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Generated Narrative: Bundle TEST PURPOSES ONLY - zavicefta

Document Subject

Generated Narrative: MedicinalProductDefinition mpff92cd53cb489e28c08e8b0937092be9

identifier: http://ema.europa.eu/identifier/EU/1/16/1109/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Zavicefta 2 g/0.5 g powder for concentrate for solution for infusion

type: Full name

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part: nan

type: Invented name part

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part: nan

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-ff92cd53cb489e28c08e8b0937092be9

identifier: http://ema.europa.eu/identifier/EU/1/16/1109/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - zavicefta

Attesters

What is in this leaflet:

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

What Zavicefta is Zavicefta is an antibiotic medicine that contains two active substances ceftazidime and avibactam.

Ceftazidime belongs to the group of antibiotics called cephalosporins . It can kill many types of bacteria.

Avibactam is a beta-lactamase inhibitor that helps ceftazidime kill some bacteria that it cannot kill on its own. What Zavicefta is used for Zavicefta is used in adults and paediatric patients aged 3 months and over to treat:

infections of the stomach and gut (abdomen)

infections of the bladder or kidneys called urinary tract infections

an infection of the lungs called pneumonia

infections caused by bacteria that other antibiotics may not be able to kill Zavicefta is used in adults to treat infection of the blood associated with infections of the abdomen, urinary tract, or pneumonia. How Zavicefta works Zavicefta works by killing certain types of bacteria, which can cause serious infections.

Do not use Zavicefta if:

you are allergic to ceftazidime, avibactam or any of the other ingredients of this medicine (listed in section 6)

you are allergic to other cephalosporin antibiotics

you have ever had a severe allergic reaction to other antibiotics belonging to the penicillin or carbapenem groups Do not use Zavicefta if any of the above apply to you. If you are not sure, talk to your doctor or nurse before using Zavicefta. Warnings and precautions Talk to your doctor or nurse before using Zavicefta if:

you have ever had any allergic reaction (even if only a skin rash) to other antibiotics belonging to the penicillin or carbapenem groups

you have kidney problems - your doctor may give you a lower dose to make sure you don t get too much medicine. This could cause symptoms such as fits (see section If you use more Zavicefta than you should) If any of the above apply to you (or you are not sure), talk to your doctor or nurse before using Zavicefta. Talk to your doctor or nurse if you suffer from diarrhoea during your treatment. Other infections There is a small possibility that you may get a different infection caused by another bacteria during or after treatment with Zavicefta. These include thrush (fungal infections of the mouth or genital area). Lab tests Tell your doctor that you are taking Zavicefta if you are going to have any tests. This is because you may get an abnormal result with a test called DAGT or Coombs . This test looks for antibodies that fight against your red blood cells. Zavicefta can also affect the results of some urine tests for sugar. Tell the person taking the sample that you have been given Zavicefta. Paediatric patients Zavicefta should not be used in paediatric patients aged under 3 months. This is because it is not known if the medicine is safe to use in this age group. Other medicines and Zavicefta Tell your doctor or nurse if you are using, have recently used or might use any other medicines. Talk to your doctor before using Zavicefta if you are taking any of the following medicines:

an antibiotic called chloramphenicol

a type of antibiotic called an aminoglycoside such as gentamicin, tobramycin

a water tablet called furosemide

a medicine for gout called probenecid Tell your doctor before using Zavicefta if any of the above apply to you. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Driving and using machines Zavicefta may make you feel dizzy. This may affect you being able to drive, use tools or machines. Zavicefta contains sodium This medicine contains approximately 146 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 7.3% of the recommended maximum daily dietary intake for sodium for an adult. Talk to your doctor or pharmacist if you need 3 or more vials daily for a prolonged period, especially if you have been advised to have a low salt (sodium) diet.

