Cefuroxime kalceks

Package leaflet: Information for the user

Cefuroxime Kalceks, 750 mg, powder for solution for injection / infusion
Cefuroxime Kalceks, 1500 mg, powder for solution for injection / infusion
Cefuroximum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse immediately. See section 4.

Contents of the leaflet

1. What Cefuroxime Kalceks is and what it is used for
2. Important information before using Cefuroxime Kalceks
3. How to use Cefuroxime Kalceks
4. Possible side effects
5. How to store Cefuroxime Kalceks
6. Contents of the pack and other information

1. What Cefuroxime Kalceks is and what it is used for

Cefuroxime Kalceks is an antibiotic used in adults and children. The medicine works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Cefuroxime Kalceks is used to treat infections of:

• lungs or bronchi;
• urinary tract;
• skin and soft tissues;
• abdomen.

Cefuroxime Kalceks is also used:

• to prevent infections during surgery.

Your doctor may test which type of bacteria caused the infection and may monitor during treatment whether the bacteria are sensitive to cefuroxime.

2. Important information before using Cefuroxime Kalceks

When not to use Cefuroxime Kalceks:

• if the patient is allergic to any antibiotics of the cephalosporin group;
• if the patient has ever experienced a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams or carbapenems);
• if the patient has ever developed severe skin rash or peeling of the skin, blisters and/or oral mucosal ulcers after treatment with cefuroxime or other antibiotics of the cephalosporin group;
• if the patient is allergic to lidocaine and will receive cefuroxime reconstituted in lidocaine solution for intramuscular injection.

If the patient thinks any of the above situations apply, they must inform the doctor before starting treatment with this medicine. The patient must not be given cefuroxime.

Warnings and precautions

During treatment with this medicine, be alert for symptoms such as allergic reactions, skin rashes, gastrointestinal disturbances such as diarrhoea, or fungal infections. This will help reduce the risk of complications. See "Symptoms to be aware of" in section 4. If the patient has previously experienced any allergic reactions to other antibiotics, such as penicillin, they may also be allergic to cefuroxime.

Severe skin adverse reactions have occurred during treatment with cefuroxime, including:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms associated with severe skin reactions described in section 4 are observed, the patient should seek immediate medical advice.

Blood and urine tests

Cefuroxime may affect the results of blood or urine glucose tests and blood tests known as the Coombs test. If the patient is to undergo such tests, they should inform the person collecting the sample that they are taking cefuroxime.

Cefuroxime Kalceks and other medicines

Tell the doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Some medicines may affect the action of cefuroxime or may increase the risk of adverse effects. These include:

• antibiotics of the aminoglycoside group;
• diuretic tablets (diuretics), such as furosemide;
• probenecid;
• oral anticoagulants. If this applies to the patient, the doctor should be informed. Additional monitoring of kidney function may be necessary during treatment with this medicine.

Oral contraceptives

Cefuroxime may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives while being treated with cefuroxime, an additional mechanical method of contraception (e.g. condom) should be used. Consult the doctor for advice.

Pregnancy, breastfeeding and fertility

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

The doctor will assess whether the benefits to the patient from using cefuroxime outweigh the risks to the unborn or nursing child.

Driving and operating machinery

It is unlikely that this medicine will affect the ability to drive or operate machinery. However, the patient should not drive or operate machinery if they do not feel well.

Cefuroxime Kalceks contains sodium

Cefuroxime Kalceks 750 mg, powder for solution for injection/infusion
This medicine contains 40.6 mg of sodium (the main component of table salt) in each vial. This corresponds to 2% of the maximum recommended daily intake of sodium in the adult diet.

Cefuroxime Kalceks 1500 mg, powder for solution for injection/infusion
This medicine contains 81.3 mg of sodium (the main component of table salt) in each vial. This corresponds to 4.1% of the maximum recommended daily intake of sodium in the adult diet.

