Daptomicin Accordpharma

Leaflet accompanying the packaging: patient information

Daptomycin Accordpharma, 350 mg,

powder for solution for injection/infusion

Daptomycin Accordpharma, 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 Accordpharma and what is it used for
• 2. Important information before taking Daptomycin Accordpharma
• 3. How to take Daptomycin Accordpharma
• 4. Possible side effects
• 5. How to store Daptomycin Accordpharma
• 6. Contents of the packaging and other information

1. What is Daptomycin Accordpharma and what is it used for

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

Daptomycin Accordpharma 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 Accordpharma is also used to treat blood infections caused by the same bacterium that causes heart infections.

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

2. Important information before taking Daptomycin Accordpharma

When not to use Daptomycin Accordpharma:

Warnings and precautions

Before starting treatment with Daptomycin Accordpharma, 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 Accordpharma (see section 3 in this leaflet).
• In patients receiving Daptomycin Accordpharma, muscle pain or sensitivity, or muscle weakness may occasionally occur (more information on this in section 4 of this leaflet). In such a case, the patient should inform their doctor. The doctor will take care of performing a blood test and deciding whether to continue using Daptomycin Accordpharma. The mentioned symptoms usually disappear within a few days after stopping the use of Daptomycin Accordpharma.
• If a severe skin rash or peeling, blisters, and (or) ulcers in the mouth or serious kidney problems have occurred after taking daptomycin.
• In case of severe obesity. The concentrations of Daptomycin Accordpharma in the blood may be increased compared to concentrations in people with average body weight, and in such a case, if side effects occur, careful monitoring of the patient is necessary. If any of the above points apply to the patient, they should tell their doctor or nurse before starting treatment with Daptomycin Accordpharma.

The patient should immediately inform their doctor or nurse about the occurrence of any of the following symptoms:

• Severe, acute allergic reactions have been observed in patients treated with almost all antibacterial medicines, including Daptomycin Accordpharma. Symptoms include wheezing, difficulty breathing, swelling of the face, neck, and throat, rash, and hives, fever.
• Severe skin diseases have been reported during treatment with daptomycin. The symptoms that occur in these diseases may include:
• the occurrence or worsening of fever,
• red, raised or fluid-filled bumps on the skin, which may appear under the arms, chest, or groin and may spread over a large area of the body,
• blisters or ulcers in the mouth or on the genitals.
• Severe kidney problems have 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 above symptoms occur, the patient 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.
• Occurrence 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 patient's lungs and decide whether to continue or stop treatment with Daptomycin Accordpharma.

Daptomycin Accordpharma 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 Accordpharma. The patient should inform their doctor about taking Daptomycin Accordpharma.

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

Children and adolescents

Daptomycin Accordpharma should not be given to children under one year of age, as animal studies have shown that it may cause severe side effects in this age group.

Use in elderly patients

Patients over 65 years of age, if they do not have kidney disease, can be given the same dose as recommended for adults.

Daptomycin Accordpharma 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:

• Medicines that lower cholesterol levels (called statins or fibrates) or cyclosporine (a medicine used in transplantology to prevent rejection of the transplant or in other conditions, such as rheumatoid arthritis or atopic dermatitis). Taking any of these (or other muscle-acting) medicines during treatment with Daptomycin Accordpharma may increase the risk of muscle side effects. The doctor will decide whether to stop taking Daptomycin Accordpharma or temporarily stop taking other medicines.
• Pain relievers, called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g., celecoxib). They may affect the action of Daptomycin Accordpharma 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 Accordpharma is not usually given to pregnant women. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

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

Driving and using machines

There are no known cases of Daptomycin Accordpharma affecting the ability to drive vehicles or operate machinery.

Daptomycin Accordpharma 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 take Daptomycin Accordpharma

Daptomycin Accordpharma is usually administered by a doctor or nurse.

Adults (18 years and older)

The dose depends on body 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 people over 65 years old, if they do not have kidney disease.

