Cefuroxime K24 Pharmaceuticals
Italy
Table of Contents
PACKAGE LEAFLET: Information for the patient
CEFUROXIMA K24 Pharmaceuticals 750 mg powder for injection solution, 1.5 g powder for infusion solution
Cefuroxime
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or nurse.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse.
Contents of this leaflet:
- What CEFUROXIMA K24 Pharmaceuticals is and what it is used for
- What you need to know before being administered CEFUROXIMA K24 Pharmaceuticals
- How CEFUROXIMA K24 Pharmaceuticals is administered
- Possible side effects
- How to store CEFUROXIMA K24 Pharmaceuticals
- Contents of the pack and other information
1. What CEFUROXIMA K24 Pharmaceuticals is and what it is used for
CEFUROXIMA K24 Pharmaceuticals is an antibiotic used in adults and children. It works by killing the
bacteria that cause infections and belongs to a group of medicines called cephalosporins.
CEFUROXIMA K24 Pharmaceuticals is used to treat infections of the:
- lungs and chest
- urinary tract
- skin and soft tissues
- abdomen
CEFUROXIMA K24 Pharmaceuticals is also used:
- to prevent infections during surgery
2. What you need to know before being given CEFUROXIMA K24 Pharmaceuticals
Do not take CEFUROXIMA K24 Pharmaceuticals if:
- you are allergic ( hypersensitive ) to any antibiotic of the cephalosporin class or to any of the other ingredients of CEFUROXIMA K24 Pharmaceuticals
- you have had a severe allergic reaction ( hypersensitivity ) to any other type of beta-lactam antibiotics (penicillins, monobactams, and carbapenems).
Talk to your doctor before starting treatment with CEFUROXIMA K24 Pharmaceuticals if you think this applies to you, because in such case CEFUROXIMA K24 Pharmaceuticals must not be administered to you.
Take special care with CEFUROXIMA K24 Pharmaceuticals
Be alert for certain symptoms such as allergic reactions and gastrointestinal disturbances like diarrhoea while being treated with CEFUROXIMA K24 Pharmaceuticals. This will reduce the risk of potential problems. See ( Conditions requiring caution ) in section 4. If you have previously had any allergic reaction to other antibiotics such as penicillin, you may also be allergic to CEFUROXIMA K24 Pharmaceuticals.
If blood or urine tests are needed
CEFUROXIMA K24 Pharmaceuticals may interfere with the results of blood or urine tests for sugar and with the blood test known as the Coombs test. If you are undergoing these tests:
- Inform the person collecting the sample that you are being treated with CEFUROXIMA K24 Pharmaceuticals.
Other medicines and CEFUROXIMA K24 Pharmaceuticals
Tell your doctor if you are taking any other medicines, if you have recently started taking any, or if you start taking new ones. This includes also medicines without a prescription.
Some medicines may affect the activity of CEFUROXIMA K24 Pharmaceuticals or make side effects more likely. These include:
- aminoglycoside-type antibiotics
- diuretic drugs such as furosemide
- probenecid
- oral anticoagulants
Inform your doctor if this applies to you. You may need additional monitoring to check kidney function while being treated with CEFUROXIMA K24 Pharmaceuticals.
Oral contraceptives
CEFUROXIMA K24 Pharmaceuticals may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while being treated with CEFUROXIMA K24 Pharmaceuticals, you should also use a barrier method of contraception (such as condoms). Please consult your doctor for advice.
Pregnancy, breastfeeding and fertility
Inform your doctor before being given CEFUROXIMA K24 Pharmaceuticals:
- if you are pregnant, think you might be pregnant, or are planning a pregnancy
- if you are breastfeeding
Your doctor will assess the benefit of treatment with CEFUROXIMA K24 Pharmaceuticals against the risk to your baby.
Driving and using machines
Do not drive or operate machinery if you do not feel well.
