Daptomycin Accord Pharma

Patient Information Leaflet

Daptomicina Accordpharma 350 mg powder for injectable/infusion solution, 500 mg powder for injectable/infusion solution

Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

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

The active substance of Daptomicina Accordpharma powder for solution for injection or infusion is
daptomycin. Daptomycin is an antibacterial agent that can stop the growth of certain bacteria.
Daptomicina Accordpharma is used in adults and in children and adolescents (aged 1 to 17 years) to treat skin and underlying tissue infections. It is also used to treat bloodstream infections when associated with skin infections.
Daptomicina Accordpharma is also used in adults to treat infections of the tissues lining the inside of the heart (including 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 heart infections.
Depending on the type of infection(s) you have, your doctor may also prescribe other antibacterial agents during treatment with Daptomicina Accordpharma.

2. What you should know before being given Daptomicina Accordpharma

Do not receive Daptomicina Accordpharma
If you are allergic to daptomycin or sodium hydroxide, or to any of the other ingredients of this
medicinal product (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 Daptomicina Accordpharma.

• If you have or have previously had kidney problems. Your doctor may need to adjust the dose of Daptomicina Accordpharma (see section 3 of this leaflet).
• Patients treated with Daptomicina Accordpharma have sometimes experienced muscle pain, weakness, or discomfort (see section 4 of this leaflet for further information). If this occurs, inform your doctor. Your doctor will arrange for a blood test and will advise whether you should continue or stop treatment with Daptomicina Accordpharma. Symptoms usually resolve within a few days after stopping Daptomicina Accordpharma.
• If you have previously developed a severe skin reaction, skin peeling, blistering rash, mouth ulcers, or serious kidney problems after taking daptomycin.
• If you are overweight. Levels of Daptomicina Accordpharma in your blood may be higher than in people of average weight, so you may need to be monitored more closely for side effects. If any of these situations apply to you, inform your doctor or nurse before receiving Daptomicina Accordpharma.

Inform your doctor or nurse immediately if any of the following symptoms occur:

• Severe acute allergic reactions have been observed in patients treated with almost all antibacterial medicines, including Daptomicina Accordpharma. Symptoms may include wheezing, difficulty breathing, swelling of the face, neck, and throat, skin rash, hives, or fever.
• Serious skin disorders have been reported with the use of daptomycin. Symptoms associated with these skin conditions may include:
  • onset or worsening of fever,
  • raised or fluid-filled red spots on the skin, which may appear under the arms, or in chest or groin areas, and may spread over large areas of the body,
  • blisters or sores in the mouth or on the genitals.
• A serious kidney problem has been reported with the use of daptomycin. Symptoms may include fever and skin rash.
• Unusual tingling or numbness in the hands or feet, loss of sensation, or difficulty moving. If this occurs, inform your doctor, who will decide whether to continue treatment.
• Diarrhea, especially if you notice blood or mucus, or if diarrhea becomes severe or persistent.
• Onset or worsening of fever, cough, or difficulty breathing. These may be signs of a rare but serious lung disease called eosinophilic pneumonia. Your doctor will check your lung condition and decide whether you should continue treatment with Daptomicina Accordpharma.

Daptomicina Accordpharma may interfere with laboratory tests measuring blood coagulation. Test results may suggest a blood clotting problem even when none exists. It is therefore important that your doctor knows you are receiving Daptomicina Accordpharma.
Inform your doctor that you are being treated with Daptomicina Accordpharma.
Your doctor will perform blood tests to monitor your muscle condition, both before starting treatment and regularly during treatment with Daptomicina Accordpharma.

Children and adolescents
Daptomicina Accordpharma must not be administered to children under one year of age, as animal studies have shown that serious adverse effects may occur in this age group.

Use in the elderly
People over 65 years of age may receive the same dose as adults, provided they have normal kidney function.

