Daptomycin Accord Pharma 500 mg powder for solution for injection and for infusion EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Daptomycin Accordpharma 350 mg powder for solution for injection and infusion EFG

Daptomycin Accordpharma 500 mg powder for solution for injection and infusion EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance in this medicine is daptomycin. Daptomycin is an antibacterial agent capable of stopping the growth of certain bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

This medicine is used in adults and in children and adolescents (aged between 1 and 17 years) to treat skin infections and underlying tissue infections. It is also used to treat bloodstream infections when associated with a skin infection.

This medicine is also used in adults to treat infections of the tissues lining the inside of the heart (including the heart valves), caused by a type of bacterium called Staphylococcus aureus. It is also used to treat bloodstream infections caused by the same type of bacterium when associated with a heart infection.

Depending on the type of infection(s) you have, your doctor may also prescribe other antibacterial agents alongside treatment with Daptomicina Accordpharma.

2. What you need to know before starting Daptomicina Accordpharma

Do not receive Daptomicina Accordpharma

If you are allergic to daptomycin or sodium hydroxide or to any of the other components of this medicine (listed in section 6).

If this applies to you, inform your doctor or nurse. If you think you may be allergic, consult your doctor or nurse.

Warnings and precautions

Talk to your doctor or nurse before receiving daptomycin.

• If you have or have previously had kidney problems. Your doctor may need to adjust the dose of daptomycin (see section 3 of this leaflet).
• Occasionally, patients receiving daptomycin may develop increased muscle sensitivity, pain, or weakness (see section 4 of this leaflet for more information). Inform your doctor if this occurs. Your doctor will ensure that you have a blood test and will advise whether or not it is advisable to continue using daptomycin. Symptoms usually resolve within a few days after stopping treatment with daptomycin.
• If you have ever had a severe skin rash, skin peeling, blisters, and/or mouth sores, or serious kidney problems after taking daptomycin.
• If you have significant overweight. There is a possibility that your blood levels of daptomycin may be higher than those found in individuals of average weight, and therefore you may require closer monitoring for adverse effects.

If any of the above situations apply to you, inform your doctor or nurse before receiving daptomycin.

Inform your doctor immediately if you develop any of the following symptoms:

• Severe and serious allergic reactions have been observed in patients treated with almost all antibacterial agents, including daptomycin. Symptoms may include wheezing, difficulty breathing, swelling of the face, neck, and throat, skin rash and hives, or fever.

• Serious skin diseases have been reported with the use of Daptomycin. Symptoms associated with these skin conditions may include:

• Onset or worsening of fever,

• Raised red spots or fluid-filled lesions on the skin, which may start in the armpits or areas of the chest or groin and may spread over a large area of the body,

• Blisters or sores in the mouth or genital area.

• Serious kidney problems have been reported with the use of Daptomycin. Symptoms may include fever and rash.

• Any type of tingling or numbness in the hands or feet, loss of sensation, or unusual movement difficulties. If this occurs, inform your doctor, who will decide whether treatment should continue.

• Diarrhea, especially if you notice blood or mucus in the stool or if diarrhea becomes severe or prolonged.

• Onset or worsening of fever, cough, or difficulty breathing. These may be signs of a rare but serious lung function deterioration known as eosinophilic pneumonia. Your doctor will check your lung condition and decide whether or not to continue treatment with daptomycin.

Daptomycin may interfere with laboratory tests measuring your blood's clotting ability. Results may falsely suggest impaired coagulation, even though no actual problem exists. Therefore, it is important that your doctor is aware that you are receiving daptomycin. Inform your doctor that you are being treated with daptomycin.

Your doctor will perform blood tests to monitor your muscle health before starting treatment and regularly during treatment with daptomycin.

Children and adolescents

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

Use in elderly patients

Patients over 65 years of age may receive the same dose as other adults, provided their kidneys are functioning properly.

