Daptomycin accord healthcare

Package leaflet: Information for the patient

Daptomycin Accord Healthcare, 350 mg,
powder for solution for injection/infusion
Daptomycin Accord Healthcare, 500 mg,
powder for solution for injection/infusion
Daptomycinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Leaflet contents

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

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

The active substance in Daptomycin Accord Healthcare powder for solution for injection/infusion is daptomycin. Daptomycin is an antibacterial medicine that can stop the growth of certain bacteria. Daptomycin Accord Healthcare is used in adults as well as in children and adolescents (aged 1 to 17 years) for the treatment of skin and underlying tissue infections. Daptomycin Accord Healthcare is also used to treat bloodstream infections related to skin infections.

Daptomycin Accord Healthcare is also used in adults to treat infections of the inner lining of the heart chamber (including heart valves) caused by a bacterium called Staphylococcus aureus. Daptomycin Accord Healthcare is also used to treat bloodstream infections caused by the same bacterium responsible for heart infections.

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

2. Important information before using 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 they may be allergic to any of the mentioned substances, they should
consult their doctor or nurse for advice.
Warnings and precautions
Before starting treatment with Daptomycin Accord Healthcare, consult a doctor or
nurse.

• If the patient has or has previously had kidney problems. The doctor may need to adjust the dose of Daptomycin Accord Healthcare (see section 3 of this leaflet).
• Rarely, patients receiving Daptomycin Accord Healthcare may experience muscle sensitivity or muscle pain, or muscle weakness (more information on this in section 4 of this leaflet). In such cases, the patient should inform their doctor. The doctor will arrange for blood tests and decide whether treatment with Daptomycin Accord Healthcare can continue. These symptoms usually resolve within a few days after stopping Daptomycin Accord Healthcare.
• If there has ever been a severe skin rash, skin peeling, blisters and/or mouth ulcers, or serious kidney function disorders after taking daptomycin.
• In cases of significant overweight. Blood concentrations of Daptomycin Accord Healthcare may be higher than in individuals with normal body weight, and in such cases, careful monitoring is required if adverse reactions occur. If any of the above points apply, the patient should inform their doctor or nurse before starting treatment with Daptomycin Accord Healthcare.

Immediately inform the doctor or nurse 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, rash, hives, or fever.
• Serious skin diseases have been reported during treatment with daptomycin. Symptoms associated with these conditions may include:
• onset or worsening of fever,
• red, raised, or fluid-filled blisters on the skin, which may appear under the arms, on the chest, or in the groin area, and may spread over large areas of the body,
• blisters or ulcers in the mouth or on the genitals.
• Serious kidney function disorders have been reported during treatment with daptomycin. Symptoms may include fever and rash.
• Tingling or numbness in the hands or feet, loss of sensation, or difficulty moving. If any of these symptoms occur, inform the doctor, who will decide whether to discontinue or continue treatment.
• Diarrhea, especially if blood or mucus is present, or if diarrhea becomes severe or persistent.
• Onset or worsening of fever, cough, or difficulty breathing. These may be symptoms of a rare but serious lung disorder called eosinophilic pneumonia. The doctor will examine the lungs and decide whether to continue or discontinue treatment with Daptomycin Accord Healthcare.

Daptomycin Accord Healthcare may affect laboratory test results assessing
blood coagulation. Laboratory results may indicate poor blood clotting even when
blood coagulation is actually normal. Therefore, it is important that the doctor takes into
account that the patient is receiving Daptomycin Accord Healthcare. Inform the
doctor about the use of Daptomycin Accord Healthcare.
To monitor muscle status, the doctor may order blood tests both before and repeatedly 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 shown that severe adverse reactions may occur in this age group.
Use in elderly patients
Patients aged 65 years and older may be given the same dose as recommended for other adult patients, provided no kidney function impairment has been diagnosed.
Daptomycin Accord Healthcare and other medicines
Inform the doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. It is especially important to inform the doctor about:

