Ceftriaxone kalceks

Package leaflet: Information for the user

Ceftriaxone Kalceks, 1 g, powder for solution for injection / infusion
Ceftriaxone Kalceks, 2 g, powder for solution for injection / infusion
Ceftriaxonum
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

1. What Ceftriaxone Kalceks is and what it is used for

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

• of the brain (meningitis);
• of the lungs;
• of the middle ear;
• of the abdomen and abdominal wall (peritonitis);
• of the urinary tract and kidneys;
• of bones and joints;
• of the skin and soft tissues;
• of the blood;
• of 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 (caused by tick bites) in adults and children, including newborns from day 15 of life;
• to prevent infections during surgery.

2. Important information before using Ceftriaxone Kalceks

When not to use Ceftriaxone Kalceks:

• if the patient is allergic to ceftriaxone or 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, monobactams or carbapenems). 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, chest pain and rapidly developing severe rash;
• if the patient is allergic to lidocaine and Ceftriaxone Kalceks is to be administered by intramuscular injection.

Do not use Ceftriaxone Kalceks in infants if:

• the child is premature;
• the child is a newborn (under 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or if the child is to receive an intravenous calcium-containing product.

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

• the patient has recently received or is about to receive calcium-containing products;
• the patient has ever felt unwell after administration of lidocaine;
• 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 (see section 4);
• the patient has gallstones or kidney stones;
• the patient has other diseases such as haemolytic anaemia (reduced number of red blood cells, which may cause paleness, weakness or shortness of breath);
• the patient is on a low-sodium diet;
• the patient currently has or has previously experienced 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").

Regarding blood or urine tests
If the patient is receiving Ceftriaxone Kalceks for a prolonged period, regular blood tests may be necessary. Ceftriaxone Kalceks may affect the results of urine glucose tests and blood tests known as the Coombs test.
If the patient is undergoing such tests, inform the person collecting the sample that the patient is receiving Ceftriaxone Kalceks.
If the patient has diabetes or requires monitoring of blood glucose levels, the patient should not use certain blood glucose monitoring systems that may inaccurately measure blood glucose levels during ceftriaxone treatment. When using such systems, check the user manual and inform your doctor, pharmacist or nurse. If necessary, alternative testing methods should be used.

Children
Before administering Ceftriaxone Kalceks, discuss with your doctor, pharmacist or nurse if the patient has recently received or is about to receive intravenous calcium-containing products.

Ceftriaxone Kalceks and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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);
• medicines used to prevent blood clots.

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 Ceftriaxone Kalceks for the mother against the potential risk to the child.

Driving and operating machinery
Ceftriaxone Kalceks may cause dizziness. If the patient experiences dizziness, he or she should not drive or operate tools or machinery. Inform the doctor if such symptoms occur.

Ceftriaxone Kalceks contains sodium
Ceftriaxone Kalceks, 1 g, powder for solution for injection / infusion
The medicine contains 83 mg of sodium (the main component of table salt) in each vial. This corresponds to 4.15% of the maximum recommended daily intake of sodium in the adult diet.
Ceftriaxone Kalceks, 2 g, powder for solution for injection / infusion
The medicine contains 166 mg of sodium (the main component of table salt) in each vial. This corresponds to 8.3% of the maximum recommended daily intake of sodium in the adult diet.

3. How to use Ceftriaxone Kalceks

Ceftriaxone Kalceks is usually administered by a doctor or nurse. Ceftriaxone Kalceks is prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with calcium-containing solutions.
Ceftriaxone Kalceks 1 g, powder for solution for injection / infusion may be given as an intravenous infusion (drip) or as an intravenous bolus injection, or as an intramuscular injection.
Ceftriaxone Kalceks 2 g, powder for solution for injection / infusion may be given as an intravenous infusion (drip) or as an intramuscular injection.

Typical dosage

Your doctor will decide the appropriate dose of Ceftriaxone Kalceks 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 Ceftriaxone Kalceks depends on the type of infection.

