CEFTRIAXON 1 g Powder

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Ceftriaxon Kabi 1 g, Powder for Solution for Injection/Infusion
   1. Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents
3. What is Ceftriaxon Kabi 1 g and What is it Used For
4. Important Information Before Using Ceftriaxon Kabi 1 g
   1. When Not to Use Ceftriaxon Kabi 1 g:
   2. Ceftriaxon Kabi 1 g Must Not be Used in Young Children if:
   3. Warnings and Precautions
   4. Blood or Urine Tests
   5. Children
   6. Ceftriaxon Kabi 1 g and Other Medicinal Products
   7. Pregnancy, Breast-Feeding, and Fertility
   8. Driving and Using Machines
   9. Ceftriaxon Kabi 1 g Contains Sodium
5. How to Use Ceftriaxon Kabi 1 g
   1. Usual Dose
   2. Adult Patients, Elderly Patients, and Children Over 12 Years Old Weighing 50 kg or More:
   3. Newborns, Infants, and Children Over 15 Days Old and Weighing Less Than 50 kg:
   4. Newborns (0-14 Days Old):
   5. Patients with Liver or Kidney Impairment
   6. Overdose of Ceftriaxon Kabi 1 g
   7. Missed Dose of Ceftriaxon Kabi 1 g
   8. Stopping Treatment with Ceftriaxon Kabi 1 g
6. Possible Side Effects
   1. Severe Allergic Reactions (Frequency Not Known - Cannot be Estimated from Available Data)
   2. Severe Skin Reactions (Frequency Not Known - Cannot be Estimated from Available Data)
   3. Common (May Affect Up to 1 in 10 People)
   4. Uncommon (May Affect Up to 1 in 100 People)
   5. Rare (May Affect Up to 1 in 1,000 People)
   6. Frequency Not Known (Cannot be Estimated from Available Data)
   7. Reporting Side Effects
7. How to Store Ceftriaxon Kabi 1 g
8. Package Contents and Other Information
   1. What Ceftriaxon Kabi 1 g Contains
   2. What Ceftriaxon Kabi 1 g Looks Like and Contents of the Package
   3. Marketing Authorization Holder and Manufacturer
   4. Marketing Authorization Holder
   5. Manufacturer
   6. This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:
   8. Ceftriaxon Kabi 1 g, Powder for Solution for Injection/Infusion
   9. Administration
   10. Instructions for Use
   11. Intramuscular Injections
   12. Intravenous Injections
   13. Intravenous Infusion
   14. Incompatibilities
   15. Reconstituted Solution
   16. Special Precautions for Storage

Package Leaflet: Information for the Patient

Ceftriaxon Kabi 1 g, Powder for Solution for Injection/Infusion

Ceftriaxonum

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

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Keep this package leaflet. You may need to read it again.
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In case of any doubts, consult a doctor, pharmacist, or nurse.
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This medicinal product has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What is Ceftriaxon Kabi 1 g and What is it Used For
• 2. Important Information Before Using Ceftriaxon Kabi 1 g
• 3. How to Use Ceftriaxon Kabi 1 g
• 4. Possible Side Effects
• 5. How to Store Ceftriaxon Kabi 1 g
• 6. Package Contents and Other Information

1. What is Ceftriaxon Kabi 1 g and What is it Used For

Ceftriaxon Kabi 1 g is an antibiotic used in adult patients and children (including newborns). Its action involves killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxon Kabi 1 g is used to treat infections of:
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the brain (meningitis);
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the lungs;
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the middle ear;
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the abdomen and abdominal wall (peritonitis);
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the urinary tract and kidneys;
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the bones and joints;
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the skin and soft tissues;
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the blood;
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the heart.
This medicinal product can be used:
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to treat certain sexually transmitted infections (gonorrhea and syphilis);
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to treat patients with a low white blood cell count (neutropenia) who have a fever caused by a bacterial infection;
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to treat infections in the chest in adult patients with chronic bronchitis;
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to treat Lyme disease (a disease transmitted by ticks) in adult patients and children, including newborns from the 15th day of life;
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to prevent infections during surgery.

