Cefotaxime Hameln

Package leaflet: Information for the patient

Cefotaxima hameln 1 g powder for injectable/infusion solution, 2 g powder for injectable/infusion solution

cefotaxime
Please read this leaflet carefully before using this medicine 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.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

1. What Cefotaxima hameln is and what it is used for
2. What you need to know before receiving Cefotaxima hameln
3. How Cefotaxima hameln is administered
4. Possible side effects
5. How to store Cefotaxima hameln
6. Contents of the pack and other information

1. What Cefotaxima hameln is and what it is used for

Cefotaxima hameln is an antibiotic, i.e. a medicine used to treat bacterial infections affecting:
the lungs (pneumonia);
the skin and soft tissues;
the urinary tract;
the genital organs (including gonorrhoea);
the heart valves (endocarditis);
the membranes covering the brain (meningitis);
the abdomen;
the blood (bacteraemia).
Cefotaxima is also used to treat Lyme disease (borreliosis, an infection mainly caused by tick bites, e.g. relapsing fever).
Cefotaxima may also be used before and during surgery to prevent possible infections.

2. What you need to know before receiving Cefotaxime hameln

Do not receive Cefotaxime hameln:

• if you are allergic (hypersensitive) to cefotaxime, to other cephalosporins (antibiotics), or to any of the other ingredients of this medicine (listed in section 6);
• if you previously had a severe allergic reaction (hypersensitivity reaction) to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems);
• if you previously developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking cefotaxime or other cephalosporins.

If any of the conditions listed above apply to you, do not take this medicine. If you have
any doubts, consult your doctor or nurse before receiving Cefotaxime hameln.
Warnings and precautions
Talk to your doctor or nurse before using Cefotaxime hameln:

• if you experience allergic reactions. If you have had allergic reactions to other antibiotics such as penicillin, you may also be allergic to Cefotaxime hameln. If an allergic reaction occurs, treatment must be stopped;
• if you develop severe and persistent diarrhoea during or after treatment with Cefotaxime hameln. In this case, contact your doctor immediately. Do not take any medicine for diarrhoea without first consulting your doctor;
• if you develop a widespread skin rash with blisters and skin peeling. These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized exanthematous pustulosis (GEP), have been reported during treatment with cefotaxime. Stop using cefotaxime and contact your doctor immediately if you notice any of the symptoms related to these potentially life-threatening skin reactions described in section 4:
• if you have kidney problems;
• if you experience, for example, altered consciousness, abnormal movements, or cramps after receiving this medicine;
• if you are on a low-salt diet. In this case, you must take into account the sodium content of this medicine.

Sometimes, Cefotaxime hameln is mixed with lidocaine. In this case, talk to your doctor or
nurse if:

• you are allergic to lidocaine or to other local anaesthetics;
• the child is under 30 months of age;
• you have heart disease, an irregular heartbeat, or severe heart failure.

If any of these conditions apply to you, your doctor may decide to modify your
treatment or give you specific recommendations.
If you are receiving this medicine for a prolonged period, your doctor will pay special
attention and carry out blood tests to detect any possible changes. In this case, you should
also be regularly monitored for excessive growth of bacteria not sensitive to cefotaxime.
Other medicines and Cefotaxime hameln
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines. This includes all medicines without a prescription, including herbal medicines.
This is because Cefotaxime hameln may affect the action of other medicines, and other medicines
may affect the action of Cefotaxime hameln.
In particular, check with your doctor if you are taking any of the following medicines:

• aminoglycoside antibiotics, including gentamicin, streptomycin, neomycin, kanamycin, amikacin, or tobramycin;
• medicines to increase urine production (diuretics), such as furosemide or ethacrynic acid;
• probenecid, used for gout.

Tests
If you need to undergo any tests (blood, urine, or diagnostic tests) while being treated with this
medicine, make sure your doctor knows that you are taking Cefotaxime hameln.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, your doctor will prescribe cefotaxime only after carefully evaluating the benefits and risks.
Cefotaxime passes into breast milk in small amounts. For this reason, it should not be used
during breastfeeding.
Driving and using machines
You may start to experience abnormal movements, sudden involuntary muscle contractions, or dizziness, or you may feel less alert. If this happens, do not drive or operate tools or machinery.
Cefotaxime hameln contains sodium
1 g vial: this medicine contains 48 mg of sodium (the main component of table salt) per vial. This corresponds to 2.4% of the maximum daily recommended intake of sodium in an adult's diet.
2 g vial: this medicine contains 96 mg of sodium (the main component of table salt) per vial. This corresponds to 4.8% of the maximum daily recommended intake of sodium in an adult's diet.

