350 mg powder for solution for injection or infusion ,
1. What Cubicin is and what it is used for
The active substance in Cubicin powder for solution for injection or infusion is daptomycin. Daptomycin is an antibacterial agent that can inhibit the growth of certain bacteria. Cubicin is used to treat infections of the skin and tissues under the skin in adults and children and adolescents (1 to 17 years). It is also used to treat infections in the blood in connection with infections in the skin.
Cubicin is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) caused by a type of bacterium called Staphylococcus aureus . It is also used to treat infections in the blood caused by the same type of bacteria associated with infections in the heart.
Depending on the type of infection (s) you have, your doctor may also prescribe other antibacterial agents while you are being treated with Cubicin.
2. What you need to know before you are given Cubicin
You should not be treated with Cubicin
If you are allergic to daptomycin or sodium hydroxide or any of the other ingredients of this medicine (listed in section 6).
If the above applies to you, tell your doctor or nurse. If you think you may be allergic, ask your doctor or nurse for advice.
Warnings and cautions
Talk to your doctor or nurse before receiving Cubicin:
- If you have or have ever had kidney problems. Your doctor may need to change the dose of Cubicin (see section 3 of this leaflet).
- In rare cases, patients treated with Cubicin may experience muscle soreness or pain or muscle weakness (see further information in section 4 of this leaflet). If this happens, tell your doctor. Your doctor will take a blood test and tell you whether or not to continue treatment with Cubicin. The symptoms usually disappear within a few days after you have stopped treatment with Cubicin.
- If you have ever had severe skin rash or dandruff, blisters and / or sores in your mouth, or severe kidney problems after taking daptomycin.
- If you are very overweight. It is possible that the level of Cubicin in your blood will be higher than that in middle-aged people. You may need to undergo careful checks for side effects .
If any of the above apply to you, talk to your doctor or nurse before taking Cubicin.
Tell your doctor or nurse as soon as possible if you get any of the following symptoms:
- Severe, acute allergic reactions have been observed in patients treated with almost all antibacterial drugs, including Cubicin. Symptoms may include wheezing, difficulty breathing, swelling of the face, neck and throat, rash and hives or fever.
- Severe skin conditions have been reported with Cubicin. The symptoms that occur in these skin diseases can include:
- new onset or worsening fever,
- red raised or fluid-filled patches of skin that may start in the armpits, on the chest or around the writing and that may spread over a large part of the body,
- blisters or sores in the mouth or on the genitals.
- A serious kidney problem has been reported with the use of Cubicin. Symptoms may include fever and rash.
- Unusual tingling or numbness in the hands or feet, loss of sensation or difficulty moving. Tell your doctor if this occurs. Your doctor will decide if you should continue treatment.
- Diarrhea, especially if it is bloody or mucous, or if the diarrhea becomes severe or prolonged.
- New onset or worsening fever, cough or difficulty breathing. This may be a sign of a rare but serious lung disease called eosinophilic pneumonia . Your doctor will check the condition of your lungs and assess whether you should continue treatment with Cubicin or not.
Cubicin can affect the method of analysis of blood samples that measure the blood’s ability to clot. The blood test may incorrectly indicate poor coagulation ability even though there is really nothing wrong with your blood. It is therefore important that your doctor considers your treatment with Cubicin. Please tell your doctor that you are being treated with Cubicin.
Your doctor will take blood tests to check your muscles both before you start treatment and regularly during treatment with Cubicin.
Children and young people
Cubicin should not be given to children under 1 year of age as animal studies have indicated that this age group may experience severe side effects .
Use in the elderly
Patients over the age of 65 can be given the same dose as other adults provided the kidneys are functioning well.
Other drugs and Cubicin
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
It is especially important that you inform about the following:
- Medicines called statins or fibrates (which lower blood fats) or ciclosporin (a medicine used in transplantation to prevent organ rejection or in conditions such as rheumatoid arthritis or atopic dermatitis ). It is possible that the risk of muscle side effects is greater if you take any of these preparations (or other preparations that may affect your muscles) during treatment with Cubicin. Your doctor may decide not to give you Cubicin or to stop you taking the other medicine temporarily.
- Painkillers, so-called non-steroidal anti-inflammatory drugs ( NSAIDs ) or COX-2inhibitors (eg celecoxib). These medicines can affect the secretion of Cubicin by the kidneys.
- Oral anticoagulants (eg warfarin ), which are medicines that prevent the blood from clotting. It may be necessary for your doctor to measure your blood clotting time.
Pregnancy and breastfeeding
Cubicin is not normally given to pregnant women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not breast-feed if you are being treated with Cubicin as the medicine may pass into breast milk and could affect the baby.
Driving and using machines
It is not known that Cubicin would have any effect on your ability to drive or use machines.
Cubicin contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose , ie essentially ‘sodium-free’.
How Cubicin is given
Cubicin is usually given by a doctor or nurse.
