InfoCons Consumer Protection informs you – Emblaveo – Package Leaflet

Before anything else

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Emblaveo is and what it is used for

What Emblaveo is Emblaveo is an antibiotic medicine that contains two active substances aztreonam and avibactam.  Aztreonam belongs to the group of antibiotics called “ monobactams ”. It can kill certain types of bacteria (so-called Gram -negative bacteria) .  Avibactam is a “beta -lactamase inhibitor” that helps aztreonam kill some bacteria that it cannot kill on its own.

What Emb laveo is used for

Emblaveo is used in adults to treat:  complicated bacterial infections of the abdomen ( stomach and gut ), where the infection has spread into abdominal cavity (space within the abdomen)  hospital -acquired pneumonia ( abacterial infection of the lungs that is picked up in hospitals), including ventilator -associated pneumonia (pneumonia that develops in patients on a machine called a ventilator to help them breathe)  complicated (difficult to treat as it has spread to other parts of the body or the patient has other conditions) urinary tract infections , including pyelonephritis (kidney infection)  infections ca used by Gram -negative bacteria that other antibiotics may not be able to kill .

⚠️ 2. What you need to know before you are given Emblaveo

You should not be given Emblaveo if:  you are allergic to aztreonam ,avibactam or any of the other ingredients of this medicine (listed in section 6).  you have ever had a severe allergic reaction (swelling of the face, hands, feet, lips, tongue or throat; or difficulty swallowing or breathing ; or a severe skin reaction ) to other antibiotics belonging to the penicillin, cephalosporin ,or carbapenem groups.

Warnings and precautions

Talk to your doctor or nurse before using Emblaveo if:  you have ever had any allergic reaction (even if only a skin rash) to other antibiotics . Signs of allergic reaction include itching, a rash on the skin or difficulty in breathing .

26 you have kidney problems or if you are taking medicines that affect your kidney function, such as other antibiotics known as aminoglycosides (streptomycin, neomycin, gentamicin) .If your kidney function is impaired, y our doctor may give you a lower dose of Emblaveo and may want to perform regular blood tests during treatment to check your kidney function . In addition, you may be at higher risk of developing serious side effects that affect the nervous system such as encephalopathy (a disorder of the brain that may be caused by disease, injury, medicines or chemicals) due to increased b lood levels of Emblaveo unless the dose is reduced .Symptoms of encephalopathy include confusion , seizures and altered mental function (see Section 3:If you use more Emblaveo than you should ).  you have any liver problems . Your doctor may want to perform regular blood tests during treatment to check your liver since increases in liver enzymes have been observed with Emblaveo  you are taking medicines known as anticoagulants (a medicine that prevents the blood from clotting). Emblaveo can affect blood clott ing. Your doctor will monitor your blood levels to check if your dose of anticoagulant needs to be changed during treatment with Emblaveo .

Talk to your doctor if after starting treatment with Emblaveo , you experience:  severe ,prolonged ,or bloody diarrho ea.This may be a sign of an inflammation of the large bowel . It may be necessary to interrupt the treatment with Emblaveo and start specific treatment for the diarrhoea (see section 4: Possible side effects) .  other infections . There is a small possibility that you may get a different infection caused by another bacteria during or after treatment with Emblaveo .

Lab tests Tell your doctor that you are taking Emblaveo if you are going to have any tests. This is because you may get an abnormal result with a test called direct or indirect Coombs test. This test looks for antibodies that fight against your red blood cells.

Children and adolescents

Emblaveo should not be used in paediatric or adolescent patients aged under 18 years . This is because it is not known if the medicine is safe to use in this age group.

Other medicines and Emblaveo

Tell your doctor if you are using, have recently used or might use any other medicines.

Talk to your doctor before using Emblaveo if you are taking any of the following medicines:  amedicine for gout called probenecid 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.

This medicine may harm your unborn child. It should only be used during pregnancy if the doctor consider sit necessary and only if the benefit for the mother outweighs the risk for the child.

This medicine may pass into breast milk. If you are breast -feeding a decision must be made whether you should discontinue breast -feeding or abstain from treatment with this medicine ,taking into account the benefit of breast -feeding for the child and the benefit of treatment for the woman.

Driving and using machines

Emblaveo may cause side effects, such as dizziness , which can affect your ability to d rive and use machines . Do not drive or use tools or machines if you experience side effects such as dizziness (see section 4 :Possible side effects) .

27Emblaveo contains Sodium

This medicine contains approximately 44.6 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 2.2% of the recommended maximum daily dietary intake for sodium for an adult.

💊 3. How to use Emblaveo

Emblaveo will be given to you by a doctor or a nurse.

How much to use Emblaveo is given as a drip directly into a vein (‘intravenous infusion’). The usual dose is one vial (containing 1.5g aztreonam and 0.5 g avibactam) every 6 hours .The first dose is higher (2g aztreonam and 0.67 g avibactam ). The infusion will last 3 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 and increase the time between the doses . This is because Emblaveo is removed from your body by the kidneys. If your kidney function is impaired your blood levels of Emblaveo may be increased.

