Cefuroxim-mip 750 mg

Package leaflet: Information for the patient

Cefuroxim-MIP 750 mg, powder for solution for injection and infusion
Cefuroxim-MIP 1500 mg, powder for solution for injection and infusion
Cefuroximum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm
another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Cefuroxim-MIP is and what it is used for
Cefuroxim-MIP 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.
Cefuroxim-MIP is used to treat infections of:
lungs or chest
urinary tract
skin and soft tissues
abdomen
Cefuroxim-MIP is also used:
• to prevent infections during surgery.
Your doctor may order a test to determine which type of bacteria caused your infection, and may check during treatment whether the bacteria are sensitive to cefuroxime.

2. Important information before using Cefuroxim-MIP

When not to use Cefuroxim-MIP:
• if you are allergic (hypersensitive) to cephalosporin antibiotics or
any of the other ingredients of Cefuroxim-MIP (listed in section 6);
• if you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams or carbapenems).
• if you have ever developed severe skin rash, skin peeling, blisters and (or) oral mucosal ulcers after treatment with cefuroxime or other cephalosporin antibiotics.
• If you think any of the above apply to you, you must tell your doctor before starting treatment with Cefuroxim-MIP. You must not take Cefuroxim-MIP.

Warnings and precautions
While being treated with Cefuroxim-MIP, watch for symptoms such as allergic reactions, skin rashes, and gastrointestinal disturbances (e.g. diarrhoea) or fungal infections.
This will reduce the risk of complications (see “Symptoms to be aware of” in section 4). If you have previously experienced allergic reactions to other antibiotics such as penicillin, you may also be allergic to Cefuroxim-MIP.
Severe skin reactions have been reported with cefuroxime treatment, such as: Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If you notice any of the symptoms related to severe skin reactions described in section 4, seek immediate medical advice.

Blood and urine tests
Cefuroxim-MIP may affect the results of tests for glucose (sugar) in urine or blood, as well as a blood test called the Coombs test. If you are due to have such tests, you should:
• tell the person taking the sample that you are taking Cefuroxim-MIP.

Cefuroxim-MIP with other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take, including medicines available without a prescription.
Some medicines may affect the action of Cefuroxim-MIP or may increase the risk of adverse effects. These include:
• antibiotics of the group called aminoglycosides
• diuretic tablets (water pills), e.g. furosemide
• probenecid
• oral anticoagulants (blood thinners)
• If any of these apply to you, tell your doctor. Additional monitoring of kidney function may be required during treatment with Cefuroxim-MIP.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before using this medicine.
Your doctor will assess whether the benefits of using Cefuroxim-MIP during pregnancy or breastfeeding outweigh any risks to the baby.

Driving and operating machinery
You should not drive or operate machinery if you do not feel well.

Cefuroxim-MIP contains sodium
Cefuroxim-MIP 750 mg:
This medicine contains 42 mg of sodium (a main component of table salt) in each 750 mg dose. This corresponds to 2.1% of the maximum recommended daily intake of sodium in the diet of adults.
Cefuroxim-MIP 1500 mg:
This medicine contains 83 mg of sodium (a main component of table salt) in each 1500 mg dose. This corresponds to 4.2% of the maximum recommended daily intake of sodium in the diet of adults.

3. How to use Cefuroxim-MIP

Cefuroxim-MIP is usually administered by a doctor or nurse. It may be given as an intravenous infusion (IV infusion) or as an injection given directly into a vein or into a muscle.
Intramuscular injections should be administered deeply into relatively large muscles. Do not inject more than 750 mg at a single site. Doses greater than 1500 mg should be given intravenously.
Typical dosage
The doctor will decide the appropriate dose of Cefuroxim-MIP for the patient, taking into account the severity and type of infection, whether the patient is taking any other antibiotics, body weight, age, and kidney function.
Newborns and infants (aged 0–3 weeks)
A dose of 30 to 100 mg of Cefuroxim-MIP per kilogram of body weight per day is given, divided into two or three doses.
Infants (over 3 weeks of age) and children
A dose of 30 to 100 mg of Cefuroxim-MIP per kilogram of body weight per day is given, divided into three or four doses.
Adults and adolescents
750 mg to 1.5 g of Cefuroxim-MIP two, three, or four times daily. No more than 6 g per day.
Patients with impaired kidney function
If the patient has kidney problems, the doctor may adjust the dosage of the medicine.
Î If this applies to the patient, he/she should inform the doctor.

4. Possible adverse reactions

Like all medicines, Cefuroxim-MIP may cause adverse reactions, although not everyone experiences them.

Symptoms to be aware of

A small number of people taking Cefuroxim-MIP have experienced an allergic reaction or potentially severe skin reaction. 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, which may develop into blisters and appear as target-like lesions (a dark spot in the centre surrounded by a paler ring and a dark circle around the edge).
• Widespread skin lesions, with blisters and peeling of the outer layer of skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis – Lyell's syndrome).
• 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 allergic heart attack (Kounis syndrome).

If any of these symptoms occur in the patient, contact a doctor or nurse immediately.

Other symptoms to be aware of during treatment

• Fungal infections. Medicines such as Cefuroxim-MIP may rarely cause overgrowth of yeasts (Candida) in the body, which may lead to fungal infection (e.g. thrush). The risk of this adverse reaction is higher if Cefuroxim-MIP is used for a prolonged period.
• Severe diarrhoea (pseudomembranous colitis). Medicines like this one may cause inflammation of the colon (large intestine), leading to severe diarrhoea, usually with blood and mucus, abdominal pain and fever.

