Tartriaxon

Package leaflet: Information for the patient

Tartriakson, 1 g, powder for solution for injection and infusion
Tartriakson, 2 g, powder for solution for injection and infusion
Ceftriaxone
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, 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, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Tartriakson is and what it is used for

Tartriakson is an antibiotic used in adults and children (including full-term newborns). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Tartriakson is used to treat infections of:

• the brain (meningitis),
• the lungs,
• the middle ear,
• the abdomen and abdominal wall (peritonitis),
• the urinary tract and kidneys,
• bones and joints,
• the skin and soft tissues,
• the blood,
• the heart.

This medicine may also be used:

• to treat certain sexually transmitted infections (gonorrhoea and syphilis),
• to treat patients with low white blood cell count (neutropenia) who have fever due to bacterial infection,
• to treat chest infections in adults with chronic bronchitis,
• to treat Lyme disease (a tick-borne illness) in adults and children, including newborns from day 15 of life,
• to prevent infections during surgery.

2. Important information before using Tartriakson

When not to use Tartriakson:

• if the patient is allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems, monobactams); symptoms of such a reaction include: sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of the hands, feet and ankles (ankle joints), chest pain, and rapidly developing severe rash;
• if the patient is allergic to lidocaine and Tartriakson is to be administered by intramuscular injection.

Tartriakson must not be used in young children if:

• the child is a premature infant,
• the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice [yellowing of the skin and/or the whites of the eyes], or if the child is to receive an intravenous medicine containing calcium.

Warnings and precautions
Before starting treatment with Tartriakson, discuss this with your doctor, pharmacist or nurse if:

• the patient has recently received or is about to receive products containing calcium,
• the patient has recently had diarrhoea after antibiotic treatment,
• the patient has ever had intestinal problems, particularly colitis (inflammation of the large intestine),
• the patient has liver or kidney problems,
• the patient has gallstones or kidney stones,
• the patient has other diseases such as haemolytic anaemia (reduced number of red blood cells causing paleness, weakness or shortness of breath),
• the patient is on a low-sodium diet,
• the patient currently has or has previously had any of the following symptoms: rash, redness of the skin, blisters around the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme activity observed in blood tests, increased number of a certain type of white blood cells (eosinophilia), and swollen lymph nodes (symptoms of severe skin reactions, see also section 4 "Possible side effects"),
• the patient has liver or kidney problems (see section 4).

Regarding blood or urine tests
If the patient is receiving Tartriakson for a prolonged period, regular blood tests may be necessary.
Tartriakson may affect the results of urine glucose tests and a blood test known as the Coombs test. If the patient is undergoing tests, inform the person collecting the sample that the patient is receiving Tartriakson.
Children
Before administering Tartriakson to a child, discuss this with a doctor, pharmacist or nurse if the child has recently received or is about to receive intravenous calcium-containing products.
Tartriakson and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• an antibiotic belonging to the aminoglycoside group,
• an antibiotic called chloramphenicol, used to treat infections, particularly eye infections.

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 the benefits of treatment with Tartriakson for the mother and the potential risks for the child.
Driving and operating machinery
Tartriakson may cause dizziness. If the patient experiences dizziness, he/she should not drive or operate any tools or machinery. Inform the doctor if such symptoms occur.
Tartriakson contains sodium
Each gram of the medicine contains 74.4 mg (3.2 mmol) of sodium. This should be taken into account in patients with impaired kidney function and in patients controlling sodium intake in their diet.

3. How to use Tartriakson

Tartriakson is usually administered by a doctor or nurse. It may be given as an intravenous infusion (drip) or by injection directly into a vein or into a muscle. Tartriakson is prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with solutions containing calcium.

Typically used dose
Your doctor will decide the appropriate dose of Tartriakson for you. The dose depends on the severity and type of infection; whether you are taking other antibiotics; your age and body weight; and your liver and kidney function. The number of days or weeks you will receive Tartriakson depends on the type of infection.

Adults, elderly patients, and children aged 12 years and older with body weight at least 50 kg

• 1 to 2 g once daily, depending on the severity and type of infection. In case of severe infection, your doctor may use a higher dose (up to 4 g once daily). If the daily dose exceeds 2 g, the medicine may be given as a single dose or in two separate doses.

