Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - quofenix

Document Subject

Generated Narrative: MedicinalProductDefinition mp27f53ce7e817ea56aac44769c7b5a3bb

identifier: http://ema.europa.eu/identifier/EU/1/19/1393/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Quofenix 300 mg powder for concentrate for solution for infusion

type: Full name

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part: nan

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-27f53ce7e817ea56aac44769c7b5a3bb

identifier: http://ema.europa.eu/identifier/EU/1/19/1393/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - quofenix

Attesters

What is in this leaflet

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

Quofenix is an antibiotic that contains the active substance delafloxacin. It belongs to a group of medicines called fluoroquinolones.

It is used to treat adults with serious short-term infections caused by certain bacteria when usual antibiotics cannot be used or have not worked:

• infections of the skin and tissue under the skin
• infection of the lungs called pneumonia .

It works by blocking bacteria enzymes needed to copy and to repair their DNA. By blocking these enzymes, Quofenix kills bacteria that cause the infection.

You must not be given Quofenix:

• If you are allergic to delafloxacin or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to any other fluoroquinolone or quinolone antibacterial medicine.
• If you have ever had a problem with your tendons such as tendonitis that was related to treatment with a quinolone antibiotic . A tendon is the cord that joins your muscle to your skeleton.
• If you are pregnant, might become pregnant, or think you might be pregnant.
• If you are breast-feeding.
• If you are a child or growing adolescent below 18 years of age.

Warnings and precautions Before you are given this medicine You should not be given fluoroquinolone/quinolone antibacterial medicines, including Quofenix, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible.

When you are given this medicine

• Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping Quofenix therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Quofenix, contact your doctor and rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
• You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking Quofenix and inform your doctor immediately in order to prevent the development of potentially irreversible condition.

Talk to your doctor or pharmacist or nurse before you are given Quofenix if:

• You have been diagnosed with an enlargement or bulge of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
• You have experienced a previous episode of aortic dissection (a tear in the aorta wall).
• You have been diagnosed with leaking heart valves (heart valve regurgitation).
• You have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e. g. connective tissue disorders such as Marfan syndrome, or Ehlers-Danlos syndrome, Turner syndrome, Sj gren s syndrome [an inflammatory autoimmune disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet s disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis [an infection of the heart] ).
• You have had tendon problems during previous treatment with a fluoroquinolone or quinolone antibiotic.
• You have or may have problems with the central nervous system (e.g. severe cerebral arteriosclerosis, epilepsy) or have other risk factors that may put you at more risk of having seizures (fits). In those cases your doctor will consider if this treatment is the best option for you.
• You have a myasthenia gravis (a type of muscle weakness), because symptoms can become worse.
• You are suffering from diarrhoea, or have previously suffered from diarrhoea while taking antibiotics or up to 2 months afterwards. Contact your doctor straight away if you have diarrhoea during or after your treatment. Do not take any medicine to treat your diarrhoea without first checking with your doctor.
• You have kidney problems.
• You had sometimes long treatment with antibiotics; it can mean that you get another infection caused by other bacteria (superinfection) which cannot be treated by the antibiotic. Talk to your doctor if you have any concerns or questions about this and using Quofenix.
• You may have a severe skin reaction such as blistering or lesion.
• You or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase.
• You have diabetes. Fluoroquinolone antibiotics, including Quofenix, may cause levels of glucose in the blood to rise too high or fall too low. If you have diabetes, you should monitor your blood glucose levels carefully.

If you feel sudden, severe pain in your abdomen, chest or back, which can be symptoms of aortic aneurysm and dissection, go immediately to an emergency room. Your risk may be increased if you are being treated with systemic corticosteroids.

If you start experiencing a rapid onset of shortness of breath, especially when you lie down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a doctor immediately.

Prolonged, disabling and potentially irreversible serious side effects Fluoroquinolone/quinolone antibacterial medicines have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders. If you experience any of these side effects after receiving Quofenix, contact your doctor immediately prior to continuing treatment. You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.

Children and adolescents This medicine must not be used in children and adolescents, as it has not been studied enough in these groups.

Other medicines and Quofenix Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. There are no data concerning an interaction of intravenous delafloxacin with multivitamins, other supplements or didanosine. However, Quofenix should not be given together with any solution containing substances such as calcium and magnesium, through the same intravenous line.

