Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - daptomycin

Document Subject

Generated Narrative: MedicinalProductDefinition mp08bd32995710017e5d1be3af6c537328

identifier: http://ema.europa.eu/identifier/EU/1/17/1175/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Daptomycin Hospira 350 mg powder for solution for injection/infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-08bd32995710017e5d1be3af6c537328

identifier: http://ema.europa.eu/identifier/EU/1/17/1175/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - daptomycin

Attesters

What is in this leaflet

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

The active substance in Daptomycin Hospira powder for solution for injection/infusion is daptomycin. Daptomycin is an antibacterial that can stop the growth of certain bacteria. Daptomycin Hospira is used in adults and in children and adolescents (age from 1 to 17 years) to treat infections of the skin and the tissues below the skin. It is also used to treat infections in the blood when associated with skin infection.

Daptomycin Hospira is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a type of bacteria called Staphylococcus aureus. It is also used to treat infections in the blood caused by the same type of bacteria when associated with heart infection.

Depending on the type of infection(s) that you have, your doctor may also prescribe other antibacterials while you are receiving treatment with Daptomycin Hospira.

You should not be given Daptomycin Hospira
If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor or nurse. If you think you may be allergic, ask your doctor or nurse for advice.

Warnings and precautions
Talk to your doctor or nurse before you are given Daptomycin Hospira:

• If you have, or have previously had kidney problems. Your doctor may need to change the dose of Daptomycin Hospira (see section 3 of this leaflet).
• Occasionally, patients receiving Daptomycin Hospira may develop tender or aching muscles or muscle weakness (see section 4 of this leaflet for more information). If this happens tell your doctor. Your doctor will make sure you have a blood test and will advise whether or not to continue with Daptomycin Hospira. The symptoms generally go away within a few days of stopping Daptomycin Hospira.
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores, or serious kidney problems after taking daptomycin.
• If you are very overweight. There is a possibility that your blood levels of Daptomycin Hospira could be higher than those found in persons of average weight and you may need careful monitoring in case of side effects.

If any of these applies to you, tell your doctor or nurse before you are given Daptomycin Hospira.

Tell your doctor or nurse straight away if you develop any of the following symptoms:

• Serious, acute allergic reactions have been observed in patients treated with nearly all antibacterial agents, including Daptomycin Hospira. The symptoms can include wheezing, difficulty breathing, swelling of the face, neck and throat, rashes and hives, or fever.

• Serious skin disorders have been reported with the use of Daptomycin Hospira. The symptoms that occur with these skin disorders can include:

• a new or worsening fever,

• red raised or fluid-filled skin spots which may start in your armpits or on your chest or groin areas and which can spread over a large area of your body,

• blisters or sores in your mouth or on your genitals.

• A serious kidney problem has been reported with the use of Daptomycin Hospira. The symptoms can include fever and rash.

• Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements. If this happens, tell your doctor who will decide whether you should continue the treatment.

• Diarrhoea, especially if you notice blood or mucus, or if diarrhoea becomes severe or persistent.

• New or worsening fever, cough or difficulty breathing. These may be signs of a rare but serious lung disorder called eosinophilic pneumonia. Your doctor will check the condition of your lungs and decide whether or not you should continue Daptomycin Hospira treatment.

Daptomycin Hospira may interfere with laboratory tests that measure how well your blood is clotting. The results can suggest poor blood clotting when, in fact, there is no problem. Therefore, it is important that your doctor takes into account that you are receiving Daptomycin Hospira. Please inform your doctor that you are on treatment with Daptomycin Hospira.

Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with Daptomycin Hospira.

Children and adolescents
Daptomycin Hospira should not be administered to children below one year of age as studies in animals have indicated that this age group may experience severe side effects.

Use in elderly
People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.

Other medicines and Daptomycin Hospira Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
It is particularly important that you mention the following:

• Medicines called statins or fibrates (to lower cholesterol) or ciclosporin (a medicinal product used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis). It is possible that the risk of side effects affecting the muscles may be higher when any of these medicines (and some others that can affect muscles) is taken during treatment with Daptomycin Hospira. Your doctor may decide not to give you Daptomycin Hospira or to stop the other medicine for a while.
• Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These could interfere with the effects of Daptomycin Hospira in the kidney.
• Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting. It may be necessary for your doctor to monitor your blood clotting times.

Pregnancy and breast-feeding
Daptomycin Hospira is not usually 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 you are given this medicine.

Do not breast-feed if you are receiving Daptomycin Hospira, because it may pass into your breast milk and could affect the baby.

Driving and using machines

Daptomycin Hospira has no known effects on the ability to drive or use machines.

Daptomycin Hospira contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

Daptomycin Hospira will usually be given to you by a doctor or a nurse.

Adults (18 years of age and above) The dose will depend on how much you weigh and the type of infection being treated. The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection. In adult patients, this dose is given directly into your blood stream (into a vein), either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes. The same dose is recommended in people aged over 65 years provided their kidneys are working well.

If your kidneys do not work well, you may receive Daptomycin Hospira less often, e.g. once every other day. If you are receiving dialysis, and your next dose of Daptomycin Hospira is due on a dialysis day, you will be usually given Daptomycin Hospira after the dialysis session.

Children and adolescents (1 to 17 years of age) The dose for children and adolescents (1 to 17 years of age) will depend on the age of patient and the type of infection being treated. This dose is given directly into the blood stream (into a vein), as an infusion lasting about 30-60 minutes.