If any of these symptoms occur in the patient, contact a doctor or nurse immediately.

Common (may occur in not more than 1 in 10 patients):

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

Æ If any of these adverse reactions occur in the patient, inform the doctor.

Common adverse reactions that may be revealed in blood tests:

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

Uncommon (may occur in not more than 1 in 100 patients):

• skin rash, urticaria
• diarrhoea, nausea, abdominal pain

Æ If any of these adverse reactions occur in the patient, inform the doctor.

Uncommon adverse reactions that may be revealed in blood tests:

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

Frequency not known (frequency cannot be estimated from the available data):

• fungal infection
• high temperature (fever)
• allergic reactions (hypersensitivity)
• inflammation of the colon (large intestine), causing diarrhoea, usually with blood and mucus, abdominal pain
• kidney inflammation and blood vessel inflammation
• excessive breakdown of red blood cells (haemolytic anaemia)
• skin rash, which may develop into blisters and appear as target-like lesions (a dark spot in the centre surrounded by a paler ring and a dark circle around the edge)

Î If any of these adverse reactions occur in the patient, inform the doctor.

Adverse reactions that may be revealed in blood tests:

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

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 Reactions to Medicinal Products at 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 may also be reported to the marketing authorization holder.

By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Cefuroxim-MIP

Keep the medicine out of sight and reach of children.
Store below 25°C. Protect from light.
The prepared solution may be stored for no longer than 5 hours at room temperature and no longer than 24 hours at 5°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Cefuroxim-MIP contains

• The active substance is cefuroxime. Cefuroxim-MIP 750 mg: One vial contains 750 mg of cefuroxime as cefuroxime sodium (789 mg). Cefuroxim-MIP 1500 mg: One vial or one bottle contains 1500 mg of cefuroxime as cefuroxime sodium (1578 mg).
• The medicine does not contain any other ingredients.

What Cefuroxim-MIP looks like and contents of the pack
Cefuroxim-MIP 750 mg: Vials made of colourless glass with a capacity of 15 mL, closed with a rubber stopper and aluminium cap, packed in a cardboard box, 10 units per pack.
Cefuroxim-MIP 1500 mg: Vials made of colourless glass with a capacity of 50 mL and bottles with a capacity of 100 mL, closed with a rubber stopper and aluminium cap, packed in a cardboard box, 10 units per pack.

Marketing Authorisation Holder
MIP Pharma Polska Sp. z o.o.
Orzechowa 5 Street
80-175 Gdańsk
Phone: 58 303 93 62
Fax: 58 322 16 13
E-mail: [email protected]

Manufacturer
Chephasaar, Chemisch-pharmazeutische Fabrik GmbH
Mühlstrasse 50
D-66386 St. Ingbert
Germany

Information intended exclusively for professional medical personnel:

Reconstitution instructions
Volumes of water added and solution concentrations useful when partial doses are required.

* The prepared solution should be added to 50 or 100 mL of a compatible infusion fluid (compatibility information – see below).
** The resulting volume of cefuroxime solution in the solvent increases due to the phase displacement factor of the active substance, resulting in the indicated concentrations (mg/mL).

Compatibility
1.5 g of sodium cefuroxime dissolved in 15 mL of water for injections can be added to a metronidazole solution (500 mg/100 mL) – the activity of both components remains stable for up to 24 hours at temperatures below 25°C.

1.5 g of sodium cefuroxime is compatible with 1 g of azlocillin solution (in 15 mL of solution) or 5 g of azlocillin (in 50 mL of solution) for up to 24 hours at 4°C or for 6 hours at temperatures below 25°C.

Sodium cefuroxime (5 mg/mL) in a 5% w/v or 10% w/v solution of xylitol for injection can be stored for up to 24 hours at 25°C.

Sodium cefuroxime is compatible with aqueous solutions containing no more than 1% lidocaine hydrochloride.

Sodium cefuroxime is compatible with the following infusion fluids. Stability is maintained for up to 24 hours at room temperature with:

• 0.9% w/v sodium chloride solution (BP)
• 5% glucose solution for injection (BP)
• 0.18% w/v sodium chloride with 4% glucose solution for injection (BP)
• 5% glucose and 0.9% sodium chloride solution for injection (BP)
• 5% glucose and 0.45% sodium chloride solution for injection
• 5% glucose and 0.225% sodium chloride solution for injection
• 10% glucose solution for injection
• 10% invert sugar solution in water for injection
• Ringer's solution for injection (USP)
• Lactated Ringer's solution for injection (USP)
• Sodium lactate solution for injection (M/6)
• Multi-electrolyte sodium lactate solution for injection (Hartmann's solution, BP)

The stability of sodium cefuroxime in 0.9% w/v sodium chloride solution for injection (BP) and in 5% glucose solution for injection is not affected in the presence of sodium phosphate hydrocortisone.

Sodium cefuroxime also shows compatibility for 24 hours at room temperature when added to intravenous infusion solutions containing: heparin (10 or 50 units/mL) in 0.9% w/v sodium chloride solution for injection; potassium chloride (10 or 40 mEq/L) in 0.9% sodium chloride solution for injection.

Any unused portions of the medicinal product or waste materials should be disposed of in accordance with local regulations.