Zavicefta will be given to you by a doctor or a nurse. How much to use The recommended dose for adults is one vial (2 g of ceftazidime and 0.5 g of avibactam), every 8 hours. The dose for paediatric patients aged 3 months and over will be calculated by the doctor based on the weight and age of the child. It is given as a drip into a vein this will normally take about 2 hours. A course of treatment usually lasts from 5 to up to 14 days, depending on the type of infection you have and how you respond to treatment. People with kidney problems If you have kidney problems your doctor may lower your dose. This is because Zavicefta is removed from your body by the kidneys. If you use more Zavicefta than you should Zavicefta will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose. However, if you have side effects or think you have been given too much Zavicefta, tell your doctor or nurse straight away. If you have too much Zavicefta it could have an effect on the brain and cause fits or coma. If you miss a dose of Zavicefta If you think you have missed a dose, tell your doctor or nurse straight away. 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. The following side effects may happen with this medicine: Serious side effects Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

severe allergic reactions signs include sudden swelling of your lips, face, throat or tongue, a severe rash or other severe skin reactions, difficulty swallowing or breathing, or sudden chest pain (which may be a sign of Kounis syndrome). These reactions may be life-threatening.

diarrhoea that keeps getting worse or does not go away, or stools that contains blood or mucus
this may happen during or after treatment is stopped with Zavicefta. If this happens do not take medicines that stop or slow bowel movement. Tell your doctor straight away if you notice any of the serious side effects above. Other side effects Tell your doctor or nurse if you notice any of the following side effects: Very common: (may affect more than 1 in 10 people)

abnormal result with a test called DAGT or Coombs . This test looks for antibodies that fight against your red blood cells. It is possible that this could cause anaemia (which may make you feel tired) and jaundice (yellowing of the skin and eyes) Common: (may affect up to 1 in 10 people)

fungal infections, including those of the mouth and vagina

change in the number of some types of blood cells (called eosinophils and thrombocytes )
shown in blood tests

headache

feeling dizzy

feeling sick (nausea) or being sick (vomiting)

stomach pain

diarrhoea

increase in the amount of some enzymes produced by your liver - shown in blood tests

raised itchy skin rash ( hives )

itchiness

redness, pain or swelling where Zavicefta was given into a vein

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

increase in the number of a type of blood cell (called lymphocytes ) shown in blood tests

decrease in the number of some types of blood cells (called leucocytes ) - shown in blood tests

tingling or numbness

bad taste in your mouth

an increase in the level of some types of substances in your blood (called creatinine and urea ). These show how well your kidneys are working. Very rare: (may affect up to 1 in 10,000 people)

swelling in a part of the kidney that causes a reduction in its normal working function Not known: (frequency cannot be estimated from the available data)

significant decrease in the type of white blood cells used to fight infection - shown in blood tests

decrease in the number of red blood cells (haemolytic anaemia) shown in blood tests

severe allergic reaction (see Serious side effects, above)

yellowing of the whites of the eyes or skin sudden onset of a severe rash or blistering or peeling skin, possibly accompanied by a high fever or joint pain (these may be signs of more serious medical conditions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme or a condition known as DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms)

swelling under the skin, particularly lips and around the eyes Tell your doctor or nurse if you notice any of the side effects listed above. Reporting of side effects If you get any side effects, talk to your doctor 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 container. The expiry date refers to the last day of that month. Store in the original package in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer require. These measures will help to protect the environment.

What Zavicefta contains

The active substances are ceftazidime and avibactam. Each vial contains ceftazidime pentahydrate equivalent to 2 g ceftazidime and avibactam sodium equivalent to 0.5 g avibactam.

The other ingredient is sodium carbonate (anhydrous) (see section 2 Zavicefta contains sodium ). What Zavicefta looks like and contents of the pack Zavicefta is a white to yellow powder for concentrate for solution for infusion in a vial. It is available in packs containing 10 vials. Marketing Authorisation Holder Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork Ireland Manufacturer ACS Dobfar S.p.A. Via Alessandro Fleming 2 Verona 37Italy 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 ,
: +359 2 970 4Magyarorsz g Pfizer Kft. Tel.: + 36 1 488 37 esk republika Pfizer, spol. s r.o. Tel: +420 283 004 Malta Vivian Corporation Ltd. Tel.: +356 21344Danmark 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 . . .: +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 T l: +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel.: +386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: + 421 2 3355 5 sland Icepharma hf. S mi: +354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550 520
Pfizer . . (Cyprus Branch) .: +357 22817United 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 MM/YYYY Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: