Amoxicillin/clavulanic acid kabi

Package leaflet: Information for the user

Amoxicillin/Clavulanic Acid Kabi
1000 mg + 200 mg, powder for solution for injection/infusion
Amoxicillinum + Acidum clavulanicum
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.
­ Keep this leaflet. You may need to read it again.
­ If you have any further questions, ask your doctor, pharmacist, or nurse.
­ If you experience any side effects, including any not listed in this leaflet, tell your doctor,
pharmacist, or nurse. See section 4.
Contents of the leaflet

1. What Amoxicillin/Clavulanic Acid Kabi is and what it is used for
2. What you need to know before you use 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 active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", the action of which can sometimes be blocked (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:
­ 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 tract infections in women.
Amoxicillin/Clavulanic Acid Kabi is used in adults and children for the prevention of infections associated with major surgical procedures.

2. Important information before using Amoxicillin/Clavulanic Acid Kabi

When not to use Amoxicillin/Clavulanic Acid Kabi
­ Do not use this medicine if the patient:

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

If any of the above situations apply, do not administer Amoxicillin/Clavulanic Acid Kabi to the patient.
If in doubt, consult a doctor, pharmacist, or nurse before starting treatment with Amoxicillin/Clavulanic Acid Kabi.

Warnings and precautions
Before starting treatment, consult a doctor, pharmacist, or nurse if the patient:

• has infectious mononucleosis,
• is being treated for liver or kidney disease,
• does not pass urine regularly.

If in doubt whether any of the above conditions apply, consult a doctor, pharmacist, or nurse before administering Amoxicillin/Clavulanic Acid Kabi.
In some cases, the doctor may test which type of bacteria caused the infection. Depending on the results, the patient may receive a different strength of Amoxicillin/Clavulanic Acid Kabi or another medicine.

Conditions to be aware of
Treatment with Amoxicillin/Clavulanic Acid Kabi may worsen the course of certain pre-existing conditions or cause serious adverse effects, including allergic reactions, seizures, and colitis. Be vigilant for specific symptoms during treatment with Amoxicillin/Clavulanic Acid Kabi to reduce the risk of complications. See "Conditions to be aware of" in section 4.

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

Interactions of Amoxicillin/Clavulanic Acid Kabi with 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 remedies.

• If the patient is taking allopurinol (used to treat gout), the risk of developing a skin allergic reaction increases when taken together with Amoxicillin/Clavulanic Acid Kabi.
• If the patient is taking probenecid (used to treat gout), the doctor may decide to adjust the dose of Amoxicillin/Clavulanic Acid Kabi.
• If the patient is taking anticoagulant medicines (such as warfarin) together with Amoxicillin/Clavulanic Acid Kabi, additional blood tests may be required.
• 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 rejection of a transplanted organ).

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor, pharmacist, or nurse before using this medicine.

Sodium and potassium content in Amoxicillin/Clavulanic Acid Kabi

• Amoxicillin/Clavulanic Acid Kabi contains approximately 62.9 mg (2.7 mmol) of sodium. This should be taken into account in patients who are on a controlled sodium diet.
• 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 those on a controlled potassium diet.

3. How to use Amoxicillin/Clavulanic Acid Kabi

The patient must never self-administer this medicine. The medicine will be administered to the patient by qualified personnel, i.e. a doctor or nurse.
The usual doses are:
Adults and children with body weight of 40 kg or more

Children weighing less than 40 kg
All doses are determined according to the child's body weight in kilograms.

Patients with kidney or liver problems
­ If the patient has kidney problems, the dose of the medicine may be adjusted. The doctor may
recommend administering a different strength or another medicine.
­ Patients with liver problems may have blood tests performed more frequently to monitor liver function.
How Amoxicillin/Clavulanic Acid Kabi is administered
­ Amoxicillin/Clavulanic Acid Kabi is administered by intravenous injection or intravenous infusion.
­ While receiving Amoxicillin/Clavulanic Acid Kabi, it is recommended to drink plenty of fluids.
­ Usually, Amoxicillin/Clavulanic Acid Kabi is not administered for longer than 2 weeks without re-evaluation of the patient's health status by the doctor.
Administration of a higher than recommended dose of Amoxicillin/Clavulanic Acid Kabi
Administration of a dose higher than recommended is unlikely, but if the patient suspects that an overdose has occurred, they should immediately contact a doctor, pharmacist, or nurse. Symptoms such as gastrointestinal irritation (nausea, vomiting, or diarrhoea) or seizures may occur.
If in doubt about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below may occur during treatment with this medicine.

Symptoms that require attention
Hypersensitivity reactions:
­ skin rash;
­ vasculitis, which may appear as red or purple raised spots on the skin, but may affect other parts of the body;
­ fever, joint pain, swelling of glands in the neck, under the arm, or in the groin;
­ swelling, sometimes involving the face or area around the mouth (angioedema), causing difficulty in breathing;
­ fainting.
If any of these symptoms occur in the patient, immediate contact with a doctor is required.
Treatment with Amoxicillin/Clavulanic Acid Kabi must be discontinued.

Colitis (inflammation of the large intestine)
Colitis causing watery diarrhoea, usually with blood and mucus, abdominal pain and/or fever.
If any of these symptoms occur in the patient, contact a doctor as soon as possible for advice.

Common adverse reactions (may occur in fewer than 1 in 10 patients):
­ fungal infections (candidiasis – yeast infections of the vagina, mouth or skin folds);
­ diarrhoea.

Uncommon adverse reactions (may occur in fewer than 1 in 100 patients):
­ skin rash, itching;
­ raised, itchy rash (urticaria);
­ nausea, particularly when high doses are administered;
if nausea occurs, take Amoxicillin/Clavulanic Acid Kabi before meals
­ vomiting;
­ indigestion;
­ dizziness;
­ headache.