3. How to use Cefuroxime Kalceks

Cefuroxime is usually administered by a doctor or nurse. It can be given as an intravenous infusion
(infusion into a vein) or as an injection directly into a vein or muscle.
Usual dose
The doctor will decide the appropriate dose of cefuroxime for the patient, taking into account the severity
and type of infection, any other antibiotics the patient may be taking; the patient's body weight
and age; and kidney function.
Newborns (aged 0–3 weeks)
A dose of 30 to 100 mg of cefuroxime per kilogram of body weight per day is given, divided into two or three doses.
Newborns (over 3 weeks of age), infants and children
A dose of 30 to 100 mg of cefuroxime per kilogram of body weight per day is given, divided into three or four doses.
Adults and adolescents
750 mg to 1500 mg of cefuroxime two, three or four times daily. Maximum dose: 6 g per day.
Patients with impaired kidney function
If the patient has kidney problems, the doctor may adjust the dosage. If this applies to the patient, they should inform the doctor.
If there are any further doubts about the use of this medicine, consult a doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Symptoms to watch for (frequency unknown)
In a small number of people taking cefuroxime, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:

• Severe allergic reaction. Symptoms include raised, itchy rash, swelling, sometimes of the face or lips, which may make breathing difficult.
• Skin rash that may develop into blisters and look like target lesions (a dark spot in the centre surrounded by a lighter ring and a dark ring around the edge) (These may be symptoms of erythema multiforme).
• Widespread rash, with blisters and peeling of the outer layer of skin (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

Other symptoms to watch for during treatment with cefuroxime
(frequency unknown):

• Fungal infections. Medicines such as cefuroxime may rarely cause overgrowth of yeast ( Candida ) in the body, leading to fungal infection (e.g. oral thrush). The risk of this adverse reaction is higher if cefuroxime is used for a prolonged period.
• Severe diarrhoea ( Pseudomembranous colitis ). Medicines such as cefuroxime may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, abdominal pain and fever. If the patient experiences any of the symptoms listed above, contact a doctor or nurse immediately.

Other adverse reactions
Common adverse reactions (may occur in up to 1 in 10 patients):

• pain at the injection site, swelling and redness along the vein.

Common adverse reactions that may be revealed in blood tests:

• increased activity of substances (enzymes) produced in the liver;
• changes in white blood cell count (neutropenia or eosinophilia);
• decreased number of red blood cells (anaemia).

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• skin rash, itchy, raised rash (urticaria);
• diarrhoea, nausea, abdominal pain.

Uncommon adverse reactions that may be revealed in blood tests:

• decreased number of white blood cells (leukopenia);
• increased levels of bilirubin (a substance produced by the liver);
• positive Coombs test.

Unknown frequency (frequency cannot be estimated from available data):

• high temperature (fever);
• allergic reactions;
• inflammation of the kidneys and blood vessels;
• excessive breakdown of red blood cells (haemolytic anaemia).

Adverse reactions that may be revealed in blood tests:

• decreased number of platelets – blood cells involved in clotting (thrombocytopenia);
• increased levels of blood urea nitrogen and serum creatinine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. 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
Website: https://smz.ezdrowie.gov.pl
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 Cefuroxime Kalceks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and outer packaging after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Keep the vials in the outer packaging to protect from light.

Intravenous or intramuscular injection
Shelf life after reconstitution in the vial:
Chemical and physical stability of the solution has been demonstrated for 6 hours at 25°C and for 72 hours at 2 to 8°C after reconstitution with water for injections (see "Information intended exclusively for medical professionals" below).
From a microbiological standpoint, the medicinal product should be used immediately after reconstitution. If not used immediately, the user is responsible for the storage conditions and duration prior to use. Storage should not exceed 24 hours at 2 to 8°C, except when reconstitution is carried out under controlled and validated aseptic conditions.

Intravenous infusion
The reconstituted solution should be diluted immediately after reconstitution.
Shelf life after reconstitution and dilution:
Chemical and physical stability of the diluted solution has been demonstrated for 6 hours at 25°C and for 72 hours at 2 to 8°C after reconstitution, provided that one of the compatible diluents is used (see "Information intended exclusively for medical professionals" below).
From a microbiological standpoint, the diluted medicinal product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions prior to use. Storage should not exceed 24 hours at 2 to 8°C, except when reconstitution/dilution is performed under controlled and validated aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so will help protect the environment.

6. Contents of the pack and other information

What Cefuroxime Kalceks contains

• The active substance is cefuroxime.

Cefuroxime Kalceks, 750 mg, powder for solution for injection / infusion
Each vial contains 750 mg of cefuroxime (as cefuroxime sodium).
Cefuroxime Kalceks, 1500 mg, powder for solution for injection / infusion
Each vial contains 1500 mg of cefuroxime (as cefuroxime sodium).

