CEFTRIAXONE 1 g Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Ceftriaxone Kalceks, 1 g, powder for solution for injection/infusion
3. Ceftriaxone Kalceks, 2 g, powder for solution for injection/infusion
   1. You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Ceftriaxone Kalceks and what is it used for
5. Important information before using Ceftriaxone Kalceks
   1. When not to use Ceftriaxone Kalceks:
   2. Ceftriaxone Kalceks must not be used in newborns, if:
   3. Warnings and precautions
   4. In case of blood or urine tests
   5. Children
   6. Ceftriaxone Kalceks and other medicines
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Ceftriaxone Kalceks contains sodium
6. How to use Ceftriaxone Kalceks
   1. Usual dose
   2. Adults, elderly, and adolescents over 12 years old and weighing 50 kg or more
   3. Newborns, infants, and children from the 15th day to 12 years old and weighing less than 50 kg
   4. Newborns (from 0 to 14 days old)
   5. Patients with liver or kidney problems
   6. Using a higher dose of Ceftriaxone Kalceks than recommended
   7. Missing a dose of Ceftriaxone Kalceks
   8. Stopping treatment with Ceftriaxone Kalceks
7. Possible side effects
   1. Severe allergic reactions (frequency not known - cannot be estimated from the available data)
   2. Severe skin reactions (frequency not known - frequency cannot be estimated from the available data)
   3. Reporting side effects
8. How to store Ceftriaxone Kalceks
9. Contents of the packaging and other information
   1. What Ceftriaxone Kalceks contains
   2. What Ceftriaxone Kalceks looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the leaflet: 05/2024

Leaflet accompanying the packaging: information for the user

Ceftriaxone Kalceks, 1 g, powder for solution for injection/infusion

Ceftriaxone Kalceks, 2 g, powder for solution for injection/infusion

Ceftriaxone

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ceftriaxone Kalceks and what is it 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 packaging and other information

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

Ceftriaxone Kalceks is an antibiotic used in adults and children (including newborns). Its action is to kill 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 be used:

• to treat certain sexually transmitted infections (gonorrhea and syphilis);
• to treat patients with a low white blood cell count (neutropenia) who have a fever caused by a 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 the 15th day 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 had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, monobactams, or carbapenems). Symptoms of such a reaction are: 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 a rapidly spreading severe rash;
• if the patient is allergic to lidocaine and is to receive Ceftriaxone Kalceks by intramuscular injection.

Ceftriaxone Kalceks must not be used in newborns, if:

• the baby is premature;
• the baby is a newborn (up to 28 days old) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes) or is to receive a product containing calcium intravenously.

Warnings and precautions

Before starting treatment with Ceftriaxone Kalceks, you should discuss it with your doctor, pharmacist, or nurse if:

• the patient has recently received or is about to receive products containing calcium;
• the patient has ever felt unwell after being given lidocaine;
• the patient has recently had diarrhea after taking antibiotics;
• the patient has ever had problems with their intestines, particularly colitis (inflammation of the colon);
• the patient has liver or kidney problems (see section 4);
• the patient has gallstones or kidney stones;
• the patient has other diseases, such as hemolytic anemia (reduced red blood cell count, which can cause pallor and weakness or shortness of breath);
• the patient is on a low-sodium diet;
• the patient has or has had any of the following symptoms: rash, skin redness, blisters around the mouth, eyes, or genital area, skin peeling, high fever, flu-like symptoms, increased liver enzyme activity in blood tests, and increased white blood cell count (eosinophilia) and swollen lymph nodes (symptoms of severe skin reactions, see also section 4 "Possible side effects").

In case of blood or urine tests

If the patient is taking Ceftriaxone Kalceks for a long time, regular blood tests may be necessary. Ceftriaxone Kalceks may affect the results of urine sugar tests and a blood test called the Coombs test.

If the patient is having such tests, they should tell the person taking the sample that they are taking Ceftriaxone Kalceks.

If the patient has diabetes or needs to have their blood glucose levels controlled, they should not use certain blood glucose monitoring systems that may incorrectly measure blood glucose levels while taking ceftriaxone. If such systems are used, the patient should check the instruction manual and inform their doctor, pharmacist, or nurse. Alternative testing methods should be used if necessary.

Children

Before administering Ceftriaxone Kalceks, the doctor, pharmacist, or nurse should be consulted if the patient has recently received or is about to receive a product containing calcium intravenously.

Ceftriaxone Kalceks and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

In particular, the patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• an antibiotic belonging to the aminoglycoside group;
• an antibiotic called chloramphenicol (used to treat infections, especially eye infections);
• medicines that prevent blood clots.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before using this medicine.

The doctor will assess the benefits of treating the mother with Ceftriaxone Kalceks compared to the risks for the baby.

Driving and using machines

Ceftriaxone Kalceks may cause dizziness. If the patient feels dizzy, they should not drive or use any tools or machines. They should inform their doctor if they experience such symptoms.

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 common salt) in each vial. This is equivalent to 4.15% of the maximum recommended daily intake of sodium in the diet for adults.