Uncommon adverse reactions that may be revealed in blood tests:
­ increased activity of certain substances (enzymes) produced in the liver.

Rare adverse reactions (may occur in fewer than 1 in 1,000 patients):
­ skin rash, which may present with blisters and resemble target-like lesions (dark spot in the centre surrounded by a lighter ring and a dark ring at the edge – erythema multiforme);
if the patient notices any of these symptoms, urgent contact with a doctor is required.
­ swelling and redness along a vein, which is very painful to touch.

Rare adverse reactions that may be revealed in blood tests:
­ low number of blood platelets;
­ low number of white blood cells.

Other adverse reactions
Other adverse reactions have occurred in a very small number of patients, but their exact frequency is unknown.
­ hypersensitivity reactions (see above);
­ inflammation of the protective membrane surrounding the brain (aseptic meningitis);
­ colitis (see above);
­ severe skin reactions:

• widespread skin rash, within which blisters and skin peeling may occur, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome) and a more severe form causing extensive skin peeling (over 30% of body surface area – toxic epidermal necrolysis);
• widespread red skin rash, within which small pustular blisters may appear (bullous exfoliative dermatitis);
• red, scaly rash with subcutaneous nodules and blisters (acute generalized exanthematous pustulosis);
• influenza-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results [including increased number of white blood cells (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS).

If any of these symptoms occur in the patient, immediate contact with a doctor is required:
­ hepatitis (liver inflammation);
­ jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may result in yellowing of the skin and whites of the eyes;
­ inflammation of renal tubules;
­ prolonged blood clotting time;
­ seizures (in patients receiving high doses of Amoxicillin/Clavulanic Acid Kabi or with kidney disease).

Adverse reactions that may be revealed in blood or urine tests:
­ marked decrease in white blood cells;
­ low number of red blood cells (haemolytic anaemia);
­ crystals in urine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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: [email protected].
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Amoxicillin/Clavulanic Acid Kabi

Keep this medicine out of 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 specified month.
Do not store above 25°C.
Store the vial in the outer packaging to protect from light.
The reconstituted injection solution should be administered within 15 minutes after reconstitution.
The time from the start of reconstitution to the end of intravenous infusion must not exceed 1 hour.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Amoxicillin/Clavulanic Acid Kabi contains
Each vial contains 1000 mg of amoxicillin (as sodium amoxicillin) and 200 mg of clavulanic acid (as potassium clavulanate).
The medicine does not contain any other ingredients. However, for further information regarding the sodium and potassium content in 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 solution for injections or infusions).

What Amoxicillin/Clavulanic Acid Kabi looks like and contents of the pack
Amoxicillin/Clavulanic Acid Kabi is available as a clear vial containing a sterile powder for preparing a solution for injection/infusion. The vial is sealed with a rubber stopper, an aluminium seal, and a flip-off cap. Vials are packed in cardboard boxes containing: 1, 5, 10 or 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

Manufacturer
Labesfal – Laboratórios Almiro, S.A.
Zona Industrial do Lagedo
3465-157 Santiago de Besteiros
Portugal

For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland
Tel.: +48 22 345 67 89

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium Amoxiclav Fresenius Kabi 1000 mg/200 mg powder for solution for injection/infusion
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 Kabi 1000 mg/200 mg poeder voor oplossing voor injectie/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

Information intended exclusively for healthcare professionals:

For additional information, see the Summary of Product Characteristics.
Reconstitution
Preparation of solution for intravenous injection
Amoxicillin/Clavulanic Acid Kabi, 1000 mg + 200 mg should be dissolved in 20 mL of water for
injections. This yields approximately 20.9 mL of solution for single use [(47.8 mg +
9.6 mg)/mL]. A transient pinkish discoloration may appear during reconstitution.
Reconstituted solutions are usually colorless or pale yellow in color.
Amoxicillin/Clavulanic Acid Kabi should be administered within 15 minutes after reconstitution.

Preparation of 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 should be added to the solution using a mini-bag or the burette of an infusion set.
Amoxicillin/Clavulanic Acid Kabi may be administered as a slow intravenous injection
over approximately 3 to 4 minutes directly into a vein or via an infusion line, or as an intravenous infusion lasting 30 to 40 minutes. Amoxicillin/Clavulanic Acid Kabi is not intended for intramuscular administration.
Vials of Amoxicillin/Clavulanic Acid Kabi are not intended for multiple use. Any unused portions of the solution must be discarded.
The medicinal product should be reconstituted and diluted under aseptic conditions. Before administration, the solution should be inspected visually for particulate matter and discoloration. The solution should only be administered if it is clear and free of visible particles.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.

Stability of prepared solutions
The reconstituted injection solution should be administered within 15 minutes after reconstitution.
The time from the start of reconstitution to the end of intravenous infusion should not exceed 1 hour.
Amoxicillin/Clavulanic Acid Kabi must not be mixed with blood products or other protein-containing fluids, such as protein hydrolysates, or with fat emulsions intended for intravenous administration.
If Amoxicillin/Clavulanic Acid Kabi has been prescribed by a physician to be administered simultaneously with an aminoglycoside antibiotic, the two antibiotics must not be mixed in the same syringe, container, or infusion apparatus due to the risk of loss of aminoglycoside antibiotic activity.
Amoxicillin/Clavulanic Acid Kabi is less stable in solutions containing glucose, dextran, or bicarbonate. Reconstituted Amoxicillin/Clavulanic Acid Kabi must not be added to the above-mentioned solutions.