Using Daptomicina Accordpharma with other medicines

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines. It is particularly important to mention the following:

• Medications called statins or fibrates (used to lower cholesterol) or cyclosporine (a medicine used in organ transplants to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis). The risk of muscle-related adverse effects may increase if you take any of these medicines (and others that may affect muscles) during treatment with daptomycin. Your doctor may decide not to administer daptomycin or to temporarily interrupt treatment with the other medicine.
• Pain-relieving medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These may interfere with the kidney elimination of daptomycin.
• Oral anticoagulants (e.g. warfarin), which are medicines that prevent blood clotting. Your doctor may need to monitor your blood clotting times.

Pregnancy and breastfeeding

Daptomycin is generally not given to pregnant women. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before receiving this medicine.

You must not breastfeed while receiving daptomycin, as it may pass into breast milk and affect the baby.

Driving and using machines

Daptomycin has no known effects on the ability to drive or use machines.

Daptomicina Accordpharma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per vial; hence, it is essentially “sodium-free”.

3. How to take Daptomycin Accordpharma

This medicine will normally be administered by your doctor or nurse.

Adults (18 years of age and older)

The dose will depend on your body weight and the type of infection being treated. The usual dose for adults is 4 mg per 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 administered directly into the bloodstream (into a vein), either as an infusion lasting approximately 30 minutes or as an injection lasting approximately 2 minutes. The same dose is recommended for people over 65 years of age, provided their kidneys are functioning properly.

If your kidneys are not working properly, you may receive this medicine less frequently, e.g. once every other day. If you are undergoing dialysis and your next dose of this medicine is due on a dialysis day, you will usually receive the medicine after the dialysis session.

Children and adolescents (1 to 17 years of age)

Doses in children and adolescents (1 to 17 years of age) will depend on the patient's age and the type of infection being treated. This dose is administered directly into the bloodstream (into a vein) as an infusion lasting approximately 30–60 minutes.

A full course of treatment for skin infections usually lasts between 1 and 2 weeks. Your doctor will decide the duration of your treatment for bloodstream or heart infections and for skin infections.

Detailed instructions for use and handling are provided at the end of the leaflet.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following are the most serious adverse effects:

Serious adverse effects with unknown frequency (cannot be estimated from available data)

During administration of this medicine, some cases of hypersensitivity reactions (serious allergic reactions including anaphylaxis, angioedema) have been reported. These serious allergic reactions require immediate medical attention. Inform your doctor or nurse immediately if you experience any of the following symptoms:

• Chest pain or tightness,
• Rash or hives,
• Swelling around the throat,
• Rapid or weak pulse,
• Wheezing,
• Fever,
• Chills or shivering,
• Flushing,
• Dizziness,
• Fainting,
• Metallic taste.

Consult your doctor immediately if you experience pain, increased tenderness, or muscle weakness of unknown origin. Muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which may lead to kidney damage.

Other adverse effects reported with the use of Daptomycin are:

• A rare but potentially serious lung disorder called eosinophilic pneumonia, mostly after more than 2 weeks of treatment. Symptoms may include difficulty breathing, new or worsening cough, or new or worsening fever.
• Serious skin diseases. Symptoms may include:
  • New or worsening fever,
  • Raised red spots or fluid-filled blisters on the skin, which may start in the armpits or on the chest or groin and may spread over a large area of the body,
  • Blisters or sores in the mouth or genital area.
• A serious kidney problem. Symptoms may include fever and rash.

If you experience these symptoms, inform your doctor or nurse immediately. Your doctor will carry out additional tests to establish a diagnosis.

The following are the most frequently reported adverse effects:

Frequent adverse effects (may affect up to 1 in 10 patients)

• Fungal infections, such as thrush,
• Urinary tract infection,
• Decrease in the number of red blood cells (anaemia),
• Dizziness, anxiety, difficulty sleeping,
• Headache,
• Fever, weakness (asthenia),
• High or low blood pressure,
• Constipation, abdominal pain,
• Diarrhoea, discomfort (nausea or vomiting),
• Flatulence,
• Bloating or gas (abdominal distension),
• Skin rash or itching,
• Pain, itching or redness at the infusion site,
• Pain in arms or legs,
• Elevated levels of liver enzymes or creatine phosphokinase (CPK) in blood tests.