• Medicines known as statins or fibrates (cholesterol-lowering agents) or cyclosporine (a medicine used in transplantation to prevent graft rejection or in other conditions, e.g., rheumatoid arthritis or atopic dermatitis). Using any of these (or other muscle-affecting) medicines during treatment with Daptomycin Accord Healthcare may increase the risk of muscle-related adverse effects. The doctor will decide whether to discontinue Daptomycin Accord Healthcare or temporarily withhold the other medicines.
• Pain-relieving medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g., celecoxib). These may affect the action of Daptomycin Accord Healthcare on the kidneys.
• Oral anticoagulant medicines (e.g., warfarin), which prevent blood clotting. The doctor may need to monitor blood clotting time.

Pregnancy and breastfeeding
Daptomycin Accord Healthcare is generally not given to pregnant women. If the patient is
pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should
consult her doctor or pharmacist before using this medicine.
Do not use this medicine during breastfeeding, as Daptomycin Accord Healthcare may pass into breast milk and may harm the infant.
Driving and operating machinery
There are no known cases of Daptomycin Accord Healthcare affecting 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, meaning 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 (aged 18 years and above)
The dose depends on body weight and the type of infection being treated. The usual dose for adults is 4 mg per kilogram (kg) of body weight once daily for skin infections, or 6 mg per kg of body weight once daily for heart infection or bloodstream infection associated with skin or heart infection. In adult patients, this dose is given directly into the blood (intravenously) as an infusion lasting approximately 30 minutes or as an injection lasting approximately 2 minutes. The same dose is recommended for patients over 65 years of age, unless impaired kidney function has been diagnosed.
If kidney function is impaired, Daptomycin Accord Healthcare may be given less frequently, for example every other day. In dialysis patients, if the next dose of Daptomycin Accord Healthcare is scheduled on a dialysis day, Daptomycin Accord Healthcare is usually administered after completion of dialysis.
Children and adolescents (aged 1 to 17 years)
The dose for children and adolescents (aged 1 to 17 years) will depend on the patient's age and the type of infection being treated. The dose is administered directly into the bloodstream (intravenously) by infusion lasting approximately 30–60 minutes.
Treatment usually lasts from 1 to 2 weeks for skin infections. For bloodstream or heart infections, as well as for skin infections, the duration of treatment will be determined by the doctor.
Detailed instructions for preparation and administration of the medicinal product are provided at the end of this leaflet.
If you have further questions about the use of this medicinal product, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most serious adverse reactions are described below:
Serious adverse reactions with unknown frequency (frequency cannot be estimated from the available data)

• Cases of hypersensitivity reactions (severe allergic reactions, including anaphylaxis and angioedema) have been reported during administration of Daptomycin Accord Healthcare. This severe allergic reaction requires immediate medical attention. You should inform your doctor or nurse immediately if you experience any of the following symptoms:
  • chest pain or chest tightness,
  • rash or hives,
  • swelling of the throat,
  • rapid or weak pulse,
  • wheezing,
  • fever,
  • chills or shivering,
  • hot flushes,
  • dizziness,
  • fainting,
  • metallic taste in the mouth.
• If you experience unexplained muscle pain, tenderness, or weakness, you should inform your doctor immediately. Muscle-related symptoms may be serious. Muscle cells may break down (a condition known as rhabdomyolysis), which may lead to kidney damage. Other serious adverse reactions reported with daptomycin include:
• Rare but potentially serious lung disorder called eosinophilic pneumonia, which may occur when treatment lasts longer than 2 weeks. Symptoms may include difficulty breathing, new or worsening cough, or new or worsening fever.
• Severe skin disorders. Symptoms may include:
  • new or worsening fever,
  • red, raised, or fluid-filled blisters on the skin, which may appear under the arms, on the chest, or in the genital area, and which may spread over large areas of the body,
  • blisters or ulcers in the mouth or on the genitals.
• Serious kidney dysfunction. Symptoms may include fever and rash. You should inform your doctor or nurse immediately if you experience such symptoms. Your doctor will perform additional tests to confirm the diagnosis.