3. How Cefotaxima hameln is administered

Administration
Cefotaxima hameln is always administered by healthcare personnel. First, the medicine is dissolved in sterile water or another suitable solution. The solution may be given by injection or through a tube into a vein (infusion). For certain infections, it may also be injected into a muscle.

Dosage
Adults and adolescents over 12 years of age
The usual daily dose is 2 to 6 g of cefotaxime. The total daily dose should be divided into two single doses given every 12 hours. The dosage may be adjusted according to the severity of the infection and the patient's condition:

• Common infections with known (or suspected) susceptible bacteria: 1 g every 12 hours (i.e., a total daily dose of 2 g);
• Infections with known (or suspected) various susceptible or moderately susceptible bacteria: 1–2 g every 12 hours (i.e., a total daily dose of 2–4 g);
• Severe infections or infections difficult to localize: 2–3 g as a single dose every 6–8 hours (i.e., a total daily dose of up to 12 g).

Neonates (0–28 days), infants, and children under 12 years of age
Children: the usual dosage range is 100–150 mg/kg per day, given in 2–4 divided doses. However, in cases of very severe infections, doses up to 200 mg/kg per day may be required.
Neonates: the recommended dosage is 50 mg/kg per day, given in 2–4 divided doses. In case of severe infections, doses of 150–200 mg/kg per day have been administered in divided doses.

Elderly
If your liver and kidney function are normal, dosage adjustment is not necessary.

Patients with kidney and/or liver problems
If you have kidney and/or liver problems, you may be given a lower dose. You may need blood tests to ensure the dose you are receiving is appropriate. Your doctor will determine the correct dosage.

Special additional recommendations
Gonorrhoea
To treat gonorrhoea, you will receive a single intramuscular or intravenous injection of 0.5–1 g of Cefotaxima hameln.

Bacterial meningitis
Adults receive a daily dose of 6–12 g of cefotaxime, divided into equal doses every 6–8 hours.
Children receive 150–200 mg per kg of body weight, divided into equal doses every 6–8 hours.
Neonates: neonates aged 0–7 days receive 50 mg per kg of body weight every 12 hours; those aged 7–28 days receive the same dose every 8 hours.

Prevention of infections (perioperative prophylaxis)
Before undergoing surgery, you may receive 1–2 g of cefotaxime to prevent possible infections. If the surgery lasts longer than 90 minutes, an additional prophylactic dose may be administered.

Intra-abdominal infections
You will be given a combination of cefotaxime together with an antibiotic active against "anaerobic" bacteria.

Duration of treatment
The duration of treatment depends on both the severity of the infection and your recovery from the illness. Normally, you will continue to receive the medicine for at least 2–3 days after you begin to recover. In infections caused by the bacterium Streptococcus pyogenes, a minimum treatment duration of 10 days is required.

Method of administration
Cefotaxima hameln 1 g powder for injectable solution/infusion can be administered intramuscularly (by slow injection) or intravenously (by injection or slow infusion).
Cefotaxima hameln 2 g powder for injectable solution/infusion can be administered intravenously (by injection or slow infusion).

For further details on dosage and preparation of the medicine for administration, see the section “The following information is intended exclusively for doctors or healthcare professionals” at the end of this leaflet.

If you receive more Cefotaxima hameln than you should
If you think you have been given too much Cefotaxima hameln, inform your doctor or nurse immediately.

If you miss a dose of Cefotaxima hameln
Contact your doctor immediately. Do not administer a double dose to make up for a missed dose. A missed dose may only be administered if there is a sufficiently long interval before the next scheduled dose.

If you stop treatment with Cefotaxima hameln
Low dosing, irregular administration, or premature discontinuation of treatment may impair treatment efficacy or lead to relapse, which may be more difficult to treat. Follow your doctor's instructions.