If kidney function is impaired, Daptomycin Accordpharma may be administered less frequently, e.g., every other day. In patients undergoing dialysis, if the next dose of Daptomycin Accordpharma is due on the day of dialysis, Daptomycin Accordpharma is usually administered after dialysis is completed.

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. For blood or heart infections, as well as 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.

4. Possible side effects

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

The most serious side effects are described below:

Severe side effects, frequency unknown(frequency cannot be determined based on available data)

Reports of hypersensitivity reactions (severe allergic reaction, including anaphylaxis and angioedema) have been received during treatment with Daptomycin Accordpharma. The occurrence of this severe allergic reaction requires immediate medical attention. The patient should immediately inform their doctor or nurse about the occurrence 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 occurs, 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:

Severe side effects, frequency unknown(frequency cannot be determined based on available data):

• A rare but potentially severe lung disorder called eosinophilic pneumonia, occurring in cases of treatment lasting more than 2 weeks. Its symptoms include difficulty breathing, occurrence or worsening of cough, occurrence or worsening of fever.
• Severe skin diseases. The symptoms may include:
• the occurrence or worsening of fever,
• red, raised or fluid-filled bumps on the skin, which may appear under the arms, chest, or groin and may spread over a large area of the body,
• blisters or ulcers in the mouth or on the genitals.
• Severe kidney problems. The symptoms may include fever and rash.

The patient should immediately inform their doctor or nurse about the occurrence of such symptoms. The doctor will perform additional tests to make a diagnosis.

The most common 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 Accordpharma are described below:

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

• blood disorders (e.g., increased number of small blood cells called platelets, which can increase blood clotting, or increased number of certain types of white blood cells),
• decreased appetite,
• numbness or tingling of the hands or feet, taste disorders,
• 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 problems,
• vaginal 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,
• prolonged prothrombin time.

Frequency unknown(frequency cannot be determined based on available data)

Colitis associated with antibacterial action, 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 side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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

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 Accordpharma

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

6. Contents of the packaging and other information

What Daptomycin Accordpharma contains

• The active substance of the medicine is daptomycin. One vial of powder contains 350 mg or 500 mg of daptomycin.
• The other ingredient is sodium hydroxide (to adjust pH).

What Daptomycin Accordpharma looks like and contents of the pack

Daptomycin Accordpharma powder for solution for injection/infusion is available as a yellow to light brown disc or powder in glass vials. Before administration, the powder must be mixed with a solvent, so that a liquid is formed.

Daptomycin Accordpharma is available in packs containing 1 vial or 5 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.

ul. Taśmowa 7

02-677 Warsaw

Manufacturer/Importer

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

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,

32009, Lamia, Schimatari

Greece

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

Date of last revision of the leaflet: February 2025

Information intended for healthcare professionals only

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

Instructions for use and handling

Vial 350 mg:

For adult patients, daptomycin can be administered intravenously in an infusion over 30 minutes or as an injection over 2 minutes. Unlike adult patients, children and adolescents should not be given daptomycin as a 2-minute injection. Children and adolescents between 7 and 17 years old should be given daptomycin as an infusion over 30 minutes. Children under 7 years old receiving a dose of 9-12 mg/kg body weight should be given daptomycin over 60 minutes. Preparation of the infusion solution requires an additional dilution step, which is detailed below.

Daptomycin Accordpharma administered as a 30- or 60-minute intravenous infusion

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

Reconstitution of the lyophilized product takes about 20 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 Accordpharma for intravenous infusion, follow the instructions below.

During reconstitution or dilution of the lyophilized product, always follow the rules of asepsis.