The most commonly reported adverse reactions are described below:
Adverse reactions occurring commonly (may affect up to 1 in 10 people)

• fungal infections, such as candidiasis,
• urinary tract infection,
• decreased number of red blood cells (anaemia),
• dizziness, restlessness, difficulty sleeping,
• headache,
• fever, weakness (asthenia),
• increased or decreased blood pressure,
• constipation, abdominal pain,
• diarrhoea, nausea or vomiting,
• flatulence,
• abdominal distension or bloating,
• skin rash or itching,
• pain, itching or redness around the infusion site,
• pain in arms or legs,
• increased levels of liver enzymes or creatine phosphokinase (CPK) in blood.

Other adverse reactions that may occur after administration of Daptomycin Accord Healthcare are described below:
Adverse reactions occurring uncommonly (may affect up to 1 in 100 people)

• blood disorders (e.g. increased number of small blood cells called platelets, which may increase blood clotting, or increased number of certain types of white blood cells),
• decreased appetite,
• tingling or numbness in hands or feet, taste disturbances,
• tremor,
• changes in heart rhythm, sudden flushing of the face,
• indigestion (dyspepsia), inflammation of the tongue,
• itchy skin rash,
• muscle pain, cramps or weakness, muscle inflammation, joint pain,
• kidney function disorders,
• inflammation or irritation of the vagina,
• general feeling of pain or weakness, fatigue (tiredness),
• increased blood glucose, serum creatinine, myoglobin, lactate dehydrogenase (LDH) activity, prolonged blood clotting time, or electrolyte imbalance,
• eye itching.

Adverse reactions occurring rarely (may affect up to 1 in 1000 people)

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

Frequency unknown (frequency cannot be estimated from the available data)
Colitis associated with antibacterial effect, including pseudomembranous colitis [severe or persistent diarrhoea with blood and (or) mucus, associated with abdominal pain or fever], easy bruising, bleeding from gums or nosebleeds.
Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Daptomycin Accord Healthcare

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

The chemical and physical stability of the reconstituted solution in the vial is 12 hours at 25°C or
up to 48 hours at temperatures between 2°C and 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 point of view, the prepared medicinal product should be used immediately. If not used immediately, the user is responsible for the storage duration. Usually, this time should not exceed 24 hours at 2°C - 8°C, unless reconstitution 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 temperatures between 2°C and 8°C.
For a 30-minute intravenous infusion, the total storage time (reconstituted solution in the vial and diluted solution in the infusion bag, see section 6.6) must 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 reconstitution and dilution method eliminates the risk of microbiological contamination. If not used immediately, the user is responsible for the storage duration.

6. Contents of the package and other information

What Daptomycin Accord Healthcare contains

• The active substance 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.

• Other ingredients are: disodium phosphate dihydrate, monosodium dihydrogen phosphate monohydrate and sodium hydroxide (for pH adjustment).

What Daptomycin Accord Healthcare looks like and contents of the pack
Daptomycin Accord Healthcare powder for solution for injection/infusion is available as a lyophilisate in the form of a yellowish to light brownish cake or powder in glass vials, packed in a cardboard box.
Before administration, the powder must be reconstituted with a solvent to form a solution.
Daptomycin Accord Healthcare is available in packs containing 1 vial.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
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.
Lutomierska 50 Street
95-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens
Schimatari, 32009 Lamia
Greece

This medicinal product is authorised in the European Economic Area countries under the following names:

varten

Information intended exclusively for healthcare professionals

Warning: Before prescribing the medicinal product, read the Summary of Product Characteristics.
Instructions for use and handling
Daptomycin Accord Healthcare, 350 mg, powder for solution for injection/infusion
In adult patients, daptomycin may be administered intravenously as a 30-minute infusion or as a
2-minute injection. In contrast to adult patients, daptomycin should not be administered as a 2-minute
injection in children and adolescents. In children and adolescents aged 7 to 17 years, daptomycin
should be administered as a 30-minute infusion. In children under 7 years of age receiving a dose of
9–12 mg/kg body weight, daptomycin should be administered over 60 minutes. Preparation of the
infusion solution requires an additional dilution step, as specified below.

