Prospecto: information for the user

Zanetin 750 mgpowder for injectable solution and forperfusion EFG

Zanetin 1.500 mgpowder for injectable solution and forperfusion EFG

Cefuroxima

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

Content of the prospect:

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

Cefuroxima is an antibiotic used in both adults and children. It works by eliminating the bacteria that cause infections. It belongs to the group of medications known ascephalosporins.

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.

Do not use cefuroxime:

Consult your doctor beforestarting treatment with cefuroxime; if you consider that this may affect you, this medicine should not be administered to you.

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 disturbances, 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 any 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 associated 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 blood or urine tests

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

Inform the person taking the samplethat you are receiving cefuroxime.

Use of zanetin with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medicine. This includes medicines bought without a prescription.

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

?Aminoglycoside antibiotics (for treatment of serious infections),

?Probenecid (for treatment of gout or gouty arthritis),

Consult your doctorif you think this may affect you. You may need additional reviews to monitor kidney function while taking cefuroxime.

Inform your doctorif 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

Inform your doctor before being treated with cefuroxime:

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

Your doctor will assess the benefit of being treated with cefuroxime against the risk to your child.

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 use additional barrier methods (such as, for example, condoms). Ask your doctor for advice.

Driving and operating machines

Do not drive or use machines if you are not feeling well.

Zanetin contains sodium:Patients with low-sodium diets should note that:

Zanetin 750 mg powder 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 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

Cefuroxima is usually administered by a doctor or nurse. It can be administered viaintravenous infusionor directly viainjectioninto a vein or muscle.

The normal doseYour doctor will decide on the optimal dose of Zanetin for you, based on: the severity and type of infection, if you are being treated with other antibiotics, your weight and age, and how well your kidneys are functioning.

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 each kilogram of the newborn's weight, 30 to 100 mg of cefuroxima per day will be administered, divided into two or three doses.

Infants (over 3 weeks) and children

For each kilogram of the infant's or child's weight, 30 to 100 mg of cefuroxima per day will be administered, 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 other questions about the use of this medication, consult your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects:

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

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

Other potentially severe symptoms to be aware of while taking cefuroxima:

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

Frequent side effects

May affectup to 1 in 10 people:

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

Contact your doctorif you experience any of these symptoms.

Frequent side effects that may appear in blood tests:

• Increased levels of certain substances (enzymes) produced by the liver,
• Changes in white blood cell count (neutropeniaoreosinophilia),
• Low red blood cell count (anemia).

Rare side effects

May affectup to 1 in 100 people:

• Skin rash, itching, hives (urticaria),
• Diarrhea, nausea, stomach pain.

Contact your doctorif you experience any of these symptoms.

Rare side effects that may appear in blood tests:

• Low white blood cell count (leucopenia),
• Increased bilirubin levels (a substance produced by the liver),
• Positive Coombs test.

Other side effects

Unknown frequency(cannot be estimated from available data)

• Fungal infections,
• High body 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 may cause blistering, which appear like small dots (erythema multiforme)

Contact your doctorif you experience any of these symptoms.

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

• Decreased platelet count in the blood (cells that help blood to clot –trombocytopenia)
• Increased levels of urea nitrogen and creatinine in the blood.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Store below 25°C, in the original packaging.

It is recommended to use the reconstituted solution immediately.

Medicines should not be thrown down the drains or in the trash. Consult your pharmaciston how to dispose of unused medications. These measures will help protect the environment.

Composition of Zanetin:

• The active ingredient is cefuroxime 1.500 mg or 750 mg (presented as cefuroxime sodium).
• There are no other components. However, see section 2 for more important information about one of the ingredients of cefuroxime sodium.

Appearance of zanetin and packaging contents

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

Zanetin 750 mg powder for injection or infusion EFG:

15 ml capacity glass vials, sealed with a butyl rubber stopper and an aluminum cap.

Zanetin 1.500 mg powder for injection or infusion EFG:

15 ml capacity glass vials, sealed with a butyl rubber stopper and an aluminum cap.

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

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Medochemie Iberia S.A

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

Lisboa 1500-662, Portugal

Responsible 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 by contacting the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Branch in Spain

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

28044 Madrid

SPAIN

SPAIN This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:May 2023.

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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INFORMATION FOR THE HEALTHCARE PROFESSIONAL

The following information is intended only for healthcare professionals.

Administration route

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 administered well within the mass of a relatively large muscle and should not be administered in more than one site. For doses greater than 1.500 mg, intravenous administration should be used.

To consult the instructions for reconstitution of the medicine 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:

It is recommended to use the reconstituted solution immediately.

Chemical and physical stability has been demonstrated:

• for 5 hours at 25 ° C and 48 hours at 2 - 8 ° C (in the refrigerator) for reconstituted solutions for intramuscular or intravenous injection;
• for 6 hours at 25 ° C and 24 hours at 2 - 8 ° C (in the 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 storage times in use and the conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Compatibility:

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

• Sodium chloride 0.18% w/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 mEq/L) in sodium chloride 0.9%;
• Dextrose (glucose);
• Sodium chloride;
• Ringer's solution;
• Ringer's lactate.

Cefuroxime sodium 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 white.

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