If you aregiven more Emblaveo than you should be given Emblaveo will be given to you by a doctor or a nurse, so it is unlikely you will be given too much of this medicine . However, if you have side effects or think you have been given too much Emblaveo , tell your d octor or nurse straight away. You must tell your doctor if you experience confusion, altered mental function, move ment problems, or seizure.

If a dose of Emblaveo has been forgotten 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 .

❗ 4. Possible side effects

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

Serious side effects

Tell your doctor straight away if you notice any of the following serious side effects -you may need urgent medical treatment:  Swelling of the face, lips, eyes, tongue ,and/or throat , hives and with difficulty in swallowing or breathing. These may be signs of an allergic reaction orangioedema which may be life-threatening.  Severe, persistent ,or bloody diarrhoea (which may be associated with stomach pain or fever).

This may occur during or after treatment with antibiotics and can be a sign of serious bowel inflammation. If this happens do not take medicines that stop or slow bowel movement.  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, dermatitis exfoliative, erythema multiforme) .

These serious side effects are uncommon (may affect up to 1 in 100 people).

Other side effects

Tell your doctor or nurse if you notice any of the following side effects:

28Common: (may affect up to 1 in 10 people)  Decrease in the number of red blood cells –shown in blood tests  Change in the number of some types of blood cells (called “ platele ts”) –shown in blood tests  Confusion  Dizziness  Diarrhoea  Feeling sick (nausea) or being sick (vomiting)  Stomach pain  Increase in certain liver enzymes –shown in blood tests  Rash  Inflammation of a vein  Inflammation of a vein associated with a blood clot  Pain or swelling at the site of the injection  Fever

Uncommon: (may affect up to 1 in 100 peopl e)

 Increase in the number of some types of white blood cells (called “ eosinophils” and “leucocytes ”) –shown in blood tests  Difficulty falling and staying asleep  Encephalopathy (a condition that affects the brain and causes altered mental state and confusion)  Headache  Reduced sensation to touch, pain and temperature in the mouth  Taste disturbance  Extra heartbeat s  Bleeding  Reduced blood pressure  Reddening of the face  Excessive contraction of the airway muscles causing breathing difficulty  Stomach bleeding  Mouth ulcer s  Increase in the levels of some substances in your blood ( Gamma -glutamyltransferase ,Blood alkaline phosphatase, C reatinine )  Itching  purple patches like brui sing, small red spots  Excessive sweating  Chest pain  Weakness

Rare: (may affect up to 1 in 1 000 people )

 Fungal infections of the vagina  Low levels of blood cells (pancytopenia)  Significant decrease in the type of white blood cells (called “neutrophils”) used to fight infection -shown in blood tests  Lengthening of the ti me it takes for a cut to stop bleeding  Spontaneous bruising  Abnormal result with a test called direct or indirect Coombs test. This test looks for antibodies that fight against your red blood cells.  Seizure  Sensations like numbness, tingling, pins and needles  Double vision  A spinning sensation  Ringing or buzzing in the ears  Difficulty breathing 29 Breath sounds abnormal (wheezing)  Sneezing  Blocked nose (nasal congestion)  Bad breath  Inflammation of the liver  Yellowing of the skin and eyes  Muscle pain  Breast tenderness  Feeling generally unwell

Not known: (cannot be estimated from the available data)

 Superinfection (a new infection that occurs after you are treated for your current infection ) Sudden chest pain , which may be a sign of a potentially seri ous allergic reaction called Kounis syndrome has been noted with other medicines of the same type. If this happens talk to a doctor or nurse immediately.

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.

🌡️ 5. How to store Emblaveo

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 vial label andcarton after “EXP ”.

The expiry date refers to the last day of that month.

Store in a refrigerator (2°C–8℃).

Store in the original package in order toprotect from light .

Do not throw away any medicines via wastewater or household waste . Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Emblaveo contains

-The active substances are aztreonam and avibactam. Each vial contains 1.5g aztreonam and avibactam sodium equivalent to 0.5 g avibactam (see section 2: Emblaveo contains sodium) . -The other ingredient isarginine .

What Emblaveo looks like and contents of the pack

Emblaveo isawhite to slightly yellow powder for concentrate for solution for infusion in a glass vial with a rubber stopper and aluminium seal with flip -off cap . It is available in packs containing 10 vials.

Marketing Authorisation Holder

Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Brussels Belgium 30Manufacturer Pfizer Service Company BV Hermeslaan 11 1932 Zaventem Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA Tél/Tel: +32 (0)2 554 62 11Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 5 251 4000 България Пфайзер Люксембург САРЛ , Клон България Teл.: +359 2 970 4333Magyarország Pfizer Kft.

Tel.: + 36 1 488 37 00 Česká republika Pfizer, spol. s r.o.

Tel: +420 283 004 111Malta Vivian Corporation Ltd.

Tel: +356 21344610 Danmark Pfizer ApS Tlf.: +45 44 20 11 00Nederland Pfizer bv Tel: +31 (0)800 63 34 636 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055 -51000Norge Pfizer AS Tlf: +47 67 52 61 00 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500Österreich Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15 -0 Ελλάδα Pfizer Ελλάς A.E.

