Amoxicillin/clavulanic Acid Kabi

Leaflet attached to the packaging: information for the user

Amoxicillin/Clavulanic Acid Kabi

1000 mg + 200 mg, powder for solution for injection/infusion

Amoxicillin + Clavulanic Acid

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

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Keep this leaflet, so you can read it again if you need to.
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In case of any doubts, consult a doctor, pharmacist, or nurse.
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If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Amoxicillin/Clavulanic Acid Kabi and what is it used for
• 2. Important information 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 packaging and other information

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

Amoxicillin/Clavulanic Acid Kabi is an antibiotic that works by killing bacteria that cause infections. It contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins," which can sometimes be inactivated. The second active substance (clavulanic acid) counteracts this inactivation.
Amoxicillin/Clavulanic Acid Kabi is used in adults and children to treat the following infections:
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severe ear, nose, and throat infections,
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respiratory tract infections,
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urinary tract infections,
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skin and soft tissue infections, including dental infections,
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bone and joint infections,
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abdominal cavity infections,
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genital infections in women.
Amoxicillin/Clavulanic Acid Kabi is used in adults and children to prevent infections associated with major surgical procedures.

2. Important information before using Amoxicillin/Clavulanic Acid Kabi

When not to use Amoxicillin/Clavulanic Acid Kabi

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If the patient is allergic to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6).
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If the patient has ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. Such a reaction may include a skin rash, swelling of the face or neck.
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If the patient has ever had liver function disorders or jaundice (yellowing of the skin) associated with the use of an antibiotic.

If any of the above situations apply to the patient, they should not be given Amoxicillin/Clavulanic Acid Kabi

Amoxicillin/Clavulanic Acid Kabi.In case of doubt before starting treatment with Amoxicillin/Clavulanic Acid Kabi, consult a doctor, pharmacist, or nurse.

Warnings and precautions

Before starting treatment with Amoxicillin/Clavulanic Acid Kabi, consult a doctor, pharmacist, or nurse if the patient:
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has infectious mononucleosis,
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is being treated for liver or kidney disease,
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does not urinate regularly.
In case of doubt whether the above circumstances apply to the patient, consult a doctor, pharmacist, or nurse before using Amoxicillin/Clavulanic Acid Kabi.
In some cases, the doctor may examine what type of bacteria caused the infection in the patient.
Depending on the results, the patient may receive Amoxicillin/Clavulanic Acid Kabi at a different strength or a different medicine.

Conditions to watch out for

Using Amoxicillin/Clavulanic Acid Kabi may worsen the course of some existing diseases or cause severe side effects, including allergic reactions, seizures, and colitis. Pay attention to whether the patient experiences certain symptoms during treatment with Amoxicillin/Clavulanic Acid Kabi to minimize the risk of any problems. See "Conditions to watch out for" in section 4.

Blood and urine tests

If the patient is to have blood tests (such as red blood cell tests or liver function tests) or urine tests (for glucose), inform the doctor or nurse that the patient is taking Amoxicillin/Clavulanic Acid Kabi. Amoxicillin/Clavulanic Acid Kabi may affect the results of these tests.

Amoxicillin/Clavulanic Acid Kabi and other medicines

Tell the doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription and herbal medicines.
If the patient is taking allopurinol (used to treat gout) at the same time as Amoxicillin/Clavulanic Acid Kabi, the risk of a skin allergic reaction increases.
If the patient is taking probenecid (used to treat gout), the doctor may decide to modify the dose of Amoxicillin/Clavulanic Acid Kabi.
If the patient is taking medicines that reduce blood clotting (such as warfarin) at the same time as Amoxicillin/Clavulanic Acid Kabi, additional blood tests may be necessary.
Amoxicillin/Clavulanic Acid Kabi may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).
Amoxicillin/Clavulanic Acid Kabi may affect the action of mycophenolate mofetil (a medicine used to prevent organ rejection).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor, pharmacist, or nurse before using this medicine.

Amoxicillin/Clavulanic Acid Kabi contains sodium and potassium

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Amoxicillin/Clavulanic Acid Kabi contains approximately 62.9 mg (2.7 mmol) of sodium. This should be taken into account in patients controlling their sodium intake.
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Amoxicillin/Clavulanic Acid Kabi contains approximately 39.3 mg (1.0 mmol) of potassium. This should be taken into account in patients with kidney disease or controlling their potassium intake.

