Daptomycin reddy

Package leaflet: Information for the patient

Daptomycin Reddy 350 mg powder for solution for injection/infusion
Daptomycin Reddy 500 mg powder for solution for injection/infusion
Daptomycin
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm
another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet,
they should inform their doctor or nurse. See section 4.
Contents of the leaflet

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

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

The active substance in Daptomycin Reddy powder for solution for injection/infusion is daptomycin. Daptomycin is an antibacterial medicine that can stop the growth of certain bacteria. Daptomycin Reddy is used in adults and in children and adolescents (aged 1 to 17 years) for the treatment of skin and soft tissue infections. Daptomycin Reddy is also used in the treatment of bloodstream infections associated with skin infections.
Daptomycin Reddy is also used in adults for the treatment of infections of the inner lining of the heart chambers and valves (including heart valves), caused by a bacterium called Staphylococcus aureus. Daptomycin Reddy is also used in the treatment of bloodstream infections caused by the same bacterium responsible for heart infections.
Depending on the type of infection(s), during treatment with Daptomycin Reddy, your doctor may also prescribe other antibacterial medicines.

2. Important Information Before Administration of Daptomycin Reddy

When not to use Daptomycin Reddy

• if the patient is allergic to daptomycin or any of the other ingredients of this medicine (listed in section 6).
• the patient should inform the doctor or nurse about any history of allergy or hypersensitivity. If the patient suspects they may be allergic to any of the substances mentioned, they should seek advice from a doctor or nurse.

Warnings and precautions
Before starting treatment with Daptomycin Reddy, consult a doctor or nurse:
if the patient has or has previously had kidney problems. The doctor may need to
adjust the dose of Daptomycin Reddy (see section 3 of this leaflet).
muscle pain, tenderness or weakness may occasionally occur in patients receiving Daptomycin Reddy
(see more information in section 4 of this leaflet). In such cases,
the patient should inform the doctor. The doctor will arrange for blood tests and decide whether
treatment with Daptomycin Reddy should continue. These symptoms usually resolve within
a few days after discontinuation of Daptomycin Reddy.
if the patient has ever experienced a severe skin rash, skin peeling, blistering, and/or oral ulcers or serious kidney problems after receiving daptomycin.
in cases of significant overweight. Blood concentrations of daptomycin may be higher compared to individuals with average body weight, and in such cases, careful monitoring is required if adverse reactions occur.
If any of the above points apply, the patient should inform their doctor or nurse before starting treatment with Daptomycin Reddy.
Immediately inform the doctor or nurse if any of the following symptoms occur:
severe, acute allergic reactions have been observed in patients treated with nearly all antibacterial medicines, including daptomycin. Symptoms may include wheezing, difficulty breathing, swelling of the face, neck and throat, rash, urticaria, or fever.
serious skin disorders have been reported during treatment with daptomycin. Symptoms may include:
onset or worsening of fever,
raised red spots or fluid-filled blisters on the skin, which may start under the arms, on the chest, or in the groin area and may spread over large areas of the body,
blisters or ulcers in the mouth or on the genital organs.
serious kidney problems have been reported during treatment with daptomycin. Symptoms may include: fever and rash.
tingling or numbness in hands or feet, loss of sensation, or difficulty moving. If any of these symptoms occur, the patient should inform the doctor, who will decide whether to discontinue or continue treatment.
diarrhoea, especially if it contains blood or mucus, or if the diarrhoea becomes severe or persistent.
onset or worsening of fever, cough, or difficulty breathing. These may be symptoms of a rare but serious lung disorder called eosinophilic pneumonia.
The doctor will examine the lungs and decide whether to continue or discontinue treatment with Daptomycin Reddy.
Daptomycin Reddy may affect laboratory test results assessing blood coagulation.
Laboratory results may indicate poor blood clotting even when clotting function is actually normal. It is therefore important that the doctor takes into account that the patient is receiving Daptomycin Reddy. Inform the doctor about the use of Daptomycin Reddy.
To monitor muscle function, the doctor may order blood tests before starting treatment and repeatedly during treatment with Daptomycin Reddy.

