Cefuroxime Kalceks

Leaflet accompanying the packaging: information for the user

Cefuroxime Kalceks, 750 mg, powder for solution for injection/infusion

Cefuroxime Kalceks, 1500 mg, powder for solution for injection/infusion

Cefuroxime

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

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

Table of contents of the leaflet

• 1. What is Cefuroxime Kalceks and what is it 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 packaging and other information

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

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

Cefuroxime Kalceks is used to treat infections of:

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

Cefuroxime Kalceks is also used:

• to prevent infections during surgery.

The doctor may examine what type of bacteria caused the patient's infection and check during treatment if 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 cephalosporin antibiotics;
• if the patient has ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams, or carbapenems);
• if the patient has ever had a severe skin rash or skin peeling, blisters, and (or) mouth ulcers after treatment with cefuroxime or other cephalosporin antibiotics;
• if the patient is allergic to lidocaine and is to receive cefuroxime reconstituted in a lidocaine solution for intramuscular injection.

If the patient thinks that any of the above circumstances apply to them, they should tell their doctor before starting to use the medicine. The patient should not be given cefuroxime.

Warnings and precautions

During treatment with this medicine, attention should be paid to whether any symptoms such as allergic reactions, skin rashes, gastrointestinal disorders such as diarrhea or fungal infections occur. This will reduce the risk of complications. See "Symptoms to watch out for" in section 4. If the patient has had any allergic reactions to other antibiotics, such as penicillin, they may also be allergic to cefuroxime. Severe skin side effects have occurred with cefuroxime treatment, such as: 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 noticed, the patient should immediately consult a doctor.

Blood and urine tests

Cefuroxime may affect the results of tests that detect sugar in the urine or blood and blood tests known as the Coombs test. If the patient is to have such tests, they should tell the person taking the sample that they are taking cefuroxime.

Cefuroxime Kalceks and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Some medicines may interact with cefuroxime or increase the risk of side effects. These include:

• aminoglycoside antibiotics;
• diuretic tablets(such as furosemide);
• probenecid;
• oral anticoagulants. If this applies to the patient, they should tell their doctor. During treatment with this medicine, the patient may need to have additional kidney function tests.

Oral contraceptives

Cefuroxime may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives while using cefuroxime, they should also use a mechanical method of contraception(e.g., a condom). The patient should consult their doctor for advice.

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 their doctor before using this medicine. The doctor will assess whether the benefits to the patient outweigh the risks to the baby.

Driving and using machines

It is unlikely that this medicine will affect the patient's ability to drive or use machines. However, the patient should not drive or use machines 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 common salt) per vial. This is equivalent to 2% of the maximum recommended daily intake of sodium in the diet for adults. Cefuroxime Kalceks, 1500 mg, powder for solution for injection/infusion This medicine contains 81.3 mg of sodium (the main component of common salt) per vial. This is equivalent to 4.1% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Cefuroxime Kalceks

Cefuroxime is usually given by a doctor or nurse. It can be given as an intravenous infusionor as an injectiondirectly into a vein or muscle.

Usual dose

The doctor will decide on the appropriate dose of cefuroxime for the patient, taking into account the severity and type of infection, any other antibiotics the patient is taking, their body weight and age, and kidney function.

Newborns (0-3 weeks old)

The dose is 30-100 mg of cefuroxime per kilogram of body weight per day, divided into two or three doses.

Newborns (over 3 weeks old), infants, and children

The dose is 30-100 mg of cefuroxime per kilogram of body weight per day, divided into three or four doses.

Adults and adolescents

750 mg to 1500 mg of cefuroxime two, three, or four times a day. Maximum dose: 6 g per day.

Patients with kidney disease

If the patient has kidney disease, the doctor may change the dose of the medicine. If this applies to the patient, they should tell their doctor. If the patient has any further doubts about using this medicine, they should consult their doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Symptoms to watch out for(frequency not known) A small number of people taking cefuroxime have reported an allergic reactionor a potentially severe skin reaction. Their symptoms may include:

• Severe allergic reaction. Symptoms include raised and itchy rash, swelling,sometimes of the face or mouth, which can make breathing difficult.
• Skin rash, which can develop into blistersand look like small targets(a dark spot in the center surrounded by a lighter border with a dark ring around the edge) (These may be symptoms of erythema multiforme).
• Widespread rashwith blisters and peeling skin(This may be a symptom of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high fever, and enlarged lymph nodes(drug reaction with eosinophilia and systemic symptoms, DRESS).
• Chest painassociated with an allergic reaction, which can be a symptom of an allergic myocardial infarction (Kounis syndrome).

Other symptoms to watch out for while taking cefuroxime

(frequency not known):

• Fungal infections. Medicines like cefuroxime can rarely cause an overgrowth of yeast (Candida) in the body, leading to a fungal infection (e.g., thrush). The risk of this side effect is higher if cefuroxime is used for a long time.
• Severe diarrhea(pseudomembranous colitis, antibiotic-associated colitis). Medicines like cefuroxime can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain, and fever.