Pregnancy and breast-feeding Quofenix must not be used if you are pregnant or breast-feeding. Quofenix must not be used in women of childbearing potential not using contraception.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell your doctor before you are given this medicine. If you might become pregnant you have to use effective contraception during treatment with Quofenix.

Driving and using machines Quofenix can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how Quofenix affects you.

Quofenix contains cyclodextrin This medicine contains 2480 mg of sulfobutylbetadex sodiumin each vial.

Quofenix contains sodium This medicine contains 175 mg of sodium (main component of cooking salt) in each vial. This is equivalent to 8.8% of the recommended maximum daily dietary intake of sodium for an adult.

Quofenix will be given to you by a nurse or doctor via an infusion (drip) into a vein.

You will be given one infusion of Quofenix, containing 300 mg of the medicine, twice a day between 5 and 14 days for skin infections and between 5 and 10 days for pneumonia, at the discretion of your doctor. Each infusion will last about an hour. Your doctor will decide how many days treatment is needed.

Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.

If you have any further questions on the use of this medicine, ask your doctor.

If you are given more Quofenix than you should Tell your doctor or nurse immediately if you are concerned that you may have been given too much Quofenix.

If you miss a dose of Quofenix Tell your doctor or nurse immediately if you are concerned that you may have missed a dose. If you have any further questions on the use of this medicine, ask your doctor or nurse.

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

Serious side effects

Please, inform your doctor or nurse immediately if you get any of these symptoms, as the medicine should be stopped and you may need urgent medical attention:

• Difficulty in swallowing or difficulty in breathing and cough; swelling of your lips, face, throat or tongue; dry throat or throat tightening and severe rash. These may be signs and symptoms of a hypersensitivity (allergic) reaction and may be life-threatening. These severe reactions are uncommon side effects that may affect up to 1 in 100 people.
• Drop in blood pressure; blurred vision; dizziness. This severe reaction is an uncommon side effect that may affect up to 1 in 100 people.
• Abdominal (belly) pain with possible severe diarrhoea; fever and nausea. These may be signs of an infection of the bowel, which shouldn t be treated with diarrhoea medicines that stop your bowels from moving. Infection of the bowel (Clostridioides difficile infection) is an uncommon side effect that may affect up to 1 in 100 people.

Other side effects may include:

Common side effects (may affect up to 1 in 10 people):

• Fungal infection
• Headache
• Vomiting
• Swelling, redness or pain around the needle where the medicine is given into a vein (infusion site reaction)
• Increase in the amount of enzymes produced by your liver called transaminases - shown in blood tests
• Itching

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

• Reduction in the number of white cells in the blood (leukopenia)
• Low haemoglobin level (anaemia)
• Allergic reaction
• High blood glucose levels
• Decreased appetite
• Insomnia
• Muscle weakness in the extremities
• Sensations like numbness, tingling, pins and needles
• Reduced tactile sensation
• Change in taste
• Feeling your heart beat (palpitation)
• High blood pressure
• Flushing (e.g. redness of the face or neck)
• Inflammation of the lining of the stomach, inflammation of the internal tissues of the mouth, abdominal pain, stomach discomfort/pain or indigestion, dry mouth, flatulence
• Abnormal sweat
• Allergic skin reaction
• Itchiness, red rash
• Joint pain
• Pain and swelling of the tendons
• Muscle and musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle weakness
• Increased level of creatine phosphokinase in blood (an indicator of muscle damage)
• Reduced kidney function
• Feeling tired
• Blood test alteration related to liver function (blood alkaline phosphatase increased)
• Raised body temperature (pyrexia)
• Lower limb swelling

Rare side effects (may affect up to 1 in 1000 people):

