Daptomicin Accord Healthcare

Leaflet accompanying the packaging: patient information

Daptomycin Accord Healthcare, 350 mg,

powder for solution for injection/infusion

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

Daptomycin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Daptomycin Accord Healthcare and what is it used for
• 2. Important information before administering Daptomycin Accord Healthcare
• 3. How to administer Daptomycin Accord Healthcare
• 4. Possible side effects
• 5. How to store Daptomycin Accord Healthcare
• 6. Package contents and other information

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

The active substance of Daptomycin Accord Healthcare powder for solution for injection or infusion is daptomycin. Daptomycin is an antibacterial medicine that can stop the growth of certain bacteria. Daptomycin Accord Healthcare is used in adults and children and adolescents (from 1 to 17 years old) to treat skin and soft tissue infections. Daptomycin Accord Healthcare is also used to treat blood infections related to skin infections.

Daptomycin Accord Healthcare is also used in adults to treat infections of the tissue lining the heart from the inside (including heart valves), caused by a bacterium called Staphylococcus aureus. The medicine Daptomycin Accord Healthcare is also used to treat blood infections caused by the same bacterium that causes heart infections.

Depending on the type of infection, the doctor may prescribe other antibacterial medicines during treatment with Daptomycin Accord Healthcare.

2. Important information before administering Daptomycin Accord Healthcare

When not to use Daptomycin Accord Healthcare:

• If the patient is allergic to daptomycin or any of the other ingredients of this medicine (listed in section 6).

If this applies to the patient, they should inform their doctor or nurse.

If the patient suspects that they may be allergic to the mentioned substances, they should consult their doctor or nurse for advice.

Warnings and precautions

Before starting treatment with Daptomycin Accord Healthcare, the patient should consult their doctor or nurse.

• If the patient has or has had kidney problems in the past. The doctor may need to change the dose of Daptomycin Accord Healthcare (see section 3 of this leaflet).
• Rarely, patients receiving Daptomycin Accord Healthcare may experience muscle sensitivity or pain, or muscle weakness (more information on this can be found in section 4 of this leaflet). In such cases, the patient should inform their doctor. The doctor will arrange for a blood test and decide whether to continue using Daptomycin Accord Healthcare. The mentioned symptoms usually resolve within a few days after discontinuing Daptomycin Accord Healthcare.
• If the patient has ever experienced a severe skin rash or skin peeling, blisters, and/or mouth ulcers or severe kidney dysfunction after taking daptomycin.
• In case of severe obesity. The concentrations of Daptomycin Accord Healthcare in the blood may be higher compared to concentrations in people with average body weight, and in such cases, if side effects occur, careful monitoring of the patient is necessary. If any of the above points apply to the patient, they should inform their doctor or nurse before starting treatment with Daptomycin Accord Healthcare.

The patient should immediately inform their doctor or nurse if they experience any of the following symptoms:

• Severe, acute allergic reactions have been observed in patients treated with almost all antibacterial medicines, including Daptomycin Accord Healthcare. Symptoms include wheezing, difficulty breathing, swelling of the face, neck, and throat, rash, and hives or fever.
• Severe skin diseases have been reported during treatment with daptomycin. The symptoms that occur in these diseases may include:
• the onset or worsening of fever,
• red, raised, or fluid-filled bumps on the skin that may appear under the arms, on the chest, or in the groin area and may spread over a large area of the body,
• blisters or ulcers in the mouth or on the genitals.
• Severe kidney dysfunction has been reported during treatment with daptomycin. Symptoms may include fever and rash.
• Numbness or tingling of the hands or feet, loss of sensation, or difficulty moving. If the patient experiences any of these symptoms, they should inform their doctor, who will decide whether to stop or continue treatment.
• Diarrhea, especially if it contains blood or mucus, or if the diarrhea becomes acute or persistent.
• The onset or worsening of fever, cough, or difficulty breathing. These may be symptoms of a rare but serious lung condition called eosinophilic pneumonia. The doctor will examine the patient's lungs and decide whether to continue or stop treatment with Daptomycin Accord Healthcare.