Adults, elderly patients, and adolescents aged 12 years and older with body weight greater than or equal to 50 kilograms (kg)

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

Neonates, infants, and children aged from day 15 to 12 years with body weight below 50 kg

• 50–80 mg of Ceftriaxone Kalceks per kg of body weight once daily, depending on the severity and type of infection. In severe infections, 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 divided into two doses.
• Children with body weight of 50 kg or more should receive the standard adult dose.

Neonates (aged 0 to 14 days)

• 20–50 mg of Ceftriaxone Kalceks 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 receive a dose different from the usual recommended dose. Your doctor will determine the appropriate dose of Ceftriaxone Kalceks based on the severity of your liver or kidney impairment and will closely monitor your condition.

Accidental overdose of Ceftriaxone Kalceks

If you accidentally receive more than the prescribed dose, contact your doctor immediately or go to the nearest hospital.

Missed dose of Ceftriaxone Kalceks

If a dose has been missed, it should be administered as soon as possible. However, if it is almost time for the next dose, do not administer the missed dose. Do not use a double dose (two injections at the same time) to make up for a missed dose.

Stopping treatment with Ceftriaxone Kalceks

Do not stop using Ceftriaxone Kalceks 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 everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Severe allergic reactions (frequency unknown – cannot be estimated from available data)
If a severe allergic reaction occurs, inform your doctor immediately.
Symptoms may include:

• sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult;
• sudden swelling of hands, feet and ankles;
• 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 – frequency cannot be estimated from 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);
• a combination of any of the following symptoms: spreading rash, high body temperature, increased liver enzyme activity, abnormal blood test results (eosinophilia), enlarged 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 Ceftriaxone Kalceks for infections caused by spirochetes, such as Lyme disease;
• acute generalized exanthematous pustulosis (AGEP), presenting as a red, peeling, widespread rash with subcutaneous pustules and blisters, accompanied by fever. The most common sites are skin folds, trunk and upper limbs.

Other possible adverse reactions:
Common (may affect up to 1 in 10 patients)

• 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 (may affect up to 1 in 100 patients)

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

Rare (may affect up to 1 in 1,000 patients)

• inflammation of the large intestine (colitis). Symptoms include diarrhoea, usually with blood and mucus, abdominal pain and fever;
• ceftriaxone treatment, especially in elderly patients with serious kidney or nervous system disorders, may rarely cause decreased level of consciousness, abnormal movements, agitation and seizures;
• breathing difficulties (bronchospasm);
• raised, itchy rash (urticaria), which may affect large areas of the body, itching and swelling;
• blood or sugar in the urine;
• oedema (fluid retention);
• chills.

Frequency unknown (frequency cannot be estimated from available data)

• secondary infection resistant to previously prescribed antibiotics;
• a type of anaemia involving destruction of red blood cells (haemolytic anaemia);
• marked decrease in white blood cells (agranulocytosis);
• seizures;
• severe dizziness (sensation of spinning);
• inflammation of the pancreas (pancreatitis). Symptoms include severe abdominal pain radiating to the back;
• inflammation of the mucous membrane lining the mouth (stomatitis);
• inflammation of the tongue (glossitis). Symptoms include swelling, redness and pain in the tongue;
• disorders related to the gallbladder and/or liver, possibly causing pain, nausea, vomiting, yellowing of the skin, itching, very dark urine and clay-coloured stools;
• a neurological condition that may occur in newborns with severe jaundice (bilirubin encephalopathy - kernicterus);
• skin inflammation and redness (erythema multiforme);
• kidney problems due to deposition of calcium-ceftriaxone salts; symptoms may include pain during urination or production of small amounts of urine;
• false positive Coombs test result (a test detecting certain blood disorders);
• false positive galactosemia test result (abnormal accumulation of galactose sugar in the body);
• Ceftriaxone Kalceks may affect results of certain blood glucose tests – please consult your doctor about this.

Reporting of adverse reactions
If any adverse symptoms 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
PL-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 responsible entity.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Ceftriaxone Kalceks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the carton after "EXP". The expiry date refers to the last day of the stated month.
No special temperature requirements for storage of this medicine.
Store vials in the outer packaging to protect from light.

