Valoran 2 g powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Valoran 1g powder for injectable solution and for infusion EFG

Valoran 2g powder for injectable solution and for infusion EFG

Cefotaxime (as cefotaxime sodium)

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

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

1. What Valoran is and what it is used for

Valoran, which contains cefotaxime (an antibiotic belonging to the group of medicines known as cephalosporins), is a medicine used to fight bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

It is used in the treatment of severe acute and chronic bacterial infections caused by pathogens sensitive to cefotaxime:

• respiratory tract infections,
• otorhinolaryngological infections,
• renal and urinary tract infections,
• skin and soft tissue infections,
• bone and joint infections,
• gynecological infections, including gonorrhea,
• abdominal infections (including peritonitis),
• meningitis,
• blood poisoning (sepsis),
• inflammation of the heart (endocarditis),
• Lyme disease (especially stages II and III) (infection mainly caused by tick bites)

Additionally, it is used for the prevention of infections following surgical procedures in patients at higher risk of infection.

2. What you need to know before using Valoran

Do not use Valoran:

• if you are allergic to cefotaxime, to other cephalosporins, or to any of the other components of this medicine (including those listed in section 6).
• if you have previously experienced an acute or severe hypersensitivity reaction to penicillin or to other beta-lactam antibiotics. Penicillin and cephalosporins may cause cross-reactions.
• if you have ever developed a severe skin rash or peeling skin, blisters and/or mouth sores after taking cefotaxime or other cephalosporins.

The use of cefotaxime mixed with lidocaine for intramuscular injection is not indicated in children under 30 months of age. The product leaflet containing lidocaine should be consulted for product preparation.

Note:

Valoran 2 g must not be administered by intramuscular route.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Valoran:

• If you are allergic to penicillin or to other beta-lactam antibiotics in any form (for contraindications due to known hypersensitivity reactions, see above in section "Do not use Valoran").
• If you have an allergic reaction (e.g., hay fever, bronchial asthma, hives) or if you have a history of such conditions. In this case, you have a higher risk of more severe (and in rare cases, fatal) hypersensitivity reactions. If you experience chest tightness, or feel dizzy, unwell, or weak, these may be signs of a hypersensitivity reaction (see section 4).
• If a hypersensitivity reaction occurs, treatment must be discontinued.
• If you notice changes in the skin or mucous membranes during treatment (see section 4). Inform your doctor immediately, as cefotaxime may cause serious skin reactions that require treatment.
• If you develop severe or persistent diarrhoea during treatment or for several weeks after stopping treatment. Inform your doctor immediately, as diarrhoea in its most severe form (called pseudomembranous colitis) could be life-threatening and requires treatment. Do not take any medicine that reduces intestinal activity.
• If you know you have renal impairment. Inform your doctor; the dose may need to be adjusted. Your kidney function should be monitored.
• If you are receiving concomitant or subsequent treatment with aminoglycosides (other antibiotics), probenecid (for gout), or other medicines that may cause kidney damage. Your kidney function should be monitored by a doctor, as these substances may increase the harmful effects on the kidneys and caution is required.
• If you experience movement disorders, seizures, confusion, or impaired consciousness. These may be signs of what is called encephalopathy. The risk of these adverse effects increases when high doses are administered, in case of overdose, or if you have renal impairment. If such reactions occur, consult your doctor immediately.
• If your treatment lasts longer than 7 to 10 days. In this case, blood tests should be performed to monitor for possible blood changes (see also section 4).
• If you show signs of a new infection (e.g., fungal infection of mucous membranes with redness and a whitish surface). Antibiotic use may increase the number of pathogens not sensitive to the medicine used. Watch for signs of a new infection and inform your doctor if necessary.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with cefotaxime treatment. Stop using cefotaxime and seek immediate medical advice if you notice any of the symptoms related to these severe skin reactions described in section 4.

Using Valoran with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Other antibiotics

Concomitant use of certain antibiotics may reduce the effect of cefotaxime. Inform your doctor if you are taking or have recently taken other antibiotics.

Diuretics and medicines possibly harmful to the kidneys

When cefotaxime is used together with medicines that may have a harmful effect on the kidneys, such as aminoglycosides (other antibiotics) or medicines with a high potential to cause dehydration (diuretics, such as furosemide), the kidney-damaging effect of these medicines may be increased. If administered concomitantly, kidney function should be monitored (see section 2 "Warnings and precautions").