Important information about some of the excipients in CEFUROXIMA K24 Pharmaceuticals
CEFUROXIMA K24 Pharmaceuticals contains sodium. You should take into account the following if you are on a sodium-controlled diet.
| Dosage of CEFUROXIMA K24 Pharmaceuticals | Amount per vial |
| 750 mg | 42 mg |
| 1.5 g | 83 mg |
3. How CEFUROXIMA K24 Pharmaceuticals is administered
CEFUROXIMA K24 Pharmaceuticals is generally administered by a doctor or nurse. It
may be given as an intravenous infusion or as an injection directly into a vein or into a muscle.
Usual dose
The appropriate dose of CEFUROXIMA K24 Pharmaceuticals will be decided by your doctor and depends on: the severity and
type of infection; whether you are being treated with other antibiotics; your body weight and age; the condition of your kidneys.
Newborns (from 0 to 3 weeks)
For each kg of the baby's body weight, 30 to 100 mg of CEFUROXIMA K24
Pharmaceuticals per day will be administered, divided into two or three doses.
Infants (over 3 weeks old) and children
For each kg of the infant's or child's body weight, 30 to 100 mg of
CEFUROXIMA K24 Pharmaceuticals per day will be administered, divided into three or four doses.
Adults and adolescents
750 mg to 1.5 g of CEFUROXIMA K24 Pharmaceuticals two, three or four times a day.
Maximum dose: 6 g per day.
Patients with kidney problems
If you have kidney problems, your doctor may adjust the dose.
- Talk to your doctor if this applies to you. -
4. Possible side effects
Like all medicines, CEFUROXIMA K24 Pharmaceuticals can cause side effects, although not everybody gets them.
Conditions requiring attention
A small number of people being treated with CEFUROXIMA K24 Pharmaceuticals may experience an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:
- Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty in breathing.
- Skin rash with blister-like formations resembling small targets (a dark spot in the center surrounded by a pale area with a dark ring around the edge).
- Widespread rash with blisters and skin peeling. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis.)
- Fungal infections. Rarely, medicines such as CEFUROXIMA K24 Pharmaceuticals can cause an overgrowth of fungi (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely if you take CEFUROXIMA K24 Pharmaceuticals for a long time.
- Contact your doctor or nurse immediately if you experience any of these symptoms.
Common side effects
These may affect up to 1 in 10 patients:
- Pain at the injection site, swelling and redness along the vein.
Tell your doctor if any of these conditions concern you.
Common side effects that may be detected by blood tests:
- Increased levels of substances (enzymes) produced by the liver
- Changes in white blood cell count (neutropenia or eosinophilia)
- Low levels of red blood cells (anemia)
Uncommon side effects
These may affect up to 1 in 100 patients:
- Skin rash, itching, irregular rash (urticaria)
- Diarrhea, nausea, stomach pain
Tell your doctor if you experience any of these conditions.
Uncommon side effects that may be detected by blood tests:
- Low levels of white blood cells (leucopenia)
- Increased bilirubin (a substance produced by the liver)
- Positive Coombs test
Other side effects
Other side effects have occurred in a very small number of people, but their exact frequency is unknown:
- Fungal infections
- High temperature (fever)
- Allergic reactions
- Inflammation of the colon (large intestine) causing diarrhea, usually with blood and mucus, and stomach pain
- Inflammation in the kidneys and blood vessels
- Too rapid destruction of red blood cells (haemolytic anaemia)
- Skin rash with blister-like formations resembling small targets (a dark spot in the center surrounded by a pale area with a dark ring around the edge) – erythema multiforme
Tell your doctor if you experience any of these conditions.
Side effects that may be detected by blood tests:
- Decrease in platelet count (cells that help blood clot – thrombocytopenia)
- Increased blood levels of blood urea nitrogen and creatinine
If you get side effects
- Tell your doctor or pharmacist. This includes any side effect not listed in this leaflet.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store CEFUROXIMA K24 Pharmaceuticals
Before reconstitution, the product must be stored protected from light at a temperature below 25 °C.
The product must be used immediately after reconstitution.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month. The expiry date refers to the product in its original, unopened packaging and correctly stored.