2. Important Information Before Using Ceftriaxon Kabi 1 g

When Not to Use Ceftriaxon Kabi 1 g:

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if the patient is allergic to ceftriaxone or any of the other ingredients of this medicinal product (listed in section 6);
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if the patient has had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems, or 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, chest pain, and a rapidly spreading severe rash;
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if the patient is allergic to lidocaine and is to receive Ceftriaxon Kabi 1 g by intramuscular injection.

Ceftriaxon Kabi 1 g Must Not be Used in Young Children if:

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the child is premature;
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the child is a newborn (up to 28 days old) and has certain blood disorders or jaundice (yellowing of the skin and/or eyes), or is to receive a calcium-containing intravenous solution.

Warnings and Precautions

Before starting treatment with Ceftriaxon Kabi 1 g, the patient should discuss it with their doctor, pharmacist, or nurse if:
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the patient has recently received or is about to receive calcium-containing products;
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the patient has recently had diarrhea after antibiotic treatment. The patient has had intestinal problems, particularly colitis (inflammation of the large intestine);
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the patient has liver or kidney problems (see section 4);
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the patient has kidney stones or gallstones;
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the patient has other diseases, such as hemolytic anemia (reduced red blood cell count, causing pallor and weakness or shortness of breath);
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the patient is on a low-sodium diet;
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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").

Blood or Urine Tests

If the patient is receiving Ceftriaxon Kabi 1 g for a long time, regular blood tests may be necessary. The medicinal product may affect the results of urine sugar tests and a blood test called the Coombs test. If the patient is having tests:
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the person taking the sample should be informed that the patient is receiving Ceftriaxon Kabi 1 g.
If the patient has diabetes or needs to control their blood sugar levels, they should not use tests that may incorrectly measure blood sugar levels while taking ceftriaxone. If the patient is monitoring their blood sugar levels, they should check the instructions and inform their doctor, pharmacist, or nurse. Alternative testing methods should be used if necessary.

Children

Before administering Ceftriaxon Kabi 1 g to a child, the doctor, pharmacist, or nurse should be consulted if:
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the child has recently received or is about to receive a calcium-containing intravenous solution.

Ceftriaxon Kabi 1 g and Other Medicinal Products

The patient should tell their doctor or pharmacist about all medicinal products they are currently taking or have recently taken, as well as any medicinal products they plan to take.
In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicinal products:
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an aminoglycoside antibiotic;
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an antibiotic called chloramphenicol (used to treat infections, especially eye infections).

Pregnancy, Breast-Feeding, and Fertility

If the patient is pregnant or breast-feeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicinal product.
The doctor will assess the benefits of using Ceftriaxon Kabi 1 g for the mother and the risk for the child.

Driving and Using Machines

Ceftriaxon Kabi 1 g may cause dizziness. If dizziness occurs, the patient should not drive or operate any tools or machines. They should inform their doctor if they experience such symptoms.

Ceftriaxon Kabi 1 g Contains Sodium

This medicinal product contains 82.3 mg of sodium (the main component of common salt) per vial. This corresponds to 4.1% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to Use Ceftriaxon Kabi 1 g

Ceftriaxone is usually administered by a doctor or nurse. It is given as an intravenous infusion or by injection directly into a vein or muscle. Ceftriaxone is prepared by a doctor, pharmacist, or nurse and should not be mixed with or administered simultaneously with calcium-containing solutions.

Usual Dose

The doctor will decide what dose of Ceftriaxon Kabi 1 g 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 weight, and the patient's liver and kidney function. The number of days or weeks the patient will receive Ceftriaxon Kabi 1 g depends on the type of infection.

Adult Patients, Elderly Patients, and Children Over 12 Years Old Weighing 50 kg or More:

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1 g to 2 g, once a day, depending on the severity and type of infection. In cases of severe infection, the doctor may use a higher dose (up to 4 g once a day). If the daily dose is more than 2 g, the medicinal product can be administered in one dose or in two separate doses.