Children and adolescents
Daptomycin Reddy must not be given to children under one year of age, as animal studies have shown that severe adverse effects may occur in this age group.

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

Daptomycin Reddy with other medicines
Inform the doctor or nurse about all medicines currently used, recently used, or planned to be used.
It is especially important to inform the doctor about:
medicines known as statins or fibrates (which lower cholesterol levels), or cyclosporine (a medicine used in transplantation to prevent rejection or in other conditions such as rheumatoid arthritis or atopic dermatitis). Using any of these (or other muscle-affecting) medicines during treatment with Daptomycin Reddy may increase the risk of developing muscle-related adverse effects.
The doctor will decide whether to discontinue Daptomycin Reddy or temporarily suspend the other medicines.
painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These may affect the effect of Daptomycin Reddy on the kidneys.
oral anticoagulants (e.g. warfarin), which prevent blood clotting. The doctor may need to monitor blood clotting time.

Pregnancy and breastfeeding
Daptomycin Reddy is generally not given to pregnant women. If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use this medicine during breastfeeding, as Daptomycin Reddy may pass into breast milk and may harm the infant.

Driving and operating machinery
There is no known effect of Daptomycin Reddy on the ability to drive or operate machinery.

Daptomycin Reddy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to administer Daptomycin Reddy
Daptomycin Reddy is usually administered by a doctor or nurse.

Adults (aged 18 years and above)
The dose depends on body weight and the type of infection being treated. The usual dose for adults is:

• 4 mg per kilogram (kg) of body weight once daily for skin infections, or
• 6 mg per kilogram of body weight once daily for heart infection or bloodstream infection associated with skin or heart infection.

In adult patients, the medicine is given directly into the bloodstream (intravenously) as a 30-minute infusion or as a 2-minute injection. The same dose is recommended for patients aged 65 years and older, provided no kidney disease is present.
In patients with impaired kidney function, Daptomycin Reddy may be administered less frequently, e.g. every other day. In dialysed patients, if the next dose of Daptomycin Reddy falls on a dialysis day, Daptomycin Reddy is usually given after dialysis is completed.

Children and adolescents (aged 1 to 17 years)
The dose for children and adolescents (aged 1 to 17 years) will depend on the patient's age and the type of infection being treated. The dose is administered directly into the bloodstream (intravenously) as an infusion lasting approximately 30–60 minutes.

Treatment of skin infections usually lasts from 1 to 2 weeks. For bloodstream or heart infections, as well as for skin infections, the duration of treatment will be determined by the doctor.

Detailed instructions for administration and preparation of the medicine 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most serious adverse reactions are described below:
Serious adverse reactions with unknown frequency (frequency cannot be determined from available data)

• Hypersensitivity reactions (severe allergic reactions, including anaphylaxis and angioedema) have been reported in several cases during daptomycin treatment. This severe allergic reaction requires immediate medical attention. You should inform your doctor or nurse immediately if you experience any of the following symptoms: chest pain or tightness, rash or hives, throat swelling, rapid or weak pulse, wheezing, fever, chills or shivering, hot flushes, dizziness, fainting, or metallic taste in the mouth.
• If unexplained muscle pain, tenderness, or weakness occurs, you should inform your doctor immediately. Muscle-related symptoms may be serious. Muscle cell breakdown (so-called rhabdomyolysis) may occur, which can lead to kidney damage. Other serious adverse reactions reported during treatment with Daptomycin Reddy:
• Rare but potentially serious lung disorder called eosinophilic pneumonia has been most frequently observed in cases where treatment lasted longer than 2 weeks. Symptoms may include: difficulty breathing, new onset or worsening cough, or new onset or worsening fever.
• Severe skin disorders. Symptoms may include: fever, new onset or worsening of fever, red raised or fluid-filled blisters on the skin, which may start under the arms, on the chest, or in the groin area and may spread over large areas of the body, blisters or ulcers in the mouth or on the genital organs.
• Serious kidney problems. Symptoms may include: fever and rash. If these symptoms occur, you should inform your doctor or nurse immediately. Your doctor will perform additional tests to establish a diagnosis.