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking cefotaxime and inform your doctor immediately if you notice any of the
following symptoms:

• Flat, reddish spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These life-threatening skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).

Contact your doctor immediately if you notice any of the following side effects:
Uncommon side effects (may affect up to 1 in 100 people)

• Increased tendency to bleed or bruise due to a decrease in the number of platelets in the blood (thrombocytopenia), fever, sore throat or mouth ulcers due to infections caused by low levels of white blood cells in the blood (leucopenia) or high levels of a particular type of white blood cells (eosinophilia).

Not known: frequency cannot be estimated from the available data

• Inflammation of the intestine, known as colitis (or antibiotic-associated colitis), causing severe and persistent diarrhoea, sometimes mixed with blood, accompanied by stomach cramps and fever;
• Life-threatening blood problems, including changes in the number of certain white blood cells (which may cause frequent infections, fever, severe chills, sore throat or mouth ulcers);
• Damage to red blood cells (causing fatigue, shortness of breath or pale appearance);
• Severe allergic reactions with symptoms such as swelling of the lips, tongue, face and neck, sudden difficulty breathing, speaking or swallowing;
• Headache, dizziness, seizures (epileptic fits) (these may be symptoms of a brain disorder called encephalopathy);
• Changes in heart rate (rhythm or frequency) after a very rapid intravenous injection;
• Yellowing of the skin and eyes, loss of appetite, pale-coloured urine, due to inflammation of the liver;
• Increased or decreased urine production or blood traces in the urine, sometimes with swelling in the limbs and/or flank pain, due to kidney problems;
• For intramuscular injection: combination with lidocaine may cause systemic reactions.

Other possible side effects:
Very common: may affect more than 1 in 10 people

• Intramuscular injection may be painful.

Uncommon: may affect up to 1 in 100 people

• Patients being treated for infections caused by bacteria called spirochetes often develop symptoms such as fever and chills, described as a "Herxheimer reaction", indicating the effectiveness of therapy;
• Changes in blood test results monitoring liver and kidney function;
• Fever;
• Allergic reactions such as skin rash (urticaria), skin itching;
• Painful swelling and inflammation at the site of intravenous injection;
• Soft stools or diarrhoea;
• Seizures.

Not known: frequency cannot be estimated from the available data

• Feeling unwell (nausea) and actual illness (vomiting);
• Stomach (abdominal) pain.

Your doctor may decide to perform tests during treatment to monitor for any changes.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system: https://aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cefotaxime hameln

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Keep the vials in their original packaging to protect the medicine from light.
The reconstituted solution remains chemically and physically stable:

• for 24 hours at a temperature between 2 °C and 8 °C;
• for 2 hours at a temperature below 25 °C. The reconstituted medicine does not need to be protected from light.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What Cefotaxima hameln Contains

• The active substance is cefotaxime. Each vial contains 1 or 2 g of cefotaxime as cefotaxime sodium.
• This medicinal product does not contain excipients.

Description of the Appearance of Cefotaxima hameln and Contents of the Package
The medicine is a powder ranging in colour from white to slightly yellow. The vials are made of glass, closed with a bromobutyl rubber stopper and sealed with an aluminium cap and aluminium seal, or with an aluminium cap with a removable plastic cover.
Each pack contains 10 vials.

Marketing Authorization Holder
hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany

Manufacturer
hameln rds s.r.o.
Horna 36
900 01 Modra
Slovakia

This medicinal product is authorized in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:
Austria: Cefotaxim hameln 1 g Powder for the preparation of an injection/infusion solution
Cefotaxim hameln 2 g Powder for the preparation of an injection/infusion solution
Czech Republic: Cefotaxime hameln
Denmark: Cefotaxim "hameln"
Finland: Cefotaxim hameln 1 g powder for injection/infusion solution
Cefotaxim hameln 2 g powder for injection/infusion solution
Germany: Cefotaxim hameln 1 g Powder for the preparation of an injection/infusion solution
Cefotaxim hameln 2 g Powder for the preparation of an injection/infusion solution
Italy: Cefotaxima hameln
Netherlands: Cefotaxim hameln 1 g powder for solution for injection/infusion
Cefotaxim hameln 2 g powder for solution for injection/infusion
Norway: Cefotaxim hameln
Slovak Republic: Cefotaxime hameln 1 g powder for injection/infusion solution
Cefotaxime hameln 2 g powder for injection/infusion solution
Sweden: Cefotaxim hameln Powder for injection/infusion solution, 1 g
Cefotaxim hameln Powder for injection/infusion solution, 2 g
Ireland: Cefotaxime hameln 1 g powder for solution for injection/infusion
Cefotaxime hameln 2 g powder for solution for injection/infusion

