DAPTOMYCIN ACCORDPHARMA 350 mg POWDER FOR SOLUTION FOR INJECTION AND INFUSION

Introduction

Package Leaflet: Information for the Patient

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

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

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

The active substance of this medicine is daptomycin. Daptomycin is an antibacterial agent capable of stopping the growth of certain bacteria. This medicine is used in adults and in children and adolescents (aged 1 to 17 years) to treat skin and soft 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 that line the inside of the heart (including heart valves), caused by a type of bacteria called Staphylococcus aureus.It is also used to treat bloodstream infections caused by the same type of bacteria when associated with a heart infection.

Depending on the type of infection(s) you are suffering from, your doctor may also prescribe other antibacterial agents while you are being treated with Daptomicina Accordpharma.

2. What you need to know before you start taking Daptomicina Accordpharma

You must not receive Daptomicina Accordpharma

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

If this is the case, inform your doctor or nurse. If you think you may be allergic, consult your doctor or nurse.

Warnings and precautions

Consult your doctor or nurse before receiving daptomycin.

• If you have or have previously had kidney problems. Your doctor may need to change the dose of daptomycin (see section 3 of this leaflet).
• Occasionally, patients who receive daptomycin may develop increased sensitivity, muscle pain or weakness (see section 4 of this leaflet for more information). Inform your doctor if this happens. Your doctor will ensure that you have a blood test and advise whether or not it is recommended to continue using daptomycin. The symptoms usually disappear within a few days after stopping treatment with daptomycin.
• If you have ever had, after taking daptomycin, a severe skin rash or skin peeling, blisters and/or sores in the mouth, or severe kidney problems.
• If you are significantly overweight. There is a possibility that your blood levels of daptomycin may be higher than those found in people of average weight, and that you may therefore need stricter control in case of side effects.

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

Tell 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. The symptoms may include shortness of breath, difficulty breathing, swelling of the face, neck and throat, skin rash and hives, or fever.
• Severe skin diseases have been reported with the use of Daptomicina. The symptoms that occur with these skin diseases may include:

• Appearance of fever or worsening of it,
• Red spots on the skin, raised or filled with fluid, which can start in the armpits or in areas of the chest or groin and can spread over a large area of the body,
• Blisters or sores in the mouth or genitals.

• Severe kidney problems have been reported with the use of Daptomicina. The symptoms may include fever and rash.
• Any kind of tingling or numbness in the hands or feet, loss of sensitivity or unusual movement difficulties. If this happens, inform your doctor, who will decide whether or not to continue treatment.
• Diarrhea, mainly if you notice the presence of blood or mucus in stools or if the diarrhea becomes severe or lasts a long time.
• Appearance of fever or worsening of it, cough or difficulty breathing. These may be signs of a rare but serious lung function deterioration called eosinophilic pneumonia. Your doctor will check the condition of your lungs and decide whether or not to continue treatment with daptomycin.

Daptomycin may interfere with laboratory tests that measure the blood's ability to clot. The results may apparently suggest poor clotting, even if there is no actual problem. 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 check the health of your muscles, before you start treatment and frequently during treatment with daptomycin.

Children and adolescents

Daptomycin should not be administered to children under one year of age, animal studies have shown that this age group may experience severe side effects.

Use in elderly patients

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

Use of Daptomicina Accordpharma with other medicines

Tell your doctor or nurse if you are using, have recently used or might use any other medicines. It is particularly important that you mention the following:

• Medicines called statins or fibrates (to lower cholesterol) or cyclosporin (a medicine used in transplants to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis). It is possible that the risk of muscle side effects may increase if you take any of these medicines (and others that may affect the muscles) during treatment with daptomycin. Your doctor may decide not to administer daptomycin or 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 elimination of daptomycin by the kidney.
• Oral anticoagulants (e.g. warfarin), which are medicines that prevent blood clotting. Your doctor may need to check your blood clotting times.

Pregnancy and breastfeeding

Daptomycin is not normally given to pregnant women. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this medicine.

You should not breastfeed if you are receiving daptomycin, because it could 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; this is, essentially “sodium-free”.

3. How to take Daptomicina Accordpharma

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

Adults (18 years of age and older)

The dose will depend on your weight and the type of infection being treated. The normal dose for adults is 4 mg per kg of body weight once a day for skin infections or 6 mg per kg of body weight once a day for a heart infection or a bloodstream infection associated with a skin or heart infection. In adult patients, this dose is administered directly into your bloodstream (into a vein), either as an infusion that lasts approximately 30 minutes or as an injection that lasts 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 functioning properly, you may receive this medicine less frequently, e.g. every other day. If you are undergoing dialysis and your next dose of this medicine is due on a dialysis day, you will normally receive this medicine after the dialysis session.

Children and adolescents (1 to 17 years of age)

The dose in children and adolescents (1 to 17 years) 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 that lasts approximately 30-60 minutes.

A complete 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following are described the most serious side effects:

Serious side effects with frequency not known (cannot be estimated from the available data)

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

• Chest pain or pressure,
• Rash or hives,
• Swelling around the throat,
• Fast or weak pulse,
• Shortness of breath,
• Fever,
• Chills or shivering,
• Flushing,
• Dizziness,
• Fainting,
• Metallic taste.

Consult your doctor immediately if you have pain, increased sensitivity or muscle weakness of unknown origin. Muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can cause kidney damage.

Other side effects that have been reported with the use of Daptomicina Accordpharma are:

• A rare but potentially serious lung condition called eosinophilic pneumonia, mostly after more than 2 weeks of treatment. The symptoms may include difficulty breathing, appearance of cough or worsening of it, or appearance of fever or worsening of it.
• Severe skin diseases. The symptoms may include:
• appearance of fever or worsening of it,
• red spots on the skin, raised or filled with fluid, which can start in the armpits or in areas of the chest or groin and can spread over a large area of the body,
• blisters or sores in the mouth or genitals.
• A serious kidney problem. The symptoms may include fever and rash.

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

The following are described the most frequently reported side effects:

Common side 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 (anemia),
• Dizziness, anxiety, difficulty sleeping,
• Headache,
• Fever, weakness (asthenia),
• High or low blood pressure,
• Constipation, abdominal pain,
• Diarrhea, 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,
• High levels of liver enzymes or creatine phosphokinase (CPK) in blood tests.

The following are described other side effects that may occur after treatment with Daptomicina Accordpharma:

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

• Blood disorders (e.g. increased platelet count, which can increase the tendency to develop thrombosis, or increased number of certain types of white blood cells),
• Decreased appetite,
• Tingling or numbness in the hands or feet, altered sense of taste,
• Tremors,
• Changes in heart rhythm, flushing,
• Indigestion (dyspepsia), tongue inflammation,
• Itchy skin rash,
• Pain, cramps or muscle weakness, muscle inflammation (myositis), joint pain,
• Kidney problems,
• Vaginal inflammation and irritation,
• Generalized pain or weakness, fatigue,
• High blood sugar, serum creatinine, myoglobin or lactate dehydrogenase (LDH), prolonged blood clotting time or electrolyte imbalance, in blood tests.
• Itchy eyes

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

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

Frequency not known(cannot be estimated from the available data)

Antibiotic-associated colitis, including pseudomembranous colitis (severe or persistent diarrhea containing blood and/or mucus, associated with abdominal pain or fever), bruising more easily, bleeding gums or nosebleeds.

Reporting of side effects:

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

5. Storage of Daptomicina 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 EXP. The expiry date is the last day of the month shown.
• Store in a refrigerator (between 2°C and 8°C).

6. Container Content and Additional Information

Composition ofDaptomicina Accordpharma

• The active ingredient is daptomycin. A 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 Container Content

Daptomicina 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 mixed with a solvent to form a solution before administration.

Daptomicina Accordpharma is presented in containers containing 1 vial or 5 vials.

Only some 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 B.V.

Utrecht, Winthontlaan 200 3526 KV

Netherlands

or

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

Date of the last revision of this leaflet:November 2021

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

This information is intended only for healthcare professionals:

Important: Please consult the Summary of Product Characteristics or Package Leaflet before prescribing.

Instructions for use and handling

Presentation of 350 mg:

In adults, daptomycin can be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes. Unlike adults, daptomycin should not be administered to pediatric patients as an injection over 2 minutes. Pediatric patients from 7 to 17 years old should receive daptomycin as an infusion over 30 minutes. Pediatric patients under 7 years old who receive doses of 9-12 mg/kg should be administered daptomycin over 60 minutes. The preparation of the solution for infusion requires an additional dilution phase, as described below.

Daptomicina Accordpharma administered as intravenous infusion over 30 or 60 minutes

Reconstituting the lyophilized product with 7 ml of an injectable solution with 9 mg/ml (0.9%) sodium chloride can obtain a concentration of 50 mg/ml of Daptomicina Accordpharma for infusion.

The lyophilized product takes approximately 20 minutes to dissolve. The fully reconstituted product has a transparent appearance and may present some small bubbles or foam around the edge of the vial.

To prepare Daptomicina Accordpharma for intravenous infusion, follow these instructions:

To reconstitute Daptomicina Accordpharma lyophilized product, aseptic technique must be used throughout the process.

1. The "flip-off" polypropylene closure cap must be removed to expose the central part of the rubber stopper. Clean the top of the rubber stopper with a cotton swab with alcohol or another antiseptic solution and let it dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. Extract 7 ml of an injectable solution with 9 mg/ml (0.9%) sodium chloride into a syringe using a sterile transfer needle with a diameter of 21 gauge or less, or a needleless device, and slowly inject through the center of the rubber stopper into the vial, aiming the needle at the vial wall.
2. The vial should be gently rotated to ensure that the product is completely wetted, and then left to stand for 10 minutes.
3. Finally, the vial should be gently rotated/agitated for a few minutes until a transparent reconstituted solution is obtained. Avoid vigorous agitation to prevent foam formation.
4. The reconstituted solution should be carefully inspected before use to ensure that the substance is dissolved and to verify the absence of particles in suspension. The color of the reconstituted solution of Daptomicina Accordpharma may vary from pale yellow to light brown.
5. The reconstituted solution must be diluted with 9 mg/ml (0.9%) sodium chloride

(typical volume of 50 ml).

For dilution:

1. Slowly withdraw the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle with a diameter of 21 gauge or less, inverting the vial so that the solution falls towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, place the tip of the needle at the lowest point of the liquid while withdrawing the solution into the syringe. Before removing the needle from the vial, pull the plunger back to the end of the syringe cylinder to remove all the 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 to 50 ml of 9 mg/ml (0.9%) sodium chloride.
4. The reconstituted and diluted solution should be infused intravenously over 30 or 60 minutes.

Daptomicina Accordpharma is not physically or chemically compatible with solutions containing glucose. The following drugs 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 combined storage time (reconstituted solution in the vial and diluted solution in infusion bags) at 25°C should not exceed 12 hours (24 hours if refrigerated).

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

Daptomicina Accordpharma administered as intravenous injection over 2 minutes

Water should not be used for the reconstitution of Daptomicina Accordpharma for intravenous injection. Daptomicina Accordpharma should be reconstituted only with 9 mg/ml (0.9%) sodium chloride.

Reconstituting the lyophilized product with 7 ml of an injectable solution with 9 mg/ml (0.9%) sodium chloride can obtain a concentration of 50 mg/ml of Daptomicina Accordpharma for injection.

The lyophilized product takes approximately 20 minutes to dissolve. The fully reconstituted product has a transparent appearance and may present some small bubbles or foam around the edge of the vial.