The most commonly reported adverse reactions are described below:
Common adverse reactions (may occur in fewer than 1 in 10 people)

• fungal infections, such as candidiasis,
• urinary tract infection,
• decreased number of red blood cells (anaemia),
• dizziness, restlessness, sleep disturbances,
• headache,
• fever, weakness (asthenia),
• increased or decreased blood pressure,
• constipation, abdominal pain,
• diarrhoea, nausea or vomiting,
• flatulence,
• abdominal distension or bloating,
• skin rash or itching,
• pain, itching or redness around the injection site,
• pain in arms or legs,
• increased liver enzyme or creatine phosphokinase (CPK) activity in blood.

Other adverse reactions that may occur after administration of Daptomycin Reddy are described below:
Uncommon adverse reactions (may occur in fewer than 1 in 100 people)

• blood disorders (e.g.: increased number of small blood cells called platelets, which may increase blood clotting, or increased number of certain types of white blood cells),
• decreased appetite,
• tingling or numbness in hands or feet, taste disturbances,
• tremor,
• changes in heart rhythm, sudden facial flushing,
• indigestion (dyspepsia), inflammation of the tongue,
• itchy skin rash,
• muscle pain, cramps or weakness, muscle inflammation, joint pain,
• kidney problems,
• vaginal inflammation or irritation,
• general feeling of pain or weakness, fatigue (tiredness),
• increased blood glucose, plasma creatinine, myoglobin levels, increased lactate dehydrogenase (LDH) activity, prolonged blood coagulation time, or electrolyte imbalance,
• eye itching.

Rare adverse reactions (may occur in fewer than 1 in 1,000 people)

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

Frequency not known (frequency cannot be determined from available data)
Inflammation of the large intestine associated with antibacterial effect, including pseudomembranous colitis [severe or persistent diarrhoea with blood and (or) mucus, associated with abdominal pain or fever], easy bruising, bleeding gums or nosebleeds.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Daptomycin Reddy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label following EXP.
The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C–8°C).
After reconstitution: Chemical and physical stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C–8°C. Chemical and physical stability of the diluted solution in infusion bags has been demonstrated for 12 hours at 25°C or 24 hours at 2°C–8°C.
For a 30-minute intravenous infusion, the total storage time (reconstituted solution in the vial and diluted solution in the infusion bag) at 25°C must not exceed 12 hours (or 24 hours at 2°C–8°C).
For a 2-minute intravenous injection, the storage time of the reconstituted solution in the vial at 25°C must not exceed 12 hours (or 48 hours at 2°C–8°C).
However, from a microbiological standpoint, the prepared product should be used immediately. The product does not contain a preservative or bacteriostatic agent. If the product is not used immediately, the storage period and conditions prior to use are the responsibility of the user and should usually not exceed 24 hours at 2°C–8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.
Do not use this medicine if visible signs of deterioration are observed, such as the presence of particulate matter.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Daptomycin Reddy contains
The active substance is daptomycin.
One vial of powder contains 350 mg of daptomycin.
One ml of solution after reconstitution of the powder with 7 ml of 9 mg/ml (0.9%) sodium chloride solution for injection contains 50 mg of daptomycin.
One vial of powder contains 500 mg of daptomycin.
One ml of solution after reconstitution of the powder with 10 ml of 9 mg/ml (0.9%) sodium chloride solution for injection contains 50 mg of daptomycin.
The other ingredient is sodium hydroxide for pH adjustment.