Other medicines and Daptomicina Accordpharma
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
It is especially important to inform them if you are taking:

• Medicines called statins or fibrates (used to lower cholesterol), or cyclosporine (a medicine used in transplant patients to prevent organ rejection or in other conditions such as rheumatoid arthritis or atopic dermatitis). If you take any of these medicines (and others that may affect muscles) during treatment with Daptomicina Accordpharma, the risk of muscle-related side effects may be increased. Your doctor may decide not to prescribe Daptomicina Accordpharma or may temporarily discontinue the other medicines.
• Painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g., celecoxib). These may interfere with the renal effects of Daptomicina Accordpharma.
• Oral anticoagulants (e.g., warfarin), which are medicines that prevent blood from clotting. Your doctor may need to monitor your blood clotting time.

Pregnancy and breastfeeding
Daptomicina Accordpharma is generally not given to pregnant women. If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before receiving this medicine.
Do not breastfeed while taking Daptomicina Accordpharma, as daptomycin may pass into breast milk and could therefore affect the baby.

Driving and using machines
Daptomicina Accordpharma has no known effect on the ability to drive or operate machinery.

Daptomicina Accordpharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially “sodium-free”.

3. How Daptomicina Accordpharma is administered

Daptomicina Accordpharma is normally administered by a doctor or nurse.
Adults (aged 18 years and older)
The dose depends on your body weight and the type of infection being treated. In adults, the usual dose is 4 mg
per kilogram (kg) of body weight, given once daily for skin infections, or 6 mg per kg of body weight given once daily for a heart infection
or a bloodstream infection associated with skin or heart infection. In adult patients, this dose is injected 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 individuals
over 65 years of age, provided they have normal renal function.
If you have impaired renal function, you may receive Daptomicina Accordpharma less
frequently, e.g., every other day. If you are undergoing dialysis and your next dose of Daptomicina Accordpharma
is due on the same day as dialysis, Daptomicina Accordpharma will usually be administered
after completion of dialysis.
Children and adolescents (from 1 to 17 years of age)
The dose for children and adolescents (from 1 to 17 years of age) depends on the patient's age and the type of infection
being treated. This dose is injected directly into the bloodstream (into a vein) as an infusion
lasting approximately 30–60 minutes.
Typically, for skin infections, a treatment course lasts from 1 to 2 weeks. For bloodstream or heart infections and skin infections, your doctor will decide how long your treatment should continue.
Detailed instructions for use and handling are provided at the end of this leaflet.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects are described below:
Serious side effects with unknown frequency (frequency cannot be determined from the available data)
In some cases, hypersensitivity reactions (severe allergic reactions including anaphylaxis and angioedema) have been reported during administration of Daptomicina Accordpharma. This severe allergic reaction requires immediate medical intervention.
Immediately inform your doctor or nurse if you experience any of the following symptoms:

• Chest pain or tightness in the chest,
• Skin rash or hives,
• Swelling around the throat,
• Rapid or weak heartbeat,
• Wheezing,
• Fever,
• Chills or shivering,
• Hot flushes,
• Dizziness,
• Fainting,
• Metallic taste.

If you notice unexplained muscle pain, tenderness, or weakness, inform your doctor immediately. Muscle problems may be serious, including destruction of muscle tissue (rhabdomyolysis), which may lead to kidney damage.

• Other serious side effects reported with daptomycin use include: A rare but potentially serious lung disease called eosinophilic pneumonia, usually occurring after more than 2 weeks of treatment. Symptoms may include difficulty breathing, new or worsening cough, or new or worsening fever. If you experience these symptoms, inform your doctor or nurse immediately.
• Serious skin disorders. Symptoms may include:
• new or worsening fever,
• raised red spots or fluid-filled lesions appearing under the arms, on the chest, or in the groin area, which may spread over large areas of the body,
• blisters or sores in the mouth or on the genitals.
• Severe kidney problems. Symptoms may include fever and skin rash. Your doctor will perform further tests to make a diagnosis. The side effects reported most frequently are described below:

Common side effects (may affect up to 1 in 10 people)

• Fungal infections such as oral candidiasis,
• Urinary tract infections,
• Reduction 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, feeling unwell (nausea or vomiting),
• Flatulence,
• Abdominal swelling or bloated stomach,
• Skin rash or itching,
• Pain, itching or redness at the infusion site,
• Pain in the arms or legs,
• Increased levels of liver enzymes or creatine phosphokinase (CPK) shown in blood tests.