3. How to use Amoxicillin/Clavulanic Acid Kabi

The patient will never administer this medicine themselves. The medicine will be administered to the patient by qualified personnel, i.e., a doctor or nurse.
Usual doses are:

Adult patients and children with a body weight of 40 kg or more

Children with a body weight of less than 40 kg

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

Patients with kidney and liver problems

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If the patient has kidney problems, the dose of the medicine may be changed. The doctor may recommend administering the medicine at a different strength or a different medicine.
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Patients with liver problems may have more frequent blood tests to check liver function.

How Amoxicillin/Clavulanic Acid Kabi is administered

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Amoxicillin/Clavulanic Acid Kabi is administered by intravenous injection or infusion.
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During treatment with Amoxicillin/Clavulanic Acid Kabi, it is recommended to drink plenty of fluids.
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Amoxicillin/Clavulanic Acid Kabi is usually not administered for more than 2 weeks without re-examining the patient's health status by a doctor.

Using a higher dose of Amoxicillin/Clavulanic Acid Kabi than recommended

Administering a dose higher than recommended to the patient is unlikely, but if the patient believes they have received a higher dose than recommended, they should immediately consult a doctor, pharmacist, or nurse. Symptoms of stomach irritation (nausea, vomiting, or diarrhea) or seizures may occur.
In case of any further doubts related to the use of this medicine, consult a 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 during treatment with this medicine.

Conditions to watch out for

Hypersensitivity reactions:

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skin rash;
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vasculitis, which may appear as red or purple raised spots on the skin, but may also affect other parts of the body;
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fever, joint pain, swelling of the lymph nodes in the neck, armpit, or groin;
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swelling, sometimes involving the face or mouth area (angioedema) causing breathing difficulties;
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fainting.
If the patient experiences any of these symptoms, they should immediately contact a doctor. The use of Amoxicillin/Clavulanic Acid Kabi should be discontinued.

Colitis

Colitis, causing watery diarrhea, usually with blood and mucus, abdominal pain, and/or fever.
If the patient experiences any of these symptoms, they should contact a doctor as soon as possible for advice.
Common side effects(may occur in less than 1 in 10 patients):
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thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds);
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diarrhea.
Uncommon side effects(may occur in less than 1 in 100 patients):
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skin rash, itching;
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raised, itchy rash (hives);
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nausea, especially when taking high doses;
if they occur, Amoxicillin/Clavulanic Acid Kabi should be taken before meals
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vomiting;
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indigestion;
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dizziness;
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headache.
Uncommon side effects that may appear in blood test results:
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increased activity of certain substances (enzymes) produced in the liver.
Rare side effects(may occur in less than 1 in 1,000 patients):
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skin rash, which may be accompanied by blisters and look like small targets (dark spot in the center surrounded by a lighter border with a dark ring around the edge - erythema multiforme);
if the patient notices any of these symptoms, they should urgently contact a doctor.
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swelling and redness along the vein, which is very painful to the touch.
Rare side effects that may appear in blood test results:
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low number of blood cells involved in blood clotting;
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low number of white blood cells.

Other side effects

Other side effects have occurred in a very small number of patients, but their exact frequency is not known.
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hypersensitivity reactions (see above);
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aseptic meningitis (inflammation of the protective membrane surrounding the brain);
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colitis (see above);
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severe skin reactions:

• widespread rash on the skin, which may be accompanied by blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form, causing widespread peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis);
• widespread red rash on the skin, which may be accompanied by small pus-filled blisters (bullous exfoliative dermatitis);
• red, scaly rash with thickening under the skin and blisters (acute generalized exanthematous pustulosis);
• flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results [including an increased number of white blood cells (eosinophilia) and increased liver enzyme activity] (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS).

If the patient experiences any of these symptoms, they should immediately contact a doctor:
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hepatitis;
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jaundice, caused by an increase in bilirubin (a substance produced in the liver) in the blood, which can cause yellowing of the skin and eyes;
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inflammation of the renal tubules;
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prolonged blood clotting time;
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seizures (in patients receiving high doses of Amoxicillin/Clavulanic Acid Kabi or with kidney disease).