Newborns, Infants, and Children Over 15 Days Old and Weighing Less Than 50 kg:

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50 mg to 80 mg of Ceftriaxon Kabi 1 g per kg of body weight, once a day, depending on the severity and type of infection. In cases of severe infection, the doctor may use a higher dose of up to 100 mg per kg of body weight, up to a maximum of 4 g once a day. If the daily dose is more than 2 g, the medicinal product can be administered in one dose per day or in two separate doses.
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Children weighing 50 kg or more should receive the usual adult dose.

Newborns (0-14 Days Old):

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20 mg to 50 mg of Ceftriaxon Kabi 1 g per kg of body weight, once a day, depending on the severity and type of infection.
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The maximum daily dose should not exceed 50 mg per kg of body weight.

Patients with Liver or Kidney Impairment

The patient may receive a different dose than usual. The doctor will determine what dose of Ceftriaxon Kabi 1 g is suitable for the patient and will closely monitor their condition depending on the severity of liver and kidney disease.

Overdose of Ceftriaxon Kabi 1 g

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

Missed Dose of Ceftriaxon Kabi 1 g

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 Ceftriaxon Kabi 1 g

The patient should not stop treatment with Ceftriaxon Kabi 1 g unless their doctor advises them to do so. If the patient has any further doubts about using this medicinal product, they should consult their doctor or nurse.

4. Possible Side Effects

Like all medicinal products, Ceftriaxon Kabi 1 g can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with this medicinal product:

Severe Allergic Reactions (Frequency Not Known - Cannot be Estimated from Available Data)

In case of a severe allergic reaction, the patient should inform their doctor immediately.
Symptoms may include:
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sudden swelling of the face, throat, lips, or mouth; may make breathing or swallowing difficult;
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sudden swelling of the hands, feet, and ankles;
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chest pain related to an allergic reaction, which may be a sign of a heart attack caused by an allergy (Kounis syndrome).

Severe Skin Reactions (Frequency Not Known - Cannot be Estimated from Available Data)

In case of a severe skin reaction, the patient should inform their doctor immediately.
Symptoms of such a reaction may include:
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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);
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any of the following symptoms: spreading rash, high body temperature, increased liver enzyme activity in blood tests, abnormal blood test results (eosinophilia), and swollen lymph nodes (symptoms of severe skin reactions with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome);
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Jarisch-Herxheimer reaction causing fever, chills, headache, muscle pain, and skin rash, usually self-limiting; this reaction occurs shortly after starting treatment with Ceftriaxon Kabi 1 g for infections caused by spirochetes, such as Lyme disease.
Other possible side effects:

Common (May Affect Up to 1 in 10 People)

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abnormalities in white blood cell count (e.g., decreased leukocyte count and increased eosinophil count) and platelet count (decreased platelet count);
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loose stools or diarrhea;
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changes in liver function test results;
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rash.

Uncommon (May Affect Up to 1 in 100 People)

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fungal infections (e.g., thrush);
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decreased white blood cell count (granulocytopenia);
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decreased red blood cell count (anemia);
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blood clotting problems; symptoms may include easy bruising and pain or swelling in the joints;
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headache;
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dizziness;
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nausea or vomiting;
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itching (pruritus);
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pain or burning along the vein into which Ceftriaxon Kabi 1 g was administered, pain at the injection site;
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high temperature (fever);
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abnormal kidney function test results (increased creatinine levels in the blood).

Rare (May Affect Up to 1 in 1,000 People)

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inflammation of the large intestine (colitis); symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever;
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breathing difficulties (bronchospasm);
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hives (urticaria), which may spread across the body, itching, and swelling;
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blood or sugar in the urine;
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swelling (fluid retention);
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chills;
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treatment with ceftriaxone - especially in elderly patients with severe kidney or nervous system disorders - may rarely cause decreased consciousness, abnormal movements, agitation, and seizures.

