Emblaveo 1,5 g/0,5 g polvo para concentrado para solucion para perfusion

Label: Information for the User

Emblaveo 1.5 g/0.5 g Powder for Concentrate for Solution for Infusion

Aztreonam/Avibactam

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See Section 4.

What is Emblaveo

Emblaveo is an antibiotic that contains two active principles: aztreonam and avibactam.

• Aztreonam belongs to the group of antibiotics called “monobactamics”. It can kill certain types of bacteria (called gram-negative bacteria).
• Avibactam is a “beta-lactamase inhibitor” that helps aztreonam to eliminate some bacteria that it cannot eliminate on its own.

For what Emblaveo is used

Emblaveo is used in adults to treat:

• complicated abdominal infections (stomach and intestine) when the infection has spread to the abdominal cavity (space inside the abdomen).
• hospital-acquired pneumonia (bacterial infection of the lungs acquired in the hospital) including ventilator-associated pneumonia (pneumonia that develops in patients connected to a respirator).
• complicated urinary tract infections (difficult to treat because they have spread to other parts of the body or the patient has other pathologies), including pyelonephritis (kidney infection).
• bacterial infections caused by gram-negative bacteria that other antibiotics cannot eliminate.

Do not administer Emblaveo if:

• You are allergic to aztreonam or avibactam or to any of the other components of this medication (listed in section 6).
• You have ever had a severe allergic reaction (inflammation 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

Consult your doctor or nurse before starting to use Emblaveo if:

• You have ever had an allergic reaction (although only a skin rash) with other antibiotics. Signs of an allergic reaction include itching, skin rash, or difficulty breathing.
• You have kidney problems or are taking medications that affect kidney function, such as other antibiotics known as aminoglycosides (streptomycin, neomycin, gentamicin). If your renal function is impaired, your doctor may administer a lower dose of Emblaveo and perform periodic blood tests during treatment to monitor your kidney function. Additionally, you may be at a higher risk of developing severe side effects affecting the nervous system, such as encephalopathy (a brain disorder that can be caused by diseases, injuries, medications, or chemicals) due to increased Emblaveo blood levels 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 periodic blood tests during treatment to assess your liver function, as increases in liver enzymes have been observed during Emblaveo use.
• You are taking medications known as anticoagulants (a medication that prevents blood from clotting). Emblaveo may affect blood coagulation. Your doctor will monitor your blood levels to check if you need to adjust your anticoagulant dose during Emblaveo treatment.

Consult your doctor if after starting treatment with Emblaveo you experience:

• Severe, prolonged, or bloody diarrhea. This may be a sign of intestinal inflammation. You may need to discontinue Emblaveo treatment and initiate specific diarrhea treatment (see section 4: Possible adverse reactions).
• Other infections. There is a small chance that you may contract a different infection caused by another bacterium during or after Emblaveo treatment.

Laboratory tests

Inform your doctor that you are taking Emblaveo if you are to undergo any testing. This is because you may obtain an abnormal result with a test called the "Coombs" direct or indirect test. This test seeks antibodies that fight your red blood cells.

Children and adolescents

Emblaveo should not be used in pediatric or adolescent patients under 18 years of age. This is because the safety of the medication in this age group is unknown.

Other medications and Emblaveo

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Inform your doctor before using Emblaveo if you are taking any of the following medications:

• A medication for gout known as probenecid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

This medication may harm the fetus. It should only be used during pregnancy if your doctor considers it necessary and only if the benefit to the mother outweighs the risk to the child.

This medication may pass into breast milk. If you are breastfeeding, you should decide whether to stop breastfeeding or discontinue treatment after considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machinery

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

Emblaveo contains sodium

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

A doctor or nurse will administer Emblaveo to you.

How much to use

Emblaveo is administered as a direct infusion into a vein (“intravenous perfusion”). The usual dose is one vial (containing 1.5 g of aztreonam and 0.5 g of avibactam) every 6 hours. The first dose is higher (2 g of aztreonam and 0.67 g of avibactam). The infusion lasts 3 hours. Treatment usually lasts between 5 and 14 days, depending on the type of infection you have and your response to treatment.

People with kidney problems

If you have kidney problems, your doctor may reduce the dose and increase the time interval between doses. This is because Emblaveo is eliminated from the body by the kidneys. If your renal function is impaired, your Emblaveo blood levels may be elevated.

If you are given more Emblaveo than you should receive

A doctor or nurse will administer Emblaveo to you, so it is unlikely that you will receive more doses than you should of this medication. However, if you experience side effects or believe you have been given too much Emblaveo, inform your doctor or nurse immediately. You should inform your doctor if you experience confusion, alteration of mental function, movement problems, or seizures.

If a dose of Emblaveo is missed

If you believe you have not received a dose, inform your doctor or nurse immediately.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects

Contact your doctor immediately if you experience any of the following severe side effects, as you may need urgent medical attention:

• Swelling of the face, lips, eyes, tongue, and/or throat, hives, and difficulty swallowing or breathing. These may be signs of an allergic reaction or angioedema that can be potentially fatal.
• Severe, persistent, or bloody diarrhea (which may be associated with stomach pain or fever). This may occur during or after treatment with antibiotics and may be a sign of severe intestinal inflammation. Do not take medications that slow or stop bowel movements if this occurs.
• Sudden appearance of severe skin rash, blisters, or skin peeling, possibly accompanied by high fever or joint pain (may be signs of more serious underlying medical conditions such as toxic epidermal necrolysis, exfoliative dermatitis, or erythema multiforme).