Probenecid

Concomitant administration of probenecid leads to an increase in cefotaxime serum concentration and thus prolongs its effect, as probenecid reduces the renal elimination of cefotaxime. Inform your doctor if you are taking probenecid, especially if you have renal impairment, so that the dose may be adjusted if necessary.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There are insufficient data on the use of cefotaxime in pregnant women. Animal studies did not show signs of teratogenic properties of cefotaxime.

Nevertheless, cefotaxime should only be used during pregnancy, especially during the first trimester, after a strict assessment of the risks and benefits of treatment by a specialist.

Breastfeeding

Cefotaxime is excreted in breast milk only in small amounts. If you receive cefotaxime during breastfeeding, it may cause disturbances in intestinal flora, resulting in diarrhoea, fungal overgrowth, and may also lead to sensitization. Your doctor will decide whether to interrupt breastfeeding or discontinue cefotaxime treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and using machines

Based on previous experience, cefotaxime at low and medium doses has no effect on concentration or reaction ability.

If you experience adverse effects such as dizziness or encephalopathy, which may be associated with seizures, confusion, impaired consciousness, or movement disorders, you must not drive or operate machinery.

Valoran contains sodium

Valoran 1 g contains 48 mg (2.09 mmol) of sodium per dose, equivalent to 2.4% of the maximum daily recommended dietary intake of sodium for an adult.

Valoran 2 g contains 96 mg (4.18 mmol) of sodium per dose, equivalent to 4.8% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to use Valoran

Follow exactly the administration instructions for this medicine as indicated by your doctor. The dose, route of administration, and time intervals between injections depend on the required dose, pathogen sensitivity, severity of the infection, and the patient's condition.

Unless otherwise directed by the physician, the recommended dose is:

Adults and children over 12 years of age generally receive 1 to 2 g of cefotaxime every 12 hours. In severe cases, the daily dose may be increased up to 12 g of cefotaxime. Daily doses up to 6 g may be divided into at least two divided doses administered at 12-hour intervals. Higher daily doses should be divided into at least 3–4 divided doses with administration intervals of 6 or 8 hours.

The following table may be considered as a dosing guideline:

Type of infection	Single dose of cefotaxime	Dosing interval	Daily dose of cefotaxime
Typical infections in which a susceptible pathogenic microorganism is detected or suspected	1 g	12 hours	2 g
Infections in which the presence of various pathogenic microorganisms with moderate to high sensitivity is detected or suspected	2 g	12 hours	4 g
Undetermined bacterial diseases that cannot be localized, as well as in life-threatening situations for the patient	2-3 g	8 hours up to 6 hours up to 4 hours	6 g up to 8 g up to 12 g

For the treatment of gonorrhoea in adults, a single dose of 0.5 g of cefotaxime should be administered intramuscularly. In less sensitive pathogens, a higher dose may be required. Before starting treatment, check for the presence of syphilis.

For perioperative prophylaxis of infections, administration of 1–2 g of cefotaxime 30–60 minutes before surgery is recommended. Higher doses may be required for less sensitive pathogenic microorganisms. Before starting treatment, check for the presence of syphilis.

For Lyme disease, the daily dose is 6 g of cefotaxime (for 14 to 21 days). In most cases, the daily dose is divided into 3 divided doses (2 g of cefotaxime 3 times daily), but in some cases it has been administered as 2 divided doses (3 g of cefotaxime twice daily). Dosing recommendations are not based on comparative clinical trials but on observations from individual patients.

Combination therapy

In severe infections posing a life-threatening risk, combination therapy with cefotaxime and aminoglycosides is indicated, even without an antibiogram. When combined with aminoglycosides, renal function should be monitored.

In infections caused by Pseudomonas aeruginosa, combination therapy with other antibiotics effective against Pseudomonas may also be indicated.

For infection prophylaxis in patients with a weakened immune system, combination therapy with other appropriate antibiotics may also be indicated.

Infants and children up to 12 years of age receive 50 to 100 mg of cefotaxime (up to 150 mg) per kilogram of body weight daily, depending on the severity of the infection. The daily dose should be divided into 2 or more equal divided doses administered at intervals of 12 (to 6) hours. In individual cases, especially in life-threatening situations, the daily dose may be increased to 200 mg of cefotaxime per kilogram of body weight.

