AMOXICILLIN/CLAVULANIC ACID KABI 1000 mg/200 mg POWDER FOR INJECTION AND INFUSION SOLUTION

2. What you need to know before you are given Amoxicillin/Clavulanic Acid Kabi

You should not receive Amoxicillin/Clavulanic Acid Kabi:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include a skin rash or swelling of the face or neck.
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Amoxicillin/Clavulanic Acid Kabi should not be administered to you if any of the above applies to you.If you are unsure, consult your doctor, pharmacist, or nurse before administration of Amoxicillin/Clavulanic Acid Kabi.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you receive this medicine if:

• you have infectious mononucleosis
• you are receiving treatment for liver or kidney problems
• you do not urinate regularly.

If you are unsure whether any of the above symptoms apply to you, consult your doctor, pharmacist, or nurse before receiving amoxicillin/clavulanic acid.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, you may be prescribed a different formulation of Amoxicillin/Clavulanic Acid Kabi or another medication.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid Kabi can worsen certain existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while using Amoxicillin/Clavulanic Acid Kabi to reduce the risk of problems. See "Symptoms to be aware of" in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell status or liver function studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are being given Amoxicillin/Clavulanic Acid Kabi. This is because amoxicillin/clavulanic acid can alter the results of these types of tests.

Using Amoxicillin/Clavulanic Acid Kabi with other medicines

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

If you are taking allopurinol (for gout) with Amoxicillin/Clavulanic Acid Kabi, you may be more likely to have a skin allergic reaction.

If you are taking probenecid (for gout), your doctor may adjust the dose of Amoxicillin/Clavulanic Acid Kabi.

If you are taking anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid Kabi, more blood tests will be needed.

Amoxicillin/Clavulanic Acid Kabi may affect the way metotrexate (a medicine for cancer or rheumatic diseases) works.

Amoxicillin/Clavulanic Acid Kabi may affect the way mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

Amoxicillin/Clavulanic Acid Kabi contains sodium and potassium

• This medicine contains approximately 62.9 mg (2.7 mmol) of sodium (main component of kitchen salt) per vial. This is equivalent to 3.1% of the maximum recommended daily sodium intake for an adult.
• This medicine contains approximately 39.3 mg (1.0 mmol) of potassium per vial, which should be taken into account in the treatment of patients with kidney failure or those on low-potassium diets.

3. How Amoxicillin/Clavulanic Acid Kabi is given

You will never administer this medicine to yourself. A qualified person, such as a doctor or nurse, will administer it to you.

The recommended doses are:

Adults and children weighing 40 kg or more

Children weighing less than 40 kg

• All doses are calculated based on the child's body weight in kilograms.

Patients with kidney and liver problems

• If you have kidney problems, your dose may be changed. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How Amoxicillin/Clavulanic Acid Kabi will be administered to you

• Amoxicillin/Clavulanic Acid Kabi will be administered to you as an injection into a vein or by intravenous infusion.
• Make sure to drink plenty of fluids while receiving Amoxicillin/Clavulanic Acid Kabi.
• Amoxicillin/Clavulanic Acid Kabi should not be administered to you for more than 2 weeks without your doctor reviewing your treatment.

If you are given too much Amoxicillin/Clavulanic Acid Kabi

It is very unlikely that you will be given too much Amoxicillin/Clavulanic Acid Kabi, but if you think you have been given more than you should, tell your doctor, pharmacist, or nurse immediately. Symptoms may include stomach upset (nausea, vomiting, or diarrhea) or seizures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with the administration of this medicine.

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) that can appear as red or purple spots on the skin but can affect other parts of the body
• fever, joint pain, swollen glands in the neck, armpits, or groin
• swelling sometimes of the face or mouth (angioedema), which can cause difficulty breathing
• collapse.
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome).

Contact your doctor immediately if you experience any of these symptoms. Treatment with Amoxicillin/Clavulanic Acid Kabi should be discontinued.

Inflammation of the large intestine

Inflammation of the large intestine, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

If you have these symptoms, consult your doctor as soon as possible.

Acute pancreatitis

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):

DIES has been reported mainly in children receiving amoxicillin/clavulanic acid. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after administering the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

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

• thrush (candida - fungal infection of the vagina, mouth, or mucous membranes)
• diarrhea

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

• skin rash, itching
• increased pruritic rash (urticaria)
• nausea, especially when high doses are administered
  • If this happens to you, Amoxicillin/Clavulanic Acid Kabi should be administered to you before meals
• vomiting
• indigestion
• dizziness
• headache.

Uncommon side effects that may appear in your blood tests:

• increase in some substances (enzymes) produced by the liver

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

• skin rash, which can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme)
  • If you have any of these symptoms, contact a doctor urgently.
• swelling and redness along the vein, which is extremely sensitive to touch

Rare side effects that may appear in your blood tests:

• low count of cells involved in blood clotting
• low count of white blood cells

Other side effects

Other side effects that have occurred in a very small number of patients and whose exact frequency is unknown.

• Allergic reactions (see above)
• Inflammation of the membrane that surrounds the brain (aseptic meningitis)
• Rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease)
• Inflammation of the large intestine (see above)
• Severe skin reactions:
  • widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
  • widespread rash with small blisters with pus (exfoliative dermatitis or vesicular)
  • red rash with bumps under the skin and blisters (pustular exanthem)
  • flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (such as elevated white blood cell count and liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

Contact a doctor immediately if you experience any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can make the skin and the whites of the eyes turn yellow
• inflammation of the kidney ducts
• delayed blood clotting
• seizures (in patients taking high doses of Amoxicillin/Clavulanic Acid or those with kidney problems)

Side effects that may appear in your blood or urine tests:

• significant decrease in the number of white blood cells
• low count of red blood cells (hemolytic anemia)
• crystals in the urine that cause acute kidney injury.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid Kabi

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

Do not use Amoxicillin/Clavulanic Acid Kabi after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C. Store in the original package to protect from light.

