Daptomycin Accord

Package leaflet: Information for the patient

Daptomycin Accord Healthcare 350 mg powder for solution for injection/infusion, 500 mg powder for solution for injection/infusion

Generic medicine
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 other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Daptomycin Accord Healthcare is and what it is used for
2. What you need to know before being given Daptomycin Accord Healthcare
3. How Daptomycin Accord Healthcare is administered
4. Possible side effects
5. How to store Daptomycin Accord Healthcare
6. Contents of the pack and other information

1. What Daptomicina Accord Healthcare is and what it is used for

The active substance of Daptomicina Accord Healthcare powder for injectable solution or for infusion is daptomycin. Daptomycin is an antibacterial agent that can stop the growth of certain bacteria.
Daptomicina Accord Healthcare is used in adults, children and adolescents (aged 1 to 17 years) to treat skin and underlying tissue infections. It is also used to treat bloodstream infections when associated with skin infections.
Daptomicina Accord Healthcare is also used in adults to treat 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 of infection(s) you have, your doctor may also prescribe other antibacterial agents during treatment with Daptomicina Accord Healthcare.

2. What you should know before being given Daptomycin Accord Healthcare

Do not receive Daptomycin Accord Healthcare
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 receiving Daptomycin Accord Healthcare.

• If you have or have previously had kidney problems. Your doctor may need to adjust the dose of Daptomycin Accord Healthcare (see section 3 of this leaflet).
• Patients treated with Daptomycin Accord Healthcare have sometimes experienced muscle pain, tenderness, or weakness (see section 4 of this leaflet for more information). If this occurs, inform your doctor. Your doctor will arrange for a blood test and will advise whether you should continue or stop treatment with Daptomycin Accord Healthcare. Symptoms usually resolve within a few days after stopping Daptomycin Accord Healthcare.
• If you have previously developed a severe skin reaction, skin peeling, blistering rash, mouth ulcers, or serious kidney problems after taking daptomycin.
• If you are overweight. Levels of Daptomycin Accord Healthcare in the blood may be higher than in individuals of average weight, so you may need closer monitoring for adverse effects. If any of these situations apply to you, inform your doctor or nurse before receiving Daptomycin Accord Healthcare.

Inform your doctor or nurse immediately if any of the following symptoms occur:

• Severe acute allergic reactions have been observed in patients treated with nearly all antibacterial medicines, including Daptomycin Accord Healthcare. 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. 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, 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. 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 Accord Healthcare.

Daptomycin Accord Healthcare 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 Accord Healthcare.
Inform your doctor that you are being treated with Daptomycin Accord Healthcare.
Your doctor will perform blood tests to monitor your muscle function both before starting treatment and regularly during treatment with Daptomycin Accord Healthcare.

Children and adolescents
Daptomycin Accord Healthcare must not be given to children under one year of age, as animal studies have indicated 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 they have normal kidney function.

Other medicines and Daptomycin Accord Healthcare
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
It is especially important to mention 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 any of these medicines (and others that may cause muscle-related side effects) during treatment with Daptomycin Accord Healthcare, your risk of muscle-related adverse effects may be increased. Your doctor may decide not to prescribe Daptomycin Accord Healthcare 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 Accord Healthcare.
• Oral anticoagulants (e.g., warfarin), which are medicines that prevent blood from clotting. Your doctor may need to monitor your blood clotting time.

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

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

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

3. How Daptomycin Accord Healthcare is administered

Daptomycin Accord Healthcare is usually administered by a doctor or nurse.
Adults (aged 18 years and older)
The dose 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 they have normal renal function.
If you have impaired renal function, you may receive Daptomycin Accord Healthcare less frequently, e.g., every other day. If you are undergoing dialysis and your next dose of Daptomycin Accord Healthcare is due on the same day as dialysis, Daptomycin Accord Healthcare is usually 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.
Typically, 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.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

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, during administration of Daptomycin Accord Healthcare, a hypersensitivity reaction (a severe allergic reaction including anaphylaxis and angioedema) has been reported. This severe allergic reaction requires immediate medical intervention.
Immediately inform your doctor or nurse if you experience any of the following symptoms:

• Chest pain or tightness,
• Rash or hives,
• Swelling around the throat,
• Rapid or weak heartbeat,
• Wheezing,
• Fever,
• Chills or shaking,
• 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 muscle breakdown (rhabdomyolysis), which may lead to kidney damage.

