Amoxicillin/clavulanic acid kabi

Package leaflet: Information for the user

Amoxicillin/Clavulanic Acid Kabi
2000 mg + 200 mg, powder for solution for infusion
Amoxicillinum + Acidum clavulanicum
Please read all of this leaflet carefully before use, as it contains important information for the patient.
­ Keep this leaflet to read again if necessary.
­ If you have any questions, please consult your doctor, pharmacist, or nurse.
­ If you experience any adverse reactions, including any not listed in this leaflet, inform 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 being given Amoxicillin/Clavulanic Acid Kabi
3. How Amoxicillin/Clavulanic Acid Kabi is given
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 with bactericidal activity against 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 may sometimes be inhibited (inactivated). The second active substance (clavulanic acid) counteracts this inactivation.

Amoxicillin/Clavulanic Acid Kabi is used in adult patients and children to treat the following infections:
­ severe infections of the ear, nose, and throat,
­ 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 also used in adult patients and children for the prevention of infections associated with major surgical procedures.

2. 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 skin rash, swelling of the face or neck.
­ If the patient has ever experienced liver dysfunction or jaundice (yellowing of the skin) associated
with antibiotic use.
If any of the above situations apply to the patient, do not administer Amoxicillin/Clavulanic Acid Kabi.
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 to the patient, consult a doctor, pharmacist, or nurse before using 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 Amoxicillin/Clavulanic Acid Kabi at a different strength or another medicine.

Side effects to watch for
Treatment with Amoxicillin/Clavulanic Acid Kabi may worsen certain existing diseases or cause serious side effects, including allergic reactions, seizures, and colitis. It is important to monitor whether the patient develops specific symptoms during treatment with Amoxicillin/Clavulanic Acid Kabi to reduce the risk of complications. See “Side effects to watch for” 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 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), 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.

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 dietary 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 those controlling their dietary potassium intake.

3. How to use Amoxicillin/Clavulanic Acid Kabi

The patient will 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 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 a different 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 as an intravenous infusion.
­ During treatment with 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 believes that a higher
than recommended dose has been administered, they should immediately contact a doctor, pharmacist,
or nurse. Symptoms such as gastrointestinal irritation (nausea, vomiting, or diarrhoea) or seizures may occur.

If there are any further doubts regarding 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 to be aware of
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 a patient, immediate contact should be made with a doctor.
Treatment with Amoxicillin/Clavulanic Acid Kabi must be discontinued.

Inflammation of the large intestine (colitis)
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, abdominal pain and/or fever.
If any of these symptoms occur in a patient, medical advice should be sought as soon as possible.

Common adverse reactions (may occur in less than 1 in 10 patients):

• Thrush (candidiasis – fungal infections of the vagina, mouth or skin folds);
• Diarrhoea.

Uncommon adverse reactions (may occur in less than 1 in 100 patients):

• Skin rash, itching;
• Raised, itchy rash (urticaria);
• Nausea, particularly when high doses are used;
  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 less than 1 in 1,000 patients):

• Skin rash, possibly with blisters and appearing as target-like lesions (dark spot in the centre surrounded by a lighter ring and a dark ring around the edge – erythema multiforme);
  if a patient notices any of these symptoms, urgent contact should be made with a doctor.
• 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-clotting cells (thrombocytes);
• Low number of white blood cells.

Other adverse reactions
Other adverse reactions have been reported 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);
• Inflammation of the large intestine (see above);
• Severe skin reactions:
  • widespread skin rash with blisters and skin peeling, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin detachment (more than 30% of body surface area – toxic epidermal necrolysis);
  • widespread red rash with small pus-filled blisters (bullous exfoliative dermatitis);
  • red, scaly rash with subcutaneous nodules and blisters (acute generalised exanthematous pustulosis);
  • influenza-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results [including increased white blood cell count (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS).

If any of these symptoms occur in a patient, immediate contact should be made with a doctor:

• Inflammation of the liver (hepatitis);
• 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 the kidney 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 the urine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 provide 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 specified 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 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. This will help protect the environment.

6. Contents of the pack and other information

What Amoxicillin/Clavulanic Acid Kabi contains
Each vial contains 2000 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 infusion solution).

What Amoxicillin/Clavulanic Acid Kabi looks like and contents of the pack
Amoxicillin/Clavulanic Acid Kabi is available as a transparent vial containing a sterile powder for preparation of infusion solution. 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 or 10 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 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

Information intended exclusively for medical professionals:

For 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 injection
(bolus). The medicinal product must be administered by intravenous infusion.
Preparation of solution for intravenous infusion
Amoxicillin/Clavulanic Acid Kabi, 2000 mg + 200 mg should be reconstituted with 20 mL of water for
injections (minimum volume). A transient pinkish discoloration may appear during reconstitution.
Reconstituted solutions are usually colourless or pale yellow.
Immediately after reconstitution, the solution should be further diluted with 100 mL of 9 mg/mL (0.9%)
sodium chloride.
Alternatively, immediately after preparation, the solution may be diluted with 100 mL of 9 mg/mL (0.9%)
sodium chloride using a mini-bag or burette set of an infusion set.
Amoxicillin/Clavulanic Acid Kabi must be administered by intravenous infusion over 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 must be reconstituted and diluted under aseptic conditions. Prior to
administration, the solution should be inspected visually for particulate matter and discoloration. The
solution should only be administered if it is clear and free from visible particles.
Any unused medicinal product or waste material must be disposed of in accordance with local
regulations.
Stability of prepared solutions
The time from the start of reconstitution to the end of the intravenous infusion should not exceed
1 hour.
Amoxicillin/Clavulanic Acid Kabi must not be mixed with blood products or other protein-containing
solutions 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
concomitantly 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.
The reconstituted Amoxicillin/Clavulanic Acid Kabi must not be added to the above-mentioned
solutions.