ZANETIN 1500 MG POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

Zanetin 750 mgpowder for solution for injection and infusion EFG

Zanetin 1.500 mgpowder for solution for injection and infusion EFG

Cefuroxime

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Zanetin and what is it used for
2. What you need to know before you use Zanetin
3. How to use Zanetin
4. Possible side effects
5. Storage of Zanetin
6. Contents of the pack and other information

1. What is Zanetin and what is it used for

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

Zanetin is used to treat infections of:

• the lungs or chest,
• the urinary tract,
• the skin and soft tissues,
• the abdomen.

Zanetin is also used to:

prevent infections during surgical procedures.

2. What you need to know before you use Zanetin

Do not use cefuroxime:

• if you are allergic to cefuroxime, cephalosporins, or any of the other ingredients of this medicine (including those listed in section 6),
• if you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems).
• if you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.

Consult your doctor beforestarting treatment with cefuroxime; if you think this may apply to you, you should not be given this medicine.

Warnings and Precautions

Consult your doctor, nurse, or pharmacist before starting to use Zanetin.

You should be aware of certain symptoms such as allergic reactions and gastrointestinal disorders, such as diarrhea, while receiving cefuroxime. This will reduce the risk of possible complications. See (“Symptoms to be aware of”) in section 4. If you have had an allergic reaction to other antibiotics, such as penicillin, you may also be allergic to cefuroxime.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with cefuroxime treatment. Seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you need a blood or urine test

Cefuroxime may affect the results of urine and blood tests for sugar (Coombs test). If you are having tests:

Tell the person taking the samplethat you are taking cefuroxime.

Using Zanetin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines bought without a prescription.

Some medicines may affect how cefuroxime works, or make it more likely that you will have side effects. These include:

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• “Water tablets” (diuretics), such as furosemide,

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• Oral anticoagulants (used to treat blood clots).

Consult your doctorif you think this may apply to you. You may need extra checks with your doctor to monitor your kidney function while taking cefuroxime.

Tell your doctor if you are taking the contraceptive pill while being treated with cefuroxime, as this medicine may reduce the effectiveness of the contraceptive pill (see “Contraceptive pill” in “Pregnancy, breastfeeding, and fertility”).

Pregnancy, breastfeeding, and fertility

Tell your doctor before being treated with cefuroxime:

• if you are pregnant, think you may be pregnant, or plan to become pregnant,
• if you are breastfeeding.

Your doctor will weigh the benefits of being treated with cefuroxime against the risks to your baby.

Contraceptive pill

Cefuroxime may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while being treated with Zanetin, you should also use a barrier method of contraception (such as condoms). Ask your doctor for advice.

Driving and using machines

Do not drive or use machines if you do not feel well.

Zanetin contains sodium:Patients on low-sodium diets should be aware that:

Zanetin 750 mg powder for solution for injection or infusion EFG contains 40.74 mg of sodium per vial, equivalent to 2.037% of the maximum recommended daily intake of sodium for an adult.

Zanetin 1.500 mg powder for solution for injection or infusion EFG contains 81.48 mg of sodium per vial, equivalent to 4.075% of the maximum recommended daily intake of sodium for an adult.

3. How to use Zanetin

Cefuroxime is usually given by a doctor or nurse. It can be given by drip(intravenous infusion) or by injectiondirectly into a vein or into a muscle.

The usual doseYour doctor will decide what dose of Zanetin is right for you, based on: the severity and type of infection, whether you are being treated with other antibiotics, your weight and age, and how well your kidneys are working.

Use in adults and adolescents

750 mg to 1,500 mg of Zanetin per day, divided into two, three, or four doses. The maximum dose is 6 g per day.

Use in children

Newborns (0-3 weeks)

For every kilogram of body weight, 30 to 100 mg of cefuroxime per day will be given, divided into two or three doses.

Babies (over 3 weeks) and children

For every kilogram of body weight, 30 to 100 mg of cefuroxime per day will be given, divided into three or four doses.

Use in patients with kidney problems

If you have a kidney problem, your doctor may change your dose.

Consult your doctorif you are affected by this problem.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

A small number of people who received cefuroxime had a severe allergic reaction or a potentially serious skin reaction. The symptoms of these reactions include:

• Severe allergic reaction. The signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing, skin rash, which can cause blisters, that look like small targets(dark spot in the center surrounded by a lighter area, with a dark ring around the edge),
• Widespread skin rashwith blisters and skin peeling. (These can be symptoms of Stevens-Johnson syndromeor toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Chest pain in the context of allergic reactions, which can be a symptom of an allergic myocardial infarction (Kounis syndrome).

Contact a doctor or nurse immediately if you experience any of these symptoms.

Other potentially serious symptoms to look out for while taking cefuroxime:

• Fungal infections(rarely, medicines like cefuroxime can cause an overgrowth of fungi (Candida) in the body, which can lead to fungal infections (such as thrush)). This side effect is more likely to occur if you have been treated with cefuroxime for a long time.
• Severe diarrhea(Pseudomembranous colitis).Medicines like cefuroxime can cause inflammation of the colon (large intestine), causing severe diarrhea, usually with blood and mucus, stomach pain, and fever.

