Tarsime

Package leaflet: Information for the patient

TARSIME, 750 mg, powder for the preparation of a suspension for injection or solution for injection
TARSIME, 1500 mg, powder for the preparation of a solution for injection and infusion
Cefuroximum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet

1. What Tarsime is and what it is used for
2. Important information before using Tarsime
3. How to use Tarsime
4. Possible side effects
5. How to store Tarsime
6. Contents of the pack and other information

1. What Tarsime is and what it is used for

Tarsime is an antibiotic used in adults and children. The medicine works by killing bacteria
susceptible to cefuroxime that cause infections. It belongs to a group of medicines called
cephalosporins.
Tarsime is used to treat infections of:

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

Tarsime is also used:

• to prevent infections during surgery.

2. Important information before using Tarsime

When not to use Tarsime:

• if the patient has a known allergy (hypersensitivity) to cefuroxime, another cephalosporin antibiotic, or any of the other ingredients of Tarsime;
• if the patient has ever experienced a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams or carbapenems);
• if the patient has ever developed severe skin rash or peeling of the skin, blisters and/or mouth ulcers after treatment with cefuroxime or other antibiotics from the cephalosporin group.

If the patient thinks any of the above apply, they should inform the doctor before starting treatment with Tarsime. The patient must not take Tarsime.

Warnings and precautions

During treatment with Tarsime, be alert for symptoms such as allergic reactions and gastrointestinal disturbances (e.g. diarrhoea). This will help reduce the risk of complications (see "Symptoms to be aware of *" in section 4). If the patient has previously experienced any allergic reactions to other antibiotics such as penicillin, they may also be allergic to Tarsime.

Severe skin reactions have occurred during treatment with cefuroxime, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms associated with severe skin reactions described in section 4 are observed, medical advice must be sought immediately.

Blood and urine tests

Tarsime may affect the results of tests for glucose (sugar) in blood or urine, as well as a blood test known as the Coombs test. If the patient is due to have such tests, they should:

• inform the person collecting the samples that they are taking Tarsime.

Tarsime and other medicines

Tell the doctor about all medicines currently being taken, recently taken, or planned to be taken, including medicines available without a prescription.

Some medicines may affect the action of Tarsime or may increase the risk of adverse effects. These include:

• antibiotics known as aminoglycosides
• diuretic tablets (water tablets), e.g. furosemide
• probenecid
• oral anticoagulants (blood thinners). If this applies to the patient, they should inform their doctor. Additional monitoring of kidney function may be required during treatment with Tarsime.

Oral contraceptives

Tarsime may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives while being treated with Tarsime, additional mechanical methods of contraception (e.g. condoms) should be used. Consult the doctor for advice.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

The doctor will assess whether the benefits to the patient of using Tarsime during pregnancy or breastfeeding outweigh any potential risks to the child.

Driving and operating machinery

The patient should not drive or operate machinery if they do not feel well.

Tarsime 750 mg contains 38.6 mg of sodium (the main component of table salt) per vial.
This corresponds to 1.93% of the maximum recommended daily dietary intake of sodium for adults.
This should be taken into account in patients with impaired renal function and in patients controlling sodium intake in their diet.

Considering the dosing regimen described in section 3, the maximum amount of sodium that may be administered to a patient at the maximum daily dose is 308.8 mg, corresponding to 15.44% of the WHO recommended maximum daily sodium intake of 2 g for adults.

Tarsime 1500 mg contains 77.3 mg of sodium (the main component of table salt) per vial.
This corresponds to 3.86% of the maximum recommended daily dietary intake of sodium for adults.
This should be taken into account in patients with impaired renal function and in patients controlling sodium intake in their diet.

Considering the dosing regimen described in section 3, the maximum amount of sodium that may be administered to a patient at the maximum daily dose is 309.2 mg, corresponding to 15.46% of the WHO recommended maximum daily sodium intake of 2 g for adults.

3. How to use Tarsime

Tarsime is usually administered by a doctor or nurse. It may be given as an intravenous infusion (IV infusion) or as an injection administered directly into a vein or intramuscularly.
Recommended dose
The doctor will decide the appropriate dose of Tarsime for the patient, taking into account the severity and type of infection, any other antibiotics the patient is taking, body weight, age, and kidney function.
Newborns and infants (aged 0–3 weeks)
The daily dose is 30 to 100 mg of Tarsime per kilogram of body weight, divided into two or three doses.
Infants (aged over 3 weeks) and children weighing <40 kg
The daily dose is 30 to 100 mg of Tarsime per kilogram of body weight, divided into three or four doses.
Adults and children weighing >40 kg
750 mg to 1.5 g of Tarsime per day, divided into two, three, or four doses. No more than 6 g per day.
Patients with impaired kidney function
If this applies to the patient, the doctor may adjust the dosing regimen.