Ceftriaxone Kalceks, 2 g, powder for solution for injection/infusion

The medicine contains 166 mg of sodium (the main component of common salt) in each vial. This is equivalent to 8.3% of the maximum recommended daily intake of sodium in the diet for adults.

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 will not be mixed or administered simultaneously with solutions containing calcium.

Ceftriaxone Kalceks, 1 g, powder for solution for injection/infusion may be administered by intravenous infusion (intravenous infusion) or by injection directly into a vein or by intramuscular injection.

Ceftriaxone Kalceks, 2 g, powder for solution for injection/infusion may be administered by intravenous infusion (intravenous infusion) or by intramuscular injection.

Usual dose

The doctor will decide what dose of Ceftriaxone Kalceks is suitable for the patient. The dose depends on the severity and type of infection; whether the patient is taking other antibiotics; the patient's age and body weight; the patient's liver and kidney function. The number of days or weeks the patient will receive Ceftriaxone Kalceks depends on the type of infection.

Adults, elderly, and adolescents over 12 years old and weighing 50 kg or more

• 1-2 g once a day, depending on the severity and type of infection. In cases of severe infection, the doctor will administer a higher dose (up to 4 g once a day). If the daily dose is higher than 2 g, the medicine can be administered in a single dose once a day or in two divided doses.

Newborns, infants, and children from the 15th day to 12 years old and weighing less than 50 kg

• 50-80 mg of Ceftriaxone Kalceks per kg of the child's body weight once a day, depending on the severity and type of infection. In cases of severe infection, the doctor will use a higher dose, up to 100 mg per kg of the child's body weight, up to a maximum of 4 g once a day. If the daily dose is higher than 2 g, the medicine can be administered in a single dose once a day or in two divided doses.
• Children weighing 50 kg or more should receive the usual adult dose.

Newborns (from 0 to 14 days old)

• 20-50 mg of Ceftriaxone Kalceks per kg of the child's body weight once a day, depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg per kg of the child's body weight.

Patients with liver or kidney problems

The patient may receive a different dose than usual. The doctor will determine what dose of Ceftriaxone Kalceks is suitable for the patient, depending on the severity of the liver and kidney disease, and will closely monitor the patient's condition.

Using a higher dose of Ceftriaxone Kalceks than recommended

In case of accidental administration of a higher dose than prescribed by the doctor, the patient should immediately contact their doctor or go to the nearest hospital.

Missing a dose of Ceftriaxone Kalceks

If the patient misses an injection, they should receive it as soon as possible. However, if the next injection is near, the missed injection should not be taken. The patient should not take a double dose (two injections at the same time) to make up for the missed dose.

Stopping treatment with Ceftriaxone Kalceks

The patient should not stop using Ceftriaxone Kalceks unless their doctor tells them to. If the patient has any further questions about using this medicine, they should ask their doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur while using this medicine:

Severe allergic reactions (frequency not known - cannot be estimated from the available data)

In case of a severe allergic reaction, the patient should immediately inform their doctor.

Symptoms may include:

• sudden swelling of the face, throat, lips, or mouth. This may make breathing or swallowing difficult;
• sudden swelling of the hands, feet, and ankles;
• chest pain associated with an allergic reaction, which may be a sign of a heart attack caused by an allergy (Kounis syndrome).

Severe skin reactions (frequency not known - frequency cannot be estimated from the available data)

In case of a severe skin reaction, the patient should immediately inform their doctor.

Symptoms may include:

• rapidly spreading severe rash, with blisters or skin peeling, 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, blood test abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS 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), characterized by a red, scaly, widespread rash with pustules under the skin and blisters, accompanied by fever. Most common location: mainly localized to skin folds, torso, and upper limbs.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• abnormalities in white blood cells (such as decreased leukocyte count and increased eosinophil count) and platelets (decreased platelet count);
• loose stools or diarrhea;
• changes in liver function test results;
• rash.

Uncommon (may affect up to 1 in 100 people)

• fungal infections (such as thrush);
• decreased white blood cell count (granulocytopenia);
• decreased red blood cell count (anemia);
• blood clotting problems; symptoms of such an effect may include easy bruising and pain and swelling of the joints;
• 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 creatinine levels in the blood).

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

• inflammation of the colon (colitis). Symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever;
• treatment with ceftriaxone, especially in elderly patients with severe kidney or neurological disorders, may rarely cause decreased consciousness, abnormal movements, agitation, and seizures;
• breathing difficulties (bronchospasm);
• hives (urticaria), which can affect large areas of the body, itching, and swelling;
• blood or sugar in the urine;
• swelling (fluid retention);
• chills.

