Amoxicillin/clavulanic acid Kabi 1000 mg/200 mg powder for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin/Clavulanic acid Kabi 1000 mg/200 mg powder for solution for injection

and for infusion EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Amoxicillin/Clavulanic Acid Kabi is and what it is used for

Amoxicillin/Clavulanic Acid Kabi is an antibiotic that kills bacteria causing infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Amoxicillin/Clavulanic Acid Kabi is used in adults and children to treat the following infections:

• Acute ear, nose, and throat infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections, including dental infections
• Bone and skin infections
• Intra-abdominal infections
• Genital infections in women

Amoxicillin/Clavulanic Acid Kabi is used in adults to prevent infections associated with major surgical procedures.

2. What you need to know before starting to use 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) while taking an antibiotic.

You must not be given Amoxicillin/Clavulanic Acid Kabi if any of the above apply to you. If you are unsure, consult your doctor, pharmacist, or nurse before receiving Amoxicillin/Clavulanic Acid Kabi.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before receiving 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 conditions 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, they may prescribe a different formulation of Amoxicillin/Clavulanic Acid Kabi or another medicine.

Symptoms to watch out for

Amoxicillin/Clavulanic Acid Kabi may worsen certain existing conditions or cause serious adverse 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 complications. See “Symptoms to watch out for” in section 4.

Blood and urine tests

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

Use of Amoxicillin/Clavulanic Acid Kabi with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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

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

Amoxicillin/Clavulanic Acid Kabi may affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning 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 (the main component of table salt) per vial. This corresponds to 3.1% of the recommended maximum 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 when treating patients with renal insufficiency or those on potassium-restricted diets.

3. How to administer Amoxicillin/Clavulanic Acid Kabi

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

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 adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor how your liver is functioning.

How Amoxicillin/Clavulanic Acid Kabi will be administered to you

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

If you are given more Amoxicillin/Clavulanic Acid Kabi than you should

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 discomfort (nausea, vomiting, or diarrhea) or seizures.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with the use of this medicine.

Symptoms to watch for

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may also 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), causing difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome)

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

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

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

Acute inflammation of the pancreas (acute pancreatitis)

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

Drug-induced enterocolitis syndrome (DIES):

DIES has been reported mainly in children receiving amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after administration of the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.

Frequent adverse effects (may affect up to 1 in 10 people)

• thrush (candida – fungal infection in the vagina, mouth, or mucous membranes)
• diarrhoea

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

• skin rash, itching
• increased itchy rash (urticaria)
• nausea, especially when high doses are administered
  • If this occurs, Amoxicillin/Clavulanic Acid Kabi should be administered before meals
• vomiting
• dyspepsia
• dizziness
• headache

Uncommon adverse effects that may appear in blood tests:

• Increase in certain substances (enzymes) produced by the liver

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

• Skin rash, which may blister and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme)
  • If you experience any of these symptoms, contact a doctor urgently.
• Swelling and redness along the vein, which is extremely sensitive to touch

Rare adverse effects that may appear in blood tests:

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

Other adverse effects

Other adverse effects that have occurred in a very small number of patients, and whose exact frequency is unknown:

• Allergic reactions (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA disease)
• Inflammation of the large intestine (see above)
• Severe skin reactions:
  • widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin shedding (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread rash with small pus-filled blisters (exfoliative bullous vesicular dermatitis)
  • red rash with bumps under the skin and blisters (exanthematous pustulosis)
  • flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

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

• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause yellowing of the skin and whites of the eyes
• inflammation of kidney tubules
• delayed blood clotting
• seizures (in patients receiving high doses of Amoxicillin/Clavulanic Acid or who have kidney problems)

Adverse effects that may appear in blood or urine tests:

• significant reduction in white blood cell count
• low red blood cell count (haemolytic anaemia)
• crystals in the urine causing acute kidney injury

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 packaging after EXP. The expiry date is the last day of the month indicated.

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

Reconstituted injectable solutions must 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 any unused medicine and empty containers. This will help protect the environment.

6. Package contents and other 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 sodium amoxicillin) and 200 mg of clavulanic acid (as potassium clavulanate).

• Contains no excipients. However, see section 2 for additional important information regarding sodium and potassium content.
• Prior to administration, the doctor, nurse, or pharmacist will prepare the injection or infusion in the appropriate fluid (such as water for injections or an infusion/injection fluid).

Appearance of the product and contents of the container

Amoxicillin/Clavulanic Acid Kabi is supplied in clear glass vials containing a sterile powder for preparing an injection or infusion solution. The vial is sealed with a rubber stopper, an aluminum seal, and a flip-off cap. Amoxicillin/Clavulanic Acid Kabi 1,000 mg/200 mg vials are packaged in cartons containing 1, 5, 10, and 50 vials.

Only certain pack 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 European Economic Area member states under the following names:

Germany: Amoxicillin/Clavulansäure Kabi 1000 mg/200 mg Pulver zur Herstellung einer Injektions- oder Infusionslösung
Belgium: Amoxiclav Fresenius Kabi 1000 mg/200 mg poeder voor oplossing voor injectie/infusie
Cyprus: Amoxicillin+Clavulanic acid/ Kabi, κόνις για παρασκευή διαλύματος προς ένεση / έγχυση, 1000 mg/200 mg
Spain: Amoxicilina/Ácido Clavulánico Kabi 1.000 mg/200 mg powder for solution for injection and infusion EFG
France: AMOXICILLINE ACIDE CLAVULANIQUE KABI 1g/200mg ADULTES, poudre pour solution injectable/pour perfusion
Greece: Amoxicillin+Clavulanic acid/ Kabi, κόνις για παρασκευή διαλύματος προς ένεση / έγχυση, 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 Pulver zur Herstellung einer Injektions- oder Infusionslösung
Netherlands: Amoxicilline/Clavulaanzuur Fresenius Kabi 1000 mg/200 mg poeder voor oplossing voor injectie/infusie
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 most recent review of this leaflet: July 2023

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

This information is intended for healthcare professionals only:

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 injection or infusion solution must be dissolved in 20 ml of water for injections.

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. Reconstituted solutions are normally colorless or pale yellow.

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

Preparation of solutions for intravenous infusion

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

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

Amoxicillin/Clavulanic Acid Kabi vials are not suitable for multiple-dose use. Any unused solution must be discarded.

Reconstitution/dilution must be performed under aseptic conditions. Prior to administration, the solution must be visually inspected for particles or discoloration. The solution should only be used if it is clear and free from particles.

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

Stability of prepared solutions

Reconstituted injectable solutions must be administered within 15 minutes of preparation.

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

Amoxicillin/Clavulanic Acid Kabi must 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 together with an aminoglycoside, the antibiotics must not be mixed in the same syringe, infusion bag, or administered simultaneously, as this may result in loss of aminoglycoside activity.

Amoxicillin/Clavulanic Acid Kabi is less stable in infusions containing glucose, dextran, or bicarbonate.
Therefore, reconstituted solutions of the medicine must not be added to these infusions.