reconstituting the lyophilized powder with 10 mL of 9 mg/mL (0.9%) sodium chloride injectable solution.
The fully reconstituted medicinal product has a clear appearance, and there may be some bubbles or foam around the edges of the vial.
To prepare Daptomycin Hospira for intravenous infusion, follow the instructions below:
Throughout the entire reconstitution process of Daptomycin Hospira lyophilized powder, an aseptic technique must be used.
To avoid foam formation, DO NOT shake or vigorously agitate the vial during or after reconstitution.

Remove the polypropylene overcap to expose the central portion of the rubber stopper. Wipe the top of the rubber stopper with an alcohol-impregnated swab or other antiseptic solution and allow it to dry (perform the same procedure for the sodium chloride solution vial, if applicable). After cleaning, do not touch the rubber stopper or allow it to contact any other surface. Using a syringe and a sterile transfer needle with a gauge of 21 or smaller, or a needle-free device, withdraw 10 mL of 9 mg/mL (0.9%) sodium chloride injectable solution, insert the needle into the center of the rubber stopper, and inject the solution SLOWLY into the vial, directing the stream onto the product.
Release the syringe plunger and wait for pressure equalization before removing the syringe from the vial.
Hold the vial by the neck, tilt it, and gently rotate the contents until complete reconstitution of the medicinal product is achieved.
Before use, the reconstituted solution must be carefully inspected to ensure the product is fully dissolved and visually checked for particulate matter. The color of the reconstituted Daptomycin Hospira solution may range from pale yellow to light brown.
Slowly withdraw the reconstituted liquid (50 mg of daptomycin/mL) from the vial using a sterile needle with a gauge of 21 or smaller.
Invert the vial to allow the solution to flow toward the stopper. Using a new syringe, insert the needle into the inverted vial. While holding the vial inverted, keep the needle tip 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 barrel to aspirate all remaining solution from the inverted vial.
Replace the needle with a new needle for intravenous injection.
Expel air, large bubbles, and excess solution until the required dose is obtained.
The reconstituted solution should then be administered slowly by intravenous injection over 2 minutes.

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 when refrigerated (2 °C–8 °C).
However, from a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the user is responsible for ensuring the storage time during use, which under normal circumstances should not exceed 24 hours at 2 °C–8 °C, unless reconstitution/dilution has been performed under controlled and validated aseptic conditions.
This medicinal product must not be mixed with other medicinal products except those mentioned above.
Daptomycin Hospira vials are for single use only. Any unused solution remaining in the vial must be discarded.