In premature infants, it must be considered that renal function is not yet fully developed, and the dose should not exceed 50 mg of cefotaxime per kilogram of body weight per day.

In patients with severe renal impairment (creatinine clearance less than 10 ml/min), after the initial normal dose (the first dose at the beginning of treatment), the maintenance dose may be reduced to half the normal dose, maintaining the dosing interval.

Patients undergoing hemodialysis receive 1 to 2 g of cefotaxime daily, depending on the severity of the infection. On the day of hemodialysis, cefotaxime should be administered after dialysis.

Patients undergoing peritoneal dialysis receive 1 to 2 g of cefotaxime daily, depending on the severity of the infection. Cefotaxime is not removed by peritoneal dialysis.

Valoran 1 g is administered intravenously (into a vein), but may also be administered intramuscularly.

Valoran 2 g is administered intravenously (into a vein).

Elderly patients

In elderly patients, renal function should be carefully monitored and, if necessary, the dose adjusted accordingly.

Intravenous injection

For i.v. injection, dissolve 1 g of cefotaxime in at least 4 ml of water for injections, then inject directly into the vein over a period of 3 to 5 minutes.

Intravenous infusion

For rapid intravenous infusion, dissolve 1 or 2 g of cefotaxime in 40 to 50 ml of water for injections or in a dissolved solution, then infuse i.v. over approximately 20 minutes.

For slow intravenous infusion, dissolve 2 g of cefotaxime in 100 ml of isotonic sodium chloride solution or a dissolved glucose solution, then infuse i.v. over a period of 50 to 60 minutes. Another compatible infusion solution may be used for the solution.

Intramuscular injection

For intramuscular injection, dissolve 1 g of cefotaxime in 4 ml of water for injections. The injection should then be administered deeply intragluteally. Pain during i.m. injection may be avoided by dissolving 1 g of cefotaxime in 4 ml of 1% lidocaine solution. Intravascular injection (injection into a blood vessel) must be avoided, as lidocaine administered intravascularly may cause restlessness, tachycardia, conduction disorders, as well as vomiting and seizures. The cefotaxime-lidocaine combination must not be administered to children under 30 months of age. The package leaflet for the lidocaine-containing product must be consulted.

It is recommended not to inject more than 4 ml at one site. If the daily dose exceeds 2 g of cefotaxime or if cefotaxime is injected more than twice daily, intravenous administration is recommended.

Valoran 2 g must not be administered intramuscularly.

Compatibility

Unless physicochemical compatibility with other infusion solutions has been demonstrated, cefotaxime solution should, in principle, be administered separately from them.

Cefotaxime is incompatible with:

• sodium bicarbonate solution,
• infusion solutions with a pH above 7,
• aminoglycosides.

In general, cefotaxime must not be mixed or administered with other antibiotics or medications in the same syringe. Cefotaxime must not be mixed with aminoglycoside antibiotics in the infusion set or in the syringe.

Compatibility with infusion solutions

Cefotaxime may also be dissolved in sodium lactate solution or Ringer's solution.

The duration of treatment depends on the course of the disease.

If you use more Valoran than you should

Beta-lactam antibiotics, including cefotaxime, may cause so-called encephalopathies, accompanied by central nervous system excitation, myoclonus, seizures, confusion, impaired consciousness, and movement disorders. This risk exists when higher doses are used, in cases of overdose, and in patients with impaired renal function or those suffering from epilepsy or meningitis.

If cefotaxime is injected too rapidly via a central venous catheter (CVC) (in less than 1 minute), it may cause a serious cardiac arrhythmia.

If you think you have received too much cefotaxime, speak immediately with your doctor or medical staff.