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

• secondary infection that cannot be treated with previously prescribed antibiotics;
• a certain type of anemia in which red blood cells are destroyed (hemolytic anemia);
• significant decrease in white blood cell count (agranulocytosis);
• seizures;
• severe dizziness (vertigo);
• pancreatitis (inflammation of the pancreas). Symptoms include severe abdominal pain radiating to the back;
• stomatitis (inflammation of the mucous membrane lining the mouth);
• glossitis (inflammation of the tongue). Symptoms include swelling, redness, and pain of the tongue;
• problems with the gallbladder and/or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, extremely dark urine, and clay-colored stools;
• a neurological condition that can occur in newborns with severe jaundice (kernicterus);
• erythema multiforme (inflammation and redness of the skin);
• kidney problems caused by the deposition of calcium ceftriaxone salts; may be accompanied by pain when urinating or producing small amounts of urine;
• false-positive Coombs test result (a test that detects certain blood disorders);
• false-positive galactosemia test result (a test that detects abnormal galactose accumulation in the body);
• Ceftriaxone Kalceks may affect the results of some glucose tests in the blood - the patient should check with their doctor.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ceftriaxone Kalceks

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the month stated.

There are no special storage instructions for this medicine.

Store the vials in the outer carton to protect from light.

After reconstitution with lidocaine hydrochloride 10 mg/mL (1%) solution for injection

Chemical and physical stability of the solution has been demonstrated for 6 hours at 25 °C.

From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage times and conditions are the responsibility of the user.

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 point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and are normally not longer than 24 hours at 2-8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.

After reconstitution for intravenous infusion

The reconstituted solution should be diluted immediately.

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 point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and are normally not longer than 24 hours at 2-8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging 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 ceftriaxone sodium).

Ceftriaxone Kalceks, 2 g, powder for solution for injection/infusion

Each vial contains 2 g of ceftriaxone (as ceftriaxone sodium).

What Ceftriaxone Kalceks looks like and contents of the pack

White or slightly yellowish powder.

Ceftriaxone Kalceks, 1 g, powder for solution for injection/infusion

The powder is in a vial made of colorless glass type III with a gray rubber stopper and an aluminum cap with a dark blue PP "flip-off" cover.

Ceftriaxone Kalceks, 2 g, powder for solution for injection/infusion

The powder is in a vial made of colorless glass type III with a gray rubber stopper and an aluminum cap with an orange PP "flip-off" cover.

The vials are in a cardboard box.

Package sizes: 1 or 10 vials.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

AS KALCEKS

Krustpils iela 71E

LV-1057 Rīga

Latvia

Tel.: +371 67083320

e-mail: [email protected]

This medicine is authorized 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

Date of last revision of the leaflet: 05/2024

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Information intended for healthcare professionals only:

Full information on the medicine can be found in the Summary of Product Characteristics.

Method of administration

Ceftriaxone Kalceks, 1 g, powder for solution for injection/infusion may be used for intramuscular injections, slow intravenous injections, and intravenous infusions.

Ceftriaxone Kalceks, 2 g, powder for solution for injection/infusion may be used for intramuscular injections and intravenous infusions.

Incompatibilities

According to literature reports, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, and aminoglycoside antibiotics.

This medicinal product must not be mixed with other medicinal products, except for those mentioned below.

In particular, due to the risk of precipitation, calcium-containing diluents (e.g., Ringer's solution or Hartmann's solution) must not be used to reconstitute ceftriaxone in the vial or to further dilute the reconstituted solution for intravenous administration. Ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions, including total parenteral nutrition.

If treatment involves the use of another antibiotic and 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 (only for intramuscular injections);
• 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 is dissolved in 3.5 mL of 1% lidocaine hydrochloride solution or 2 g of ceftriaxone is dissolved 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 administered at more than one site. For doses greater than 2 g, intravenous administration should be considered. Intramuscular administration should be considered when the intravenous route is not possible or is less suitable for the patient.

Ceftriaxone Kalceks should not be mixed with other medicines in the same syringe, except for 1% lidocaine hydrochloride solution (only for intramuscular injections).

If lidocaine is used as a solvent, the resulting solution should never be administered intravenously.

Intravenous injection

For intravenous injection, 1 g of ceftriaxone is dissolved in 10 mL of water for injections.

The injection is administered directly into a vein or through an intravenous infusion set over 5 minutes.

The concentration of ceftriaxone in the final solution for intravenous injection is 93 mg/mL.

Intravenous infusion

For intravenous infusion, 1 g or 2 g of ceftriaxone is dissolved and, if necessary, further diluted with one of the suitable calcium-free solutions listed above (except lidocaine hydrochloride solution, as lidocaine solutions should never be administered intravenously).

The concentration of ceftriaxone in the final solution for intravenous infusion is 48 mg/mL:

Ceftriaxone concentration in the final solution

1 g

20 mL

48 mg/mL

2 g

40 mL*

48 mg/mL

* First, the powder is reconstituted in 20 mL of the suitable diluent. The reconstituted solution is further diluted to 48 mg/mL using the suitable diluent and an appropriate administration device (e.g., infusion pump, infusion bag).

It is recommended that the intravenous infusion set be flushed with sodium chloride 9 mg/mL (0.9%) solution for injections after each administration to ensure that the full dose is administered.

The infusion should be administered over at least 30 minutes.

In newborns, intravenous doses should be administered over a longer period than 60 minutes to minimize the risk of bilirubin encephalopathy.

The reconstituted/diluted solutions should be inspected before use to check for any visible signs of precipitation. Only clear solutions free from particles should be used. The reconstituted solution 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 requirements.

Ceftriaxone Kalceks powder

Volume of solvent