Tarcefandol

Patient Information Leaflet

TARCEFANDOL, 1 g, powder for solution for injection
Cefamandolum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents

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

1. What Tarcefandol is and what it is used for

Tarcefandol contains, as the active substance, cefamandolum. Cefamandolum belongs to a group of antibiotics known as cephalosporins – which are similar to penicillins.
Tarcefandol is used to treat the following infections caused by microorganisms sensitive to this medicine:

• lower respiratory tract infections;
• urinary tract infections;
• peritonitis;
• sepsis;
• skin and soft tissue infections;
• bone and joint infections;
• prevention of postoperative infections.

2. Important information before using Tarcefandol

When not to use Tarcefandol
If the patient is allergic (hypersensitive) to cefamandol or to other cephalosporin antibiotics.

Warnings and precautions
Before starting treatment with Tarcefandol, inform the doctor if the patient:

• has ever had an allergic reaction to any antibiotic;
• has ever had any other allergic reaction or bronchial asthma;
• has impaired kidney function;
• has previously suffered from intestinal inflammation (colitis) or any other severe intestinal disease;
• has vitamin K deficiency (mainly concerns elderly or weakened patients).

During treatment, inform the doctor if the patient experiences:

• sudden wheezing, difficulty breathing, eyelid, facial or lip swelling, rash or itching (symptoms of an allergic reaction);
• severe and persistent diarrhoea;
• a new infection (e.g. fungal infection).

Tarcefandol and other medicines
Tell the doctor or nurse about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is taking any of the following medicines:

• probenecid (used in the treatment of gout);
• aminoglycoside antibiotics, e.g. amikacin, streptomycin, neomycin.

Effect on laboratory test results
Tarcefandol may alter the results of urine glucose tests performed by non-enzymatic methods. If the patient has diabetes and routinely performs urine testing, they should inform their doctor. Alternative tests may be necessary to monitor diabetes during treatment with Tarcefandol.

Tarcefandol and alcohol
Do not drink alcohol while taking Tarcefandol.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Tarcefandol may be administered to pregnant women only if the doctor considers the treatment absolutely necessary.
Caution should be exercised if a woman is taking Tarcefandol and breastfeeding.

Driving and operating machinery
There is no data available regarding the negative effect of Tarcefandol on the ability to drive or operate machinery.

3. How to use Tarcefandol

Tarcefandol should be used as directed by the physician.
If in doubt, consult your doctor.
Tarcefandol is administered by a doctor or nurse.
Route and method of administration
Tarcefandol, powder for solution for injection, after reconstitution as described at the end of this leaflet under the section “Information intended exclusively for healthcare professionals”, may be administered:

• by intravenous injection over approximately 3 to 5 minutes,
• by intravenous infusion,
• by intramuscular injection.

The dose prescribed by the doctor depends on the type and severity of the infection. It also depends on the patient's body weight and renal function. Your doctor will provide appropriate guidance.
Typical doses
Adults
The usual dose is 500 mg to 1 g administered intravenously or intramuscularly every 4 to 8 hours.
In severe infections, 2 g may be given every 4 hours (up to a maximum of 12 g per day).
Infants and children
The usual dose is 50 to 100 mg/kg body weight per day, given in divided doses every 4 to 8 hours;
in severe infections, the dose may be increased up to 150 mg/kg body weight per day, without exceeding the maximum adult dose.
Prevention of perioperative infections
Adults – 1 g to 2 g administered intravenously or intramuscularly 30 minutes to 1 hour before surgery, followed by 1 g to 2 g every 6 hours for 24 to 48 hours.
Children – 50 to 100 mg/kg body weight per day in divided doses every 4 to 8 hours.
Dosing in patients with impaired renal function
The doctor will adjust the dosage according to renal function as described at the end of this leaflet in the section “Information intended exclusively for healthcare professionals.”
Duration of treatment
The duration of treatment is determined by the doctor.
Administration of a higher than recommended dose of Tarcefandol
Since Tarcefandol is administered by a doctor or nurse, administration of a dose higher than recommended is unlikely. However, if the patient suspects having received an overdose, contact a doctor immediately or go to the nearest hospital emergency department. The medicine should be taken along in its original packaging so that the medical staff can identify exactly which drug was administered.
Missed dose of Tarcefandol
Do not administer a double dose to make up for a missed dose.
Discontinuation of Tarcefandol treatment
It is important that the medicine is used according to the recommended treatment schedule. Do not stop treatment just because the patient feels better. Stopping treatment too early may cause the infection to return.
If the patient feels worse during treatment or does not feel well after completing the recommended course of treatment, they should consult their doctor.

• If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Serious adverse reactions
Occurring very rarely (less frequently than in 1 out of 10,000 patients):

• allergic reactions: fever, sudden shortness of breath and chest tightness, eyelid, facial or lip swelling, loss of consciousness (fainting).

Occurring rarely (in 1 to 10 out of 10,000 patients):

• severe diarrhoea, persisting for a prolonged period or containing blood, accompanied by abdominal pain or fever. This may be a symptom of a serious intestinal inflammation (called "pseudomembranous colitis"), which may occur following antibiotic use.

Occurring with unknown frequency (frequency cannot be estimated from available data):

• severe skin rashes, which may be associated with blister formation affecting the eyes, mouth, throat, and genital organs.
• If any of the serious adverse symptoms described above occur, administration of the medicine must be discontinued immediately and the prescribing physician must be informed without delay or the patient should go immediately to the nearest hospital emergency department.

Other adverse reactions that may occur during treatment with Tarcefandol
Occurring uncommonly (in 1 to 10 out of 1,000 patients):

• pain at the injection site after intramuscular administration.

Occurring rarely (in 1 to 10 out of 10,000 patients):

• fungal infections of the skin and mucous membranes;
• decreased platelet count, reduced number of certain types of white blood cells;
• nausea, vomiting;
• transient hepatitis, yellowing of the skin and eyes (jaundice);
• thrombophlebitis and pain at the injection site after intravenous administration.

Occurring with unknown frequency (frequency cannot be estimated from available data):

• itching of the genital organs and anus;
• minor, transient changes in blood test results used to monitor liver function;
• false positive results in direct Coombs' tests.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tarcefandol

Keep the medicine out of the sight and reach of children.
Store below 25°C. Protect from light.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated 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 Tarcefandol contains
The active substance is cefamandole in the form of nafate.
One vial contains 1 g of cefamandole.
The medicine does not contain any other ingredients.

What Tarcefandol looks like and contents of the pack
White to pale cream-colored powder.

Packaging
1 vial in a cardboard box.

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

Information intended exclusively for healthcare professionals

Dosage in patients with impaired renal function

Instructions for the Preparation of Injection Solution
Intramuscular Injection
Dissolve the contents of the 1 g vial in approximately 3 ml of water for injections or 0.9% sodium chloride solution.
Administer the prepared solution deeply into large muscles.
Intravenous Injection
Dissolve the contents of the 1 g vial in 10 ml of water for injections, 0.9% sodium chloride solution, or
5% glucose solution.
Inject slowly—over 3 to 5 minutes—into large peripheral veins.
Intravenous Infusion
Dissolve the contents of the 1 g vial in 10 ml of water for injections, then dilute with an appropriate
volume of infusion fluid (e.g., 0.9% sodium chloride solution, 5% glucose solution).
The choice of saline, glucose, or electrolyte solution and the volume to be used should follow standard principles of fluid and electrolyte therapy.
Cefamandole solutions should be administered immediately after preparation.
Pharmaceutical Incompatibilities
Cefamandole must not be mixed in the same syringe with other medicinal products.