Medicinal product Daptomycin Accord Healthcare administered as intravenous infusion lasting 30 or 60 minutes
The concentration of Daptomycin Accord Healthcare medicinal product in the infusion solution of
50 mg/mL is achieved by reconstituting the lyophilized product with 7 mL of sodium chloride 9 mg/mL
(0.9%) solution for injection.
Dissolution of the lyophilized product usually takes 3 minutes. The fully reconstituted solution is clear
and may contain a few small air bubbles or foam at the edge of the vial.
To prepare the Daptomycin Accord Healthcare medicinal product for intravenous infusion, follow the
instructions below:
Aseptic techniques must be maintained at all times during reconstitution or dilution of the lyophilized
Daptomycin Accord Healthcare medicinal product.

Reconstitution:

1. Remove the polypropylene vial cap to expose the central portion of the rubber stopper. Wipe the rubber stopper with an alcohol-impregnated swab or other antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile 21 G or smaller gauge needle or a needle-free device, draw into a syringe 7 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (physiological saline), then slowly pierce the center of the rubber stopper and inject the syringe contents, directing the needle against the vial wall.
2. Gently rotate the vial to completely wet the lyophilisate and leave it for 3 minutes.
3. Finally, gently rotate or swirl the vial for a few minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Inspect the reconstituted solution carefully before use to ensure that the medicinal product is completely dissolved and free from particulate matter. The Daptomycin Accord Healthcare medicinal product solution is pale yellow to light brown in color.
5. Dilute the reconstituted solution with 0.9% sodium chloride solution (9 mg/mL) (typically in 50 mL).

Dilution:

1. Slowly withdraw the required amount of reconstituted solution (50 mg daptomycin/mL) from the vial using a new sterile 21 G or smaller gauge needle by inverting the vial so that the solution flows toward the stopper. Using a syringe, insert the needle into the inverted vial. While holding the vial upside down, place the needle tip as deep as possible into the solution in the vial while drawing the solution into the syringe. Before removing the needle from the vial, pull the syringe plunger fully back to withdraw the desired amount of solution from the inverted vial.
2. Remove air, large bubbles, and excess solution from the syringe to achieve the required dose.
3. Transfer the required amount of reconstituted dose to 50 mL of sodium chloride 9 mg/mL (0.9%) solution.
4. The reconstituted and diluted solution may then be administered as an intravenous infusion over 30 or 60 minutes.

The Daptomycin Accord Healthcare medicinal product is physically and chemically incompatible with fluids
containing glucose. The following drugs do not show incompatibility when added to the Daptomycin Accord
Healthcare medicinal product solution: aztreonam, ceftazidime, ceftriaxone, gentamicin,
fluconazole, levofloxacin, dopamine, heparin, and lidocaine.
Information on the stability of the reconstituted and/or diluted solution is provided in section 5.

Medicinal product Daptomycin Accord Healthcare administered as a 2-minute intravenous injection (adults only)
Water must not be used to reconstitute Daptomycin Accord Healthcare medicinal product for intravenous
injection. The Daptomycin Accord Healthcare medicinal product must be reconstituted exclusively with
0.9% sodium chloride solution (9 mg/mL).
The concentration of Daptomycin Accord Healthcare injection solution of 50 mg/mL is achieved by
reconstituting the lyophilized product with 7 mL of 0.9% sodium chloride solution (9 mg/mL) for injection.
The lyophilized product dissolves in approximately 3 minutes. The fully dissolved medicinal product becomes
clear and may contain a few small bubbles or foam at the edge of the vial.
To prepare the Daptomycin Accord Healthcare medicinal product for intravenous injection, follow the
instructions below.
Aseptic techniques must be maintained at all times during reconstitution of the lyophilized Daptomycin Accord
Healthcare medicinal product.