The following are other adverse effects that may occur after treatment with Daptomycin Accordpharma:

Uncommon adverse effects (may affect up to 1 in 100 patients)

• Blood disorders (e.g. increase in platelet count, which may increase the tendency to develop blood clots, or increase in certain types of white blood cells),
• Loss of appetite,
• Tingling or numbness in hands or feet, disturbances in taste sensation,
• Tremors,
• Changes in heart rhythm, flushing,
• Indigestion (dyspepsia), inflammation of the tongue,
• Itchy skin rash,
• Muscle pain, cramps or weakness, muscle inflammation (myositis), joint pain,
• Kidney problems,
• Inflammation and irritation of the vagina,
• Generalised pain or weakness, tiredness (fatigue),
• Elevated blood sugar levels, serum creatinine, myoglobin or lactate dehydrogenase (LDH), prolonged blood clotting time, or electrolyte imbalance in blood tests.
• Eye itching

Rare adverse effects (may affect up to 1 in 1,000 patients)

• Yellowing of the skin and eyes,
• Prolonged prothrombin time.

Frequency not known (cannot be estimated from available data)

Antibiotic-associated colitis, including pseudomembranous colitis (severe or persistent diarrhoea containing blood and/or mucus, associated with abdominal pain or fever), increased tendency to bruise, bleeding gums or nosebleeds.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Daptomycin Accordpharma

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

6. Contents of the pack and other information

Composition of Daptomycin Accordpharma

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

Appearance of the product and contents of the pack

Daptomycin Accordpharma powder for solution for injection and infusion is presented in a glass vial as a pale yellow to light brown powder or cake. It is to be mixed with a solvent to form a solution prior to administration.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center. Moll de Barcelona, s/n,

Edifici Est, 6ª planta. 08039 Barcelona. Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice,

Poland

or

Pharmadox Healthcare Ltd.

KW20A, Kordin Industrial Park,

Paola, PLA3000, Malta

or

Laboratori Fundació Dau

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

08040, Barcelona,

Spain

or

Accord Healthcare Single Member S.A.,

64th Km National Road Athens Lamia,

Schimatari, 32009, Greece

This medicinal product is authorized in the EEA Member States under the following names:

Member State	Name
AT	Daptomycin Accordpharma 350 mg/500 mg powder for solution for injection/infusion
DK	Daptomycin Accordpharma
FI	Daptomycin Accordpharma 350 mg/500 mg powder for solution for injection/infusion
NL	Daptomycin Accordpharma 500 mg powder for solution for injection/infusion
NO	Daptomycin Accordpharma
SE	Daptomycin Accordpharma
IE	Daptomycin Accordpharma 350 mg/500 mg Powder for solution for injection/infusion
MT	Daptomycin Accordpharma 500 mg Powder for solution for injection/infusion
CZ	Daptomycin Accordpharma
HR	Daptomycin Accordpharma 500 mg powder for solution for injection/infusion
PL	Daptomycin Accordpharma
RO	Daptomycin Accordpharma 350 mg powder for injectable solution/perfusible solution Daptomycin Accordpharma 500 mg powder for injectable solution/perfusible solution
SI	Daptomycin Accordpharma 350 mg/500 mg powder for solution for injection/infusion
EL	Daptomycin/Accordpharma 350 mg powder for injectable solution/infusion solution Daptomycin/Accordpharma 500 mg powder for injectable solution/infusion solution
PT	Daptomycin Accordpharma
IT	Daptomycin Accordpharma 350 mg/500 mg
ES	Daptomycin Accordpharma 350 mg/500 mg powder for injectable solution and for perfusion
DE	Daptomycin Accordpharma 350 mg/500 mg powder for solution for injection/infusion
FR	DAPTOMYCIN ACCORDPHARMA 350 mg, powder for injectable solution/perfusion DAPTOMYCIN ACCORDPHARMA 500 mg, powder for injectable solution/perfusion
UK	Daptomycin 350 mg/500 mg Powder for solution for injection/infusion

Date of last review of this leaflet: October 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals only:

Important: Please consult the Summary of Product Characteristics or Technical Data Sheet before prescribing.