Daptomycin Accord Healthcare may affect the results of laboratory tests that determine blood clotting. Laboratory test results may indicate poor blood clotting when, in fact, blood clotting is normal. Therefore, it is essential for the doctor to consider that the patient is taking Daptomycin Accord Healthcare.

The patient should inform their doctor about taking Daptomycin Accord Healthcare.

To monitor muscle condition, the doctor may order blood tests, both before and repeatedly during treatment with Daptomycin Accord Healthcare.

Children and adolescents

Daptomycin Accord Healthcare should not be given to children under one year of age, as animal studies have shown that this age group may experience severe side effects.

Use in elderly patients

Patients over 65 years old, if they do not have kidney dysfunction, can be given the same dose as recommended for other adult patients.

Daptomycin Accord Healthcare and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. It is especially important to inform the doctor about:

• Statins or fibrates (cholesterol-lowering medicines) or cyclosporine (a medicine used in transplantation to prevent rejection or in other conditions, such as rheumatoid arthritis or atopic dermatitis). Taking any of these (or other muscle-affecting) medicines during treatment with Daptomycin Accord Healthcare may increase the risk of muscle side effects. The doctor will decide whether to stop Daptomycin Accord Healthcare or temporarily discontinue the use of other medicines.
• Painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g., celecoxib). They may affect the action of Daptomycin Accord Healthcare on the kidneys.
• Oral anticoagulants (e.g., warfarin), which prevent blood clotting. The doctor may need to monitor blood clotting time.

Pregnancy and breastfeeding

Daptomycin Accord Healthcare is not usually given to pregnant women. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.

The medicine should not be used during breastfeeding, as Daptomycin Accord Healthcare may pass into breast milk and harm the baby.

Driving and using machines

There are no known cases of Daptomycin Accord Healthcare affecting the ability to drive or use machines.

Daptomycin Accord Healthcare contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per vial, which means the medicine is considered "sodium-free".

3. How to administer Daptomycin Accord Healthcare

Daptomycin Accord Healthcare is usually administered by a doctor or nurse.

Adults (18 years and older)

The dose depends on the patient's weight and the type of infection being treated. The usual dose of the medicine for adults is 4 mg per kilogram (kg) of body weight once a day for skin infections or 6 mg per kilogram of body weight once a day for heart or blood infections related to skin or heart infections.

In adult patients, this dose is administered directly into the blood (through a vein) as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes.

The same dose is recommended for patients over 65 years old, if they do not have kidney dysfunction.

If kidney function is impaired, Daptomycin Accord Healthcare may be administered less frequently, e.g., every other day.

In patients undergoing dialysis, if the next dose of Daptomycin Accord Healthcare is due on the day of dialysis, Daptomycin Accord Healthcare is usually administered after dialysis.

Children and adolescents (from 1 to 17 years old)

The dose for children and adolescents (from 1 to 17 years old) will depend on the patient's age and the type of infection being treated.

The dose is administered directly into the bloodstream (intravenously) as an infusion lasting about 30-60 minutes.

Treatment usually lasts from 1 to 2 weeks for skin infections.

In blood or heart infections, as well as in skin infections, the duration of treatment will be decided by the doctor.

Detailed instructions for preparing and administering the medicine are provided at the end of this leaflet.

If the patient has any further questions about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Daptomycin Accord Healthcare can cause side effects, although not everybody gets them.

The most serious side effects are described below:

Severe side effects, the frequency of which is unknown (cannot be estimated from the available data)