If the patient experiences any of the above symptoms, they should immediately contact their doctor or nurse.

Other side effects

Common side effects (may affect up to 1 in 10 people)

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

Common side effects that may be seen in blood tests:

• increased activity of substances (enzymes) produced in the liver;
• change in the number of white blood cells (neutropenia or eosinophilia);
• decrease in the number of red blood cells (anemia).

Uncommon side effects (may affect up to 1 in 100 people)

• skin rash, itchy, lumpy rash (hives);
• diarrhea, nausea, abdominal pain.

Uncommon side effects that may be seen in blood tests:

• decrease in the number of white blood cells (leukopenia);
• increase in bilirubin levels (a substance produced by the liver);
• positive Coombs test result.

Unknown (frequency cannot be estimated from the available data)

• high fever;
• allergic reactions;
• kidney and blood vessel inflammation;
• rapid breakdown of red blood cells (hemolytic anemia).

Side effects that may be seen in blood tests:

• decrease in the number of platelets (thrombocytopenia);
• increase in urea and creatinine levels in the blood.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Cefuroxime Kalceks

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month. Do not store above 25°C. Store the vials in the outer packaging to protect from light. Intravenous injection or intramuscular injection Shelf-life after reconstitution in the vial: The chemical and physical stability of the solution has been demonstrated for 6 hours at 25°C and for 72 hours at 2-8°C, after reconstitution in water for injections (see "Information intended for healthcare professionals only" below). From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user. The storage time should not exceed 24 hours at 2-8°C, unless reconstitution is performed in controlled and validated aseptic conditions. Intravenous infusion The reconstituted solution should be diluted immediately after reconstitution. Shelf-life after reconstitution and dilution:The chemical and physical stability of the diluted solution has been demonstrated for 6 hours at 25°C and for 72 hours at 2-8°C, if one of the compatible diluents is used (see "Information intended for healthcare professionals only" below). From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user. The storage time should not exceed 24 hours at 2-8°C, unless reconstitution/dilution is performed in controlled and validated aseptic conditions. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 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, in a vial made of colorless glass, with a rubber stopper and an aluminum seal, and a blue (750 mg) or orange (1500 mg) plastic flip-off cap. The vials are placed in cardboard boxes. Pack sizes: 1, 5, 10, or 100 vials Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: ---------------------------------------------------------------------------

Information intended for healthcare professionals only:

For single use only. Method of administration Cefuroxime should be administered by intravenous injection over 3-5 minutes directly into a vein or by infusion over 30-60 minutes, or by deep intramuscular injection. Intramuscular injections should be administered deep into a relatively large muscle. Do not inject more than 750 mg into one site. Caution should be exercised when administering a 1500 mg dose by intramuscular injection: 2 doses of 750 mg should be injected, each into a different site. Doses greater than 1500 mg should be administered intravenously. If the solvent used for reconstitution of cefuroxime for intramuscular injection is lidocaine, the reconstituted product should never be administered intravenously. The information contained in the Summary of Product Characteristics of lidocaine should be taken into account. Instructions for reconstitution Volumes of water and concentrations useful when partial doses are to be used.

* The reconstituted solution should be added to 50 or 100 mL of a compatible infusion fluid (compatibility information, see below).
** The resulting volume of the cefuroxime solution in the reconstitution vehicle is increased due to the phase shift factor of the active substance, resulting in the concentrations presented in mg/mL.
*** The method of preparation of both 750 mg doses for administration at the same time should be in accordance with standard quality requirements (see above "Method of administration").
Compatibility 1500 mg of cefuroxime sodium dissolved in 15 mL of water for injections can be added to a metronidazole solution (500 mg/100 mL). 1500 mg of cefuroxime sodium is compatible with 1 g of azlocillin (in 15 mL of solution) or 5 g of azlocillin (in 50 mL of solution). Cefuroxime sodium (5 mg/mL) can be used in a 5% or 10% xylitol solution for injection. Cefuroxime sodium is compatible with aqueous solutions containing no more than 1% lidocaine hydrochloride (only for intramuscular injections). Lidocaine should never be administered intravenously. Cefuroxime sodium is compatible with the following infusion solutions:

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

The stability of cefuroxime sodium in 9 mg/mL (0.9%) sodium chloride solution and in 50 mg/mL (5%) glucose solution is not affected by the presence of sodium phosphate salts. Cefuroxime sodium is also compatible when mixed in an intravenous infusion with:

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

After adding a certain volume of solvent for intramuscular injection, a suspension is formed. The color of the suspension is almost white to yellowish-white. After adding a certain volume of solvent for intravenous injection or infusion, a clear yellowish solution is formed. The intensity of the color of the solution after reconstitution/dilution may vary depending on the storage time and concentration, but this does not affect the effectiveness of the medicinal product. The solution should be inspected before use. Only clear, yellowish solutions that do not contain solid particles should be used. Disposal Any unused medicinal product or waste material should be disposed of in accordance with local requirements.