• Other serious side effects reported with daptomycin use include: A rare but potentially serious lung disease called eosinophilic pneumonia, occurring mostly 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.
• Severe kidney problems. 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 side effects reported most frequently are listed 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 (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 Accord Healthcare are listed below:
Uncommon side effects (may affect up to 1 in 100 people)

• Blood disorders (such as increased number of small blood 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, muscle inflammation (myositis), joint pain,
• Kidney problems,
• Inflammation and irritation of the vagina,
• Generalised pain or weakness, tiredness (fatigue),
• Blood tests showing increased levels of blood sugar, serum creatinine, myoglobin or lactate dehydrogenase (LDH), prolonged blood clotting time, electrolyte imbalance,
• Itching of the eyes.

Rare side effects (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 or 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 get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Daptomycin Accord Healthcare

• Keep this medicinal product out of the sight and reach of children.
• Do not use this medicinal product after the expiry date stated on the label and the carton after "Exp.". The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C - 8°C).

The chemical and physical stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C - 8°C.
For a 2-minute intravenous injection, the storage time of the reconstituted solution in the vial (see section 6.6) at 25°C must not exceed 12 hours (or 48 hours at 2°C - 8°C).
However, from a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless reconstitution has taken place under controlled and validated aseptic conditions.

After dilution:
The chemical and physical stability of the diluted solution in infusion bags is established for 12 hours at 25°C or 24 hours at 2°C - 8°C.
For a 30-minute intravenous infusion, the combined storage time (reconstituted solution in the vial and diluted solution in the infusion bag; see section 6.6) at 25°C must not exceed 12 hours (or 24 hours at 2°C - 8°C).
However, from a microbiological standpoint, unless the reconstitution and dilution method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user.

6. Package Contents and Other Information

What Daptomicin Accord Healthcare Contains

• The active substance is daptomycin.

Daptomycin Accord Healthcare 350 mg powder for injectable solution/infusion
One vial of powder contains 350 mg of daptomycin.
Daptomycin Accord Healthcare 500 mg powder for injectable solution/infusion
One vial of powder contains 500 mg of daptomycin.

• The other ingredients are disodium phosphate dihydrate, monosodium dihydrogen phosphate monohydrate, and sodium hydroxide.

Appearance of Daptomycin Accord Healthcare and Contents of the Pack
Daptomycin Accord Healthcare powder for injectable solution/infusion is supplied as a cake or lyophilized powder ranging in colour from pale yellow to light brown in a clear glass vial (type I).
It is mixed with a solvent to form a liquid prior to administration.
Daptomycin Accord Healthcare is available in packs containing 1 vial.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040, Spain
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA 3000, Malta
Accord Healthcare Polska Sp. z.o.o.
Magazyn Importera
ul. Lutomierska 50
95-200 Pabianice, Poland
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia,
Schimatari, 32009, Greece

The following information is intended exclusively for healthcare professionals

Important: Before prescribing the medicine, consult the Summary of Product Characteristics.

Instructions for Use and Handling

Daptomycin Accord Healthcare 350 mg powder for injectable solution/infusion

In adults, daptomycin may be administered intravenously 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. Pediatric patients aged 7 to 17 years should receive daptomycin as a 30-minute infusion. In pediatric patients under 7 years of age receiving a dose of 9–12 mg/kg, daptomycin must be administered over 60 minutes. Preparation of the infusion solution requires an additional dilution step, as described below.

Daptomycin Accord Healthcare administered as intravenous infusion over 30 or 60 minutes

A concentration of 50 mg/ml of Daptomycin Accord Healthcare for infusion can be obtained by reconstituting the lyophilized product with 7 ml of 9 mg/ml (0.9%) sodium chloride injectable solution.
Dissolution of the lyophilized product takes approximately 3 minutes. The fully reconstituted product will appear clear and may contain a few small bubbles or foam around the edge of the vial.

To prepare Daptomycin Accord Healthcare for intravenous infusion, follow these instructions:
Aseptic technique must be used when reconstituting or diluting Daptomycin Accord Healthcare lyophilized powder.

For reconstitution:

1. Remove the polypropylene flip-off cap to expose the central portion of the rubber stopper. Clean the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper and do not allow it to come into contact with other surfaces. Draw 7 ml of 9 mg/ml (0.9%) sodium chloride injectable solution into a syringe using a sterile transfer needle with a diameter equal to or less than 21 gauge or a needle-free device, then slowly inject through the center of the rubber stopper into the vial, directing the needle toward the vial wall.
2. Gently rotate the vial to ensure complete wetting of the product and allow it to stand for 3 minutes.
3. Finally, gently rotate/agitate the vial for several minutes, if necessary, to obtain a clear reconstituted solution. Avoid vigorous shaking or agitation to prevent foam formation.
4. The reconstituted solution must be carefully inspected to ensure the product is fully dissolved and visually checked for particulate matter before use. Reconstituted solutions of Daptomycin Accord Healthcare range in colour from pale yellow to light brown.
5. The reconstituted solution must be diluted with 9 mg/ml (0.9%) sodium chloride (typical volume 50 ml).

