2 g powder for solution for infusion 
ceftriaxone

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Ceftriaxone Fresenius Kabi is and what it is used for 
2. What you need to know before you get Ceftriaxone Fresenius Kabi 
3. How Ceftriaxone Fresenius Kabi is given 
4. Possible side effects 
5. How Ceftriaxone Fresenius Kabi should be stored 
6. Contents of the packaging and other information 

What Ceftriaxone Fresenius Kabi is and what it is used for

Ceftriaxone Fresenius Kabi is an antibiotic given to adults and children (including newborns). It works by killing bacteria that cause infection. It belongs to a group of medicines called cephalosporins.

Ceftriaxone Fresenius Kabi is used to treat infections in:

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

It can be given:

  • to treat certain sexually transmitted diseases ( gonorrhea and syphilis ).
  • to treat patients with low white blood cell count ( neutropenia ) who have a fever caused by a bacterial infection.
  • to treat your chest infection in adults with chronic bronchitis.
  • to treat Lyme disease (caused by tick bites) in adults and children including newborns from 15 days of age.
  • to prevent infection during surgery.

Ceftriaxone contained in Ceftriaxone Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you get Ceftriaxone Fresenius Kabi

You should not be treated with Ceftriaxone Fresenius Kabi if:

  • You are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6).
  • You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems, or monobactams). Symptoms include sudden swelling of the throat or face which may make it difficult to breathe or swallow, sudden swelling of the hands, feet, and ankles, and severe rashes that develop rapidly.
  • You are allergic to lidocaine and you should receive Ceftriaxone Fresenius Kabi as an injection into a muscle.

Ceftriaxone Fresenius Kabi should not be given to infants if:

  • The baby is born prematurely.
  • The baby is a newborn (up to 28 days of age) and has certain types of blood problems or jaundice (yellowing of the skin or whites of the eyes) or if the baby is to be given a product that contains calcium in a vein.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before you are treated with Ceftriaxone Fresenius Kabi if:

  • You have recently received or will receive products that contain calcium.
  • You have recently had diarrhea after taking an antibiotic. Have you ever had problems with your stomach, especially colitis ( inflammation of the intestines)?
  • You have liver or kidney problems.
  • You have gallstones or kidney stones.
  • You have had other diseases, such as hemolytic anemia (a decrease in your red blood cells that can make your skin pale yellow and cause weakness or shortness of breath).
  • You are on a sodium controlled diet.
  • You are experiencing or have previously experienced a combination of some of the following symptoms: rash, redness, blisters on the lips, eyes, and mouth, scaly skin, high fever, flu-like symptoms , increased levels of liver enzymes seen in blood tests, and an increase in a type of white blood cells ( eosinophilia ) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).

If you need a blood or urine sample

If you are being treated with Ceftriaxone Fresenius Kabi for a long time, you may need to have regular blood tests. Ceftriaxone Fresenius Kabi can affect the results of tests for sugar in the urine and a blood test called the Coombs test. If you are going to take a test:

  • Tell the person taking the test that you are being treated with Ceftriaxone Fresenius Kabi.

Some blood glucose monitoring systems may measure your blood sugar incorrectly while you are receiving ceftriaxone. If you are diabetic or need to monitor your blood sugar level, do not use them. Check the instructions for use for your blood glucose monitoring system and talk to your doctor, pharmacist, or nurse. Alternative test methods should be used if necessary.

Children

Talk to your doctor, pharmacist, or nurse before treating your child with Ceftriaxone Fresenius Kabi if:

  • He/she has recently received or will receive, a product that contains calcium in a vein.

Other medicines and Ceftriaxone Fresenius Kabi

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are taking any of the following medicines, tell your doctor or pharmacist in particular:

  • A type of antibiotic called aminoglycoside.
  • An antibiotic called chloramphenicol (used to treat infections, especially in the eyes).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will weigh the benefits of treating you with Ceftriaxone Fresenius Kabi against the risk to your child.

Driving and using machines

Ceftriaxone Fresenius Kabi may cause dizziness. If you feel dizzy, do not drive or use any tools or machines. Talk to your doctor if you experience any of these symptoms.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ceftriaxone Fresenius Kabi contains sodium

Ceftriaxone Fresenius Kabi 2 g contains 7.2 mmol (166 mg) sodium per dose . This should be considered by patients on a low-salt diet.

3. How Ceftriaxone Fresenius Kabi is given

Ceftriaxone Fresenius Kabi is usually given by a doctor or nurse. It can be given as a drip ( intravenous infusion ) or as an injection directly into a vein or muscle. Ceftriaxone Fresenius Kabi is prepared by your doctor, pharmacist, or nurse and will not be mixed with or given at the same time as calcium-containing injections.

The usual dose is one

Your doctor will determine the correct dose of Ceftriaxone Fresenius Kabi for you. Dose one depends on the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys and liver are working. The number of days or weeks you receive Ceftriaxone Fresenius Kabi depends on the type of infection you have.

Adults, the elderly, and children 12 years or older and weighing 50 kilograms (kg) or more:

  • 1 to 2 g once a day depending on the severity and type of infection. If you have a serious infection, your doctor will give you a higher dose (up to 4 g once a day). If your daily dose is higher than 2 g, you can get it as a single dose once a day or as two separate doses.

Newborns and children from 15 days to 12 years of age with a bodyweight of less than 50 kg:

  • 50-80 mg Ceftriaxone Fresenius Kabi for each kg of the child’s body failure once daily depending on the severity and type of infection. If you have a serious infection , your doctor will give you a higher dose of up to 100 mg per kg of body weight up to a maximum of 4 g once daily. If your daily dose is higher than 2 g, you can get it as a single dose once a day or as two separate doses.
  • Children with a bodyweight of 50 kg or more should be given the usual adult dose.