What Cefuroxime Kalceks looks like and contents of the pack
Cefuroxime Kalceks is a white or almost white powder for solution for injection / infusion, placed in a vial made of colourless glass, closed with a rubber stopper and aluminium seal, and a plastic flip-off cap that is blue (750 mg) or orange (1500 mg).
Vials are placed in cardboard boxes.
Pack sizes: 1, 5, 10 or 100 vials
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
LV-1057 Rīga
Latvia
Tel.: +371 67083320
e-mail: [email protected]

Information intended exclusively for healthcare professionals:

For single use only.
Administration method
Cefuroxime should be administered by intravenous injection over 3 to 5 minutes directly into a vein, or by intravenous infusion lasting 30 to 60 minutes, or by deep intramuscular injection.
Intramuscular injections should be administered deeply into relatively large muscles. Do not inject more than 750 mg at a single site.
Caution is required when administering a 1500 mg dose by intramuscular injection: administer two 750 mg doses, each at a separate site.
Doses exceeding 1500 mg should be administered intravenously.
If lidocaine is used as the solvent for reconstitution of cefuroxime for intramuscular injection, the reconstituted medicinal product must never be administered intravenously. Consider the information provided in the lidocaine medicinal product's Summary of Product Characteristics.
Reconstitution instructions
Volumes of water added and resulting concentrations useful when fractional doses are required.

* The reconstituted solution should be added to 50 or 100 mL of a compatible infusion fluid (for
compatibility information, see below).
** The final volume of cefuroxime solution in the reconstitution diluent is increased due to the phase
displacement factor of the active substance, resulting in the concentrations expressed in mg/mL.
*** Preparation of both 750 mg doses to be administered simultaneously should comply with
standard quality requirements (see above “Method of administration”).

Compatibility
1500 mg of sodium cefuroxime dissolved in 15 mL of Water for Injections may be added to a
solution of metronidazole (500 mg/100 mL).
1500 mg of sodium cefuroxime is compatible with 1 g of azlocillin (in 15 mL solution) or 5 g of
azlocillin (in 50 mL solution).
Sodium cefuroxime (5 mg/mL) may be used with 5% or 10% xylitol solution for injection.
Sodium cefuroxime is compatible with aqueous solutions containing not more than 1% lidocaine
hydrochloride (for intramuscular injection only). Lidocaine must never be administered
intravenously.
Sodium cefuroxime is compatible with the following infusion fluids:

• Sodium chloride 9 mg/mL (0.9%) solution
• Glucose 50 mg/mL (5%) solution
• Glucose 40 mg/mL (4%) and sodium chloride 1.8 mg/mL (0.18%) solution
• Glucose 50 mg/mL (5%) and sodium chloride 9 mg/mL (0.9%) solution
• Glucose 50 mg/mL (5%) and sodium chloride 4.5 mg/mL (0.45%) solution
• Glucose 50 mg/mL (5%) and sodium chloride 2.25 mg/mL (0.225%) solution
• Glucose 100 mg/mL (10%) solution
• Hartmann’s solution (Ringer’s lactate solution)

The stability of sodium cefuroxime in sodium chloride 9 mg/mL (0.9%) solution and glucose
50 mg/mL (5%) solution is unaffected by the presence of sodium phosphate hydrocortisone.
Sodium cefuroxime also shows compatibility when mixed in intravenous infusion with:

• Heparin (10 and 50 units/mL) in sodium chloride 9 mg/mL (0.9%) infusion solution
• Potassium chloride (10 and 40 mEq/L) in sodium chloride 9 mg/mL (0.9%) infusion solution

After adding the specified amount of diluent for intramuscular injection, a suspension is formed.
The suspension color ranges from almost white to yellowish-white.
After adding the specified amount of diluent for intramuscular or intravenous injection, a clear
yellowish solution is obtained. The intensity of the solution color after reconstitution/dilution may
vary depending on storage time and concentration, but this does not affect the efficacy of the
medicinal product. The solution should be visually inspected before use. Only clear yellowish
solutions free from particulate matter should be used.

Disposal
Any unused medicinal product or waste material should be disposed of in accordance with
local regulations.