Daptomycin accordpharma

Package leaflet: Information for the patient

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents

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

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

The active substance in Daptomycin Accordpharma, a powder for solution for injection/infusion, is daptomycin. Daptomycin is an antibacterial agent that can stop the growth of certain bacteria. Daptomycin Accordpharma is used in adults and in children and adolescents (from 1 year to 17 years of age) for the treatment of skin and soft tissue infections. Daptomycin Accordpharma is also used in the treatment of bloodstream infections associated with skin infections.
Daptomycin Accordpharma is also used in adults for the treatment of infections of the inner lining of the heart chambers and valves (endocarditis), caused by a bacterium called Staphylococcus aureus. Daptomycin Accordpharma is also used in the treatment of 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 Accordpharma.

2. Important information before using Daptomycin Accordpharma

When not to use Daptomycin Accordpharma:

• if the patient is allergic to daptomycin or sodium hydroxide (listed in section 6). The patient should inform the doctor or nurse if they have any allergies or hypersensitivity. If the patient suspects they may be allergic to any of these substances, they should consult their doctor or nurse for advice.

Warnings and precautions
Before starting treatment with Daptomycin Accordpharma, 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 Accordpharma (see section 3 of this leaflet).
• Muscle pain, tenderness, or weakness may occasionally occur in patients receiving Daptomycin Accordpharma (more information on this is provided 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 Accordpharma should continue. These symptoms usually resolve within a few days after stopping Daptomycin Accordpharma.
• If the patient has ever experienced severe skin rash, skin peeling, blisters, and/or mouth ulcers, or serious kidney problems after taking daptomycin.
• In cases of significant overweight. Blood concentrations of Daptomycin Accordpharma may be higher than in individuals with normal body weight, and careful monitoring may be 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 Accordpharma.

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 agents, including Daptomycin Accordpharma. Symptoms may include wheezing, difficulty breathing, swelling of the face, neck, and throat, rash, hives, and fever.
• Serious skin disorders have been reported during treatment with daptomycin. Symptoms associated with these disorders 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 problems have been reported during daptomycin treatment. 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, the patient should inform their 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 Accordpharma.

Daptomycin Accordpharma may affect laboratory test results assessing blood coagulation. Laboratory results may suggest poor blood clotting even when clotting function is actually normal. It is therefore important that the doctor takes into account that the patient is receiving Daptomycin Accordpharma. The patient should inform their doctor about the use of Daptomycin Accordpharma.
To monitor muscle function, the doctor may order blood tests both before and repeatedly 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 severe adverse effects may occur in this age group.

Use in elderly patients
Patients aged 65 years and older may receive the same dose as recommended for adults, provided no kidney disease has been diagnosed.

Daptomycin Accordpharma and other medicines
Inform the doctor or nurse about all medicines currently used, recently used, or planned for use. It is especially important to inform the doctor about:

• Medicines that lower cholesterol (known as statins or fibrates) or cyclosporine (a medicine used in transplant medicine to prevent organ rejection or in other conditions such as rheumatoid arthritis or atopic dermatitis). Using any of these (or other muscle-affecting) medicines during treatment with Daptomycin Accordpharma may increase the risk of muscle-related adverse effects. The doctor will decide whether to discontinue Daptomycin Accordpharma or temporarily suspend the use of other medicines.
• Painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These may affect the impact 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 generally not given to pregnant women. If the patient is pregnant, 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 Accordpharma may pass into breast milk and may harm the child.

Driving and operating machinery
There are no known effects of Daptomycin Accordpharma on the ability to drive or operate machinery.

Daptomycin Accordpharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning it is considered "sodium-free".