Adults (18 years or older)
The size of the dose you receive depends on your weight and the type of infectionyou have. The usual dose of an adult is 4 mg per kilogram (kg) of body weight once daily for skin infections or 6 mg per kg of body weight once a day at the infection of the heart or infection in bloodstream associated with infection s skin or heart. In adult patients, a dose is given directly into the bloodstream ( intravenously ) either as an infusion for 30 minutes or as an injection for about 2 minutes. Same doserecommended for patients over 65 years of age provided their kidneys are functioning well.
If your kidney function is impaired, you may receive Cubicin less often, e.g. once every two days. If you are being treated with dialysis and if your next dose of Cubicin is to be given on a dialysis day, you will usually receive Cubicin after completion of dialysis .
Children and adolescents (1 to 17 years)
Dosage one for children and adolescents (1 to 17 years) depends on the patient’s age and the type of infection being treated. This dose is given directly into the bloodstream (in a vein), as an infusion lasting for about 30-60 minutes.
A treatment regimen usually lasts 1 to 2 weeks for skin infections. In case of infectionin the blood or heart and in case of infection in the skin, your doctor will decide how long you should be treated.
Detailed instructions for use and handling are provided at the end of this information.
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 adverse events are of unknown frequency (frequency can not be estimated from the available data)
Hypersensitivity reactions (severe allergic reaction including allergic shock and angioedema have been reported occasionally during administration of Cubicin. These severe allergic reactions require immediate medical attention. Tell your doctor or nurse immediately if you get any of the following symptoms:
- Chest pain or pressure over the chest,
- Rash or hives ,
- Swelling of the throat,
- Fast or weak pulse ,
- Beep in the chest,
- Shaking or trembling,
- Metal taste in the mouth.
Tell your doctor as soon as possible if you experience unexplained muscle pain, tenderness or weakness. Muscle problems can be serious and lead to muscle breakdown ( rhabdomyolysis ), which in turn can damage the kidneys.
Other serious adverse event is reported with the use of Cubicin is:
- A rare but potentially serious lung disease called eosinophilic pneumonia , usually after more than 2 weeks of treatment. Symptoms may include difficulty breathing, new onset or worsening of cough, or new onset or worsening fever.
- Serious skin diseases. Symptoms may include:
- new onset or worsening fever,
- red raised or fluid-filled patches of skin that may start in the armpits, on the chest or around the writing and that may spread over a large area of the body,
- blisters or sores in the mouth or on the genitals.
- A serious kidney problem. Symptoms may include fever and rash.
If you experience any of these symptoms, talk to your doctor or nurse as soon as possible. Your doctor will perform additional tests to make a diagnosis.
The most frequently reported adverse reactions are described below:
Common adverse s (affecting less than 1 in 10)
- Fungal infections such as cod,
- Urinary tract infection,
- Decreased red blood cell count (low blood count ),
- Dizziness, anxiety, difficulty sleeping,
- Fever, weakness ( asthenia ),
- High or low blood pressure ,
- Constipation, abdominal pain,
- Diarrhea, nausea or vomiting,
- Weather voltage,
- Swollen abdomen or rash,
- Skin rash or itching ,
- Pain, itching or redness at the puncture site,
- Pain in arms or legs,
- Blood tests show higher levels of liver enzymes or creatine phosphokinase (CK).
Other side effects that may occur during treatment with Cubicin are described below:
Less common side effects are (by less than 1 in 100)
- Blood diseases (eg increased number of small blood cells called platelets , which can increase the blood’s tendency to clot, or increased number of a certain type of white blood cell ),
- Reduced appetite,
- Tingling or numbness in the hands or feet, taste disturbances,
- Changes in heart rate, hot flashes,
- Indigestion ( dyspepsia ), inflammation of the tongue,
- Itchy rash,
- Muscle pain, cramps or weakness, muscle inflammation (myositis), joint pain,
- Kidney problems,
- Inflammation and irritation of the vagina,
- General ache or weakness, fatigue,
- Blood tests show elevated levels of blood sugar, serum creatinine , myoglobin, or lactate dehydrogenase (LDH), prolonged blood clotting time, or salt balance disorders.
- Itchy eyes.
Rare side effects are (by less than 1 in 1 000)
- Yellowing of the skin and whites of the eyes,
- Prolonged prothrombin time (coagulation time).
No known frequency (frequency can not be calculated from available data)
Antibacterial-associated colitis including pseudomembranous colitis (severe or prolonged diarrhea that is bloody and / or mucous, with concomitant abdominal pain or fever), increased tendency to bruise, bleeding gums or nosebleeds.
5. How to store Cubicin
- 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. dat. respectively EXP. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C – 8 ° C).
6. Contents of the packaging and other information
- The active substance is daptomycin. One vial of powder contains 350 mg of daptomycin.
- The other ingredient is sodium hydroxide.
What the medicine looks like and contents of the pack
Cubicin powder for solution for injection or infusion is supplied as a light yellow to light brown cake or powder in a glass bottle. It is mixed with a liquid so that a solution is obtained before it is given.
Cubicin is available in packs of 1 bottle or 5 bottles.
Marketing Authorisation Holder
Merck Sharp & Dohme BV
2031 BN Haarlem
Laboratories Merck Sharp & Dohme Chibret
Route de Marsat
63963, Clermont Ferrand Cedex 9
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