After reconstitution with lidocaine hydrochloride 10 mg/mL (1%) for intramuscular injection
Chemical and physical stability of the solution has been demonstrated for 6 hours at 25 °C.
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 and should usually not exceed 6 hours at 25 °C.

After reconstitution for intravenous injection
Chemical and physical stability of the solution has been demonstrated for 48 hours at 2–8 °C and 12 hours at 25 °C.
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 and should usually not exceed 24 hours at 2–8 °C, unless reconstitution has been carried out under controlled and validated aseptic conditions.

After reconstitution for intravenous infusion
The reconstituted solution should be diluted immediately after reconstitution.

After dilution for intravenous infusion
Chemical and physical stability of the solution has been demonstrated for 48 hours at 2–8 °C and 12 hours at 25 °C.
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 and should usually not exceed 24 hours at 2–8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Ceftriaxone Kalceks contains

• The active substance is ceftriaxone.

Ceftriaxone Kalceks, 1 g, powder for solution for injection / infusion
Each vial contains 1 g of ceftriaxone (as sodium ceftriaxone).
Ceftriaxone Kalceks, 2 g, powder for solution for injection / infusion
Each vial contains 2 g of ceftriaxone (as sodium ceftriaxone).

What Ceftriaxone Kalceks looks like and contents of the pack
A powder which is almost white or yellowish in colour.
Ceftriaxone Kalceks, 1 g, powder for solution for injection / infusion
The powder is placed in a vial made of colourless glass type III with a grey bromobutyl rubber stopper and an aluminium cap with a dark blue polypropylene "flip-off" seal.
Ceftriaxone Kalceks, 2 g, powder for solution for injection / infusion
The powder is placed in a vial made of colourless glass type III with a grey bromobutyl rubber stopper and an aluminium cap with an orange polypropylene "flip-off" seal.
Vials are packed in a cardboard box.
Pack sizes: 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
LV-1057 Rīga
Latvia
Tel.: +371 67083320
e-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Finland Ceftriaxone Kalceks 1 g, 2 g injektio-/infuusiokuiva-aine liuosta varten
Austria, Germany Ceftriaxon Kalceks 1 g, 2 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Belgium Ceftriaxone Kalceks 1 g, 2 g poeder voor oplossing voor injectie/infusie
Ceftriaxone Kalceks 1 g, 2 g poudre pour solution injectable/pour perfusion
Ceftriaxone Kalceks 1 g, 2 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Croatia Ceftriakson Kalceks 1 g, 2 g prašak za otopinu za injekciju/infuziju
Czech Republic, Italy, Poland Ceftriaxone Kalceks
Denmark, Norway Ceftriaxon Kalceks
France CEFTRIAXONE KALCEKS 1 g, 2 g poudre pour solution injectable/pour perfusion
Hungary Ceftriaxone Kalceks 1 g és 2 g por oldatos injekcióhoz vagy infúzióhoz
Ireland Ceftriaxone 1 g, 2 g powder for solution for injection/infusion
Latvia Ceftriaxone Kalceks 1 g, 2 g pulveris injekciju/infūziju šķīduma pagatavošanai
Lithuania Ceftriaxone Kalceks 1 g, 2 g milteliai injekciniam ar infuziniam tirpalui
Netherlands Ceftriaxon Kalceks 1 g, 2 g poeder voor oplossing voor injectie/infusie
Slovenia Ceftriakson Kalceks 1 g, 2 g prašek za raztopino za injiciranje/infundiranje
Slovakia Ceftriaxone Kalceks 1 g, 2 g prášok na injekčný/infúzny roztok
Spain Ceftriaxona Kalceks 1 g, 2 g polvo para solución inyectable y para perfusión

Information intended exclusively for healthcare professionals:

Complete information on the medicinal product is available in the Summary of Product Characteristics.