3. How to take Daptomycin Accordpharma

Daptomycin Accordpharma 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 infections or bloodstream infections associated with skin or heart infections. In adult patients, this dose is given directly into the bloodstream (intravenously) as an infusion lasting approximately 30 minutes or as an injection lasting approximately 2 minutes. The same dose is recommended for individuals over 65 years of age, unless kidney problems have been diagnosed.
If kidney function is impaired, Daptomycin Accordpharma may be administered less frequently, for example, every other day. In dialysis patients, if the next dose of Daptomycin Accordpharma falls on a dialysis day, Daptomycin Accordpharma is usually given 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 to 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 the preparation and administration of the medicine are provided at the end of this leaflet.
If you have further questions about the use of this medicine, please 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 reaction, including anaphylaxis and angioedema)
have been reported during administration of Daptomycin Accordpharma. This severe allergic reaction
requires immediate medical attention. Immediately inform your doctor or nurse 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 immediately inform
your doctor. 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 after daptomycin use include:
Serious adverse reactions with unknown frequency (frequency cannot be estimated from the
available data):

• Rare but potentially serious lung disorder called eosinophilic pneumonia, occurring during treatment lasting more than 2 weeks. Symptoms include difficulty breathing, new or worsening cough, or new or worsening fever.
• Serious skin diseases. 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 groin area and may spread over large areas of the body,
• blisters or ulcers in the mouth or on the genitals.
• serious kidney problems. Symptoms may include fever and rash.

Immediately inform your doctor or nurse if you experience any of these symptoms. Your doctor will
perform additional tests to establish a diagnosis.
The most commonly reported adverse reactions are described below:
Adverse reactions occurring commonly (may affect fewer than 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 Accordpharma are
described below:
Adverse reactions occurring uncommonly (may affect fewer than 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 problems,
• inflammation or irritation of the vagina,
• general feeling of pain or weakness, fatigue (tiredness),
• increased blood glucose, serum creatinine, myoglobin levels, lactate dehydrogenase (LDH) activity, prolonged blood clotting time, or electrolyte imbalance,
• eye itching.

Adverse reactions occurring rarely (may affect fewer than 1 in 1000 people)

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

Frequency unknown (frequency cannot be estimated from the available data)
Inflammation of the large intestine due to 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 nose.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your
doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of
Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Daptomycin Accordpharma

• 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 label after: EXP. The expiry date refers to the last day of the stated month.
• Store in a refrigerator (2°C - 8°C).

6. Contents of the packaging and other information

What Daptomycin Accordpharma contains

• The active substance is daptomycin. One vial of powder contains 350 mg or 500 mg of daptomycin.
• The other ingredient is: sodium hydroxide (for pH adjustment).

What Daptomycin Accordpharma looks like and contents of the pack
Daptomycin Accordpharma powder for solution for injection/infusion is available as a yellowish to light brownish cake or powder in glass vials. Before administration, the powder must be mixed with a solvent to form a solution.
Daptomycin Accordpharma is available in packs containing 1 vial or 5 vials.
Not all pack sizes may be marketed.

Marketing Authorisation 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,
32009, Lamia, Schimatari
Greece

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

Information intended exclusively for healthcare professionals

Warning: Before prescribing the medicinal product, refer to the Product Characteristics.
Instructions for use and handling
Vial 350 mg:
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, specified below.

Daptomycin Accordpharma medicinal product administered as an intravenous infusion lasting 30 or 60 minutes
The concentration of Daptomycin Accordpharma 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 typically takes about 20 minutes. The fully reconstituted product is clear and may contain a few small air bubbles or foam at the edge of the vial.
To prepare the Daptomycin Accordpharma medicinal product for intravenous infusion, follow the instructions below.
Throughout the reconstitution and dilution process of the lyophilized Daptomycin Accordpharma medicinal product, aseptic techniques must be strictly maintained.