These severe side effects are rare (may affect up to 1 in 100 people).

Other side effects

Inform your doctor or nurse if you observe any of the following side effects:

Frequent:(may affect up to 1 in 10 people)

• Decreased red blood cell count, as reflected in blood tests.
• Change in the count of certain types of blood cells (called "platelets"), as observed in blood tests.
• Confusion.
• Dizziness.
• Diarhea.
• Nausea or vomiting.
• Stomach pain.
• Increased levels of certain liver enzymes in blood tests.
• Rash.
• Phlebitis.
• Phlebitis associated with blood clots.
• Pain or swelling at the injection site.
• Fever.

Occasional:(may affect up to 1 in 100 people)

• Increased count of some types of white blood cells (called "eosinophils" and "leukocytes"), as reflected in blood tests.
• Difficulty falling asleep or staying asleep.
• Encephalopathy (a disease that affects the brain and causes mental state alterations and confusion).
• Headache.
• Decreased sensitivity to touch, pain, and temperature in the mouth.
• Alteration of the sense of taste.
• Extra heartbeats.
• Bleeding.
• Decreased blood pressure.
• Face redness.
• Excessive muscle contraction of the respiratory tract causing difficulty breathing.
• Stomach bleeding.
• Mouth sores.
• Increased levels of certain substances in the blood (gamma-glutamyltransferase, alkaline phosphatase in blood, creatinine).
• Itching.
• Purple spots like bruises, small red spots.
• Excessive sweating.
• Chest pain.
• Weakness.

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

• Vaginal fungal infection.
• Low blood cell count (pancytopenia).
• Significant decrease in a type of white blood cell (called "neutrophils") used to fight infections, as observed in blood tests.

• Prolonged bleeding time for a cut.
• Spontaneous bruising.
• Abnormal result in a test called the "Coombs" test direct or indirect. This test looks for antibodies that fight red blood cells.
• Seizures.
• Sensations such as numbness, tingling, or pins and needles.
• Diplopia.
• Sensation of spinning.
• Tinnitus or buzzing in the ears.
• Difficulty breathing.
• Adventitious respiratory sounds (sibilance).
• Runny nose.
• Stuffy nose (nasal congestion).
• Bad breath.
• Liver inflammation.
• Yellow discoloration of the skin and eyes.
• Muscle pain.
• Mammary sensitivity.
• General feeling of discomfort.

Unknown frequency:(cannot be estimated from available data)

• Superinfection (a new infection that occurs after receiving treatment for the current infection).

There has been observedsudden chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome, which has appeared with other medications of the same type. If this occurs, speak with a doctor or nurse immediately.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial label and on the box after “EXP”. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2 °C and 8 °C).

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Emblaveo

• The active principles are aztreonam and avibactam. Each vial contains 1.5 g of aztreonam and avibactam sodium equivalent to 0.5 g of avibactam (see section 2: Emblaveo contains sodium).
• The other component is arginine.

Appearance of the product and contents of the container

Emblaveo is a white to slightly yellowish powder for concentrate solution for intravenous infusion, conditioned in a glass vial with a rubber stopper and an aluminum seal with a easy-open capsule.

It is available in packs of 10 vials.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Responsible for manufacturing

Pfizer Service Company BV

Hoge Wei 10

1930, Zaventem

Belgium

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:02/2025.

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu

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This information is intended solely for healthcare professionals:

Important: Consult the technical data sheet or the summary of the product characteristics before prescribing.

This medicine should not be mixed with others, except with sodium chloride injection solution (0.9%), glucose injection solution (5%) or Ringer lactate solution as mentioned below.

The powder must be reconstituted with sterile water for injection and the resulting concentrate must be diluted immediately before use. The reconstituted solution is a transparent, colorless to yellowish solution without visible particles.

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

Standard aseptic techniques must be used for the preparation and administration of the solution. The doses must be prepared in a suitable infusion bag.

Parenteral medications must be visually inspected for particles before administration.

Each vial is for single use.

The total time interval between the start of reconstitution and the completion of preparation of the intravenous infusion should not exceed 30 minutes.

Instructions for preparing doses for adults in an INFUSION BAG:

NOTE: The following procedure describes the steps for preparing a solution for infusion with a final concentration of 1.5-40 mg/ml ofaztreonamand 0.50-13.3 mg/ml ofavibactam. All calculations must be completed before starting these steps.

1. Prepare thereconstituted solution(131.2 mg/mlof aztreonam and43.7 mg/mlof avibactam):

1. Insert the needle through the stopper of the vial and inject 10 ml of sterile water for injection.
2. Remove the needle and gently agitate the vial to obtain a transparent, colorless to yellowish solution without visible particles.

1. Prepare thefinal solutionfor infusion (the final concentration must be 1.5-40 mg/ml of aztreonam and 0.50-13.3 mg/ml of avibactam):

Infusion bag: for further dilution, transfer a suitably calculated volume of the reconstituted solution to an infusion bag containing any of the following: sodium chloride injection solution (0.9%), glucose injection solution (5%) or Ringer lactate solution.

Consult Table 1 below:

From a microbiological point of view, the medicine should be used immediately, unless reconstitution and dilution have been performed in controlled and validated aseptic conditions. If not used immediately, the times of conservation during use and the conditions before administration are the responsibility of the user and should not exceed those mentioned above.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.