Other side effects that may occur during treatment with Daptomicina Accordpharma are described below:
Uncommon side effects (may affect up to 1 in 100 people)

• Blood disorders (such as increased number of small blood particles called platelets, which could increase the tendency for blood to clot, or increased levels of certain types of white blood cells),
• Loss of appetite,
• Tingling or numbness in hands or feet, altered taste sensation,
• Tremor,
• Changes in heart rhythm, hot flushes,
• Indigestion (dyspepsia), inflammation of the tongue,
• Skin rash associated with itching,
• Muscle pain, cramps or weakness, muscle inflammation (myositis), joint pain,
• Kidney problems,
• Inflammation and irritation of the vagina,
• Generalised pain or weakness, tiredness (fatigue),
• Blood tests showing increased levels of blood sugar, serum creatinine, myoglobin or lactate dehydrogenase (LDH), prolonged blood clotting time, electrolyte imbalance,
• Itching of the eyes.

Rare side effects (may affect up to 1 in 1,000 people)

• Yellowing of the skin and eyes (jaundice),
• Prolongation of prothrombin time.

Frequency not known (cannot be estimated from the available data)
Colitis associated with antibiotic use, including pseudomembranous colitis (severe or persistent diarrhoea containing blood and/or mucus, associated with abdominal pain or fever), easy bruising, bleeding gums, or nosebleeds.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly.
By reporting side effects, you can help provide more information on the safety of this 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 label and the carton after “Exp.”. The expiry date refers to the last day of that month.
• Store in the refrigerator (2°C - 8°C).

6. Package contents 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 component is sodium hydroxide (for pH adjustment).

Description of the appearance of Daptomycin Accordpharma and contents of the pack
Daptomycin Accordpharma powder for solution for injection/infusion is supplied as a powder or tablet
ranging in colour from pale yellow to light brown, in a glass vial. It must be mixed with a solvent to
form a liquid prior to administration.
Daptomycin Accordpharma is available in packs containing 1 vial or 5 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Laboratori Fundaciò Dau
C/c, 12-14 Pol. Ind. Zona Franca
Barcelona 08040
Spain
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp. z.o.o.
Ul. Lutomierska 50, Pabianice, 95-200
Poland

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

| Country | Trade Name | |---------|------------| | AT | Daptomycin Accordpharma 350 mg/500 mg pulver zur Herstellung einer Injektions-/Infusionslösung | | DK | Daptomycin Accordpharma | | FI | Daptomycin Accordpharma 350 mg/500 mg injektio-/infuusiokuiva-aine liuosta varten | | NL | Daptomycine Accordpharma 500 mg poeder voor oplossing voor injectie/infusie | | 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 | Daptomicin Accordpharma 500 mg prašak za otopinu za injekciju/infuziju | | IT | Daptomicina Accordpharma | | PL | Daptomycin Accordpharma | | SI | Daptomicin Accordpharma 350 mg/500 mg prašek za raztopino za injiciranje/infundiranje | | EL | Daptomycin/Accordpharma 350 mg kόνις για ενέσιμο διάλυμα/ διάλυμα προς έγχυση
Daptomycin/Accordpharma 500 mg kόνις για ενέσιμο διάλυμα/ διάλυμα προς έγχυση | | PT | Daptomicina Accordpharma |

The following information is intended for healthcare professionals only:

Important: Please refer to the Summary of Product Characteristics before prescribing.