• Reports of hypersensitivity reactions (severe allergic reaction, including anaphylaxis and angioedema) have been received during treatment with Daptomycin Accord Healthcare.
• The occurrence of this severe allergic reaction requires immediate medical attention.
• The patient should immediately inform their doctor or nurse if they experience any of the following symptoms:
• chest pain or tightness in the chest,
• rash or hives,
• swelling of the throat,
• rapid or weak pulse,
• wheezing,
• fever,
• chills or shivering,
• hot flashes,
• dizziness,
• fainting,
• metallic taste in the mouth.
• If unexplained muscle pain, sensitivity, or weakness occur, the patient should immediately inform their doctor.
• Muscle symptoms can be serious.
• There may be a breakdown of muscle cells (so-called rhabdomyolysis), which can lead to kidney damage.
• Other severe side effects reported after taking daptomycin include:
• A rare but potentially severe lung condition called eosinophilic pneumonia, which occurs with treatment lasting more than 2 weeks.
• Its symptoms include difficulty breathing, onset or worsening of cough, onset or worsening of fever.
• Severe skin diseases.
• Symptoms may include:
• onset or worsening of fever,
• red, raised, or fluid-filled bumps on the skin that may appear under the arms, on the chest, or in the groin area and may spread over a large area of the body,
• blisters or ulcers in the mouth or on the genitals.
• Severe kidney dysfunction.
• Symptoms may include fever and rash.
• The patient should immediately inform their doctor or nurse if they experience any of these symptoms.
• The doctor will perform additional tests to diagnose the condition.

The most commonly reported side effects are described below:

Common side effects (may occur in less than 1 in 10 people)

• fungal infections, such as thrush,
• urinary tract infections,
• decreased red blood cell count (anemia),
• dizziness, anxiety, sleep disturbances,
• headache,
• fever, weakness (asthenia),
• increased or decreased blood pressure,
• constipation, abdominal pain,
• diarrhea, nausea, or vomiting,
• gas,
• bloating or swelling of the abdomen,
• skin rash or itching,
• pain, itching, or redness at the injection site,
• pain in the arms or legs,
• increased levels of liver enzymes or creatine phosphokinase (CPK) in the blood.

Other side effects that may occur after taking Daptomycin Accord Healthcare are described below:

Uncommon side effects (may occur in less than 1 in 100 people)

• blood disorders (e.g., increased platelet count, which can increase blood clotting, or increased white blood cell count),
• decreased appetite,
• tingling or numbness of the hands or feet, taste disturbances,
• tremors,
• changes in heart rhythm, sudden flushing of the face,
• indigestion (dyspepsia), tongue inflammation,
• itchy skin rash,
• pain, cramps, or weakness of the muscles, muscle inflammation, joint pain,
• kidney dysfunction,
• vaginal or vulvar inflammation or irritation,
• general feeling of pain or weakness, fatigue (exhaustion),
• increased blood sugar levels, creatinine in serum, myoglobin, lactate dehydrogenase (LDH) activity, prolonged blood clotting time, or electrolyte imbalance,
• eye itching.

Rare side effects (may occur in less than 1 in 1000 people)

• jaundice (yellowing of the skin and eyes),
• prolonged prothrombin time.

Frequency not known (cannot be estimated from the available data)

Colitis associated with antibacterial agents, including pseudomembranous colitis (severe or persistent diarrhea with blood and/or mucus, associated with abdominal pain or fever), easy bruising, bleeding from the gums, or nosebleeds.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:

Al. Jerozolimskie 181C,

02-222 Warsaw

tel.: +48 22 49 21 301,

fax: +48 22 49 21 309,

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Daptomycin Accord Healthcare

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and label of the vial after EXP.
• The expiry date refers to the last day of the month stated.
• Store in a refrigerator (2°C - 8°C).

The chemical and physical stability of the reconstituted solution of the medicine in an ampoule is 12 hours at 25°C or up to 48 hours at a temperature of 2°C to 8°C.

In the case of a 2-minute intravenous injection, the storage time of the reconstituted solution in the vial (see section 6.6) at 25°C should not exceed 12 hours (or at 2°C - 8°C for 48 hours).

However, from a microbiological point of view, the prepared medicinal product should be used immediately.

If it is not used immediately, the user is responsible for the storage time.

Usually, this time should not exceed 24 hours at 2°C - 8°C, unless the dissolution and dilution were carried out under controlled and validated aseptic conditions.

After dilution:

The chemical and physical stability of the diluted solution in an infusion bag is 12 hours at 25°C or 24 hours at a temperature of 2°C - 8°C.

In the case of a 30-minute intravenous infusion, the total storage time (of the reconstituted solution in the vial and the diluted solution in the infusion bag, see section 6.6) should not exceed 12 hours at 25°C (or 24 hours at 2°C - 8°C).