To prepare Daptomicina Accordpharma for intravenous injection, follow these instructions:

To reconstitute Daptomicina Accordpharma lyophilized product, aseptic technique must be used throughout the process.

1. The "flip-off" polypropylene closure cap must be removed to expose the central part of the rubber stopper. Clean the top of the rubber stopper with a cotton swab with alcohol or another antiseptic solution and let it dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. Extract 7 ml of an injectable solution with 9 mg/ml (0.9%) sodium chloride into a syringe using a sterile transfer needle with a diameter of 21 gauge or less, or a needleless device, and slowly inject through the center of the rubber stopper into the vial, aiming the needle at the vial wall.
2. The vial should be gently rotated to ensure that the product is completely wetted, and then left to stand for 10 minutes.
3. Finally, the vial should be gently rotated/agitated for a few minutes until a transparent reconstituted solution is obtained. Avoid vigorous agitation to prevent foam formation.
4. The reconstituted solution should be carefully inspected before use to ensure that the substance is dissolved and to verify the absence of particles in suspension. The color of the reconstituted solution of Daptomicina Accordpharma 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 with a diameter of 21 gauge or less.
6. Invert the vial so that the solution falls towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, place the tip of the needle at the lowest point of the liquid while withdrawing the solution into the syringe. Before removing the needle from the vial, pull the plunger back to the end of the syringe cylinder to remove all the 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 should be slowly injected intravenously over 2 minutes.

The physical and chemical stability during use 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 point of view, the product should be used immediately. If not used immediately, the storage time during use is the responsibility of the user and should not normally exceed 24 hours at 2°C-8°C unless the reconstitution/dilution has taken place in controlled and validated aseptic conditions.

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

The vials of Daptomicina Accordpharma are for single use only. Any remaining contents of the vial should be discarded.

This information is intended only for healthcare professionals:

Important: Please consult the Summary of Product Characteristics or Package Leaflet before prescribing.

Instructions for use and handling

Presentation of 500 mg:

In adults, daptomycin can be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes. Unlike adults, daptomycin should not be administered to pediatric patients as an injection over 2 minutes. Pediatric patients from 7 to 17 years old should receive daptomycin as an infusion over 30 minutes. Pediatric patients under 7 years old who receive doses of 9-12 mg/kg should be administered daptomycin over 60 minutes. The preparation of the solution for infusion requires an additional dilution phase, as described below.

Daptomicina Accordpharma administered as intravenous infusion over 30 or 60 minutes

Reconstituting the lyophilized product with 10 ml of an injectable solution with 9 mg/ml (0.9%) sodium chloride can obtain a concentration of 50 mg/ml of Daptomicina Accordpharma for infusion.

The lyophilized product takes approximately 20 minutes to dissolve. The fully reconstituted product has a transparent appearance and may present some small bubbles or foam around the edge of the vial.

To prepare Daptomicina Accordpharma for intravenous infusion, follow these instructions:

To reconstitute Daptomicina Accordpharma lyophilized product, aseptic technique must be used throughout the process.

For reconstitution

1. The "flip-off" polypropylene closure cap must be removed to expose the central part of the rubber stopper. Clean the top of the rubber stopper with a cotton swab with alcohol or another antiseptic solution and let it dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. Extract 10 ml of an injectable solution with 9 mg/ml (0.9%) sodium chloride into a syringe using a sterile transfer needle with a diameter of 21 gauge or less, or a needleless device, and slowly inject through the center of the rubber stopper into the vial, aiming the needle at the vial wall.
2. The vial should be gently rotated to ensure that the product is completely wetted, and then left to stand for 10 minutes.
3. Finally, the vial should be gently rotated/agitated for a few minutes until a transparent reconstituted solution is obtained. Avoid vigorous agitation to prevent foam formation.
4. The reconstituted solution should be carefully inspected before use to ensure that the substance is dissolved and to verify the absence of particles in suspension. The color of the reconstituted solution of Daptomicina Accordpharma may vary from pale yellow to light brown.
5. The reconstituted solution must be diluted with 9 mg/ml (0.9%) sodium chloride

(typical volume of 50 ml).

For dilution:

1. Slowly withdraw the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle with a diameter of 21 gauge or less, inverting the vial so that the solution falls towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, place the tip of the needle at the lowest point of the liquid while withdrawing the solution into the syringe. Before removing the needle from the vial, pull the plunger back to the end of the syringe cylinder to remove all the 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 to 50 ml of 9 mg/ml (0.9%) sodium chloride.
4. The reconstituted and diluted solution should be infused intravenously over 30 or 60 minutes.

Daptomicina Accordpharma is not physically or chemically compatible with solutions containing glucose. The following drugs 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 combined storage time (reconstituted solution in the vial and diluted solution in infusion bags) at 25°C should not exceed 12 hours (24 hours if refrigerated).

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

Daptomicina Accordpharma administered as intravenous injection over 2 minutes

Water should not be used for the reconstitution of Daptomicina Accordpharma for intravenous injection. Daptomicina Accordpharma should be reconstituted only with 9 mg/ml (0.9%) sodium chloride.

Reconstituting the lyophilized product with 10 ml of an injectable solution with 9 mg/ml (0.9%) sodium chloride can obtain a concentration of 50 mg/ml of Daptomicina Accordpharma for injection.

The lyophilized product takes approximately 20 minutes to dissolve. The fully reconstituted product has a transparent appearance and may present some small bubbles or foam around the edge of the vial.

To prepare Daptomicina Accordpharma for intravenous injection, follow these instructions:

To reconstitute Daptomicina Accordpharma lyophilized product, aseptic technique must be used throughout the process.

1. The "flip-off" polypropylene closure cap must be removed to expose the central part of the rubber stopper. Clean the top of the rubber stopper with a cotton swab with alcohol or another antiseptic solution and let it dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. Extract 10 ml of an injectable solution with 9 mg/ml (0.9%) sodium chloride into a syringe using a sterile transfer needle with a diameter of 21 gauge or less, or a needleless device, and slowly inject through the center of the rubber stopper into the vial, aiming the needle at the vial wall.
2. The vial should be gently rotated to ensure that the product is completely wetted, and then left to stand for 10 minutes.
3. Finally, the vial should be gently rotated/agitated for a few minutes until a transparent reconstituted solution is obtained. Avoid vigorous agitation to prevent foam formation.
4. The reconstituted solution should be carefully inspected before use to ensure that the substance is dissolved and to verify the absence of particles in suspension. The color of the reconstituted solution of Daptomicina Accordpharma may vary from pale yellow to light brown.

1. Remove the rubber stopper from the vial, pointing the needle towards the vial wall.
2. The vial should be gently rotated to ensure that the product is completely wetted, and then left to stand for 10 minutes.
3. Finally, the vial should be gently swirled/shaken for a few minutes until a clear reconstituted solution is obtained. Too vigorous agitation should be avoided to prevent foam formation.
4. The reconstituted solution should be carefully inspected before use to ensure that the substance is dissolved and to verify the absence of suspended particles. The color of the reconstituted solution of Daptomicina Accordpharma may vary from pale yellow to light brown.
5. Slowly withdraw the reconstituted liquid (50 mg daptomicina/ml) from the vial using a sterile needle with a diameter of 21 gauge or less.
6. Invert the vial so that the solution falls towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, place the tip of the needle at the lowest point of the liquid while withdrawing the solution into the syringe. Before removing the needle from the vial, pull the plunger back to the end of the syringe cylinder to remove all the 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 should be injected slowly intravenously over more than 2 minutes.

The 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 point of view, the product should be used immediately. If not used immediately, the storage time during use is the responsibility of the user and, normally, should not exceed 24 hours at 2°C-8°C unless the reconstitution/dilution has taken place in controlled and validated aseptic conditions.

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

The vials of Daptomicina Accordpharma are for single use only. Any remaining contents of the vial that have not been used should be discarded.