For dilution:

1. Slowly withdraw the appropriate volume of reconstituted liquid (50 mg daptomycin/ml) from the vial using a new sterile needle with a diameter equal to or less than 21 gauge, by inverting the vial so that the solution flows toward the stopper. With a syringe, insert the needle into the inverted vial. While keeping the vial inverted, position the needle tip at the bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger to the end of the syringe barrel to withdraw the required solution from the inverted vial.
2. Expel air, large bubbles, and excess solution to obtain the required dose.
3. Transfer the required reconstituted dose into 50 ml of 9 mg/ml (0.9%) sodium chloride.
4. The reconstituted and diluted solution must be administered by intravenous infusion over 30 or 60 minutes.

Daptomycin Accord Healthcare is not physically or chemically compatible with glucose-containing solutions. Compatibility has been demonstrated with infusion solutions containing Daptomycin Accord Healthcare and aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.
For stability of the reconstituted/diluted solution, refer to section 5.

Daptomycin Accord Healthcare administered as a 2-minute intravenous injection (for adult patients only)

For reconstitution of Daptomycin Accord Healthcare for intravenous injection, water must not be used. Daptomycin Accord Healthcare must be reconstituted only with 9 mg/ml (0.9%) sodium chloride.

A concentration of 50 mg/ml of Daptomycin Accord Healthcare for injection is obtained by reconstituting the lyophilized product with 7 ml of 9 mg/ml (0.9%) sodium chloride injectable solution.
Dissolution of the lyophilized product takes approximately 3 minutes. The fully reconstituted product will appear clear and may contain a few small bubbles or foam around the edge of the vial.

To prepare Daptomycin Accord Healthcare for intravenous injection, follow these instructions:
Aseptic technique must be used when reconstituting Daptomycin Accord Healthcare lyophilized powder.

1. Remove the polypropylene flip-off cap to expose the central portion of the rubber stopper. Clean the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper and do not allow it to come into contact with other surfaces. Draw 7 ml of 9 mg/ml (0.9%) sodium chloride injectable solution into a syringe using a sterile transfer needle with a diameter equal to or less than 21 gauge or a needle-free device, then slowly inject through the center of the rubber stopper into the vial, directing the needle toward the vial wall.
2. Gently rotate the vial to ensure complete wetting of the product and allow it to stand for 3 minutes.
3. Finally, gently rotate/agitate the vial for several minutes, if necessary, to obtain a clear reconstituted solution. Avoid vigorous shaking or agitation to prevent foam formation.
4. The reconstituted solution must be carefully inspected to ensure the product is fully dissolved and visually checked for particulate matter before use. Reconstituted solutions of Daptomycin Accord Healthcare range in colour from pale yellow to light brown.
5. Slowly withdraw the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle with a diameter equal to or less than 21 gauge.
6. Invert the vial to allow the solution to flow toward the stopper. With a new syringe, insert the needle into the inverted vial. While keeping the vial inverted, position the needle tip at the bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger to the end of the syringe barrel to withdraw all the solution from the inverted vial.
7. Replace the needle with a new one for intravenous injection.
8. Expel air, large bubbles, and excess solution to obtain the required dose.
9. The reconstituted solution must be administered slowly by intravenous injection over 2 minutes.

For stability of the reconstituted/diluted solution, refer to section 5.
This medicinal product must not be mixed with other medicinal products except those mentioned above.
Daptomycin Accord Healthcare vials are for single use only. Any unused portion remaining in the vial must be discarded.
Use only clear solutions that are practically free from particles.

Daptomycin Accord Healthcare 500 mg powder for injectable solution/infusion

In adults, daptomycin may be administered intravenously 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. Pediatric patients aged 7 to 17 years should receive daptomycin as a 30-minute infusion. In pediatric patients under 7 years of age receiving a dose of 9–12 mg/kg, daptomycin must be administered over 60 minutes. Preparation of the infusion solution requires an additional dilution step, as described below.

Daptomycin Accord Healthcare administered as intravenous infusion over 30 or 60 minutes

A concentration of 50 mg/ml of Daptomycin Accord Healthcare for infusion can be obtained by reconstituting the lyophilized product with 10 ml of 9 mg/ml (0.9%) sodium chloride injectable solution.
Dissolution of the lyophilized product takes approximately 3 minutes. The fully reconstituted product will appear clear and may contain a few small bubbles or foam around the edge of the vial.