Reconstitution:

1. Remove the polypropylene cap from the vial to expose the central area 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. Draw 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline) into a syringe using a sterile 21 G needle or smaller gauge, or a needle-free device. Then slowly pierce the center of the rubber stopper with the needle, directing the needle against the vial wall, and inject the syringe contents.
2. Gently rotate the vial to completely wet the lyophilized material and leave it for 10 minutes.
3. Finally, gently rotate or swirl the vial for several minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Carefully inspect the reconstituted solution before use to ensure the medicinal product is completely dissolved and free of particulate matter. The Daptomycin Accordpharma medicinal product solution ranges in color from pale yellow to light brown.
5. Dilute the reconstituted solution with 0.9% sodium chloride solution (9 mg/ml) (typically in 50 ml).

Dilution:

1. Slowly withdraw the appropriate amount of reconstituted solution (50 mg daptomycin/ml) from the vial using a new sterile 21 G needle or smaller gauge 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 deeply as possible into the solution during withdrawal. Before removing the needle from the vial, pull back the syringe plunger fully 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 Accordpharma medicinal product is physically and chemically incompatible with glucose-containing solutions. The following drugs have shown no incompatibility when added to the Daptomycin Accordpharma medicinal product solution: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.
The total storage time (reconstituted solution in vial and diluted solution in infusion bag) must not exceed 12 hours at 25°C or 24 hours if stored refrigerated.
The stability of the diluted solution in the infusion bag is 12 hours at 25°C or 24 hours if stored refrigerated at 2°C–8°C.

Daptomycin Accordpharma medicinal product administered as a 2-minute intravenous injection (adult patients only)
Water must not be used to reconstitute Daptomycin Accordpharma medicinal product for intravenous injection. The Daptomycin Accordpharma medicinal product must be reconstituted exclusively with 0.9% sodium chloride solution (9 mg/ml).
The concentration of the Daptomycin Accordpharma 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 20 minutes. The fully dissolved medicinal product becomes clear and may contain a few small air bubbles or foam at the edge of the vial.
To prepare the Daptomycin Accordpharma medicinal product for intravenous injection, follow the instructions below.
Throughout the reconstitution process of the lyophilized Daptomycin Accordpharma medicinal product, aseptic techniques must be strictly maintained.

1. Remove the polypropylene cap from the vial to expose the central area 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. Draw 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline) into a syringe using a sterile 21 G needle or smaller gauge, or a needle-free device. Then slowly pierce the center of the rubber stopper with the needle, directing the needle against the vial wall, and inject the syringe contents.
2. Gently rotate the vial to completely wet the lyophilized material and leave it for 10 minutes.
3. Finally, gently rotate or swirl the vial for several minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Carefully inspect the reconstituted solution before use to ensure the product is completely dissolved and free of particulate matter. The Daptomycin Accordpharma medicinal product solution ranges in color from pale yellow to light brown.
5. Slowly withdraw the reconstituted solution (50 mg daptomycin/ml) from the vial using a sterile 21 G needle or smaller gauge.
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 deeply as possible into the solution during withdrawal. Before removing the needle from the vial, pull back the syringe plunger fully 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 administered slowly into the 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 refrigerated (2°C–8°C).
However, from a microbiological standpoint, the prepared product should be used immediately. If not used immediately, the storage time is the responsibility of the user and generally should not exceed 24 hours at 2°C–8°C, unless reconstitution and dilution were performed under controlled and validated aseptic conditions.
The Daptomycin Accordpharma medicinal product must not be mixed with other medicinal products except those listed above.
Vials containing the Daptomycin Accordpharma medicinal product are intended for single use only. Any unused product or waste material should be discarded.

Information intended exclusively for healthcare professionals

Warning: Read the Summary of Product Characteristics before prescribing the medicinal product.
Instructions for use and handling
Vial 500 mg:
In adult patients, daptomycin may be administered intravenously either 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.