Instructions for use and handling

350 mg presentation:

In adults, daptomycin may be administered intravenously either as an infusion lasting more than 30 minutes or as an injection over more than 2 minutes. Unlike in adults, daptomycin must not be administered as a 2-minute injection in paediatric patients. Paediatric patients aged 7 to 17 years should receive daptomycin by infusion lasting more than 30 minutes. Paediatric patients under 7 years of age receiving doses of 9–12 mg/kg should be administered daptomycin over more than 60 minutes. Preparation of the infusion solution requires an additional dilution step, as described below.

Daptomycin Accordpharma administered as intravenous infusion over more than 30 or 60 minutes

Reconstituting the lyophilised product with 7 ml of an injectable solution containing 9 mg/ml (0.9%) sodium chloride yields a concentration of 50 mg/ml of Daptomycin Accordpharma for infusion.

The lyophilised product takes approximately 20 minutes to dissolve. The fully reconstituted product is clear and may contain a few small bubbles or foam around the edge of the vial.

To prepare Daptomycin Accordpharma for intravenous infusion, follow the instructions below:

An aseptic technique must be used throughout the reconstitution process.

For reconstitution

1. Remove the polipropylene "flip-off" cap to expose the central portion of the rubber stopper. Clean the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to contact any other surface. Draw 7 ml of an injectable solution containing 9 mg/ml (0.9%) sodium chloride into a syringe using a sterile transfer needle of 21 gauge or smaller, or a needle-free device, and slowly inject through the centre of the rubber stopper into the vial, directing the needle towards the vial wall.
2. Gently rotate the vial to ensure complete wetting of the product, then allow to stand for 10 minutes.
3. Finally, gently rotate or shake the vial for a few minutes until a clear reconstituted solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Carefully inspect the reconstituted solution before use to ensure the substance is fully dissolved and to verify the absence of particulate matter. The colour of the reconstituted Daptomycin Accordpharma solution may vary from pale yellow to light brown.
5. The reconstituted solution should then be diluted with 9 mg/ml sodium chloride (0.9%) (typical volume of 50 ml).

For dilution:

1. Slowly withdraw the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle of 21 gauge or smaller, inverting the vial so that the solution flows towards the stopper. Using a new syringe, insert the needle into the inverted vial. While keeping the vial inverted, place the needle tip at the lowest point of the liquid and withdraw the solution into the syringe. Before removing the needle from the vial, pull the plunger back to the end of the syringe barrel to withdraw all solution from the inverted vial.
2. Expel air, large bubbles, and any excess solution to obtain the required dose.
3. Transfer the required dose of reconstituted solution into 50 ml of 9 mg/ml sodium chloride (0.9%).
4. The reconstituted and diluted solution must be administered by intravenous infusion over more than 30 or 60 minutes.

Daptomycin Accordpharma is neither physically nor chemically compatible with glucose-containing solutions. The following drugs have been shown to be compatible when added to infusion solutions containing Daptomycin Accordpharma: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.

The combined storage time (reconstituted solution in vial and diluted solution in infusion bags) at 25°C must not exceed 12 hours (24 hours if refrigerated).

The stability of the diluted solution in infusion bags has been established as 12 hours at 25°C or 24 hours if refrigerated at 2°C–8°C.

Daptomycin Accordpharma administered as intravenous injection over 2 minutes

Water must not be used for reconstitution of Daptomycin Accordpharma for intravenous injection. Daptomycin Accordpharma must be reconstituted exclusively with 9 mg/ml sodium chloride (0.9%).

Reconstituting the lyophilised product with 7 ml of an injectable solution containing 9 mg/ml (0.9%) sodium chloride yields a concentration of 50 mg/ml of Daptomycin Accordpharma for injection.