However, from a microbiological point of view, the prepared product should be used immediately, unless the method of reconstitution and dilution excludes the risk of microbiological contamination.

If it is not used immediately, the user is responsible for the storage time.

6. Package contents and other information

What Daptomycin Accord Healthcare contains

• The active substance of the medicine is daptomycin.

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

One vial of powder contains 350 mg of daptomycin.

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

One vial of powder contains 500 mg of daptomycin.

• The other ingredients are disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, and sodium hydroxide (to adjust pH).

What Daptomycin Accord Healthcare looks like and contents of the pack

Daptomycin Accord Healthcare powder for solution for injection or infusion is available as a lyophilisate in the form of a yellowish to light brown disc or powder in glass vials in a cardboard box.

Before administration, the powder should be mixed with a solvent to form a solution.

Daptomycin Accord Healthcare is available in packs containing 1 vial.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.

ul. Taśmowa 7

02-677 Warsaw

Tel: +48 22 577 28 00

Manufacturer/Importer

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca

08040 Barcelona

Spain

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA3000

Malta

Accord Healthcare Polska Sp. z o.o.

ul. Lutomierska 50

95-200 Pabianice

Accord Healthcare Single Member S.A.

64th Km National Road Athens

Schimatari, 32009 Lamia

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

varten

Date of last revision of the leaflet: April 2025

Information intended for healthcare professionals only

Note: Before prescribing the medicine, the doctor should read the Summary of Product Characteristics.

Instructions for use and handling

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

Adult patients may be administered daptomycin intravenously in an infusion over 30 minutes or in an injection over 2 minutes.

In contrast to adult patients, children and adolescents should not be administered daptomycin in a 2-minute injection.

Children and adolescents from 7 to 17 years old should be administered daptomycin in an infusion lasting 30 minutes.

Children under 7 years old receiving a dose of 9-12 mg/kg body weight should be administered daptomycin over 60 minutes.

Preparation of the infusion solution requires an additional dilution step, which is described below.

Daptomycin Accord Healthcare administered in a 30-minute or 60-minute intravenous infusion

The concentration of Daptomycin Accord Healthcare in the infusion solution is 50 mg/mL, which is achieved by reconstituting the lyophilized product in 7 mL of 0.9% sodium chloride solution (9 mg/mL) for injection.

The reconstitution of the lyophilized product takes approximately 3 minutes.

The completely reconstituted product is clear and may contain a few small air bubbles or foam at the edge of the vial.

To prepare Daptomycin Accord Healthcare for intravenous infusion, the following instructions should be followed:

During the reconstitution or dilution of the lyophilized product, the principles of asepsis should be observed at all times.

Reconstitution:

• 1. Remove the polypropylene cap from the vial to expose the central portion of the rubber stopper.
• Wipe the rubber stopper with an alcohol swab or other antiseptic solution and let it dry.
• Do not touch the rubber stopper or allow it to come into contact with any other surface.
• Draw up 7 mL of 0.9% sodium chloride solution (9 mg/mL) for injection into a syringe using a sterile needle of 21 G or smaller.
• Slowly insert the needle into the center of the rubber stopper and inject the contents of the syringe into the vial, directing the needle onto the vial wall.

Then gently rotate the vial to completely wet the lyophilized product and let it stand for 3 minutes.

Finally, gently rotate the vial or shake it in a rotary motion for a few minutes until a clear solution is obtained.

Avoid vigorous shaking to prevent foaming of the solution.

The reconstituted solution should be inspected before use to ensure that the product is completely dissolved and does not contain any particulate matter.

The solution of Daptomycin Accord Healthcare has a color ranging from light yellow to light brown.

Dilution:

• 1. Slowly withdraw the required amount of reconstituted solution (50 mg daptomycin/mL) from the vial using a new sterile needle of 21 G or smaller.
• 2. Remove air, large bubbles, and excess solution from the syringe to obtain the desired dose.
• 3. Transfer the required amount of reconstituted dose to 50 mL of 0.9% sodium chloride solution (9 mg/mL).
• 4. The reconstituted and diluted solution can then be administered in an intravenous infusion over 30 or 60 minutes.