Τηλ: +30 210 6785800Polska Pfizer Polska Sp. z o.o.

Tel.: +48 22 335 61 00 España Pfizer, S.L.

Tel: +34 91 490 99 00Portugal Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500 France Pfizer Tél: +33 (0)1 58 07 34 40România Pfizer Romania S.R.L.

Tel: +40 (0) 21 207 28 00 Hrvatska Pfizer Croatia d.o.o.

Tel: +385 1 3908 777Slovenija Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 400 Ireland Pfizer Healthcare Ireland Unlimited Company Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616161Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: + 421 2 3355 5500 31Ísland Icepharma hf.

Sími: +354 540 8000Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 040 Italia Pfizer S.r.l.

Tel: +39 06 33 18 21Sverige Pfizer AB Tel: +46 (0)8 550 520 00 Κύπρος Pfizer Ελλάς Α.Ε. (Cyprus Branch) Τηλ: +357 22817690 Latvija Pfizer Luxembourg SARL filiāle Latvijā Tel: + 371 670 35 775

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: https://www.ema.europa.eu ——————————————————————————————— —————————

🩺 Information intended for healthcare professionals only

Important: Please refer to the Summary of Product Character istics before prescribing.

This medicinal product must not be mixed with other medicinal products except sodium chloride (0.9% )solution for injection, glucose (5%) solution for injection, or Lactated Ringer’s solution as mentioned below.

The powder must be reconstituted with sterile water for injections and the resulting concentrate must then be immediately diluted prior to use. The reconstituted solution is a clear, colourless to yellow solution and is free of visible particles.

Emblaveo (aztreonam/avibactam) is a combination product; each vial contains 1.5 g of aztreonam and 0.5g of avibactam in a fixed 3:1 ratio.

Standard aseptic techniques should be used for solution preparation and administration. Doses must be prepared in an appropriately sized infusion bag.

Parenteral medicinal products should be inspected visually for particulate matter prior to administration.

Each vial is for single use only.

The total time interval between starting reconst itution and completing preparation of the intravenous infusion should not exceed 30 minutes.

32Instructions for preparing adult doses in an INFUSION BAG:

NOTE: The following procedure describes the steps to prepare an infusion solution with a final concentration of 1.5 -40mg/mL of aztreonam and 0.50-13.3 mg/mL of avibactam . All calculations should be completed prior to initiating these steps.

1.Prepare the reconstituted solution (131.2 mg/mL of aztreonam and 43.7 mg/mL of avibactam ): a)Insert the needle through the vial closure and inject 10 mL of sterile water for injections. b)Withdraw the needle and shake the vial gently to give a clear, colourless to yellow solution free of visible particles.

2.Prepare the final solution for infusion (final concentration must be 1.5-40mg/mL of aztreonam and 0.50-13.3 mg/mL of avibactam ):

Infusion bag: Further dilute the reconstituted solution by transferring an appropriately calculated volume of the reconstituted solution to an infusion bag containing any of the following: sodium chloride (0.9%) solution for injection, glucose (5%) solution for injection, or Lactated Ringer’s solution.

Refer to T able 1below.

Table 1: Preparation of Emblaveo for adult doses in an INFUSION BAG Total dose (aztreonam /avibactam )Volume to withdraw from reconstituted vial(s)Final volume after dilution in infusion bag1,2 2000 mg/667 mg 15.2 mL 50 mL to 250 mL 1500 mg/500 mg 11.4 mL 50 mL to 250 mL 1350 mg/450 mg 10.3 mL 50 mL to 250 mL 750 mg/250 mg 5.7 mL 50 mL to 250 mL 675 mg/225 mg 5.1 mL 50 mL to 250 mL All other doses Volume (mL) calculated based on dose required:

Dose (mg aztreonam) ÷ 131.2 mg/mL aztreonam Or Dose (mg avibactam ) ÷ 43.7 mg/mL a vibactamVolume (mL) will vary based on infusion bag size availability and preferred final concentration (Must be 1.5 -40mg/mL of aztreonam and 0.50-13.3 mg/mL of avibactam ) 1 Dilute to final aztreonam concentration of 1.5 -40mg/mL (final avibactam concentration of 0.50-13.3 mg/mL) for in -use stability up to 24 hours at 2 °C–8°C, followed by up to 12hours up to 30 °Cfor infusion bags containing sodium chloride (0.9%) solution for injection or Lactat ed Ringer’s solution.

2 Dilute to final aztreonam concentration of 1.5 -40mg/mL (final avibactam concentration of 0.50-13.3 mg/mL) for in -use stability up to 24 hours at 2 °C–8°C, followed by up to 6hours up to 30 °Cfor infusion bags containing glucos e (5%) solution for injection.

From a microbiological point of view, the medicinal product should be used immediately, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions. If not used immediately, in -use storage times and conditions prior to use are the responsibility of the user and must not exceed those stated above.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Emblaveo (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/24/1808).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.