The lyophilised product takes approximately 20 minutes to dissolve. The fully reconstituted product is clear and may contain a few small bubbles or foam around the edge of the vial.

To prepare Daptomycin Accordpharma for intravenous injection, follow the instructions below:

An aseptic technique must be used throughout the reconstitution process.

1. Remove the polipropylene "flip-off" cap to expose the central portion of the rubber stopper. Clean the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to contact any other surface. Draw 7 ml of an injectable solution containing 9 mg/ml sodium chloride (0.9%) into a syringe using a sterile transfer needle of 21 gauge or smaller, or a needle-free device, and slowly inject through the centre of the rubber stopper into the vial, directing the needle towards the vial wall.
2. Gently rotate the vial to ensure complete wetting of the product, then allow to stand for 10 minutes.
3. Finally, gently rotate or shake the vial for a few minutes until a clear reconstituted solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Carefully inspect the reconstituted solution before use to ensure the substance is fully dissolved and to verify the absence of particulate matter. The colour of the reconstituted Daptomycin Accordpharma solution may vary from pale yellow to light brown.
5. Slowly withdraw the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle of 21 gauge or smaller.
6. Invert the vial so that the solution flows towards the stopper. Using a new syringe, insert the needle into the inverted vial. While keeping the vial inverted, place the needle tip at the lowest point of the liquid and withdraw the solution into the syringe. Before removing the needle from the vial, pull the plunger back to the end of the syringe barrel to withdraw all solution from the inverted vial.
7. Replace the needle with a new one for intravenous injection.
8. Expel air, large bubbles, and any excess solution to obtain the required dose.
9. The reconstituted solution must be administered slowly by intravenous injection over more than 2 minutes.

Physical and chemical stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to a maximum of 48 hours if refrigerated (2°C–8°C).

However, from a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage time is the responsibility of the user and should normally not exceed 24 hours at 2°C–8°C, unless reconstitution/dilution has taken place under controlled and validated aseptic conditions.

This medicinal product must not be mixed with other medicinal products except those mentioned above.

Daptomycin Accordpharma vials are for single use only. Any unused residue in the vial must be discarded.

This information is intended for healthcare professionals only:

Important: Please consult the Summary of Product Characteristics or Technical Data Sheet before prescribing.

Instructions for use and handling

500 mg presentation:

In adults, daptomycin may be administered intravenously either as an infusion lasting more than 30 minutes or as an injection over more than 2 minutes. Unlike in adults, daptomycin must not be administered as a 2-minute injection in paediatric patients. Paediatric patients aged 7 to 17 years should receive daptomycin by infusion lasting more than 30 minutes. Paediatric patients under 7 years of age receiving doses of 9–12 mg/kg should be administered daptomycin over more than 60 minutes. Preparation of the infusion solution requires an additional dilution step, as described below.

Daptomycin Accordpharma administered as intravenous infusion over more than 30 or 60 minutes

Reconstituting the lyophilised product with 10 ml of an injectable solution containing 9 mg/ml (0.9%) sodium chloride yields a concentration of 50 mg/ml of Daptomycin Accordpharma for infusion.

The lyophilised product takes approximately 20 minutes to dissolve. The fully reconstituted product is clear and may contain a few small bubbles or foam around the edge of the vial.

To prepare Daptomycin Accordpharma for intravenous infusion, follow the instructions below:

An aseptic technique must be used throughout the reconstitution process.

For reconstitution

1. Remove the polipropylene "flip-off" cap to expose the central portion of the rubber stopper. Clean the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to contact any other surface. Draw 10 ml of an injectable solution containing 9 mg/ml (0.9%) sodium chloride into a syringe using a sterile transfer needle of 21 gauge or smaller, or a needle-free device, and slowly inject through the centre of the rubber stopper into the vial, directing the needle towards the vial wall.
2. Gently rotate the vial to ensure complete wetting of the product, then allow to stand for 10 minutes.
3. Finally, gently rotate or shake the vial for a few minutes until a clear reconstituted solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Carefully inspect the reconstituted solution before use to ensure the substance is fully dissolved and to verify the absence of particulate matter. The colour of the reconstituted Daptomycin Accordpharma solution may vary from pale yellow to light brown.
5. The reconstituted solution should then be diluted with 9 mg/ml sodium chloride (0.9%) (typical volume of 50 ml).