Daptomycin Accord Healthcare is physically and chemically incompatible with glucose-containing solutions.

The following medicines do not show incompatibility when added to the solution of Daptomycin Accord Healthcare: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.

Information on the stability of the reconstituted and/or diluted solution can be found in section 5.

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

Water should not be used to reconstitute Daptomycin Accord Healthcare for intravenous injection.

Daptomycin Accord Healthcare should only be reconstituted in 0.9% sodium chloride solution (9 mg/mL).

The concentration of the injection solution of Daptomycin Accord Healthcare is 50 mg/mL, which is achieved by reconstituting the lyophilized product in 7 mL of 0.9% sodium chloride solution (9 mg/mL) for injection.

The reconstitution of the lyophilized product takes approximately 3 minutes.

The completely reconstituted product is clear and may contain a few small air bubbles or foam at the edge of the vial.

To prepare Daptomycin Accord Healthcare for intravenous injection, the following instructions should be followed:

During the reconstitution of the lyophilized product, the principles of asepsis should be observed at all times.

• 1. Remove the polypropylene cap from the vial to expose the central portion of the rubber stopper.
• Wipe the rubber stopper with an alcohol swab or other antiseptic solution and let it dry.
• Do not touch the rubber stopper or allow it to come into contact with any other surface.
• Draw up 7 mL of 0.9% sodium chloride solution (9 mg/mL) for injection into a syringe using a sterile needle of 21 G or smaller.
• Slowly insert the needle into the center of the rubber stopper and inject the contents of the syringe into the vial, directing the needle onto the vial wall.

Then gently rotate the vial to completely wet the lyophilized product and let it stand for 3 minutes.

Finally, gently rotate the vial or shake it in a rotary motion for a few minutes until a clear solution is obtained.

Avoid vigorous shaking to prevent foaming of the solution.

The reconstituted solution should be inspected before use to ensure that the product is completely dissolved and does not contain any particulate matter.

The solution of Daptomycin Accord Healthcare has a color ranging from light yellow to light brown.

• 5. Slowly withdraw the reconstituted solution (50 mg daptomycin/mL) from the vial using a sterile needle of 21 G or smaller.
• 6. Invert the vial and, using a new syringe, insert the needle into the inverted vial.
• 7. Change the needle to a new one intended for intravenous injection.
• 8. Remove air, large bubbles, and excess solution from the syringe to obtain the desired dose.
• 9. The reconstituted solution should be injected slowly into a vein over 2 minutes.

Information on the stability of the reconstituted and/or diluted solution can be found in section 5.

Daptomycin Accord Healthcare should not be mixed with other medicines, except those listed above.

Vials containing Daptomycin Accord Healthcare are intended for single use only.

Any unused product should be discarded.

Only a clear solution that is practically free from particles should be used.

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

Adult patients may be administered daptomycin intravenously in an infusion over 30 minutes or in an injection over 2 minutes.

In contrast to adult patients, children and adolescents should not be administered daptomycin in a 2-minute injection.

Children and adolescents from 7 to 17 years old should be administered daptomycin in an infusion lasting 30 minutes.

Children under 7 years old receiving a dose of 9-12 mg/kg body weight should be administered daptomycin over 60 minutes.

Preparation of the infusion solution requires an additional dilution step, which is described below.

Daptomycin Accord Healthcare administered in a 30-minute or 60-minute intravenous infusion

The concentration of Daptomycin Accord Healthcare in the infusion solution is 50 mg/mL, which is achieved by reconstituting the lyophilized product in 10 mL of 0.9% sodium chloride solution (9 mg/mL) for injection.

The reconstitution of the lyophilized product takes approximately 3 minutes.

The completely reconstituted product is clear and may contain a few small air bubbles or foam at the edge of the vial.

To prepare Daptomycin Accord Healthcare for intravenous infusion, the following instructions should be followed:

During the reconstitution or dilution of the lyophilized product, the principles of asepsis should be observed at all times.