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

Marketing Authorisation Holder
Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Tel.: +49 821 74881 0

Importer/Manufacturer
betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany
SC Rual Laboratories SRL
Splaiul Unirii nr 313, Building H, 1st floor, sector 3
030138 Bucharest
Romania

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

Information intended exclusively for healthcare professionals

Warning: Before prescribing the medicinal product, refer to the Summary of Product Characteristics.
Instructions for use and handling
350 mg powder for solution for injection/infusion
500 mg powder for solution for injection/infusion

Daptomycin may be administered intravenously to adult patients either as a 30-minute infusion or as a 2-minute injection. In contrast to adult patients, daptomycin should not be administered to children and adolescents as a 2-minute injection. For children and adolescents aged 7 to 17 years, daptomycin should be administered as a 30-minute infusion. For children under 7 years of age receiving a dose of 9–12 mg/kg body weight, daptomycin should be administered over 60 minutes. Preparation of the infusion solution requires an additional dilution step, specified below.

Daptomycin Reddy medicinal product administered as a 30- or 60-minute intravenous infusion

The concentration of Daptomycin Reddy medicinal product in the infusion solution of 50 mg/ml is achieved by reconstituting the lyophilized product with 7 ml (for the 350 mg Daptomycin Reddy powder) of 9 mg/ml (0.9%) sodium chloride solution for injection.

The concentration of Daptomycin Reddy medicinal product in the infusion solution of 50 mg/ml is achieved by reconstituting the lyophilized product with 10 ml (for the 500 mg Daptomycin Reddy powder) of 9 mg/ml (0.9%) sodium chloride solution for injection.

Dissolving the lyophilized product typically takes 15 minutes. The completely reconstituted product is clear and may contain a few small air bubbles or foam at the edge of the vial.

To prepare Daptomycin Reddy medicinal product for intravenous infusion, follow the instructions below.
Throughout the reconstitution or dilution of the lyophilized Daptomycin Reddy medicinal product, aseptic techniques must be strictly maintained.

Reconstitution:

1. Remove the polypropylene cap from the vial to expose the central area of the rubber stopper. Wipe the rubber stopper with an alcohol-impregnated swab or another antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile 21 G needle or smaller, or a needle-free device, draw into a syringe 7 ml (for the 350 mg Daptomycin Reddy powder) of 9 mg/ml (0.9%) sodium chloride solution for injection. Then slowly pierce the center of the rubber stopper with the needle and inject the syringe contents, directing the needle against the vial wall.
2. Remove the polypropylene cap from the vial to expose the central area of the rubber stopper. Wipe the rubber stopper with an alcohol-impregnated swab or another antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile 21 G needle or smaller, or a needle-free device, draw into a syringe 10 ml (for the 500 mg Daptomycin Reddy powder) of 9 mg/ml (0.9%) sodium chloride solution for injection. Then slowly pierce the center of the rubber stopper with the needle and inject the syringe contents, directing the needle against the vial wall.
3. Gently rotate the vial to completely wet the lyophilisate and leave it for 10 minutes.
4. Finally, gently rotate or swirl the vial for several minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming.
5. Inspect the prepared solution carefully before use to ensure that the medicinal product is completely dissolved and contains no solid particles. The Daptomycin Reddy medicinal product solution ranges in color from pale yellow to light brown.
6. Dilute the reconstituted solution with 0.9% sodium chloride solution for injection (9 mg/ml), typically in 50 ml.

Dilution:

1. Slowly withdraw the appropriate amount of reconstituted solution (50 mg daptomycin/ml) from the vial using a new sterile 21 G needle or smaller by inverting the vial so that the solution flows toward the stopper. Using a syringe, insert the needle into the inverted vial. While holding the vial upside down, place the needle tip as deep as possible into the vial while drawing the solution into the syringe. Before removing the needle from the vial, pull back the syringe plunger fully to withdraw the desired amount of solution from the inverted vial.
2. Remove air, large bubbles, and excess solution from the syringe to achieve the required dose.
3. Transfer the required amount of the prepared dose into 50 ml of 9 mg/ml (0.9%) sodium chloride solution.
4. The reconstituted and diluted solution may then be administered as an intravenous infusion over 30 or 60 minutes.

The Daptomycin Reddy medicinal product is physically and chemically incompatible with fluids containing glucose. The following drugs have shown no incompatibility when added to daptomycin solution: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.