Newborns, infants, and children from day 15 to 12 years of age with body weight below 50 kg

• 50 to 80 mg of Tartriakson per kg of body weight once daily, depending on the severity and type of infection. In case of severe infection, your doctor may use a higher dose, up to 100 mg per kg of body weight, with a maximum of 4 g once daily. If the daily dose exceeds 2 g, the medicine may be given as a single daily dose or in two separate doses.

• Children with body weight of 50 kg or more should receive the standard adult dose.

Newborns aged 0–14 days

• 20 to 50 mg of Tartriakson per kg of body weight once daily, depending on the severity and type of infection.

• The maximum daily dose must not exceed 50 mg per kg of body weight.

Patients with impaired liver or kidney function
You may require a dose different from the usual recommended dose. Your doctor will determine the appropriate dose of Tartriakson for you and will closely monitor your condition depending on the severity of liver or kidney impairment.

Accidental overdose of Tartriakson
If you accidentally receive more Tartriakson than prescribed, contact your doctor or nearest hospital immediately.

Missed dose of Tartriakson
If you miss an injection, it should be given as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not administer a double dose (two injections at the same time) to make up for the missed dose.

Stopping Tartriakson treatment
Do not stop using Tartriakson unless instructed by your doctor. If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
The adverse reactions described below may occur during treatment with this medicine.
Serious adverse reactions – frequency unknown, cannot be estimated from the available data

• Severe allergic reactions Symptoms to watch for:

• sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.

• sudden swelling of the hands, feet and ankles (ankle joints).

• chest pain associated with an allergic reaction, which may be a sign of an allergy-induced heart attack (Kounis syndrome).

• Severe skin reactions (frequency unknown – cannot be estimated from the available data) If a severe skin reaction occurs, inform your doctor immediately. Symptoms may include:

• rapidly developing severe rash, with blisters or peeling skin and possible blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN);

• any of the following symptoms: spreading rash, high body temperature, increased liver enzyme activity, abnormal blood test results (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome);

• Jarisch-Herxheimer reaction causing fever, chills, headache, muscle pain and skin rash, usually self-limiting; this reaction occurs shortly after starting treatment with Tartriakson for infections caused by spirochetes, such as Lyme disease.

➢ If any of the serious adverse symptoms occur, stop taking the medicine and inform your doctor immediately.
Treatment with ceftriaxone – especially in elderly patients with severe kidney or nervous system disorders – may rarely cause decreased level of consciousness, abnormal movements, agitation and seizures.

Other possible adverse reactions

Common (affects up to 1 in 10 people)

• abnormalities in white blood cells (such as decreased leukocyte count and increased eosinophilia) and platelets (decreased platelet count),
• loose stools or diarrhoea,
• changes in blood test results assessing liver function,
• rash.

Uncommon (affects up to 1 in 100 people)

• fungal infections (e.g. candidiasis),
• decreased white blood cell count (granulocytopenia),
• decreased red blood cell count (anaemia),
• problems with blood clotting; symptoms may include easy bruising, as well as joint pain and swelling,
• headache,
• dizziness,
• nausea and (or) vomiting,
• itching,
• pain or burning along the vein into which Tartriakson was administered; pain at the injection site,
• high body temperature (fever),
• abnormal kidney function test result (increased blood creatinine concentration).

Rare (affects up to 1 in 1000 people)

• inflammation of the large intestine (colitis); symptoms include diarrhoea, usually with blood and mucus, abdominal pain and fever,
• difficulty breathing (bronchospasm),
• raised rash (urticaria), which may affect large areas of the body, itching and swelling,
• blood or sugar in the urine,
• oedema (fluid retention),
• chills.