Newborn babies (0 – 14 days)

  • 20-50 mg Ceftriaxone Fresenius Kabi for each kg of body weight once daily depending on the severity and type of infection.
  • The maximum daily dose should not exceed 50 mg per kg of body weight of the child.

People with liver and kidney problems

You may be given a different dose than the standard dose. Your doctor will decide how much of Ceftriaxone Fresenius Kabi you need and will monitor you carefully depending on how severe your liver or kidney disease is.

If you receive more Ceftriaxone Fresenius Kabi than you should

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

If you forget to use Ceftriaxone Fresenius Kabi

If you miss a dose , get it as soon as possible. However, if it is soon time for your next dose, skip the missed dose. Do not take a double dose (two injections at the same time) to compensate for a missed dose.

If you stop using Ceftriaxone Fresenius Kabi

Do not stop taking Ceftriaxone Fresenius Kabi unless your doctor tells you to.

If you have any further questions on the use of this product, ask your 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 with this medicine:

Severe allergic reactions (frequency not known, cannot be calculated from the available data)

If you get a severe allergic reaction, tell your doctor immediately.

Symptoms may include:

  • Sudden swelling of the face, neck, lips, or mouth. This may make it difficult to breathe or swallow.
  • Sudden swelling of hands, feet, or ankles.

Severe skin reactions (not known frequency, can not be calculated from the available data)

If you get a severe rash, tell your doctor immediately.

Symptoms may include.

  • Severe rash that develops suddenly, with blisters or scaling of the skin and possibly blisters in the mouth. (Steven-Johnson syndrome and toxic epidermal necrolysis knew as SJS and TEN).
  • A combination of some of the following symptoms: scattered skin rash, high body temperature, elevated liver enzyme levels, abnormal blood levels ( eosinophilia ), enlarged lymph nodes, and effects on other organs (drug reaction with eosinophilia and systemic symptoms also known as DRESS or hypersensitivity syndrome).
  • Jarisch-Herxheimer reaction causes fever, chills, headache, muscle aches, and rash which is usually transient. This occurs shortly after treatment with ceftriaxone Kabi spiroket- against infection s such as Lyme disease has begun.

Other possible side effects:

Common (may affect up to 1 in 10 people )

  • Abnormalities in your white blood cells (such as a decrease in leukocytes and an increase in eosinophils ) and platelets (decrease in platelets ).
  • Loose stools or diarrhea.
  • Changes in the results of blood tests for liver function.
  • Rash.

Uncommon (may affect up to 1 in 100 people )

  • Fungal infections (eg cod).
  • A decrease in the number of white blood cells ( granulocytopenia ).
  • A decrease in the number of red blood cells ( anemia ).
  • Problems with how your blood clots. Symptoms may include bruising and joint pain and swelling.
  • Headache.
  • Dizziness.
  • Nausea or vomiting.
  • Pruritus ( itching ).
  • Pain or a burning sensation along the vein in which Ceftriaxone Fresenius Kabi was given. Pain where the injection was given.
  • High body temperature (fever).
  • Abnormal kidney function test (increased blood creatinine).

Rare (may affect up to 1 in 1000 people )

  • Inflammation of the colon ( colon ). Symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever.
  • Difficulty breathing ( bronchospasm ).
  • Elevated rash ( hives ) that can cover large parts of your body, and itchy feeling, and swelling.
  • Blood or sugar in your urine.
  • Edema (fluid retention).
  • Overindulge.

No known frequency (cannot be calculated from the available data)

  • A secondary infection may not respond to the antibiotics previously prescribed.
  • A type of anemia in which red blood cells are destroyed ( hemolytic anemia ).
  • Severe decrease in white blood cells ( agranulocytosis ).
  • Cramps.
  • Dizziness (a tingling sensation).
  • Inflammation of the pancreas ( pancreatitis ). Symptoms include severe abdominal pain that spreads to your back.
  • Inflammation of the mucous membrane of the mouth ( stomatitis ).
  • Inflammation of the tongue ( glossitis ). Symptoms include swelling, redness, and soreness of the tongue.
  • Problems with your gallbladder, which can cause pain, nausea, and vomiting.
  • A neurological condition that can occur in newborns with severe jaundice (kernicterus).
  • Kidney problems caused by precipitation of calcium ceftriaxone. Pain may occur when urinating or with low urine output.
  • A false-positive result for the Coombs test (a test for certain blood problems).
  • A false-positive test for galactosemia (an abnormal accumulation of galactose sugar).
  • Ceftriaxone Fresenius Kabi may interfere with certain types of blood glucose tests – ask your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Ceftriaxone Fresenius Kabi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Keep the vial in the outer carton. Sensitive to light.

The reconstituted ceftriaxone solution should be used immediately. However, the solution can be stored for a maximum of 12 hours at 25 ° C, or for 2 days at 2 – 8 ° C.

Do not use this medicine if you notice that the solution is cloudy. Only clear solutions should be used. Unused solution should be discarded.

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

6. Contents of the packaging and other information

Content declaration

  • The active substance is ceftriaxone sodium corresponding to ceftriaxone 2.0 g. The amount of sodium is 166 mg/vial.

What the medicine looks like and the contents of the pack

The color of the solution may vary from colorless to pale yellow.

Pack sizes: 5, 7, or 10 vials of powder for solution for infusion, closed with a rubber stopper and an aluminum cap. Not all pack sizes may be marketed.

Manufacturer: 
Labesfal – Laboratorios Almiro, SA, Lagedo, 3465-157 Santiago de Besteiros, Portugal

Muhammad Nadeem

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