• The patient should inform the doctor if this applies.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Symptoms to be aware of
In a small number of people taking Tarsime, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:

• Allergic reaction: raised, itchy rash, drop in blood pressure, swelling of the upper airways, sometimes of the face or lips, which may make breathing difficult, including anaphylaxis, anaphylactic shock – rapidly progressing, life-threatening reactions accompanied by dizziness, disorientation and fainting due to insufficient blood flow to organs;
• Angioedema (Quincke's oedema), characterized by localized swelling of the skin and mucous membranes, which may be life-threatening if affecting the throat or larynx;
• widespread skin lesions (pink skin rashes on limbs and inside the mouth), with blisters and peeling skin; may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis – Lyell's disease;
• extensive rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• chest pain associated with an allergic reaction, possibly indicating heart attack triggered by allergy (Kounis syndrome).

➢ Profuse, watery diarrhoea persisting for a prolonged period, accompanied by fever and abdominal pain; may indicate inflammation of the large intestine (known as pseudomembranous colitis).
If any of these symptoms occur in a patient, contact a doctor or nurse immediately.
Other side effects that may occur during treatment
Common side effects (occurring in 1 to 10 out of 100 patients):

• pain at injection site, swelling and redness along the vein
• increased activity of substances (enzymes) produced in the liver
• change in white blood cell count (neutropenia or eosinophilia)
• decreased hemoglobin concentration in red blood cells.

Uncommon side effects (occurring in 1 to 10 out of 1,000 patients):

• skin rash, urticaria and itching
• decreased number of white blood cells (leukopenia)
• gastrointestinal disturbances
• increased bilirubin concentration (a substance produced by the liver)
• positive Coombs test result in laboratory tests.

Side effects for which frequency cannot be estimated from available data:

• fungal or bacterial infection (Clostridioides difficile)
• excessive breakdown of red blood cells (hemolytic anemia)
• decreased number of platelets (cells involved in blood clotting – thrombocytopenia)
• high temperature (fever), skin vasculitis
• interstitial nephritis (fever, dull pain in the lumbar region), laboratory findings: increased blood urea nitrogen and serum creatinine concentration, decreased creatinine clearance.

Reporting of side effects
If any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301; fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Tarsime

Keep this medicine out of the sight and reach of children.
Store below 25 °C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Tarsime contains
The active substance is cefuroxime (in the form of cefuroxime sodium).
Tarsime, 750 mg – one vial contains 750 mg of cefuroxime.
Tarsime, 1500 mg – one vial contains 1500 mg of cefuroxime.
Tarsime contains sodium (see section 2).

What the medicine looks like and contents of the pack
White or almost white powder.
Pack: one vial in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Telephone number: 22 811-18-14
For further information on this medicinal product, please contact the Marketing Authorisation Holder.

Information intended exclusively for healthcare professionals

• Preparation of solutions

Intramuscular injections
Add 4 mL of water for injections to the vial containing 750 mg of cefuroxime. Gently shake until a uniform suspension is obtained.

Intravenous injections
Add approximately 9 mL or 15 mL of water for injections to the vial containing 750 mg or 1500 mg of cefuroxime, respectively. This results in a solution with a concentration of 83.3 mg/mL or 100 mg/mL, respectively. Gently shake to obtain a clear solution.
Inject slowly over approximately 3 to 5 minutes.

Intravenous infusions
Dilute cefuroxime solutions prepared as described for intravenous injections to a final volume of 50 to 100 mL with water for injections, 5% glucose solution, or 0.9% sodium chloride solution. Gently shake to obtain a clear solution. Administer into large veins. The infusion should last 30 to 60 minutes.

According to good medical practice, solutions should be administered immediately after preparation. If the solution is not used immediately, the user is responsible for the storage duration and conditions. The solution or suspension remains stable for 24 hours at 2°C to 8°C (refrigerated), provided it was prepared under controlled aseptic conditions.

A change in solution color to yellow or amber does not affect the activity or properties of the product.

• Pharmaceutical incompatibilities

Cefuroxime must not be mixed in the same syringe with aminoglycoside antibiotics.
Cefuroxime mixed with sodium bicarbonate solutions significantly changes the solution color; therefore, sodium bicarbonate solutions are not recommended for dilution of cefuroxime. If necessary, the cefuroxime solution in water for injections may be administered via a side port of the infusion set in patients receiving sodium bicarbonate infusion.

For additional information, refer to the Product Characteristics document.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.