Route of administration
Ceftriaxone Kalceks, 1 g, powder for solution for injection/infusion, may be used for intramuscular injection, slow intravenous injection, and intravenous infusion.
Ceftriaxone Kalceks, 2 g, powder for solution for injection/infusion, may be used for intramuscular injection and intravenous infusion.

Incompatibilities
According to literature reports, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, and aminoglycoside antibiotics.
Do not mix this medicinal product with other medicinal products except those listed below.
In particular, due to the risk of precipitate formation, diluents containing calcium (e.g. Ringer's solution or Hartmann's solution) must not be used for reconstitution of ceftriaxone in the vial or for further dilution of the prepared solution for intravenous administration. Ceftriaxone must not be mixed or co-administered with solutions containing calcium, including those used in total parenteral nutrition.
If treatment involves combining another antibiotic with ceftriaxone, they should not be administered in the same syringe or infusion solution.

For single use only.
Storage conditions for reconstituted and diluted solutions, see section 5.

Compatibility has been demonstrated with the following solutions:

• Water for injections;
• Lidocaine hydrochloride 10 mg/mL (1%) solution (for intramuscular injection only);
• Sodium chloride 9 mg/mL (0.9%) solution;
• Glucose 50 mg/mL (5%) solution;
• Glucose 100 mg/mL (10%) solution;
• Sodium chloride 4.5 mg/mL (0.45%) and glucose 25 mg/mL (2.5%) solution.

Intramuscular injection
For intramuscular injection, 1 g of ceftriaxone should be dissolved in 3.5 mL of 1% lidocaine hydrochloride solution or 2 g of ceftriaxone in 7 mL of 1% lidocaine hydrochloride solution.
The solution should be administered by deep intramuscular injection. Doses greater than 1 g should be divided and injected at more than one site. For doses exceeding 2 g, intravenous administration should be used. Intramuscular administration should be considered when the intravenous route is not feasible or less appropriate for the patient.
The medicinal product Ceftriaxone Kalceks should not be mixed with other drugs in the same syringe, except with 1% lidocaine hydrochloride solution (for intramuscular injection only).
If lidocaine is used as the solvent, the resulting solution must never be administered intravenously.

Intravenous injection
For intravenous injection, 1 g of ceftriaxone should be dissolved in 10 mL of water for injections.
The injection should be administered directly into the vein or via an intravenous infusion set over 5 minutes.
The final concentration of ceftriaxone in the intravenous injection solution is 93 mg/mL.

Intravenous infusion
For intravenous infusion, 1 g or 2 g of ceftriaxone should be dissolved and, if necessary, further diluted with one of the appropriate calcium-free diluents listed above (excluding lidocaine hydrochloride solution, as lidocaine solutions must never be administered intravenously).
The final concentration of ceftriaxone in the intravenous infusion solution is 48 mg/mL:

| Ceftriaxone Kalceks powder | Solvent volume | Final ceftriaxone concentration in solution |
|----------------------------|----------------|---------------------------------------------|
| 1 g | 20 mL | 48 mg/mL |
| 2 g | 40 mL* | 48 mg/mL |

* First, the powder is reconstituted with 20 mL of an appropriate diluent. The resulting solution is then further diluted with 20 mL of an appropriate diluent to achieve a concentration of 48 mg/mL, using an appropriate delivery device (e.g. infusion pump, infusion bag).

It is recommended that the intravenous infusion set be flushed after each administration with 0.9% sodium chloride solution for injection to ensure complete delivery of the dose.
The infusion should be administered over at least 30 minutes.
In neonates, intravenous doses should be administered over a period longer than 60 minutes to minimize the risk of bilirubin encephalopathy.

The reconstituted/diluted solution ranges in color from slightly yellowish to brownish-yellow, depending on storage time, concentration, and solvent used; however, this does not affect the efficacy of the medicinal product.
Reconstituted/diluted solutions should be inspected visually prior to use. Only clear solutions free from particulate matter should be used. The prepared product is for single use only, and any unused solution should be discarded.

This medicinal product may pose a risk to the environment.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.