Frequency Not Known (Cannot be Estimated from Available Data)

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secondary infection that cannot be treated with previously used antibiotics;
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a certain type of anemia in which red blood cells are destroyed (hemolytic anemia);
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significant decrease in white blood cell count (agranulocytosis);
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seizures;
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severe dizziness (feeling of spinning);
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pancreatitis; symptoms include severe abdominal pain radiating to the back;
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inflammation of the mouth mucosa;
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inflammation of the tongue; symptoms include swelling, redness, and pain in the tongue;
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problems related to the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, extremely dark urine, and clay-colored stools;
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a nervous system disease that may occur in newborns with severe jaundice (kernicterus);
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kidney problems caused by the deposition of ceftriaxone calcium salt; may cause pain when urinating or producing a small amount of urine;
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false-positive Coombs test result (a test that detects certain blood disorders);
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false-positive galactosemia test result (a test for abnormal galactose accumulation in the body);
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Ceftriaxon Kabi 1 g 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 the package leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
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 medicinal product.

5. How to Store Ceftriaxon Kabi 1 g

The medicinal product should be stored out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store the vial in the outer packaging to protect it from light.
The ceftriaxone solution prepared after dissolving the powder should be used immediately. However, the solution can be stored for 12 hours at 25°C or for 2 days at a temperature between 2°C and 8°C.
Do not use this medicinal product if it is visible that the solution is cloudy, the solution should be completely clear. Unused solution should be discarded.
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. This will help protect the environment.

6. Package Contents and Other Information

What Ceftriaxon Kabi 1 g Contains

The active substance of the medicinal product is ceftriaxone. Each vial contains 1 g of ceftriaxone in the form of ceftriaxone sodium.

What Ceftriaxon Kabi 1 g Looks Like and Contents of the Package

Solutions may be colorless to pale yellow.
Ceftriaxon Kabi 1 g, powder for solution for injection/infusion, is available in packs of 5 or 10 glass vials with powder, closed with a butyl rubber stopper with an aluminum seal. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Labesfal, Laboratorios Almiro, S.A. (Fresenius Kabi Group)
3465-157 Santiago de Besteiros
Portugal
To obtain more detailed information, the patient should contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria
Ceftriaxon Kabi 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Belgium
Ceftriaxone Fresenius Kabi 1g poeder voor oplossing voor injectie/infusie
Czech Republic
Ceftriaxon Kabi 1g, prášek pro injekční/infuzní roztok
Denmark
Ceftriaxon Fresenius Kabi
Estonia
Ceftriaxone Kabi 1 g
Finland
Ceftriaxon Fresenius Kabi 1 g injektio-/infuusiokuiva-aine, liuosta varten
Greece
Ceftriaxone Kabi 1g, κόνις για ενέσιμο διάλυμα/διάλυμα προς έγχυση
Netherlands
Ceftriaxone Fresenius Kabi 1g poeder voor oplossing voor injectie/infusie
Lithuania
Ceftriaxone Kabi 1 g milteliai injekciniam / infuziniam tirpalui
Luxembourg
Ceftriaxon Kabi 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Latvia
Ceftriaxone Kabi 1 g pulveris injekciju/infūziju šķīduma pagatavošanai
Germany
Ceftriaxon Kabi 1 g
Norway
Ceftriaxon Fresenius Kabi 1 g pulver til injeksjons-/infusjonsvæske, oppløsning
Poland
Ceftriaxon Kabi 1 g
Portugal
CEFTRIAXONA KABI
Slovakia
Ceftriaxon Kabi 1 g
Sweden
Ceftriaxon Fresenius Kabi 1 g, pulver till injektions-/ infusionsvätska, lösning
Hungary
Ceftriaxon Kabi 1 g por oldatos injekcióhoz / infúzióhoz
Date of Last Revision of the Package Leaflet:02.05.2024
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Information Intended for Healthcare Professionals Only:

Ceftriaxon Kabi 1 g, Powder for Solution for Injection/Infusion

See the Summary of Product Characteristics (SPC).