Instructions for Use and Handling

350 mg Presentation
In adults, daptomycin may be administered intravenously either as an infusion lasting 30 minutes or as an injection lasting 2 minutes. Unlike adults, daptomycin must not be administered as a 2-minute injection in pediatric patients. Pediatric patients aged 7 to 17 years should receive daptomycin by infusion over 30 minutes. In pediatric patients under 7 years of age receiving a dose of 9–12 mg/kg, daptomycin must be administered over at least 60 minutes. Preparation of the infusion solution requires further dilution, as described below.

Administration of Daptomicina Accordpharma as a 30- or 60-minute intravenous infusion

A concentration of 50 mg/ml of Daptomicina Accordpharma for infusion is obtained by reconstituting the lyophilisate with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Approximately 20 minutes are required for complete dissolution of the lyophilisate. The fully reconstituted medicinal product has a clear appearance, and there may be some bubbles or foam around the edges of the vial.
To prepare Daptomicina Accordpharma for intravenous infusion, the following instructions must be followed: an aseptic technique must be used throughout the entire reconstitution and dilution process of Daptomicina Accordpharma lyophilisate.

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-impregnated swab or other antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper and do not allow it to come into contact with any other surface. Withdraw 7 ml of 9 mg/ml (0.9%) sodium chloride solution for injection into a syringe using a sterile transfer needle with a gauge equal to or smaller than 21 gauge or a needle-free device, then slowly inject through the center of the rubber stopper into the vial, directing the needle toward the vial wall.
2. Gently rotate the vial to ensure the product is completely wetted by the liquid, then allow it to stand for 10 minutes.
3. Finally, gently swirl the vial for several minutes until a clear reconstituted solution is obtained. Avoid vigorous shaking or agitation to prevent foam formation in the product.
4. Before use, the reconstituted solution must be carefully inspected visually to confirm complete dissolution of the product and absence of particulate matter. The reconstituted solution of Daptomicina Accordpharma ranges in color from pale yellow to light brown.
5. The reconstituted solution must then be diluted with 9 mg/ml (0.9%) sodium chloride (typical volume 50 ml).

Dilution:

1. Slowly withdraw the properly reconstituted liquid (50 mg of daptomycin/ml) from the vial using a new sterile needle with a gauge equal to or smaller than 21 gauge, by inverting the vial so that the solution flows toward the stopper. Using a syringe, insert the needle into the inverted vial. While keeping the vial inverted, position the tip of the needle in the lower part of the solution in the vial and pull the plunger to the end of the syringe barrel to aspirate the required amount of solution from the inverted vial.
2. Expel air, larger bubbles, and any excess solution to obtain the required dose.
3. Transfer the required reconstituted dose into 50 ml of 9 mg/ml (0.9%) sodium chloride solution.
4. The reconstituted and diluted solution must then be administered intravenously over 30 or 60 minutes.

Daptomicina Accordpharma is physically and chemically incompatible with glucose-containing solutions. The following substances have been shown to be compatible when added to infusion solutions containing Daptomicina Accordpharma: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.

The total storage period (reconstituted solution in the vial and diluted solution in the infusion bag) must not exceed 12 hours at 25°C (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.

Administration of Daptomicina Accordpharma by 2-minute intravenous injection (adults only)

For reconstitution of Daptomicina Accordpharma for intravenous injection, water must not be used. Daptomicina Accordpharma must only be reconstituted with 9 mg/ml (0.9%) sodium chloride solution.

A concentration of 50 mg/ml of Daptomicina Accordpharma for injection is obtained by reconstituting the lyophilisate with 7 ml of 9 mg/ml (0.9%) sodium chloride solution for injection.

Approximately 20 minutes are required for complete dissolution of the lyophilisate. The fully reconstituted medicinal product has a clear appearance, and there may be some bubbles or foam around the edges of the vial.

To prepare Daptomicina Accordpharma for intravenous injection, the following instructions must be followed: an aseptic technique must be used throughout the entire reconstitution process of the Daptomicina Accordpharma lyophilisate.