Reconstituted injection solutions should be administered within 15 minutes of preparation.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicillin/Clavulanic Acid Kabi

Each vial of Amoxicillin/Clavulanic Acid Kabi 1,000 mg/200 mg contains 1,000 mg of amoxicillin (as amoxicillin sodium) and 200 mg of clavulanic acid (as potassium clavulanate).

• It does not contain excipients. However, consult section 2 for additional important information about sodium and potassium content.
• Before administration, the doctor, nurse, or pharmacist will prepare the injection or infusion in the appropriate fluid (such as water for injectable preparations or a fluid for infusion/injection).

Appearance of the Product and Container Content

Amoxicillin/Clavulanic Acid Kabi is supplied in transparent glass vials containing a sterile powder for preparing an injection or infusion. The vial is closed with a rubber stopper, an aluminum cap, and a flip-top cap. The vials of Amoxicillin/Clavulanic Acid Kabi 1,000 mg/200 mg are packaged in boxes of 1, 5, 10, and 50 vials.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FRESENIUS KABI ESPAÑA, S.A.U.

C/ Marina, 16-18,

08005 Barcelona

Spain

Manufacturer

Labesfal – Laboratórios Almiro S.A.

Lagedo, Santiago de Besteiros,

3465-157 Santiago de Besteiros

Portugal

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Germany: Amoxicillin/Clavulansäure Kabi 1000 mg/200 mg Powder for Solution for Injection/Infusion

Belgium: Amoxiclav Fresenius Kabi 1000 mg/200 mg Powder for Solution for Injection/Infusion

Cyprus: Amoxicillin+Clavulanic acid/ Kabi, κ?νις για παρασκευ? διαλ?ματος προς ?νεση / ?γχυση, 1000 mg/200 mg

Spain: Amoxicillin/Clavulanic Acid Kabi 1,000 mg/200mg Powder for Solution for Injection and Infusion EFG

France: AMOXICILLINE ACIDE CLAVULANIQUE KABI 1g/200mg ADULTES, Powder for Solution for Injection/Infusion

Greece: Amoxicillin+Clavulanic acid/ Kabi, κ?νις για παρασκευ? διαλ?ματος προς ?νεση / ?γχυση, 1000 mg/200 mg

Hungary: Amoxicillin/Klavulánsav Kabi

Ireland: Co-Amoxiclav, 1000 mg/200 mg Powder for Solution for Injection/Infusion

Italy: Amoxicillina e Acido Clavulanico Kabi

Luxembourg: Amoxicillin/Clavulansäure Kabi 1000 mg/200 mg Powder for Solution for Injection/Infusion

Netherlands: Amoxicilline/Clavulaanzuur Fresenius Kabi 1000 mg/200 mg Powder for Solution for Injection/Infusion

Poland: Amoxicillin/Clavulanic Acid Kabi

Portugal: Amoxicilina/Ácido Clavulânico Kabi

United Kingdom: Co-Amoxiclav, 1000 mg/200 mg Powder for Solution for Injection/Infusion

Date of the Last Revision of this Leaflet: July 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This Information is Intended Exclusively for Healthcare Professionals:

See the Summary of Product Characteristics for additional information

Reconstitution

Preparation of Solutions for Intravenous Injection

Amoxicillin/Clavulanic Acid Kabi 1,000 mg/200 mg Powder for Solution for Injection or Infusion must be dissolved in 20 ml of water for injectable preparations.

This results in approximately 20.9 ml of solution for single-dose use (47.8 mg/9.6 mg/ml). A transient pale pink coloration may be observed during reconstitution. The reconstituted solutions are normally colorless or pale straw-colored.

Amoxicillin/Clavulanic Acid Kabi should be administered within 15 minutes after reconstitution.

Preparation of Solutions for Intravenous Infusion

Amoxicillin/Clavulanic Acid Kabi 1,000 mg/200 mg should be reconstituted as described above for injection. The reconstituted solution should be added immediately to 100 ml of a 9 mg/ml NaCl solution (0.9%) using a minibag or in-line burette.

Amoxicillin/Clavulanic Acid Kabi can be administered by slow intravenous injection over a period of 3 to 4 minutes directly into a vein or by a drip infusion over 30-40 minutes. Amoxicillin/Clavulanic Acid Kabi is not suitable for intramuscular administration.

The vials of Amoxicillin/Clavulanic Acid Kabi are not suitable for multiple-dose use. Discard any remaining solution.

Reconstitution/dilution must be performed under aseptic conditions. Before administration, the solution must be inspected visually for particles or discoloration. It should only be used if the solution is clear and free of particles.

Disposal of the unused medicinal product and all materials that have come into contact with it should be done in accordance with local regulations.

Stability of the Prepared Solutions

The reconstituted injectable solutions must be administered within 15 minutes after preparation.

The time between the start of reconstitution and the end of intravenous infusion should not exceed 1 hour.

Amoxicillin/Clavulanic Acid Kabi should not be mixed with blood and its derivatives, other protein-containing fluids such as protein hydrolysates, or with intravenous lipid emulsions.

If Amoxicillin/Clavulanic Acid Kabi is prescribed in conjunction with an aminoglycoside, the antibiotics should not be mixed in the same syringe, infusion bottle, or administered together, as this may result in a loss of aminoglycoside activity.

Amoxicillin/Clavulanic Acid Kabi is less stable in infusions containing glucose, dextran, or bicarbonate.

Therefore, the reconstituted solutions of the medicinal product should not be added to these infusions.