350 mg powder for solution for injection
or infusion daptomycin
What Daptomycin Hospira is and what it is used for
The active substance in Daptomycin Hospira powder for solution for injection or infusion is daptomycin. Daptomycin is an antibacterial agent that can inhibit the growth of certain bacteria. Daptomycin Hospira is used for treating skin and subcutaneous tissue infections 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.
Daptomycin Hospira 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 Daptomycin Hospira.
2. What you need to know before you use Daptomycin Hospira
You should not be treated with Daptomycin Hospira
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 Daptomycin Hospira:
- If you have or have ever had kidney problems. Your doctor may need to change the dose of Daptomycin Hospira (see section 3 of this leaflet).
- In rare cases, patients treated with Daptomycin Hospira 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 Daptomycin Hospira. Symptoms usually disappear within a few days after stopping treatment with Daptomycin Hospira.
- 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 any of the above apply to you, talk to your doctor or nurse before taking Daptomycin Hospira.
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 Daptomycin Hospira. Symptoms may include wheezing, difficulty breathing, swelling of the face, neck, and throat, rash, and hives, or fever.
- Serious skin conditions have been reported with Daptomycin Hospira. The symptoms that occur in these skin diseases can include:
- new-onset or worsening fever,
- red raised or fluid-filled skin spots that may begin in the armpits, on the chest, or around the groin and 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 Daptomycin Hospira. 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 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 or not you should continue treatment with Daptomycin Hospira.
Daptomycin Hospira may 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 Daptomycin Hospira. Please tell your doctor that you are being treated with Daptomycin Hospira.
Your doctor will take blood tests to check your muscles both before you start treatment and regularly during treatment with Daptomycin Hospira.
Children and young people
Daptomycin Hospira 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
People over the age of 65 can be given the same dose as other adults provided the kidneys work well.
Other medicines and Daptomycin Hospira
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
You must inform about the following:
- Medicines called statins or fibrates (which lower blood fats) or cyclosporine (a medicine used in transplantation to prevent organ rejection or in conditions such as rheumatoid arthritis or atopic dermatitis ). The risk of muscle side effects may be greater if you are taking any of these medicines (or other medicines that may affect your muscles) while you are taking Daptomycin Hospira. Your doctor may decide that you should not take Daptomycin Hospira or that you should temporarily stop taking the other medicine.
- Painkillers, so-called non-steroidal anti-inflammatory drugs ( NSAIDs ), or COX-2inhibitors (eg celecoxib). These medicines can affect the secretion of Daptomycin Hospira by the kidneys.
- Oral anticoagulants (eg warfarin ), are medicines that prevent the blood from clotting. It may be necessary for your doctor to measure your blood clotting time.
Pregnancy, breastfeeding, and fertility
Daptomycin Hospira 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 Daptomycin Hospira as the medicine may pass into breast milk and could affect the baby.
Driving and using machines
Daptomycin Hospira is not known to have any effect on your ability to drive or use machines.
Daptomycin Hospira contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
How Daptomycin Hospira is given
Daptomycin Hospira 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 infection you 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. The same dose is recommended for patients over 65 years of age provided their kidneys are functioning well.
If your kidney function is impaired, you may receive Daptomycin Hospira less often, e.g. once every two days. If you are being treated with dialysis and if your next dose of Daptomycin Hospira is to be given on a dialysis day, you will usually be given Daptomycin Hospira after 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 infection in the blood or heart and case of infection in the skin, your doctor will decide how long you should be treated.
Detailed instructions for use and handling can be found at the end of this leaflet.
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 reactions with an unknown frequency: the frequency can not be calculated from the available data
- Hypersensitivity reactions (severe allergic reaction including allergic shock and angioedema ) have been reported in isolated cases during the administration of Daptomycin Hospira. 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,
- Fever,
- Shaking or trembling,
- Hemorrhoids,
- Dizziness,
- Fainting,
- 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 side effects that have been reported with Daptomycin Hospira are:
– 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 a 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 which may spread over a large area of the body,
blisters or sores in the mouth or 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: may affect up to 1 in 10 users
- Fungal infections such as cod,
- Urinary tract infection,
- Decreased red blood cell count (low blood count ),
- Dizziness, anxiety, difficulty sleeping,
- Headache,
- 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 daptomycin are described below:
Uncommon: may affect up to 1 in 100 people
- Blood diseases (eg increased number of small blood cells called platelets which can increase the blood’s tendency to clot, or increased the number of a certain type of white blood cell ),
- Reduced appetite,
- Tingling or numbness in the hands or feet, taste disturbances,
- Shaking,
- 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: may affect up to 1 in 1,000 users
- Yellowing of the skin and whites of the eyes,
- Prolonged prothrombin time (coagulation time).
No known frequency: the frequency can not be calculated from the 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 Daptomycin Hospira
- 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 expiration date is the last day of the specified month.
- Do not store above 30 ° C.
6. Contents of the packaging and other information
Content declaration
- The active substance is daptomycin. One vial of powder contains 350 mg of daptomycin.
- The other ingredients are sodium hydroxide and citric acid.
What the medicine looks like and the contents of the pack
Daptomycin Hospira powder for solution for injection or infusion is a light yellow to light brown lyophilized cake or powder in a glass vial. It is mixed with a solvent into a liquid before being given to the patient.
Daptomycin Hospira is available in packs of 1 or 5 vials.
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Service Company BVBA
High Way 10
1930 Zaventem
Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine:
| ASKPfizer SA / NVTel: + 32 2 554 62 11 | LUPfizer SA / NVTel: + 32 2 554 62 11 |
| BGPfizer Luxembourg SAAR С, Clone of BulgariaTel: +359 2 970 4333 | LTPfizer Luxembourg SARL branches in LithuaniaTel: + 370 52 51 4000 |
| CZPfizer, spol. s roTel: + 420-283-004-111 | HUPfizer Kft.Tel: + 36 1 488 37 00 |
| DKPfizer ApSTel: + 45 44 20 11 00 | MTDrugsales LtdTel: + 356 21 419 070/1/2 |
| THEPFIZER PHARMA GmbHTel: + 49 (0) 30 550055-51000 | NLPfizer bvTel: +31 (0) 10 406 43 01 |
| EEPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | NOPfizer ASTel: +47 67 52 61 00 |
| Pfizer ΕΛΛΑΣ AE.:Ηλ .: +30 210 6785 800 | ATPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| ESPfizer, SLTel: +34 91 490 99 00 | PLPfizer Polska Sp. z ooTel: +48 22 335 61 00 |
| FRPfizerTel: + 33 (0) 1 58 07 34 40 | PTPfizer Laboratories, Lda.Tel: +351 21 423 55 00 |
| HRPfizer Croatia dooTel: +385 1 3908 777 | ROPfizer România SRLTel: +40 (0) 21 207 28 00 |
| IEPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | SIPfizer Luxembourg SARL Pfizer, a company in the field of pharmaceuticals, LjubljanaTel: +386 (0) 1 52 11 400 |
| ISIcepharma hf.Phone: +354 540 8000 | SKPfizer Luxembourg SARL, organizer el: + 421–2–3355 5500 |
| ITPfizer SrlTel: +39 06 33 18 21 | FIPfizer OyPuh / Tel: +358 (0) 9 430 040 |
| CYPharmaceutical Trading Co. LtdFile: 24656165 | SEEPfizer ABTel: +46 (0) 8 550 520 00 |
| LVPfizer Luxembourg SARL subsidiary LatvijāTel: + 371 670 35 775 | UKHospira UK LimitedTel: + 44 (0) 1628 515500 |