If you forget to use Valoran

Your doctor or nurse will have instructions on when to administer the medicine, so it is unlikely that the medication will not be administered according to instructions. If you think a dose has been missed, speak with your doctor or nurse.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking cefotaxime and immediately contact your doctor if you notice any of the following symptoms:

• Seizures (uncommon, may affect up to 1 in 100 people)
• Frequency not known (cannot be estimated from available data)
  • Severe acute hypersensitivity reactions and life-threatening allergic reactions, including swelling (angioedema) and narrowing of the airways (bronchospasm). If you experience chest tightness, or feel dizzy, sick, or weak, these could be signs of a hypersensitivity reaction.
  • Red, non-swollen skin lesions with target- or circular-shaped rashes on the trunk, often with blisters in the center, peeling skin, and ulcers in the mouth, throat, nose, genital organs, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Generalized skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
  • Generalized, red, scaly rash with small swellings under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
  • Persistent or bloody diarrhoea due to possible life-threatening intestinal inflammation.
  • Decrease in red blood cells (haemolytic anaemia), change in urine colour (to reddish-brown).
  • Acute kidney failure.

Inform your doctor or nurse if you experience any of the following adverse effects with a frequency not known (cannot be estimated from available data):

• Jaundice as a sign of possible hepatitis.
• Severe decrease in white blood cells (agranulocytosis), which may present as sudden signs of infection, as well as inflammation in the oral, nasal, pharyngeal, genital, and anal areas.
• Marked decrease in all blood cells and bone marrow failure. Acute signs of infection and inflammation (see above), bleeding, bruising (due to low platelets), fatigue, paleness, or difficulty breathing (due to low red blood cells) may also occur.

Inform your doctor or nurse if any of the following adverse effects worsen or last longer than a few days:

Very common (may affect more than 1 in 10 people)

• Pain at the injection site, also hardening after intramuscular administration.

Common (may affect up to 1 in 10 people)

• Joint problems (e.g., swelling).

Uncommon (may affect up to 1 in 100 people)

• Increase in eosinophils (eosinophilia).
• Decrease in platelet count (thrombocytopenia) and certain white blood cells (leukopenia, granulocytopenia).
• Jarisch-Herxheimer reaction (see explanation below).
• Diarrhoea.
• Loss of appetite.
• Increase in bilirubin (a bile pigment in the blood) and liver enzymes in serum (SGOT, SGPT, γ-GT, alkaline phosphatase, LDH).
• Allergic skin reactions such as rash, itching, hives.
• Impaired kidney function, e.g., increased serum creatinine and urea levels.
• Fever.
• Inflammatory reactions at the injection site and vein inflammation (phlebitis/thrombophlebitis).

Frequency not known (cannot be estimated from available data)

• Secondary infections caused by bacteria or fungi (e.g., in the mouth or vagina).
• Decrease in certain white blood cells (neutropenia).
• Tachycardia, cardiac arrhythmia (after rapid administration via a central venous access).
• Central nervous system excitation, altered consciousness, confusion, movement disorders, muscle spasms (encephalopathy symptoms, especially with high doses, overdose, or impaired renal function).
• Headache.
• Dizziness.
• Nausea, vomiting, abdominal pain.
• Kidney inflammation (interstitial nephritis).
• Intolerance reactions such as sensation of warmth or nausea during faster intravenous administration.

Jarisch-Herxheimer reaction:

When starting treatment for spirochetal infections (e.g., Lyme disease), you may experience fever, chills, headache, and joint pain. After several weeks of treatment for Lyme disease, one or more of the following symptoms have been reported: rash, itching, fever, decreased white blood cells, increased liver enzymes, difficulty breathing, and joint pain. These symptoms partially overlap with the underlying disease symptoms in treated patients.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valoran

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

Do not use this medicine after the expiry date stated on the label. The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect from light.

Reconstituted solution

Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C–8°C. However, from a microbiological standpoint, unless the method of opening/reconstitution prevents the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valoran

• The active substance is cefotaxime (as cefotaxime sodium).

Valoran 1 g contains 1 g of cefotaxime (as cefotaxime sodium).

Valoran 2 g contains 2 g of cefotaxime (as cefotaxime sodium).

• There are no other components.

Appearance of the product and contents of the container

The powder is white or slightly yellowish in clear glass vials, sealed with a bromobutyl rubber stopper and an aluminum seal or removable flip-off aluminum cap.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Medochemie Ltd.

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Manufacturer

Medochemie Limited (Factory C)

2 Michael Erakleous Street,

Agios Athanassios, Industrial Area,

4101 Agios Athanassios, Limassol,

Cyprus

Further information about this medicinal product is available from 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

Date of the most recent revision of this leaflet: April 2025

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