Side effects that may appear in blood or urine test results:

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significant decrease in the number of white blood cells;
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low number of red blood cells (hemolytic anemia);
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crystals in the urine.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Amoxicillin/Clavulanic Acid Kabi

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C.
Store the vial in the outer packaging to protect from light.
The prepared solution for injection should be administered within 15 minutes of reconstitution.
The time from the start of reconstitution to the end of intravenous infusion should not exceed 1 hour.
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. Contents of the packaging and other information

What Amoxicillin/Clavulanic Acid Kabi contains

Each vial contains 1000 mg of amoxicillin (as amoxicillin sodium) and 200 mg of clavulanic acid (as potassium clavulanate).
The medicine does not contain other ingredients. However, for more information about the sodium and potassium content of Amoxicillin/Clavulanic Acid Kabi, see section 2.
The medicine will be prepared by a doctor, pharmacist, or nurse using appropriate fluids (such as water for injection or injection/infusion solution).

What Amoxicillin/Clavulanic Acid Kabi looks like and contents of the pack

Amoxicillin/Clavulanic Acid Kabi is available in a transparent vial containing a sterile powder for solution for injection/infusion. The vial is closed with a rubber stopper, an aluminum seal, and a flip-off cap. The vials are packed in cardboard boxes containing: 1, 5, 10, or 50 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Labesfal – Laboratórios Almiro, S.A.
Zona Industrial do Lagedo
3465-157 Santiago de Besteiros
Portugal
To obtain more detailed information, contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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

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

Spain

Amoxicilina/Ácido Clavulánico Kabi 1g/200mg Polvo para solución inyectable y para perfusión

Netherlands

Amoxicilline/Clavulaanzuur Fresenius Kabi1000 mg/200 mg poeder voor oplossing voor in-jectie/infusie

Ireland

Co-Amoxiclav, 1000 mg/200 mg powder for solution for injection/infusion

Luxembourg

Amoxicillin/Clavulansäure Kabi 1000 mg/200 mg Pulver zur Herstellung einer Injektions- oder Infusionslösung

Germany

Amoxicillin/Clavulansäure Kabi 1000 mg/200 mg Pulver zur Herstellung einer Injektions- oder Infusionslösung

Poland

Amoxicillin/Clavulanic Acid Kabi

Portugal

Amoxicilina/Ácido Clavulânico Kabi

Hungary

Amoxicillin/Klavulánsav Kabi

United Kingdom

Co-Amoxiclav, 1000 mg/200 mg powder for solution for injection/infusion

Italy

Amoxicillina e Acido Clavulanico Kabi
Date of last revision of the leaflet: 22.09.2017
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Information intended for healthcare professionals only:
To obtain additional information, see the Summary of Product Characteristics.

Reconstitution

Preparation of the solution for intravenous injection
Amoxicillin/Clavulanic Acid Kabi, 1000 mg + 200 mg should be dissolved in 20 ml of water for injection. This allows for the preparation of approximately 20.9 ml of solution for single use [(47.8 mg + 9.6 mg)/ml]. During reconstitution, a transient, pink discoloration may appear.
The reconstituted solutions are usually colorless or pale yellow.
Amoxicillin/Clavulanic Acid Kabi should be administered within 15 minutes of reconstitution.
Preparation of the solution for intravenous infusion
Amoxicillin/Clavulanic Acid Kabi, 1000 mg + 200 mg should be reconstituted as described above. Immediately after reconstitution, 100 ml of 9 mg/ml (0.9%) sodium chloride solution should be added to the solution using a mini-bag or burette infusion set.
Amoxicillin/Clavulanic Acid Kabi can be administered by slow intravenous injection, lasting approximately 3 to 4 minutes, directly into a vein or using a drip infusion, or in intravenous infusion lasting 30 to 40 minutes. Amoxicillin/Clavulanic Acid Kabi is not intended for intramuscular administration.

Stability of the reconstituted solutions

The reconstituted solution for injection should be administered within 15 minutes of reconstitution.
The time from the start of reconstitution to the end of intravenous infusion should not exceed 1 hour.
Amoxicillin/Clavulanic Acid Kabi should not be mixed with blood products or other fluids containing proteins, such as hydrolyzed proteins, and with fat emulsions for intravenous administration.
If Amoxicillin/Clavulanic Acid Kabi is prescribed by a doctor at the same time as an aminoglycoside antibiotic, the two antibiotics should not be mixed in a syringe, container, or infusion device due to the risk of loss of aminoglycoside antibiotic activity.
Amoxicillin/Clavulanic Acid Kabi is less stable in solutions containing glucose, dextran, or bicarbonate. The reconstituted Amoxicillin/Clavulanic Acid Kabi should not be added to these solutions.