1. Remove the polypropylene vial cap to expose the central portion of the rubber stopper. Wipe the rubber stopper with an alcohol-impregnated swab or other antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile 21 G or smaller gauge needle or a needle-free device, draw into a syringe 7 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (physiological saline), then slowly pierce the center of the rubber stopper and inject the syringe contents, directing the needle against the vial wall.
2. Gently rotate the vial to completely wet the lyophilisate and leave it for 3 minutes.
3. Finally, gently rotate or swirl the vial for a few minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Inspect the reconstituted solution carefully before use to ensure that the product is completely dissolved and free from particulate matter. The Daptomycin Accord Healthcare medicinal product solution is pale yellow to light brown in color.
5. Slowly withdraw the reconstituted solution (50 mg daptomycin/mL) from the vial using a sterile 21 G or smaller gauge needle.
6. Invert the vial so that the solution flows toward the stopper. Using a new syringe, insert the needle into the inverted vial. While holding the vial upside down, place the needle tip as deep as possible into the solution in the vial while drawing the solution into the syringe. Before removing the needle from the vial, pull the syringe plunger fully back to withdraw the entire solution from the inverted vial.
7. Change the needle to a new one suitable for intravenous injection.
8. Remove air, large bubbles, and excess solution from the syringe to achieve the required dose.
9. The reconstituted solution should be injected slowly into the vein over 2 minutes.

Information on the stability of the reconstituted/diluted solution is provided in section 5.
Daptomycin Accord Healthcare medicinal product must not be mixed with other medicinal products except
those listed above.
Vials containing Daptomycin Accord Healthcare medicinal product are for single use only. Any unused
residual product must be discarded.
Use only a clear solution that is practically free from particles.

Daptomycin Accord Healthcare, 500 mg, powder for solution for injection/infusion
In adult patients, daptomycin may be administered intravenously as a 30-minute infusion or as a
2-minute injection. In contrast to adult patients, daptomycin should not be administered as a 2-minute
injection in children and adolescents. In children and adolescents aged 7 to 17 years, daptomycin
should be administered as a 30-minute infusion. In children under 7 years of age receiving a dose of
9–12 mg/kg body weight, daptomycin should be administered over 60 minutes. Preparation of the
infusion solution requires an additional dilution step, as specified below.

Medicinal product Daptomycin Accord Healthcare administered as intravenous infusion lasting 30 or 60 minutes
The concentration of Daptomycin Accord Healthcare medicinal product in the infusion solution of
50 mg/mL is achieved by reconstituting the lyophilized product with 10 mL of sodium chloride 9 mg/mL
(0.9%) solution for injection.
Dissolution of the lyophilized product usually takes 3 minutes. The fully reconstituted solution is clear
and may contain a few small air bubbles or foam at the edge of the vial.
To prepare the Daptomycin Accord Healthcare medicinal product for intravenous infusion, follow the
instructions below:
Aseptic techniques must be maintained at all times during reconstitution or dilution of the lyophilized
Daptomycin Accord Healthcare medicinal product.

Reconstitution:

1. Remove the polypropylene vial cap to expose the central portion of the rubber stopper. Wipe the rubber stopper with an alcohol-impregnated swab or other antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile 21 G or smaller gauge needle or a needle-free device, draw into a syringe 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (physiological saline), then slowly pierce the center of the rubber stopper and inject the syringe contents, directing the needle against the vial wall.
2. Gently rotate the vial to completely wet the lyophilisate and leave it for 3 minutes.
3. Finally, gently rotate or swirl the vial for a few minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Inspect the reconstituted solution carefully before use to ensure that the medicinal product is completely dissolved and free from particulate matter. The Daptomycin Accord Healthcare medicinal product solution is pale yellow to light brown in color.
5. Dilute the reconstituted solution with 0.9% sodium chloride solution (9 mg/mL) (typically in 50 mL).