Reconstitution:

• 1. Remove the polypropylene cap from the vial to expose the central portion of the rubber stopper.
• Wipe the rubber stopper with an alcohol swab or other antiseptic solution and let it dry.
• Do not touch the rubber stopper or allow it to come into contact with any other surface.
• Draw up 10 mL of 0.9% sodium chloride solution (9 mg/mL) for injection into a syringe using a sterile needle of 21 G or smaller.
• Slowly insert the needle into the center of the rubber stopper and inject the contents of the syringe into the vial, directing the needle onto the vial wall.

Then gently rotate the vial to completely wet the lyophilized product and let it stand for 3 minutes.

Finally, gently rotate the vial or shake it in a rotary motion for a few minutes until a clear solution is obtained.

Avoid vigorous shaking to prevent foaming of the solution.

The reconstituted solution should be inspected before use to ensure that the product is completely dissolved and does not contain any particulate matter.

The solution of Daptomycin Accord Healthcare has a color ranging from light yellow to light brown.

Dilution:

• 1. Slowly withdraw the required amount of reconstituted solution (50 mg daptomycin/mL) from the vial using a new sterile needle of 21 G or smaller.
• 2. Remove air, large bubbles, and excess solution from the syringe to obtain the desired dose.
• 3. Transfer the required amount of reconstituted dose to 50 mL of 0.9% sodium chloride solution (9 mg/mL).
• 4. The reconstituted and diluted solution can then be administered in an intravenous infusion over 30 or 60 minutes.

Daptomycin Accord Healthcare is physically and chemically incompatible with glucose-containing solutions.

The following medicines do not show incompatibility when added to the solution of Daptomycin Accord Healthcare: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.

Information on the stability of the reconstituted and/or diluted solution can be found in section 5.

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

Water should not be used to reconstitute Daptomycin Accord Healthcare for intravenous injection.

Daptomycin Accord Healthcare should only be reconstituted in 0.9% sodium chloride solution (9 mg/mL).

The concentration of the injection solution of Daptomycin Accord Healthcare is 50 mg/mL, which is achieved by reconstituting the lyophilized product in 10 mL of 0.9% sodium chloride solution (9 mg/mL) for injection.

The reconstitution of the lyophilized product takes approximately 3 minutes.

The completely reconstituted product is clear and may contain a few small air bubbles or foam at the edge of the vial.

To prepare Daptomycin Accord Healthcare for intravenous injection, the following instructions should be followed:

During the reconstitution of the lyophilized product, the principles of asepsis should be observed at all times.

• 1. Remove the polypropylene cap from the vial to expose the central portion of the rubber stopper.
• Wipe the rubber stopper with an alcohol swab or other antiseptic solution and let it dry.
• Do not touch the rubber stopper or allow it to come into contact with any other surface.
• Draw up 10 mL of 0.9% sodium chloride solution (9 mg/mL) for injection into a syringe using a sterile needle of 21 G or smaller.
• Slowly insert the needle into the center of the rubber stopper and inject the contents of the syringe into the vial, directing the needle onto the vial wall.

Then gently rotate the vial to completely wet the lyophilized product and let it stand for 3 minutes.

Finally, gently rotate the vial or shake it in a rotary motion for a few minutes until a clear solution is obtained.

Avoid vigorous shaking to prevent foaming of the solution.

The reconstituted solution should be inspected before use to ensure that the product is completely dissolved and does not contain any particulate matter.

The solution of Daptomycin Accord Healthcare has a color ranging from light yellow to light brown.

• 5. Slowly withdraw the reconstituted solution (50 mg daptomycin/mL) from the vial using a sterile needle of 21 G or smaller.
• 6. Invert the vial and, using a new syringe, insert the needle into the inverted vial.
• 7. Change the needle to a new one intended for intravenous injection.
• 8. Remove air, large bubbles, and excess solution from the syringe to obtain the desired dose.
• 9. The reconstituted solution should be injected slowly into a vein over 2 minutes.

Information on the stability of the reconstituted and/or diluted solution can be found in section 5.

Daptomycin Accord Healthcare should not be mixed with other medicines, except those listed above.

Vials containing Daptomycin Accord Healthcare are intended for single use only.

Any unused product should be discarded.

Only a clear solution that is practically free from particles should be used.