For dilution:

1. Slowly withdraw the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle of 21 gauge or smaller, inverting the vial so that the solution flows towards the stopper. Using a new syringe, insert the needle into the inverted vial. While keeping the vial inverted, place the needle tip at the lowest point of the liquid and withdraw the solution into the syringe. Before removing the needle from the vial, pull the plunger back to the end of the syringe barrel to withdraw all solution from the inverted vial.
2. Expel air, large bubbles, and any excess solution to obtain the required dose.
3. Transfer the required dose of reconstituted solution into 50 ml of 9 mg/ml sodium chloride (0.9%).
4. The reconstituted and diluted solution must be administered by intravenous infusion over more than 30 or 60 minutes.

Daptomycin Accordpharma is neither physically nor chemically compatible with glucose-containing solutions. The following drugs have been shown to be compatible when added to infusion solutions containing Daptomycin Accordpharma: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.

The combined storage time (reconstituted solution in vial and diluted solution in infusion bags) at 25°C must not exceed 12 hours (24 hours if refrigerated).

The stability of the diluted solution in infusion bags has been established as 12 hours at 25°C or 24 hours if refrigerated at 2°C–8°C.

Daptomycin Accordpharma administered as intravenous injection over 2 minutes

Water must not be used for reconstitution of Daptomycin Accordpharma for intravenous injection. Daptomycin Accordpharma must be reconstituted exclusively with 9 mg/ml sodium chloride (0.9%).

Reconstituting the lyophilised product with 10 ml of an injectable solution containing 9 mg/ml (0.9%) sodium chloride yields a concentration of 50 mg/ml of Daptomycin Accordpharma for injection.

The lyophilised product takes approximately 20 minutes to dissolve. The fully reconstituted product is clear and may contain a few small bubbles or foam around the edge of the vial.

To prepare Daptomycin Accordpharma for intravenous injection, follow the instructions below:

An aseptic technique must be used throughout the reconstitution process.

1. Remove the polipropylene "flip-off" cap to expose the central portion of the rubber stopper. Clean the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to contact any other surface. Draw 10 ml of an injectable solution containing 9 mg/ml sodium chloride (0.9%) into a syringe using a sterile transfer needle of 21 gauge or smaller, or a needle-free device, and slowly inject through the centre of the rubber stopper into the vial, directing the needle towards the vial wall.
2. Gently rotate the vial to ensure complete wetting of the product, then allow to stand for 10 minutes.
3. Finally, gently rotate or shake the vial for a few minutes until a clear reconstituted solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Carefully inspect the reconstituted solution before use to ensure the substance is fully dissolved and to verify the absence of particulate matter. The colour of the reconstituted Daptomycin Accordpharma solution may vary from pale yellow to light brown.
5. Slowly withdraw the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle of 21 gauge or smaller.
6. Invert the vial so that the solution flows towards the stopper. Using a new syringe, insert the needle into the inverted vial. While keeping the vial inverted, place the needle tip at the lowest point of the liquid and withdraw the solution into the syringe. Before removing the needle from the vial, pull the plunger back to the end of the syringe barrel to withdraw all solution from the inverted vial.
7. Replace the needle with a new one for intravenous injection.
8. Expel air, large bubbles, and any excess solution to obtain the required dose.
9. The reconstituted solution must be administered slowly by intravenous injection over more than 2 minutes.

Physical and chemical stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to a maximum of 48 hours if refrigerated (2°C–8°C).

However, from a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage time is the responsibility of the user and should normally not exceed 24 hours at 2°C–8°C, unless reconstitution/dilution has taken place under controlled and validated aseptic conditions.

This medicinal product must not be mixed with other medicinal products except those mentioned above.

Daptomycin Accordpharma vials are for single use only. Any unused residue in the vial must be discarded.