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-impregnated swab or other antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper and do not allow it to come into contact with any other surface. Withdraw 7 ml of 9 mg/ml (0.9%) sodium chloride solution for injection into a syringe using a sterile transfer needle with a gauge equal to or smaller than 21 gauge or a needle-free device, then slowly inject through the center of the rubber stopper into the vial, directing the needle toward the vial wall.
2. Gently rotate the vial to ensure the product is completely wetted by the liquid, then allow it to stand for 10 minutes.
3. Finally, gently swirl the vial for several minutes until a clear reconstituted solution is obtained. Avoid vigorous shaking or agitation to prevent foam formation in the product.
4. Before use, the reconstituted solution must be carefully inspected visually to confirm complete dissolution of the product and absence of particulate matter. The reconstituted solution of Daptomicina Accordpharma ranges in color from pale yellow to light brown.
5. Slowly withdraw the reconstituted liquid (50 mg of daptomycin/ml) from the vial using a sterile needle with a gauge equal to or smaller than 21 gauge.
6. Invert the vial to allow the solution to flow toward the stopper. Using a new syringe, insert the needle into the inverted vial. While keeping the vial inverted, position the tip of the needle in the lower part of the solution in the vial when withdrawing the solution with the syringe. Before removing the needle from the vial, pull back the plunger to the end of the syringe barrel to withdraw all the solution from the inverted vial.
7. Replace the needle with a new needle for intravenous injection.
8. Expel air, large bubbles, and any excess solution to obtain the required dose.
9. The reconstituted solution must then be administered slowly by intravenous injection over 2 minutes.

Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours when refrigerated (2°C – 8°C).
However, from a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the user is responsible for the in-use storage time, which under normal circumstances must not exceed 24 hours at 2°C – 8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

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

Daptomicina Accordpharma vials are for single use only. Any unused solution remaining in the vial must be discarded.

The following information is intended for healthcare professionals only:

Important: Please refer to the Summary of Product Characteristics before prescribing.

Instructions for Use and Handling

500 mg Presentation
In adults, daptomycin may be administered intravenously as an infusion lasting 30 minutes or as an injection administered over 2 minutes. Unlike adults, daptomycin must not be administered as a 2-minute injection in pediatric patients. In pediatric patients aged 7 to 17 years, daptomycin should be administered by infusion over 30 minutes. In pediatric patients under 7 years of age receiving a dose of 9–12 mg/kg, daptomycin must be administered over at least 60 minutes. Preparation of the infusion solution requires further dilution, as described below.

Administration of Daptomycin Accordpharma as a 30- or 60-minute intravenous infusion

A concentration of 50 mg/ml of Daptomycin Accordpharma for infusion is obtained by reconstituting the lyophilized powder with 10 ml of sodium chloride 9 mg/ml (0.9%) injection solution.
Approximately 20 minutes are required for complete dissolution of the lyophilized powder. The fully reconstituted medicinal product has a clear appearance, and there may be some bubbles or foam around the edges of the vial.
When preparing Daptomycin Accordpharma for intravenous infusion, the following instructions must be followed: an aseptic technique must be used throughout the entire process of reconstitution or dilution of the Daptomycin Accordpharma lyophilized powder.

For reconstitution:

1. Remove the polypylene flip-off cap to expose the central portion of the rubber stopper. Clean the top of 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 and ensure it does not come into contact with any other surface. Draw 10 ml of sodium chloride 9 mg/ml (0.9%) injection solution into a syringe using a sterile transfer needle with a gauge equal to or smaller than 21 gauge or a needle-free device, then slowly inject through the center of the rubber stopper into the vial, directing the needle toward the vial wall.
2. Gently rotate the vial to ensure the product is completely wetted by the liquid, then allow it to stand for 10 minutes.
3. Finally, gently rotate the vial in a circular motion for several minutes, sufficient to obtain a clear reconstituted solution. Avoid vigorous shaking or agitation to prevent foam formation.
4. Before use, the reconstituted solution must be carefully inspected visually to confirm complete dissolution of the product and absence of particulate matter. The reconstituted solution of Daptomycin Accordpharma ranges in color from pale yellow to light brown.
5. The reconstituted solution must then be diluted with 9 mg/ml (0.9%) sodium chloride solution (typical volume 50 ml).

