Amoxicillin/clavulanic Acid Kabi

Leaflet attached to the packaging: information for the user

Amoxicillin/Clavulanic Acid Kabi

2000 mg + 200 mg, powder for solution for infusion

Amoxicillin + Clavulanic Acid

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

­
Keep this leaflet, so that you can read it again if necessary.
­
In case of any doubts, consult a doctor, pharmacist, or nurse.
­
If the patient experiences any side effects, including those 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 bactericidally on bacteria that cause infections. It contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", whose action may sometimes be inhibited (inactivated). The second active substance (clavulanic acid) counteracts this inactivation.
Amoxicillin/Clavulanic Acid Kabi is used in adult and pediatric patients to treat the following infections:
­
severe ear, nose, and throat infections,
­
respiratory tract infections,
­
urinary tract infections,
­
skin and soft tissue infections, including dental infections,
­
bone and joint infections,
­
intra-abdominal infections,
­
genital infections in women.
Amoxicillin/Clavulanic Acid Kabi is used in adult and pediatric patients to prevent infections related to major surgical procedures.

2. Important information before using Amoxicillin/Clavulanic Acid Kabi

When not to use Amoxicillin/Clavulanic Acid Kabi

­
If the patient is allergic to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6).
­
If the patient has ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. Such a reaction may include a skin rash, facial or neck swelling.
­
If the patient has ever had liver function disorders or jaundice (yellowing of the skin), related to 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 the medicine, consult a doctor, pharmacist, or nurse if the patient:
­
has infectious mononucleosis,
­
is being treated for liver or kidney disease,
­
does not urinate regularly.
In case of doubt whether the above circumstances apply to the patient, before using Amoxicillin/Clavulanic Acid Kabi, consult a doctor, pharmacist, or nurse.
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 be aware of

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 be aware of" 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 over-the-counter medicines 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

­
Amoxicillin/Clavulanic Acid Kabi contains approximately 125.9 mg (5.5 mmol) of sodium. This should be taken into account in patients controlling their sodium intake.
­
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

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

How Amoxicillin/Clavulanic Acid Kabi is administered

­
Amoxicillin/Clavulanic Acid Kabi is administered by intravenous infusion.
­
During treatment with Amoxicillin/Clavulanic Acid Kabi, it is recommended to drink plenty of fluids.
­
Amoxicillin/Clavulanic Acid Kabi is usually not administered for more than 2 weeks without re-examining the patient's health 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 been given a dose higher 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 about using 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 be aware of

Hypersensitivity reactions:

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

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 their doctor as soon as possible for advice.
Common side effects(may occur in less than 1 in 10 patients):
­
thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds);
­
diarrhea.
Uncommon side effects(may occur in less than 1 in 100 patients):
­
skin rash, itching;
­
raised, itchy rash (hives);
­
nausea, especially when using high doses;
if they occur, Amoxicillin/Clavulanic Acid Kabi should be taken before meals
­
vomiting;
­
indigestion;
­
dizziness;
­
headache.
Uncommon side effects that may appear in blood test results:
­
increased activity of certain substances (enzymes) produced in the liver.
Rare side effects(may occur in less than 1 in 1,000 patients):
­
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 their doctor.
­
swelling and redness along the vein, which is very painful to the touch.
Rare side effects that may appear in blood test results:
­
low number of blood cells involved in blood clotting;
­
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.
­
hypersensitivity reactions (see above);
­
aseptic meningitis (inflammation of the protective membrane surrounding the brain);
­
colitis (see above);
­
severe skin reactions:

• widespread skin rash, 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 skin rash, which may be accompanied by small pus-filled blisters (bullous exfoliative dermatitis);
• red, scaly skin 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].

If the patient experiences any of these symptoms, they should immediately contact their doctor:
­
hepatitis;
­
jaundice, caused by an increase in bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and eyes;
­
interstitial nephritis;
­
prolonged blood clotting time;
­
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:

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

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 to gather more information on the safety of this medicine.

5. How to store Amoxicillin/Clavulanic Acid Kabi

The medicine should be stored 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 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Amoxicillin/Clavulanic Acid Kabi contains

Each vial contains 2000 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 injections or infusion solution).

What Amoxicillin/Clavulanic Acid Kabi looks like and what the pack contains

Amoxicillin/Clavulanic Acid Kabi is available in a transparent vial containing a sterile powder for solution for 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, or 10 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 2000 mg/200 mg powder for solution for infusion

France

AMOXICILLINE ACIDE CLAVULANIQUE KABI 2g/200mg ADULTES,
poudre pour solution pour perfusion

Spain

Amoxicilina/Ácido Clavulánico Kabi 2g/200mg Polvo para solución para perfusión

Netherlands

Amoxicilline/Clavulaanzuur Fresenius Kabi 2000 mg/200 mg poeder voor
oplossing voor infusie

Luxembourg

Amoxicillin/Clavulansäure Kabi 2000 mg/200 mg Pulver zur Herstellung einer
Infusionslösung

Germany

Amoxicillin/Clavulansäure Kabi 2000 mg/200 mg Pulver zur Herstellung einer
Infusionslösung

Poland

Amoxicillin/Clavulanic Acid Kabi

Portugal

Amoxicilina/Ácido Clavulânico Kabi

Hungary

Amoxicillin/Klavulánsav Kabi

Italy

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

Reconstitution

Preparation of solution for intravenous injection
Amoxicillin/Clavulanic Acid Kabi, 2000 mg + 200 mg is not suitable for intravenous bolus injections. The medicine should be administered by intravenous infusion.
Preparation of solution for intravenous infusion
Amoxicillin/Clavulanic Acid Kabi, 2000 mg + 200 mg should be dissolved in 20 ml of water for injections (minimum volume). During reconstitution, a transient, pinkish color may appear. The reconstituted solutions are usually colorless or pale yellow.
Immediately after reconstitution, 100 ml of 9 mg/ml (0.9%) sodium chloride solution should be added to the solution.
Alternatively, immediately after preparation, 100 ml of 9 mg/ml (0.9%) sodium chloride solution can be added to the solution using a mini-bag or burette infusion set.
Amoxicillin/Clavulanic Acid Kabi should be administered by intravenous infusion over 30 to 40 minutes.
Amoxicillin/Clavulanic Acid Kabi is not intended for intramuscular administration .
The vials of Amoxicillin/Clavulanic Acid Kabi are not intended for multiple use. Any unused solution should be discarded.
The medicine should be reconstituted and diluted in accordance with aseptic principles. Before administration, the solution should be inspected for visible particles and color change. The solution should only be administered if it is clear and free of visible particles.
Any unused medicine or waste material should be disposed of in accordance with local regulations.

Stability of the reconstituted solution

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, or 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 solution should not be added to these solutions.