To prepare Daptomycin Accord Healthcare for intravenous infusion, follow these instructions:
Aseptic technique must be used when reconstituting or diluting Daptomycin Accord Healthcare lyophilized powder.

For reconstitution:

1. Remove the polypropylene flip-off cap to expose the central portion of the rubber stopper. Clean the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper and do not allow it to come into contact with other surfaces. Draw 10 ml of 9 mg/ml (0.9%) sodium chloride injectable solution into a syringe using a sterile transfer needle with a diameter equal to or less than 21 gauge or a needle-free device, then slowly inject through the center of the rubber stopper into the vial, directing the needle toward the vial wall.
2. Gently rotate the vial to ensure complete wetting of the product and allow it to stand for 3 minutes.
3. Finally, gently rotate/agitate the vial for several minutes, if necessary, to obtain a clear reconstituted solution. Avoid vigorous shaking or agitation to prevent foam formation.
4. The reconstituted solution must be carefully inspected to ensure the product is fully dissolved and visually checked for particulate matter before use. Reconstituted solutions of Daptomycin Accord Healthcare range in colour from pale yellow to light brown.
5. The reconstituted solution must be diluted with 9 mg/ml (0.9%) sodium chloride (typical volume 50 ml).

For dilution:

1. Slowly withdraw the appropriate volume of reconstituted liquid (50 mg daptomycin/ml) from the vial using a new sterile needle with a diameter equal to or less than 21 gauge, by inverting the vial so that the solution flows toward the stopper. With a syringe, insert the needle into the inverted vial. While keeping the vial inverted, position the needle tip at the bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger to the end of the syringe barrel to withdraw the required solution from the inverted vial.
2. Expel air, large bubbles, and excess solution to obtain the required dose.
3. Transfer the required reconstituted dose into 50 ml of 9 mg/ml (0.9%) sodium chloride.
4. The reconstituted and diluted solution must be administered by intravenous infusion over 30 or 60 minutes.

Daptomycin Accord Healthcare is not physically or chemically compatible with glucose-containing solutions. Compatibility has been demonstrated with infusion solutions containing Daptomycin Accord Healthcare and aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.
For stability of the reconstituted/diluted solution, refer to section 5.
Daptomycin Accord Healthcare administered as a 2-minute intravenous injection (for adult patients only)

For reconstitution of Daptomycin Accord Healthcare for intravenous injection, water must not be used. Daptomycin Accord Healthcare must be reconstituted only with 9 mg/ml (0.9%) sodium chloride.

A concentration of 50 mg/ml of Daptomycin Accord Healthcare for injection is obtained by reconstituting the lyophilized product with 10 ml of 9 mg/ml (0.9%) sodium chloride injectable solution.
Dissolution of the lyophilized product takes approximately 3 minutes. The fully reconstituted product appears clear and may contain a few small bubbles or foam around the edge of the vial.

To prepare Daptomycin Accord Healthcare for intravenous injection, follow these instructions:
Aseptic technique must be used when reconstituting Daptomycin Accord Healthcare lyophilized powder.

1. Remove the polypropylene flip-off cap to expose the central portion of the rubber stopper. Clean the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper and do not allow it to come into contact with other surfaces. Draw 10 ml of 9 mg/ml (0.9%) sodium chloride injectable solution into a syringe using a sterile transfer needle with a diameter equal to or less than 21 gauge or a needle-free device, then slowly inject through the center of the rubber stopper into the vial, directing the needle toward the vial wall.
2. Gently rotate the vial to ensure complete wetting of the product and allow it to stand for 3 minutes.
3. Finally, gently rotate/agitate the vial for several minutes, if necessary, to obtain a clear reconstituted solution. Avoid vigorous shaking or agitation to prevent foam formation.
4. The reconstituted solution must be carefully inspected to ensure the product is fully dissolved and visually checked for particulate matter before use. Reconstituted solutions of Daptomycin Accord Healthcare range in colour from pale yellow to light brown.
5. Slowly withdraw the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle with a diameter equal to or less than 21 gauge.
6. Invert the vial to allow the solution to flow toward the stopper. With a new syringe, insert the needle into the inverted vial. While keeping the vial inverted, position the needle tip at the bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger to the end of the syringe barrel to withdraw all the solution from the inverted vial.
7. Replace the needle with a new one for intravenous injection.
8. Expel air, large bubbles, and excess solution to obtain the required dose.
9. The reconstituted solution must be administered slowly by intravenous injection over 2 minutes.

For stability of the reconstituted/diluted solution, refer to section 5.
This medicinal product must not be mixed with other medicinal products except those mentioned above.
Daptomycin Accord Healthcare vials are for single use only. Any unused portion remaining in the vial must be discarded.
Use only clear solutions that are practically free from particles.