For dilution:

1. Slowly withdraw the properly reconstituted liquid (50 mg of daptomycin/ml) from the vial using a new sterile needle with a gauge equal to or larger than 21 gauge, inverting the vial so that the solution flows toward the stopper. Using a syringe, insert the needle into the inverted vial. While keeping the vial inverted, position the tip of the needle in the lower part of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger to the end of the syringe barrel to aspirate the required amount of solution from the inverted vial.

2. Expel air, large bubbles, and excess solution until the required dose is obtained.

3. Transfer the required reconstituted dose into 50 ml of sodium chloride 9 mg/ml (0.9%).

4. The reconstituted and diluted solution must then be administered intravenously over 30 or 60 minutes.

Daptomycin Accordpharma is physically and chemically incompatible with glucose-containing solutions.
The following substances 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 total storage period (reconstituted solution in the vial and diluted solution in the infusion bag) must not exceed 12 hours at 25°C (24 hours if 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.

Administration of Daptomycin Accordpharma by 2-minute intravenous injection (adults only)

For reconstitution of Daptomycin Accordpharma for intravenous injection, water must not be used. Daptomycin Accordpharma must be reconstituted only with sodium chloride 9 mg/ml (0.9%).
A concentration of 50 mg/ml of Daptomycin Accordpharma for injection is obtained by reconstituting the lyophilized powder with 10 ml of sodium chloride 9 mg/ml (0.9%) injection solution.
Approximately 20 minutes are required for complete dissolution of the lyophilized powder. The fully reconstituted medicinal product has a clear appearance, and there may be some bubbles or foam around the edges of the vial.
The following instructions must be followed when preparing Daptomycin Accordpharma for intravenous injection:
An aseptic technique must be used throughout the entire reconstitution process of the Daptomycin Accordpharma lyophilized powder.

1. Remove the polypylene flip-off cap to expose the central portion of the rubber stopper. Clean the top of 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 and ensure it does not come into contact with any other surface. Draw 10 ml of sodium chloride 9 mg/ml (0.9%) injection solution into a syringe using a sterile transfer needle with a gauge equal to or smaller than 21 gauge or a needle-free device, then slowly inject through the center of the rubber stopper into the vial, directing the needle toward the vial wall.
2. Gently rotate the vial to ensure the product is completely wetted by the liquid, then allow it to stand for 10 minutes.
3. Finally, gently rotate the vial in a circular motion for several minutes, sufficient to obtain a clear reconstituted solution. Avoid vigorous shaking or agitation to prevent foam formation.
4. Before use, the reconstituted solution must be carefully inspected visually to confirm complete dissolution of the product and absence of particulate matter. The reconstituted solution of Daptomycin Accordpharma ranges in color from pale yellow to light brown.
5. Slowly withdraw the reconstituted liquid (50 mg of daptomycin/ml) from the vial using a sterile needle with a gauge equal to or smaller than 21 gauge.
6. Invert the vial to allow the solution to flow toward the stopper. Using a new syringe, insert the needle into the inverted vial. While keeping the vial inverted, position the tip of the needle in the lower part of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger to the end of the syringe barrel to withdraw the entire solution from the inverted vial.
7. Replace the needle with a new needle for intravenous injection.
8. Expel air, large bubbles, and any excess solution to obtain the required dose.
9. The reconstituted solution must then be administered slowly by intravenous injection over 2 minutes.

Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours if refrigerated (2°C – 8°C).
However, from a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the user is responsible for the in-use storage time, which under normal circumstances must not exceed 24 hours at 2°C – 8°C, unless reconstitution/dilution has been performed under controlled and validated aseptic conditions.
The medicinal product must not be mixed with other products except those mentioned above.
Daptomycin Accordpharma vials are for single use only. Any unused solution remaining in the vial must be discarded.