Cefuroxim-mip 1500 mg

Leaflet attached to the packaging: patient information

Cefuroxim-MIP 750 mg, powder for solution for injection and infusion

Cefuroxim-MIP 1500 mg, powder for solution for injection and infusion

Cefuroxime

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

Keep this leaflet, so you can read it again if you need to. If you have any doubts, consult your doctor or pharmacist. This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Cefuroxim-MIP and what is it 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 the lungs or chest
of the urinary system
of the skin and soft tissues
of the abdomen
Cefuroxim-MIP is also used:
to prevent infections during surgery. Your doctor may order a test to determine the type of bacteria that caused the infection in the patient and to check if the bacteria are sensitive to cefuroxime during treatment.

2. Important information before taking Cefuroxim-MIP

When not to take Cefuroxim-MIP:

x
If the patient has been found to be allergic(hypersensitive) to cephalosporin antibioticsor
any of the other ingredients of Cefuroxim-MIP (listed in section 6);
x
If the patient has ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams, or carbapenems).
x
If the patient has ever had a severe skin rash or skin peeling and blisters and (or)
mouth ulcers after treatment with cefuroxime or other cephalosporin antibiotics.
If the patient thinks that any of the above applies to them, they should tell their doctorbeforestarting to take Cefuroxim-MIP. The patient must not take Cefuroxim-MIP.

Warnings and precautions

During treatment with Cefuroxim-MIP, pay attention to whether the following symptoms occur: allergic reactions, skin rashes, and gastrointestinal disorders (e.g., diarrhea) or fungal infections. 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 Cefuroxim-MIP.
Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with cefuroxime treatment. If the patient notices any of the symptoms associated with severe skin reactions described in section 4, they should seek medical attention immediately.

Blood and urine tests

Cefuroxim-MIP may affect the results of tests that detect sugar in urine or blood and a blood test called the Coombs test. If the patient is to have such tests, they should:
tell the person taking the sample that they are taking Cefuroxim-MIP.

Cefuroxim-MIP and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines that are available without a prescription. Some medicines may affect the action of Cefuroxim-MIP or increase the risk of side effects. These include:
x
aminoglycoside antibiotics
x
diuretic tablets(e.g., furosemide)
x
probenecid
x
oral anticoagulants(blood thinners)
If this applies to the patient, they should tell their doctor. During treatment with Cefuroxim-MIP, it may be necessary to perform additional kidney function tests on the patient.

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 taking this medicine. The doctor will assess whether the benefits of taking Cefuroxim-MIP during pregnancy and breastfeeding outweigh the risks to the child.

Driving and using machines

The patient should not drive or operate machinery if they do not feel well.

Cefuroxim-MIP contains sodium

Cefuroxim-MIP 750 mg:
The medicine contains 42 mg of sodium (the main ingredient of common salt) per 750 mg dose. This corresponds to 2.1% of the maximum recommended daily intake of sodium in the diet for adults.
Cefuroxim-MIP 1500 mg:
The medicine contains 83 mg of sodium (the main ingredient of common salt) per 1500 mg dose. This corresponds to 4.2% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Cefuroxim-MIP

Cefuroxim-MIP is usually administered by a doctor or nurse.It can be given as an infusion(intravenous infusion) or as an injectionadministered directly into a vein or into a muscle. Intramuscular injections should be performed deeply into relatively large muscles. Do not inject more than 750 mg into one site. Doses greater than 1500 mg should be administered intravenously.

Usual dose

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

Newborns and infants (0-3 weeks old)

For every kilogram of the infant's body weight, a dose of 30 to 100 mg of Cefuroxim-MIP is administered per day, divided into two or three doses.

Infants (over 3 weeks old) and children

For every kilogram of the infant's or child's body weight, a dose of 30 to 100 mg of Cefuroxim-MIP is administered per day, divided into three or four doses.

Adults and adolescents

From 750 mg to 1.5 g of Cefuroxim-MIP, two, three, or four times a day. No more than 6 g per day.

Patients with kidney disease

If the patient has kidney disease, the doctor may change the dosage of Cefuroxim-MIP.
If this applies to the patient, they should tell their doctor.

4. Possible side effects

Like all medicines, Cefuroxim-MIP can cause side effects, although not everybody gets them.

Symptoms to watch out for

In a small number of people taking Cefuroxim-MIP, an allergic reaction or potentially severe skin reaction has been reported. Their symptoms may be as follows.
x
Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or mouth, which can make breathing difficult.
x
Skin rash, which can develop into blistersand look like small rings(a dark spot in the center surrounded by a lighter border with a dark ring around the edge).
x
Widespread skin changeswith blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis, also known as Lyell's disease).
x
Widespread rash, high fever, swollen lymph nodes(DRESS syndrome or hypersensitivity syndrome).
x
Chest painassociated with an allergic reaction, which can be a sign of an allergic myocardial infarction (Kounis syndrome).

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

Other symptoms to watch out for while taking Cefuroxim-MIP

x
Fungal infections. Medicines like Cefuroxim-MIP 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 Cefuroxim-MIP is used for a long time.
x
Severe diarrhea (pseudomembranous colitis). Medicines like this one 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 these symptoms, they should contact their doctor or nurse immediately.

Common(may affect up to 1 in 10 people):
x
pain at the injection site, swelling, and redness along the vein.
If the patient experiences any of these side effects, they should tell their doctor.
Common side effects that may be seen in blood test results:
x
increased activity of substances (enzymes) produced in the liver
x
change in the number of white blood cells (neutropenia or eosinophilia)
x
decrease in the number of red blood cells (anemia)
Uncommon(may affect up to 1 in 100 people):
x
skin rash, hives
x
diarrhea, nausea, abdominal pain
If the patient experiences any of these side effects, they should tell their doctor.
Uncommon side effects that may be seen in blood test results:
x
decrease in the number of white blood cells (leukopenia)
x
increase in bilirubin levels (a substance produced by the liver)
x
positive Coombs test result
Frequency not known(frequency cannot be estimated from the available data):
x
fungal infection
x
high fever
x
allergic reactions (hypersensitivity)
x
inflammation of the colon (large intestine), leading to diarrhea, usually with blood and mucus, abdominal pain
x
inflammation of the kidneys and blood vessels
x
rapid breakdown of red blood cells (hemolytic anemia)
x
skin rash, which can develop into blisters and look like small rings (a dark spot in the center surrounded by a lighter border with a dark ring around the edge).
If the patient experiences any of these side effects, they should tell their doctor.
Side effects that may be seen in blood test results:
x
decrease in the number of platelets (cells involved in blood clotting - thrombocytopenia)
x
increase in urea and creatinine levels in the blood.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor or pharmacist. 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
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Cefuroxim-MIP

The medicine should be stored out of sight and reach of children.
Store at a temperature not exceeding 25°C. Protect from light.
The prepared solution can 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 given month.
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 Cefuroxim-MIP contains

• The active substance of the medicine is cefuroxime. Cefuroxim-MIP 750 mg: 1 vial contains 750 mg of cefuroxime in the form of cefuroxime sodium (789 mg). Cefuroxim-MIP 1500 mg: 1 vial or 1 bottle contains 1500 mg of cefuroxime in the form of 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 colorless glass with a capacity of 15 mL, sealed with a rubber stopper and an aluminum cap, in a cardboard box, packaged in packs of 10.
Cefuroxim-MIP 1500 mg: vials made of colorless glass with a capacity of 50 mL and bottles with a capacity of 100 mL, sealed with a rubber stopper and an aluminum cap, in a cardboard box, packaged in packs of 10.

Marketing authorization holder

MIP Pharma Polska Sp. z o.o.
ul. Orzechowa 5
80-175 Gdańsk
phone: 58 303 93 62
fax: 58 322 16 13
email: info@mip-pharma.pl

Manufacturer

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

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Instructions for dissolution

Volumes of water to be added and concentrations of the solution useful when partial doses are to be used.

* The prepared solution should be added to 50 or 100 mL of compatible infusion fluid (compatibility information - see below)
** The resulting volume of the cefuroxime solution in the solvent increases due to the phase shift coefficient of the active substance, resulting in the presented concentrations (mg/mL).
Compatibility
1.5 g of cefuroxime sodium dissolved in 15 mL of water for injection can be added to a solution of metronidazole (500 mg/100 mL) - the action of both components is maintained for 24 hours at a temperature below 25°C.
1.5 g of cefuroxime sodium is compatible with 1 g of azlocillin solution (in 15 mL of solution) or 5 g of azlocillin (in 50 mL of solution) for 24 hours at 4°C or 6 hours at a temperature below 25°C.
Cefuroxime sodium (5 mg/mL) in 5% or 10% xylitol solution for injection can be stored for 24 hours at 25°C.
Cefuroxime sodium is compatible with aqueous solutions containing no more than 1% lidocaine hydrochloride.
Cefuroxime sodium is compatible with the following infusion fluids. The activity is maintained for 24 hours at room temperature with:
0.9% sodium chloride solution (BP)
5% glucose solution for injection (BP)
0.18% sodium chloride solution with 4% glucose solution for injection (BP)
5% glucose solution and 0.9% sodium chloride solution for injection (BP)
5% glucose solution and 0.45% sodium chloride solution for injection
5% glucose solution 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-component sodium lactate solution for injection (Hartmann's solution, BP)
The stability of cefuroxime sodium in 0.9% sodium chloride solution for injection (BP) and 5% glucose solution for injection is not affected by the presence of sodium phosphate hydrocortisone.
Cefuroxime sodium also shows compatibility for 24 hours at room temperature if added to an intravenous infusion solution containing: heparin (10 or 50 units/mL) in 0.9% sodium chloride solution for injection; potassium chloride (10 or 40 mEq/L) in 0.9% sodium chloride solution for injection.
Any unused product or waste material should be disposed of in accordance with local regulations.