A course of treatment usually lasts for 1 to 2 weeks for skin infections. For blood or heart infections and skin infections your doctor will decide how long you should be treated.

Detailed instructions for use and handling are given at the end of the leaflet.

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 frequency not known: frequency cannot be estimated from the available data

• A hypersensitivity reaction (serious allergic reaction including anaphylaxis and angioedema) has been reported, in some cases during administration of daptomycin. This serious allergic reaction needs immediate medical attention. Tell your doctor or nurse straight away if you experience any of the following symptoms:

• Chest pain or tightness,

• Rash or hives,

• Swelling around throat,

• Rapid or weak pulse,

• Wheezing,

• Fever,

• Shivering or trembling,

• Hot flushes,

• Dizziness,

• Fainting,

• Metallic taste.

• Tell your doctor straight away if you experience unexplained muscle pain, tenderness, or weakness. Muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in kidney damage.
  Other serious side effects that have been reported with the use of Daptomycin Hospira are:

• A rare but potentially serious lung disorder called eosinophilic pneumonia, mostly after more than 2 weeks of treatment. The symptoms can include difficulty breathing, new or worsening cough, or new or worsening fever.

• Serious skin disorders. The symptoms can include:

• a new or worsening fever,

• red raised or fluid-filled skin spots which may start in your armpits or on your chest or groin areas and which can spread over a large area of your body,

• blisters or sores in your mouth or on your genitals.

• A serious kidney problem. The symptoms can include fever and rash. If you experience these symptoms, tell your doctor or nurse straight away. Your doctor will perform additional tests to make a diagnosis.

The most frequently reported side effects are described below:

Common: may affect up to 1 in 10 people

• Fungal infections such as thrush,
• Urinary tract infection,
• Decreased number of red blood cells (anaemia),
• Dizziness, anxiety, difficulty in sleeping,
• Headache,
• Fever, weakness (asthenia),
• High or low blood pressure,
• Constipation, abdominal pain,
• Diarrhoea, feeling sick (nausea) or being sick (vomiting),
• Flatulence,
• Abdominal swelling or bloating,
• Skin rash or itching,
• Pain, itchiness or redness at the site of infusion,
• Pain in arms or legs,
• Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).

Other side effects which may occur following daptomycin treatment are described below:

Uncommon: may affect up to 1 in 100 people

• Blood disorders (e.g. increased number of small blood particles called platelets, which may increase the tendency for blood clotting, or higher levels of certain types of white blood cells),
• Decreased appetite,
• Tingling or numbness of the hands or feet, taste disturbance,
• Trembling,
• Changes in heart rhythm, flushes,
• Indigestion (dyspepsia), inflammation of the tongue,
• Itchy rash of skin,
• Muscle pain, cramping, or weakness, inflammation of the muscles (myositis), joint pain,
• Kidney problems,
• Inflammation and irritation of the vagina,
• General pain or weakness, tiredness (fatigue),
• Blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or lactate dehydrogenase (LDH), prolonged blood clotting time or imbalance of salts,
• Itchy eyes.

Rare: may affect up to 1 in 1,000 people

• Yellowing of the skin and eyes,
• Prothrombin time prolonged.

Frequency not known: frequency cannot be estimated from the available data
Antibacterial-associated colitis, 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• 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 refers to the last day of the month.
• Do not store above 30 C.

What Daptomycin Hospira contains

• The active substance is daptomycin. One vial of powder contains 350 mg daptomycin.
• The other ingredients are sodium hydroxide and citric acid.

What Daptomycin Hospira looks like and contents of the pack
Daptomycin Hospira powder for solution for injection/infusion is supplied as a light yellow to light brown lyophilised cake or powder in a glass vial. It is mixed with a solvent to form a liquid before it is administered.

Daptomycin Hospira is available in packs containing 1 vial or 5 vials.

Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 1050 Bruxelles Belgium

Manufacturer
Pfizer Service Company BV Hoge Wei 1930 Zaventem
Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: + 32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: + 370 5 251 4
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.: + 359 2 970 4Magyarorsz g Pfizer Kft. Tel.: + 36 1 488 37 esk republika Pfizer, spol. s r.o. Tel: +420 283 004 Malta Drugsales Ltd Tel: + 356 21419070/1/2

Danmark Pfizer ApS Tlf: + 45 44 20 11 Nederland Pfizer bv Tel: + 31 (0)800 63 34 Deutschland PFIZER PHARMA GmbH Tel: + 49 (0)30 550055-51Norge Pfizer AS Tlf: + 47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: + 372 666 7 sterreich
Pfizer Corporation Austria Ges.m.b.H. Tel: + 43 (0)1 521 15-0

Pfizer A.E. .: + 30 210 6785Polska Pfizer Polska Sp. z o.o. Tel.: + 48 22 335 61 Espa a Pfizer, S.L.
Tel: + 34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: + 351 21 423 5France Pfizer
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Tel: + 39 06 33 18 Sverige Pfizer AB Tel: + 46 (0)8 550 520
Pharmaceutical Trading Co Ltd
: + 357 24656United Kingdom (Northern Ireland) Pfizer Limited
Tel: + 44 (0) 1304 616Latvija Pfizer Luxembourg SARL fili le Latvij
Tel: + 371 670 35 This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: