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 medication, 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.

No use cefuroxima:

Consult with your doctor beforestarting treatment with cefuroxima; if you consider this may affect you, this medication 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 cefuroxima. 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 cefuroxima.

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

If you need blood or urine tests

Cefuroxima 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 cefuroxima.

Use of zanetin with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications purchased without a prescription.

Some medications may affect the way cefuroxima works, or make it more likely that you may have adverse effects. These include:

?Aminoglycoside antibiotics (for treatment of serious infections),

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

Consult with your doctorif you think this may affect you. You may need additional reviews to monitor renal function while taking cefuroxima.

Inform your doctorif you are taking the contraceptive pill while being treated with cefuroxima, as this medication 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 cefuroxima:

• 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 cefuroxima against the risk to your child.

Contraceptive pill

Cefuroxima 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 machinery

Do not drive or operate machinery if you are not feeling well.

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

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

Zanetin 1,500 mg powder for injectable or infusion EFG contains 81.48 mg of sodium per vial, equivalent to 4.075% of the maximum recommended daily sodium intake for an adult

Cefuroxima is usually administered by a doctor or nurse. It can be administered throughintravenous infusionor directly throughintravenous injectionor muscle injection.

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 function.

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.

Babies (over 3 weeks) and children

For each kilogram of the baby'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 cefuroxime 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 cefuroxime:

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,
• Elevated 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 (dark spot in the center surrounded by a lighter area, with a dark ring around the edge - 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 the Vigilance of Medicinal Products 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 drain 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, please 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 injectable solution or EFG infusion: :

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

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

Transparent type I glass vials of 15 ml capacity, 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 commercially available.

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.

The 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 injected well into the mass of a relatively large muscle and should not be injected more than 750 mg in one site. For doses above 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 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 storage times in use and the conditions prior to use are the responsibility of the user and should not normally be greater than 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 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 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, a change 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.