Reconstitution:

• 1. Break the polypropylene cap of the vial to expose the central part of the rubber stopper. Wipe the rubber stopper with an alcohol swab or other antiseptic solution and let it dry. After cleaning, do not touch the rubber stopper and do not 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, or a needleless device. Then, slowly insert the needle into the center of the rubber stopper and inject the contents of the syringe, directing the needle towards the vial wall.
• 2. Then, gently rotate the vial to completely wet the lyophilizate and let it stand for 10 minutes.
• 3. 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.
• 4. The reconstituted solution should be carefully inspected before use to ensure that the product is completely dissolved and does not contain any solid particles. The solution of Daptomycin Accordpharma has a color from light yellow to light brown.
• 5. The reconstituted solution should be diluted with 0.9% sodium chloride solution (9 mg/ml) (usually in 50 ml).

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. Invert the vial and, using a syringe, insert the needle into the inverted vial. Hold the vial upside down and place the needle tip as deep as possible in the solution in the vial while withdrawing the solution into the syringe. Before removing the needle from the vial, pull the syringe plunger all the way back to withdraw the desired amount of solution from the inverted vial.

• 2. Remove air, large bubbles, and excess solution from the syringe to obtain the desired dose.
• 3. Transfer the desired 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 as an intravenous infusion over 30 or 60 minutes.

Daptomycin Accordpharma is physically and chemically incompatible with glucose-containing solutions. The following medicines do not show incompatibility when added to the solution of Daptomycin Accordpharma: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.

The total storage time (reconstituted solution in the vial and diluted solution in the infusion bag) should not exceed 12 hours at 25°C or 24 hours (if stored in a refrigerator).

The stability of the diluted solution in the infusion bag is 12 hours at 25°C or 24 hours if stored in a refrigerator at 2°C - 8°C.

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

Water should not be used to reconstitute Daptomycin Accordpharma for intravenous injection. Daptomycin Accordpharma should be reconstituted only with 0.9% sodium chloride solution (9 mg/ml).

The concentration of the injection solution of 50 mg/ml is achieved by reconstituting the lyophilized product in 7 ml of 0.9% sodium chloride solution (9 mg/ml) for injection.

Reconstitution of the lyophilized product takes about 20 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 Accordpharma for intravenous injection, follow the instructions below.

During reconstitution of the lyophilized product, always follow the rules of asepsis.

• 1. Break the polypropylene cap of the vial to expose the central part of the rubber stopper. Wipe the rubber stopper with an alcohol swab or other antiseptic solution and let it dry. After cleaning, do not touch the rubber stopper and do not 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, or a needleless device. Then, slowly insert the needle into the center of the rubber stopper and inject the contents of the syringe, directing the needle towards the vial wall.
• 2. Then, gently rotate the vial to completely wet the lyophilizate and let it stand for 10 minutes.
• 3. 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.
• 4. The reconstituted solution should be carefully inspected before use to ensure that the product is completely dissolved and does not contain any solid particles. The solution of Daptomycin Accordpharma has a color 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. Hold the vial upside down and place the needle tip as deep as possible in the solution in the vial while withdrawing the solution into the syringe. Before removing the needle from the vial, pull the syringe plunger all the way back to withdraw the entire solution from 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.

The chemical and physical stability of the reconstituted solution in the vial is 12 hours at 25°C or up to 48 hours when stored in a refrigerator (2°C - 8°C).

However, from a microbiological point of view, the prepared product should be used immediately. If not used immediately, the storage time is the responsibility of the user, usually not more than 24 hours at 2°C - 8°C, unless reconstitution and dilution were performed under controlled and validated aseptic conditions.

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

Vials containing Daptomycin Accordpharma are intended for single use only. Any unused product or waste should be disposed of.

Information intended for healthcare professionals only

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

Instructions for use and handling

Vial 500 mg:

For adult patients, daptomycin can be administered intravenously in an infusion over 30 minutes or as an injection over 2 minutes. Unlike adult patients, children and adolescents should not be given daptomycin as a 2-minute injection. Children and adolescents between 7 and 17 years old should be given daptomycin as an infusion over 30 minutes. Children under 7 years old receiving a dose of 9-12 mg/kg body weight should be given daptomycin over 60 minutes. Preparation of the infusion solution requires an additional dilution step, which is detailed below.

Daptomycin Accordpharma administered as a 30- or 60-minute intravenous infusion

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

Reconstitution of the lyophilized product takes about 20 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 Accordpharma for intravenous infusion, follow the instructions below.

During reconstitution or dilution of the lyophilized product, always follow the rules of asepsis.

Reconstitution:

• 1. Break the polypropylene cap of the vial to expose the central part of the rubber stopper. Wipe the rubber stopper with an alcohol swab or other antiseptic solution and let it dry. After cleaning, do not touch the rubber stopper and do not 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, or a needleless device. Then, slowly insert the needle into the center of the rubber stopper and inject the contents of the syringe, directing the needle towards the vial wall.
• 2. Then, gently rotate the vial to completely wet the lyophilizate and let it stand for 10 minutes.
• 3. 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.
• 4. The reconstituted solution should be carefully inspected before use to ensure that the product is completely dissolved and does not contain any solid particles. The solution of Daptomycin Accordpharma has a color from light yellow to light brown.
• 5. The reconstituted solution should be diluted with 0.9% sodium chloride solution (9 mg/ml) (usually in 50 ml).

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. Invert the vial and, using a syringe, insert the needle into the inverted vial. Hold the vial upside down and place the needle tip as deep as possible in the solution in the vial while withdrawing the solution into the syringe. Before removing the needle from the vial, pull the syringe plunger all the way back to withdraw the desired amount of solution from the inverted vial.

• 2. Remove air, large bubbles, and excess solution from the syringe to obtain the desired dose.
• 3. Transfer the desired 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 as an intravenous infusion over 30 or 60 minutes.

Daptomycin Accordpharma is physically and chemically incompatible with glucose-containing solutions. The following medicines do not show incompatibility when added to the solution of Daptomycin Accordpharma: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.

The total storage time (reconstituted solution in the vial and diluted solution in the infusion bag) should not exceed 12 hours at 25°C or 24 hours (if stored in a refrigerator).

The stability of the diluted solution in the infusion bag is 12 hours at 25°C or 24 hours if stored in a refrigerator at 2°C - 8°C.

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

Water should not be used to reconstitute Daptomycin Accordpharma for intravenous injection. Daptomycin Accordpharma should be reconstituted only with 0.9% sodium chloride solution (9 mg/ml).

The concentration of the injection solution of 50 mg/ml is achieved by reconstituting the lyophilized product in 10 ml of 0.9% sodium chloride solution (9 mg/ml) for injection.

Reconstitution of the lyophilized product takes about 20 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 Accordpharma for intravenous injection, follow the instructions below.

During reconstitution of the lyophilized product, always follow the rules of asepsis.

• 1. Break the polypropylene cap of the vial to expose the central part of the rubber stopper. Wipe the rubber stopper with an alcohol swab or other antiseptic solution and let it dry. After cleaning, do not touch the rubber stopper and do not 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, or a needleless device. Then, slowly insert the needle into the center of the rubber stopper and inject the contents of the syringe, directing the needle towards the vial wall.
• 2. Then, gently rotate the vial to completely wet the lyophilizate and let it stand for 10 minutes.
• 3. 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.
• 4. The reconstituted solution should be carefully inspected before use to ensure that the product is completely dissolved and does not contain any solid particles. The solution of Daptomycin Accordpharma has a color 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. Hold the vial upside down and place the needle tip as deep as possible in the solution in the vial while withdrawing the solution into the syringe. Before removing the needle from the vial, pull the syringe plunger all the way back to withdraw the entire solution from 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.

The chemical and physical stability of the reconstituted solution in the vial is 12 hours at 25°C or up to 48 hours when stored in a refrigerator (2°C - 8°C).

However, from a microbiological point of view, the prepared product should be used immediately. If not used immediately, the storage time is the responsibility of the user, usually not more than 24 hours at 2°C - 8°C, unless reconstitution and dilution were performed under controlled and validated aseptic conditions.

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

Vials containing Daptomycin Accordpharma are intended for single use only. Any unused product or waste should be disposed of.