Dilution:

1. Slowly withdraw the required amount of reconstituted solution (50 mg daptomycin/mL) from the vial using a new sterile 21 G or smaller gauge needle by inverting the vial so that the solution flows toward the stopper. Using a syringe, insert the needle into the inverted vial. While holding the vial upside down, place the needle tip as deep as possible into the solution in the vial while drawing the solution into the syringe. Before removing the needle from the vial, pull the syringe plunger fully back to withdraw the desired amount of solution from the inverted vial.
2. Remove air, large bubbles, and excess solution from the syringe to achieve the required dose.
3. Transfer the required amount of reconstituted dose to 50 mL of sodium chloride 9 mg/mL (0.9%) solution.
4. The reconstituted and diluted solution may then be administered as an intravenous infusion over 30 or 60 minutes.

The Daptomycin Accord Healthcare medicinal product is physically and chemically incompatible with fluids
containing glucose. The following drugs do not show incompatibility when added to the Daptomycin Accord
Healthcare medicinal product solution: aztreonam, ceftazidime, ceftriaxone, gentamicin,
fluconazole, levofloxacin, dopamine, heparin, and lidocaine.
Information on the stability of the reconstituted/diluted solution is provided in section 5.

Medicinal product Daptomycin Accord Healthcare administered as a 2-minute intravenous injection (adults only)
Water must not be used to reconstitute Daptomycin Accord Healthcare medicinal product for intravenous
injection. The Daptomycin Accord Healthcare medicinal product must be reconstituted exclusively with
0.9% sodium chloride solution (9 mg/mL).
The concentration of Daptomycin Accord Healthcare injection solution of 50 mg/mL is achieved by
reconstituting the lyophilized product with 10 mL of 0.9% sodium chloride solution (9 mg/mL) for injection.
The lyophilized product dissolves in approximately 3 minutes. The fully dissolved medicinal product becomes
clear and may contain a few small bubbles or foam at the edge of the vial.
To prepare the Daptomycin Accord Healthcare medicinal product for intravenous injection, follow the
instructions below:
Aseptic techniques must be maintained at all times during reconstitution of the lyophilized Daptomycin Accord
Healthcare medicinal product.

1. Remove the polypropylene vial cap to expose the central portion of the rubber stopper. Wipe the rubber stopper with an alcohol-impregnated swab or other antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile 21 G or smaller gauge needle or a needle-free device, draw into a syringe 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (physiological saline), then slowly pierce the center of the rubber stopper and inject the syringe contents, directing the needle against the vial wall.
2. Gently rotate the vial to completely wet the lyophilisate and leave it for 3 minutes.
3. Finally, gently rotate or swirl the vial for a few minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Inspect the reconstituted solution carefully before use to ensure that the product is completely dissolved and free from particulate matter. The Daptomycin Accord Healthcare medicinal product solution is pale yellow to light brown in color.
5. Slowly withdraw the reconstituted solution (50 mg daptomycin/mL) from the vial using a sterile 21 G or smaller gauge needle.
6. Invert the vial so that the solution flows toward the stopper. Using a new syringe, insert the needle into the inverted vial. While holding the vial upside down, place the needle tip as deep as possible into the solution in the vial while drawing the solution into the syringe. Before removing the needle from the vial, pull the syringe plunger fully back to withdraw the entire solution from the inverted vial.
7. Change the needle to a new one suitable for intravenous injection.
8. Remove air, large bubbles, and excess solution from the syringe to achieve the required dose.
9. The reconstituted solution should be injected slowly into the vein over 2 minutes.

Information on the stability of the reconstituted/diluted solution is provided in section 5.
Daptomycin Accord Healthcare medicinal product must not be mixed with other medicinal products except
those listed above.
Vials containing Daptomycin Accord Healthcare medicinal product are for single use only. Any unused
residual product must be discarded.
Use only a clear solution that is practically free from particles.