Administration

Ceftriaxon Kabi 1 g can be administered by intravenous infusion over at least 30 minutes (recommended administration method) or by slow intravenous injection over 5 minutes, or by deep intramuscular injection. Intravenous injection in a longer period than 5 minutes should be performed preferably in a large vein. In infants and children under 12 years old, intravenous doses of 50 mg/kg or more should be administered by intravenous infusion. In newborns, intravenous doses should be administered over a period longer than 60 minutes to reduce the potential risk of bilirubin encephalopathy (see sections 4.3 and 4.4 of the SPC). Intramuscular injections should be administered to an appropriate depth in a relatively large muscle. Do not administer more than 1 g per injection site. Intramuscular administration should be considered when intravenous administration is not possible or is less appropriate for the patient. Doses of 2 g or more should be administered intravenously.
In case of using a lidocaine solution as a solvent, the resulting solution should never be administered intravenously (see section 4.3 of the SPC). The information provided in the Lidocaine Summary of Product Characteristics should be taken into account.
Ceftriaxone is contraindicated in neonates (≤28 days) who are receiving (or are expected to receive) calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition, due to the risk of precipitation of ceftriaxone-calcium salt (see section 4.3 of the SPC).
Due to the risk of precipitation, ceftriaxone should not be used with calcium-containing solutions (e.g., Ringer's solution, Hartmann's solution) for dissolution or further dilution for intravenous administration. Ceftriaxone-calcium salt may also precipitate in a mixture of ceftriaxone and a calcium-containing solution in the same intravenous administration set. Therefore, ceftriaxone should not be mixed or administered simultaneously with calcium-containing solutions (see sections 4.3, 4.4, and 6.2 of the SPC).

Instructions for Use

Ceftriaxone should not be mixed in the same syringe with any other medicinal product except 1% lidocaine hydrochloride solution (only for intramuscular injections).
The prepared solution should be shaken for at least 60 seconds to ensure complete dissolution of ceftriaxone.
Ceftriaxone has been shown to be compatible with the following solutions:

• 0.9% (9 mg/ml) sodium chloride solution;
• 1% (10 mg/ml) lidocaine hydrochloride solution;
• 5% (50 mg/ml) glucose solution;
• water for injections.

To prepare the solution for administration, the following should be used exclusively:

Intramuscular Injections

The prepared solution should be administered by deep intramuscular injection into the gluteal muscle.
The lidocaine solution should not be administered intravenously.

Intravenous Injections

The prepared solution should be injected over at least 5 minutes, directly into a vein or through an intravenous infusion set.
Solutions prepared for injection are pale yellow, which does not affect the efficacy or tolerance of Ceftriaxon Kabi 1 g.

Intravenous Infusion

Preparation of the final solution for infusion involves two stages to achieve the desired infusion volume:

• 1. Ceftriaxon Kabi 1 g, powder for solution for infusion, should be dissolved in a vial with 10 ml of one of the compatible infusion solutions. This solution should be transferred to an appropriate infusion bag. Controlled and validated aseptic conditions should be maintained.
• 2. The prepared solution should be diluted with 9.5 ml of solvent to achieve a final volume of 20 ml and a concentration of 50 mg/ml.

The infusion should be administered over at least 30 minutes.
To ensure that the entire volume of the Ceftriaxon Kabi 1 g solution is administered, it is recommended to flush the infusion line with one of the solvents at the end of the infusion.
The solution should be inspected after preparation. Only a clear solution without visible particles should be used. The reconstituted solution is for single use only, and any unused solution should be discarded.
Any unused medicinal product or waste materials should be disposed of in accordance with local requirements.

Incompatibilities

According to literature data, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, aminoglycoside antibiotics, and labetalol.
Do not mix the medicinal product with other medicinal products except those mentioned in the "Instructions for Use" section.
In particular, do not use calcium-containing solvents (e.g., Ringer's solution, Hartmann's solution) for dissolving ceftriaxone or further diluting the dissolved powder for intravenous administration, as precipitation may occur. Do not mix ceftriaxone with or administer it simultaneously with calcium-containing solutions, including parenteral nutrition solutions.

Reconstituted Solution

Chemical and physical stability of the solution has been demonstrated for 12 hours at 25°C and for 2 days at a temperature between 2°C and 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions. The solution should not be stored for more than 24 hours at a temperature between 2°C and 8°C, unless it has been prepared in controlled and validated aseptic conditions.

Special Precautions for Storage

Store the vial in the outer packaging to protect it from light.
Storage conditions for the reconstituted solution, see "Reconstituted Solution" section.