Contact a doctor or nurse immediately if you experience any of these symptoms.

Common side effects

May affect up to 1 in 10 people:

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

Consult your doctorif you experience any of these symptoms.

Common side effects that may appear in blood tests:

• increase in some substances (enzymes) produced by the liver,
• changes in white blood cell count (neutropeniaor eosinophilia),
• low red blood cell count (anemia).

Uncommon side effects

May affect up to 1 in 100 people:

• skin rash, itching, urticaria (hives),
• diarrhea, nausea, stomach pain.

Consult your doctorif you experience any of these symptoms.

Uncommon side effects that may appear in blood tests:

• low white blood cell count (leukopenia),
• increase in bilirubin (a substance produced by the liver),
• positive Coombs test.

Other side effects

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

• fungal infections,
• high temperature (fever),
• allergic reactions,
• inflammation of the colon (large intestine), causing diarrhea, usually with blood and mucus, stomach pain,
• inflammation in the kidneys and blood vessels,
• rapid destruction of red blood cells (hemolytic anemia),
• skin rash, which can form blisters, that look like small targets (dark spot in the center surrounded by a lighter area, with a dark ring around the edge - erythema multiforme)

Consult your doctorif you experience any of these symptoms.

Side effects with unknown frequency that may appear in blood tests:

• Decrease in the number of platelets in the blood (cells that help the blood to clot – thrombocytopenia)
• Increase in blood urea and serum creatinine levels.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zanetin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Store below 25°C, in the original packaging.

It is recommended to use the reconstituted solution immediately.

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

6. Contents of the pack and other information

Composition of Zanetin:

• The active substance is cefuroxime 1,500 mg or 750 mg (presented as cefuroxime sodium).
• There are no other ingredients. However, see section 2 for more important information about one of the ingredients of cefuroxime sodium.

Appearance of Zanetin and contents of the pack

Cefuroxime is a white or off-white to yellowish powder.

Zanetin 750 mg powder for solution for injection or infusion EFG:

15 ml Type I glass vials, sealed with a bromobutyl rubber stopper and an aluminum cap.

Zanetin 1,500 mg powder for solution for injection or infusion EFG:

15 ml Type I glass vials, sealed with a bromobutyl rubber stopper and an aluminum cap.

The vials are supplied in boxes containing 1, 10, 50, or 100 vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medochemie Iberia S.A

Rua Jose Maria Nicolau, nº 6, 7ºB, São Domingos de Benfica

Lisbon 1500-662, Portugal

Manufacturer

Medochemie Limited (Factory C)

2 Michael Erakleous street, Agios Athanassios, Industrial Area,

4101 Agios Athanassios, Limassol,

Cyprus

You can request more information about this medicine from the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Spanish Branch

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

SPAIN This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:May 2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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INFORMATION FOR HEALTHCARE PROFESSIONALS

The following information is intended only for healthcare professionals.

Method of administration

Cefuroxime should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or through a drip or infusion over 30 to 60 minutes, or by deep intramuscular injection.

Intramuscular injections should be injected well into the mass of a relatively large muscle and no more than 750 mg should be injected at one site. For doses greater than 1,500 mg, intravenous administration should be used.

To consult the instructions for the reconstitution of the medication before administration, see below.

Instructions for reconstitution

Volumes of addition and concentrations of the solution, which may be useful when fractional doses are required.

• 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 by the displacement factor of the resulting drug in the listed concentrations in mg/ml.

Reconstituted solution:

Immediate use of the reconstituted solution is recommended.

Chemical and physical stability has been demonstrated:

• for 5 hours at 25 ° C and 48 hours at 2 - 8 ° C (in refrigerator) for reconstituted solutions for intramuscular or intravenous injection;
• for 6 hours at 25 ° C and 24 hours at 2 - 8 ° C (in refrigerator) for reconstituted solutions for intravenous infusion.

From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours at 2-8ºC, unless reconstitution has taken place in controlled and validated aseptic conditions.

Compatibility:

Sodium cefuroxime is compatible with the following infusion fluids. It will retain its potency for up to 6 hours at 25 ° C and 24 hours at 2 - 8 ° C (in refrigerator) in:

• Sodium chloride 0.18% p/v + Dextrose 4%;
• Sodium chloride 0.9% + Dextrose 5%;
• Sodium chloride 0.45% + Dextrose 5%;
• Sodium chloride 0.225% + Dextrose 5%;
• Sodium lactate 1/6 M injectable;
• Potassium chloride (10 and 40 mEqL) in sodium chloride 0.9%;
• Dextrose (glucose);
• Sodium chloride;
• Ringer's solution;
• Ringer's lactate.

Sodium cefuroxime is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.

The freshly prepared solution for IV administration is yellowish, while the suspension for IM administration is whitish.

During the storage of prepared solutions, an increase in color intensity may occur, but the change in color intensity of the diluted solution does not affect the safety of administration or the efficacy of the medication.