Frequency not known (cannot be estimated from the available data)

• secondary infection that cannot be treated with previously prescribed antibiotics,
• a type of anaemia in which red blood cells are destroyed (haemolytic anaemia),
• marked decrease in white blood cell count (agranulocytosis),
• seizures,
• severe dizziness (sensation of spinning),
• pancreatitis; symptoms include severe abdominal pain radiating to the back,
• inflammation of the mucous membrane lining the mouth,
• inflammation of the tongue; symptoms include swelling, redness and tenderness of the tongue,
• gallbladder and/or liver problems, which may cause pain, nausea, vomiting, yellowing of the skin, itching, very dark urine and pale stools,
• neurological condition that may occur in newborns with severe jaundice (kernicterus),
• kidney problems caused by deposition of calcium-ceftriaxone salts. These may manifest as pain during urination or production of small amounts of urine,
• false positive Coombs test result (a test detecting certain blood disorders),
• false positive galactosaemia test result (abnormal accumulation in the body of a sugar called galactose),
• Tartriakson may affect the results of certain blood glucose tests – this should be checked with your doctor.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tartriakson

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C. Protect from light.
Any unused injection or infusion solution must be discarded.
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 packaging and other information

What Tartriakson contains
The active substance is ceftriaxone.
Tartriakson 1 g: each vial contains 1 g of ceftriaxone (as sodium salt).
Tartriakson 2 g: each vial contains 2 g of ceftriaxone (as sodium salt).
The medicine does not contain any other ingredients.

What Tartriakson looks like and contents of the pack
White to creamy-yellow crystalline powder.
Packaging: one vial in a cardboard box.

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

Information intended exclusively for healthcare professionals

• Shelf life after vial opening and after solution preparation

According to good practice, solutions should be administered immediately after preparation. Ceftriaxone solutions prepared with the solvents listed below remain stable for 24 hours when stored at 2°C to 8°C (in a refrigerator).
From the standpoint of microbiological safety, the product should be used immediately after preparation.
If not, the user is responsible for the storage conditions and duration, which must not exceed 24 hours at a temperature of 2°C to 8°C.

• Method of administration

Ceftriaxone may be administered via deep intramuscular injection, intravenous injection, or intravenous infusion.
Intramuscular injection
Inject deeply into a large muscle. Do not administer more than 1 g at a single injection site.
Solutions containing more than 1 g of ceftriaxone should be divided and administered at two separate sites.
Intravenous injection
Administer slowly over 3 to 5 minutes into large peripheral veins.
Intravenous infusion
Intravenous infusion should last at least 30 minutes.

• Preparation of solutions

Intramuscular injection
Dissolve the contents of a 1 g vial in approximately 3.5 ml of solvent, and the contents of a 2 g vial in 7 ml to 10 ml of solvent.
Solvents: Water for injections, 0.9% sodium chloride solution, 1% lidocaine solution.
Warning! The ceftriaxone solution prepared with 1% lidocaine solution must not be administered intravenously.
If a lidocaine solution is used to prepare the intramuscular injection, the Summary of Product Characteristics for the selected lidocaine-containing solution must be consulted prior to intramuscular administration.

Intravenous injection
Dissolve the contents of a 1 g vial in 10 ml, and the contents of a 2 g vial in at least 20 ml of Water for injections.
Administer slowly over 3 to 5 minutes.
Solvents: Water for injections; 0.9% sodium chloride solution; 0.45% sodium chloride solution + 2.5% glucose solution (1:1); 5% glucose solution; 10% glucose solution; 6% dextran in 5% glucose solution.

Intravenous infusion
The contents of a 1 g or 2 g vial should be dissolved in one of the following calcium-free solvents listed below. Ceftriaxone is best administered as a solution with a concentration between 10 mg/ml and 40 mg/ml, infused over at least 30 minutes.
Solvents: Water for injections; 0.9% sodium chloride solution; 0.45% sodium chloride solution + 2.5% glucose solution (1:1); 5% glucose solution; 10% glucose solution; 6% dextran in 5% glucose solution.
Ceftriaxone solutions may range in color from pale yellow to amber, depending on the solvent used, concentration, and storage time. This does not affect the drug's activity or tolerability.

• Pharmaceutical incompatibilities

According to literature reports, ceftriaxone is incompatible with amikacin, vancomycin, fluconazole, and aminoglycoside antibiotics.
Solutions containing ceftriaxone must not be mixed or combined with other medicinal products except those specifically mentioned above. In particular, due to the risk of precipitation, diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) must not be used to reconstitute ceftriaxone in the vial or for further dilution of the prepared intravenous solution. Ceftriaxone must not be mixed or co-administered with calcium-containing solutions, including those used in total parenteral nutrition.