The total storage time (reconstituted solution in the vial and diluted solution in the infusion bag) must not exceed 12 hours at 25°C or 24 hours if stored refrigerated.
The stability of the diluted solution in the infusion bag is 12 hours at 25°C or 24 hours if stored refrigerated at 2°C–8°C.

Daptomycin Reddy medicinal product administered as a 2-minute intravenous injection (adult patients only)

Do not use water to reconstitute the Daptomycin Reddy medicinal product for intravenous injection. The Daptomycin Reddy medicinal product must be reconstituted exclusively with 0.9% sodium chloride solution (9 mg/ml) for injection.

The concentration of Daptomycin Reddy medicinal product in the infusion solution of 50 mg/ml is achieved by reconstituting the lyophilized product with 7 ml (for the 350 mg Daptomycin Reddy powder) of 9 mg/ml (0.9%) sodium chloride solution for injection.

The concentration of Daptomycin Reddy medicinal product in the infusion solution of 50 mg/ml is achieved by reconstituting the lyophilized product with 10 ml (for the 500 mg Daptomycin Reddy powder) of 9 mg/ml (0.9%) sodium chloride solution for injection.

The lyophilized product dissolves within approximately 15 minutes. The completely dissolved medicinal product is clear and may contain a few small bubbles or foam at the edge of the vial.

To prepare the Daptomycin Reddy medicinal product for intravenous injection, follow the instructions below.
Throughout the reconstitution of the lyophilized Daptomycin Reddy medicinal product, aseptic techniques must be strictly maintained.

1. Remove the polypropylene cap from the vial to expose the central area of the rubber stopper. Wipe the rubber stopper with an alcohol-impregnated swab or another antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile 21 G needle or smaller, or a needle-free device, draw into a syringe 7 ml (for the 350 mg Daptomycin Reddy powder) of 9 mg/ml (0.9%) sodium chloride solution for injection. Then slowly pierce the center of the rubber stopper with the needle and inject the syringe contents, directing the needle against the vial wall.
2. Remove the polypropylene cap from the vial to expose the central area of the rubber stopper. Wipe the rubber stopper with an alcohol-impregnated swab or another antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile 21 G needle or smaller, or a needle-free device, draw into a syringe 10 ml (for the 500 mg Daptomycin Reddy powder) of 9 mg/ml (0.9%) sodium chloride solution for injection. Then slowly pierce the center of the rubber stopper with the needle and inject the syringe contents, directing the needle against the vial wall.
3. Gently rotate the vial to completely wet the lyophilisate and leave it for 10 minutes.
4. Finally, gently rotate or swirl the vial for several minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming.
5. Inspect the prepared solution carefully before use to ensure that the product is completely dissolved and contains no solid particles. The Daptomycin Reddy medicinal product solution ranges in color from pale yellow to light brown.
6. Slowly withdraw the reconstituted solution (50 mg daptomycin/ml) from the vial using a sterile 21 G needle or smaller.
7. Invert the vial so that the solution flows toward the stopper. Using a new syringe, insert the needle into the inverted vial. While holding the vial upside down, place the needle tip as deep as possible into the vial while drawing the solution into the syringe. Before removing the needle from the vial, pull back the syringe plunger fully to withdraw the entire solution from the inverted vial.
8. Change the needle to a new one intended for intravenous injection.
9. Remove air, large bubbles, and excess solution from the syringe to achieve the required dose.
10. Administer the reconstituted solution slowly into the vein over 2 minutes.

The chemical and physical stability of the reconstituted medicinal product solution in the vial is 12 hours at 25°C or up to 48 hours when stored refrigerated (2°C–8°C).
However, from a microbiological standpoint, the prepared product should be used immediately. If not used immediately, the user is responsible for the storage time, which generally must not exceed 24 hours at 2°C–8°C, unless reconstitution and dilution were performed under controlled and validated aseptic conditions.

The medicinal product must not be mixed with other medicinal products except those listed above.
Vials containing the Daptomycin Reddy medicinal product are intended for single use only.
Any unused product or waste material must be disposed of appropriately.