The following information is intended exclusively for physicians or healthcare professionals:

Method of Administration
Cefotaxima hameln 1 g powder for injectable solution/for infusion may be administered via intramuscular injection, intravenous injection, or slow intravenous infusion.
Cefotaxima hameln 2 g powder for injectable solution/for infusion may be administered via intravenous injection or slow intravenous infusion.

Reconstitution
After adding the solvent to the vial contents, the vial should be shaken until the powder is completely dissolved. The solution should become clear within 1–2 minutes.
After reconstitution, the solution may range from colourless to yellow.
The reconstituted medicinal solution must be visually inspected for clarity and absence of particulate matter before administration. The solution should only be used if it is free from particles or precipitate.
If the solution is cloudy or contains particulate matter, it is not suitable for use.
For single use only.
Solutions of cefotaxime with lidocaine must not be administered intravenously.

Preparation of Injectable and Infusion Solution and Method of Administration

Intravenous Injection (administered over 3–5 minutes)
For intravenous injection, 1 g of cefotaxime should be dissolved in 4 mL of water for injections, 9 mg/mL (0.9%) sodium chloride injection solution, or 50 mg/mL (5%) glucose injection solution; 2 g of cefotaxime should be dissolved in 10 mL of water for injections, 9 mg/mL (0.9%) sodium chloride injection solution, or 50 mg/mL (5%) glucose injection solution. The injection must be administered over a period of 3–5 minutes.

Intravenous Infusion (administered over 20–60 minutes)
To prepare cefotaxime solutions for intravenous infusion, the powder should first be dissolved in water for injections (as described for intravenous injections).
The resulting solution must then be further diluted with one of the following solutions:

• 9 mg/mL (0.9%) sodium chloride solution;
• 50 mg/mL (5%) glucose solution;
• 50 mg/mL (5%) glucose solution and 9 mg/mL (0.9%) sodium chloride solution in a 1:1 ratio;
• 50 mg/mL (5%) glucose solution and 9 mg/mL (0.9%) sodium chloride solution in a 2:1 ratio;
• Ringer's solution;
• sodium lactate compound for injections (Ringer's lactate for injections).

To avoid the risk of infection, reconstitution of the infusion solution must be carried out under strictly aseptic conditions. Do not delay the infusion after reconstituting the solution.
For short-term intravenous infusion: after reconstitution, the solution must be administered within 20 minutes.
For long-term intravenous infusion: after reconstitution, the solution must be administered within 50–60 minutes.
Intramuscular injection (recommended only for 1 g vials)
The contents of the 1 g vial must be dissolved in 4 mL of water for injections, sodium chloride 9 mg/mL (0.9%) solution, or lidocaine 10 mg/mL (1%) solution.

Intramuscular administration should only be used under exceptional clinical circumstances (e.g., gonorrhea), and the risk-benefit ratio must be carefully evaluated. A single unilateral injection of no more than 4 mL is recommended. If the daily dose exceeds 2 g of cefotaxime or if cefotaxime is administered more frequently than twice daily, the recommended route of administration is intravenous.

For intramuscular administration, 1 g of cefotaxime should be dissolved in 4 mL of water for injections. To prevent injection pain, a solution of 10 mg/mL (1%) lidocaine hydrochloride may alternatively be used (only for adults). The solution must be administered by deep intramuscular injection. Solutions containing lidocaine must not be administered intravenously. Reference must be made to the product information for the selected lidocaine-containing solution.

If reconstituted with lidocaine, cefotaxime must not be administered to children under 30 months of age.

In cases of severe infection, intramuscular injection is not recommended.

Incompatibilities
Aminoglycosides are incompatible with cephalosporins in parenteral mixtures.

This medicinal product must not be mixed with other medicinal products except those mentioned above.