• Urinary tract infection
• Inflammation of the nasal mucosa tract
• Low white blood cell count (reduction of an amount of blood cells)
• Decrease of special blood cells necessary for blood clotting
• Changes in tests which measure how well your blood clots
• Seasonal allergy
• Low blood glucose levels
• High level of uric acid
• High level of blood potassium
• Low level blood potassium
• Hearing things that do not exist (auditory hallucination)
• Anxiety
• Abnormal dreams
• Confusion
• Somnolence
• Feeling lightheaded or faint, usually because of a drop in blood pressure
• Dry eye
• Dizziness or loss of balance (vertigo)
• Ringing or buzzing in the ears (tinnitus)
• Alteration of the sense of balance
• Irregular or rapid heart beats, decrease of heart beat
• Swollen, red, irritated veins (phlebitis)
• Blood clot, known as a thrombus in the deep vein
• Heartburn/acid regurgitation
• Loss of tactile sensation at the mouth
• Reduced tactile sensation at the mouth
• Burning sensation in the mouth
• Discoloured faeces
• Blood test alteration related to liver function (blood albumin decreased and gamma- glutamyltransferase increased)
• Cold sweat
• Night sweat
• Abnormal hair loss
• Muscle spasm
• Muscle inflammation/pain
• Inflammation of joints, pain in hands or feet, back pain
• Blood in urine
• Cloudy urine because of the presence of solid component
• Chills
• Worsening of a wound
• Oedema peripheral
• Medical device occlusion

Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.

Cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients receiving fluoroquinolones. See also section 2. 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 or blister after EXP . The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions if kept unopened in the original container.

After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at to 25 C or at 2 to 8 C. From a microbiological point of view, the product should be used immediately after reconstitution and dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.

Do not freeze.

What Quofenix contains

• The active substance is delafloxacin. Each vial of powder contains 300 mg of delafloxacin (as meglumine).
• The other excipients are meglumine, sulfobutylbetadex sodium,disodium edetate, sodium hydroxide (for pH-adjustment), hydrochloric acid, concentrated (for pH-adjustment).

What Quofenix looks like and contents of the pack Quofenix powder for concentrate for solution for infusion is provided in 20 ml clear glass vial. The vial contains light yellow to tan cake powder. It is available in packs containing 10 vials.

Marketing Authorisation Holder A. Menarini Industrie Farmaceutiche Riunite s.r.l. Via Sette Santi 3 50131 Florence Italy

Manufacturer Patheon Italia S.p.A. 2 Trav. SX Via Morolense 5 03013 Ferentino (FR) Italy

or

AlfaSigma 1 Via Enrico Fermi 65020 Alanno (PE) Italy

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

Belgi /Belgique/Belgien Menarini Benelux NV/SA T l/Tel: + 32 (0)2 721 4Lietuva UAB BERLIN-CHEMIE MENARINI BALTIC
Tel: +370 52 691

• / .
  .: +359 2 454 0Luxembourg/Luxemburg Menarini Benelux NV/SA T l/Tel: + 32 (0)2 721 4 esk republika Berlin-Chemie/A.Menarini Ceska republika s.r.o. Tel: +420 267 199 Magyarorsz g Berlin-Chemie/A. Menarini Kft. Tel.: +36 17997Danmark A. Menarini - Industrie Farmaceutiche Riunite - s.r.l. Tel: +39-055 56Malta A. Menarini - Industrie Farmaceutiche Riunite - s.r.l. Tel: +39-055 56Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67Nederland Menarini Benelux NV/SA Tel: +32 (0)2 721 4Eesti O Berlin-Chemie Menarini Eesti Tel: +372 667 5Norge A. Menarini - Industrie Farmaceutiche Riunite - s.r.l. Tel: +39-055 56
  MENARINI HELLAS AE : +30 210 8316111- sterreich A. Menarini Pharma GmbH. Tel: +43 1 879 95 85-0 Espa a Laboratorios Menarini S.A. Tel: +34-93 462 88 Polska Berlin-Chemie/Menarini Polska Sp. z o.o. Tel.: +48 22 566 21 France MENARINI France T l: +33 (0)1 45 60 77 Portugal A. Menarini Portugal Farmac utica, S.A. Tel: +351 210 935 Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: + 385 1 4821 Rom nia Berlin-Chemie A. Menarini S.R.L. Tel: +40 21 232 34 Ireland A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.
  Tel: +386 01 300 2 sland A. Menarini - Industrie Farmaceutiche Riunite - s.r.l. Tel: +39-055 56Slovensk republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 Italia A. Menarini - Industrie Farmaceutiche Riunite - s.r.l. Tel: +39-055 56Suomi/Finland Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000
  MENARINI HELLAS AE : +30 210 8316111-Sverige A. Menarini - Industrie Farmaceutiche Riunite - s.r.l. Tel: +39-055 56Latvija SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103United Kingdom (Northern Ireland) A. Menarini Farmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856This leaflet was last revised in

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