Daptomycin Accordpharma medicinal product administered as a 30- or 60-minute intravenous infusion
The concentration of Daptomycin Accordpharma medicinal product in the infusion solution of 50 mg/ml is achieved by reconstituting the lyophilized product with 10 ml of 9 mg/ml (0.9%) sodium chloride solution for injection.
Dissolution of the lyophilized product usually takes 20 minutes. The fully reconstituted product is clear and may contain a few small air bubbles or foam at the edge of the vial.
To prepare Daptomycin Accordpharma medicinal product for intravenous infusion, follow the instructions below.
Throughout the reconstitution and dilution process of the lyophilized Daptomycin Accordpharma medicinal product, aseptic techniques must be strictly maintained.

Reconstitution:

1. Remove the polypropylene cap from the vial to expose the central area 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. Draw 10 ml of 9 mg/ml (0.9%) sodium chloride solution for injection (physiological saline) into a syringe using a sterile 21 G or smaller gauge needle, or a needle-free device. Then slowly pierce the center of the rubber stopper with the needle 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 10 minutes.
3. Finally, gently rotate or invert the vial several times for a few minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Carefully inspect the reconstituted solution before use to ensure the medicinal product is completely dissolved and free from particulate matter. The Daptomycin Accordpharma medicinal product solution ranges in color from pale yellow to light brown.
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 deeply as possible into the solution during withdrawal. Before removing the needle from the vial, pull the syringe plunger fully back to withdraw the desired volume from the inverted vial.
2. Remove air, large bubbles, and excess solution from the syringe to obtain the required dose.
3. Transfer the required volume of reconstituted dose into 50 ml of 9 mg/ml (0.9%) sodium chloride solution.
4. The reconstituted and diluted solution may then be administered as an intravenous infusion over 30 or 60 minutes.

The Daptomycin Accordpharma medicinal product is physically and chemically incompatible with glucose-containing solutions. The following medicinal products have shown no incompatibility when added to the Daptomycin Accordpharma medicinal product solution: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.
The total storage time (reconstituted solution in vial and diluted solution in infusion bag) must not exceed 12 hours at 25°C or 24 hours if stored refrigerated.
The stability of the diluted solution in the infusion bag is 12 hours at 25°C or 24 hours if stored refrigerated at 2°C–8°C.

Daptomycin Accordpharma medicinal product administered as a 2-minute intravenous injection (adults only)
Do not use water to reconstitute Daptomycin Accordpharma medicinal product for intravenous injection. The Daptomycin Accordpharma medicinal product must be reconstituted exclusively with 0.9% sodium chloride solution (9 mg/ml).
The concentration of 50 mg/ml in the injection solution 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 20 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 Daptomycin Accordpharma medicinal product for intravenous injection, follow the instructions below.
Throughout the reconstitution process of the lyophilized Daptomycin Accordpharma medicinal product, aseptic techniques must be strictly maintained.

1. Remove the polypropylene cap from the vial to expose the central area 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. Draw 10 ml of 9 mg/ml (0.9%) sodium chloride solution for injection (physiological saline) into a syringe using a sterile 21 G or smaller gauge needle, or a needle-free device. Then slowly pierce the center of the rubber stopper with the needle 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 10 minutes.
3. Finally, gently rotate or invert the vial several times for a few minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Carefully inspect the reconstituted solution before use to ensure the product is completely dissolved and free from particulate matter. The Daptomycin Accordpharma medicinal product solution ranges in color from pale yellow to light brown.
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 deeply as possible into the solution during withdrawal. 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 obtain the required dose.
9. The reconstituted solution should be injected slowly into the vein over 2 minutes.

The chemical and physical stability of the reconstituted medicinal product solution in the vial is 12 hours at 25°C or up to 48 hours when stored refrigerated (2°C–8°C).
However, from a microbiological standpoint, the prepared product should be used immediately. If not used immediately, the storage time is the responsibility of the user, but generally should not exceed 24 hours at 2°C–8°C, unless reconstitution and dilution were performed under controlled and validated aseptic conditions.
Daptomycin Accordpharma medicinal product must not be mixed with other medicinal products except those listed above.
Vials containing Daptomycin Accordpharma medicinal product are for single use only. Any unused product or waste material should be discarded.