Do not dispose of any medicine via wastewater or household waste. Unused medicines will be disposed of by your doctor or nurse. This will help protect the environment.
6. Package contents and other information
What CEFUROXIMA K24 Pharmaceuticals contains
CEFUROXIMA K24 Pharmaceuticals 750 mg powder for injectable solution
One vial contains:
Cefuroxime sodium 789 mg
equivalent to Cefuroxime 750 mg
CEFUROXIMA K24 Pharmaceuticals 1.5 g powder for infusion solution
One vial contains:
Cefuroxime sodium 1.578 g
equivalent to Cefuroxime 1.5 g
Description of the appearance of CEFUROXIMA K24 Pharmaceuticals and contents of the pack
CEFUROXIMA K24 Pharmaceuticals is supplied in colorless glass vials (Type III) with a butyl rubber stopper and aluminum cap.
CEFUROXIMA K24 Pharmaceuticals 750 mg powder for injectable solution: 50 or 100 vials of powder
CEFUROXIMA K24 Pharmaceuticals 1.5 g powder for infusion solution: 1, 50 or 100 vials of powder
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
K24 Pharmaceuticals S.r.l. - Via Generale Orsini 46 - 80132 Naples
Manufacturer:
Biopharma S.r.l. – Via delle Gerbere, 22/30 – 00134 – Santa Palomba (Rome)
The following information is intended exclusively for physicians or healthcare professionals:
Reconstitution instructions
Volumes to be added and concentrations of the solution that may be useful when fractional doses are required.
| Addition of volumes and concentrations of the solution that may be useful if fractional doses are required | |||
| Type of vial | Amount of water to add (ml) | Approximate concentration of cefuroxime (mg/ml)** | |
| 750 mg powder for injectable solution | |||
| 750 mg | intramuscular intravenous bolus | 3 ml at least 6 ml | 216 116 |
| 1.5 g powder for infusion solution | |||
| 1.5 g | intravenous infusion | 15 ml* | 94 |
*Reconstituted solution to be added to 50 or 100 ml of compatible infusion fluid (see compatibility information
below).
**The resulting volume of the cefuroxime solution in the reconstitution medium is increased due to the displacement
volume of the active substance, resulting in the concentrations listed in mg/ml.*
Compatibility
1.5 g of cefuroxime sodium reconstituted with 15 ml of water for injections can be added to an injectable solution of metronidazole (500 mg/100 ml), and both retain their activity for up to 24 hours below 25°C.
1.5 g of cefuroxime sodium is compatible with azlocillin 1 g (in 15 ml) or 5 g (in 50 ml) for up to 24 hours at 4°C or for 6 hours below 25°C.
Cefuroxime sodium (5 mg/ml) in an injectable solution of 5% w/v or 10% w/v xylitol can be stored for up to 24 hours at 25°C.
Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.
Cefuroxime sodium is compatible with the following infusion fluids. It retains activity for up to 24 hours at room temperature in:
Sodium chloride 0.9% w/v for injections BP
Dextrose 5% for injections BP
Sodium chloride 0.18% w/v plus Dextrose 4% for injections BP
Dextrose 5% and Sodium chloride 0.9% for injections
Dextrose 5% and Sodium chloride 0.45% for injections
Dextrose 5% and Sodium chloride 0.225% for injections
Dextrose 10% for injections
Invert sugar 10% in water for injections
Ringer's solution for injections USP
Ringer's lactate solution for injections USP
Sodium lactate M/6 for injections
Compound sodium lactate for injections BP (Hartmann's solution)
The stability of cefuroxime sodium in 0.9% w/v sodium chloride solution for injections BP and in 5% dextrose solution for injections is not affected by the presence of sodium hydrocortisone phosphate.
Cefuroxime sodium has also been found to be compatible for 24 hours at room temperature when co-administered by intravenous infusion with:
Heparin (10 and 50 units/ml) in 0.9% sodium chloride injection; Potassium chloride (10 and 40 mEq/L) in 0.9% sodium chloride injection.