Observe the patient - CEFTRIAXONE VIATRIS 1 g, pour pour solution for injection (2023)

ANSM - Updated on: 06/14/2022

CEFTRIAXONE VIATRIS 1 g, pour pour solution for injection

ceftriaxone

Read this leaflet carefully before using this medicine as it contains important information for you.

· Save this note. 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. Do not share it with anyone else. This can harm them even if the signs of illness are the same as yours.

· If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to side effects not mentioned in this leaflet. See section 4.

What does this booklet contain?

1. What is CEFTRIAXON VIATRIS 1 g powder for solution for injection and when is it used?

2. What information do you need to know before using CEFTRIAXONE VIATRIS 1 g powder for solution for injection?

3. How to use CEFTRIAXON VIATRIS 1 g powder for solution for injection?

4. What are the possible side effects?

5. How to store CEFTRIAXON VIATRIS 1 g powder for solution for injection?

6. Package contents and other information.

1. WHAT IS CEFTRIAXON VIATRIS 1 g powder for solution for injection AND WHAT IS IT USED FOR?

Pharmacotherapeutic group: antibacterials for systemic use, third-generation cephalosporins, ATC code: J01DD04.

This medicine is an antibiotic indicated for adults and children (including newborns). It works by killing the bacteria responsible for infections. It belongs to a group of medicines called cephalosporins.

This medicine is used to treat infections:

· of the brain (meningitis);

· Thrust;

· middle ear;

· the abdomen and abdominal wall (peritonitis);

· urine and kidneys;

· bones and joints;

· skin and soft tissues;

· you sang

· from my heart.

Can be given to:

· treatment of specific sexually transmitted infections (gonorrhea and syphilis);

· to treat patients with low white blood cell counts (neutropenia) and fever suspected to be caused by bacteria;

· Treatment of acute exacerbations 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 infections associated with surgery.

2. BEFORE YOU USE CEFTRIAXONE VIATRIS 1 g powder for solution for injection?

Never use CEFTRIAXONE VIATRIS 1 g powder for solution for injection:

· if you are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6);

· if you have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems or monobactams). Signs include sudden swelling of the throat or face that can cause difficulty breathing or swallowing, sudden swelling of the hands, feet and ankles, and a severe rash that develops quickly;

· If you are allergic to lidocaine and need an injection of ceftriaxone into a muscle.

CEFTRIAXONE VIATRIS 1 g powder for solution for injection should not be used in infants if:

· Premature;

· Newborns (up to 28 days old) with certain blood problems or jaundice (yellowing of the skin or whites of the eyes) or when a product containing calcium needs to be injected into a vein.

Warnings and Precautions

Please talk to your doctor, pharmacist or nurse before usingCEFTRIAXONE VIATRIS 1 g, pour pour solution for injection:

· if you have recently used or are about to use products containing calcium;

· if you have recently had diarrhea after taking an antibiotic. if you have ever had bowel problems, particularly colitis (inflammation of the bowel);

· if you have liver or kidney problems (see section 4);

· if you have gallstones or kidney stones;

· if you have other medical conditions, such as B. hemolytic anemia (decrease in red blood cells that can turn the skin pale yellow and cause weakness or shortness of breath);

· If you are on a low sodium diet.

· if you have or have ever had a combination of the following symptoms: rash, red skin, blistering of the lips, eyes and mouth, peeling skin, high fever, flu-like symptoms, increased liver enzymes in blood tests and increased a type of white blood cell (eosinophilia) and Swelling of the lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).

3. HOW TO USE CEFTRIAXON VIATRIS 1 g powder for solution for injection?

Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, ask your doctor or pharmacist.

This medication is usually given by a doctor or nurse. It can be given as a drip (intravenous infusion) or injected directly into a vein or muscle. This medicine is being prepared by the doctor, pharmacist or nurse and must not be mixed or given at the same time as injections containing calcium.

Dose habitual

Your doctor will prescribe the appropriate dose of ceftriaxone for you. The dose depends on the severity and type of infection, whether you are taking other antibiotics, your weight and age, and how well your kidneys and liver are working. The number of days or weeks you take this medication depends on the type of infection you have.

Adults, elderly patients, and children 12 years and older 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 severe infection, your doctor will give you a higher dose (up to 4 g once a day). If your daily dose is more than 2g, you can take it as a single dose, once a day or in two divided doses.

Newborns, infants and children aged 15 days to 12 years weighing less than 50 kg:

· 50 to 80 mg of ceftriaxone per kilogram of the child's body weight once a day, depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose of up to 100mg per kilogram of body weight, up to a maximum of 4g once a day. If your daily dose is more than 2g, you can take it as a single dose, once a day or in two divided doses.

· Children weighing 50 kg or more should receive the usual adult dose.

Newborn (0-14 days)

· 20 to 50 mg of ceftriaxone per kilogram 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.

People with liver and kidney problems

You can take a different dose than usual. Your doctor will determine the dose of ceftriaxone you need and will monitor you carefully depending on the severity of your liver and kidney disease.

If you use more CEFTRIAXON VIATRIS 1 g powder for solution for injection than you should

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

If you forget to use CEFTRIAXON VIATRIS 1 g powder for solution for injection

If you miss an injection, give the injection as soon as possible. However, if the time for the next injection is too close, do not give the missed injection. Do not take a double dose (two injections at a time) to make up for the missed injection.

If you stop using CEFTRIAXON VIATRIS 1 g powder for solution for injection

Do not stop using CEFTRIAXON VIATRIS 1 g powder for solution for injectionunless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. WHAT ARE THE 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 medication:

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

If you have a severe allergic reaction, see a doctor right away.

Signs can be:

· A sudden swelling of the face, throat, lips or mouth. You may then have difficulty breathing or swallowing;

· Sudden swelling of the hands, feet and ankles.

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

If you have a severe rash, see a doctor right away.

Signs can be:

· A rapidly developing severe rash with blistering or peeling skin and possibly blisters in the mouth (Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

· A combination of the following symptoms: generalized rash, increased body temperature, increased liver enzymes, abnormal blood tests (eosinophilia), swollen lymph nodes, and other organ involvement (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or systemic drug syndrome). hypersensitivity syndrome with eosinophilia).

· Jarisch-Herxheimer reaction, which causes fever, chills, headache, muscle pain, and rash that usually goes away on its own. This occurs shortly after starting ceftriaxone treatment for spirochetal infections such as Lyme disease.

Other possible side effects:

Common (may affect up to 1 in 10 people)

· abnormalities in white blood cells (such as decreased white blood cells and increased eosinophils) and platelets (decreased platelets);

· loose stools or diarrhea;

· changes in blood test results to measure liver function;

· skin irritation

Uncommon (may affect up to 1 in 100 people)

· infection with a fungus (for example, candidiasis);

· reduced number of white blood cells (granulocytopenia);

· reduced number of red blood cells (anaemia);

· blood clotting problems. Signs can include easy bruising, joint pain and swelling;

· Headache ;

· Dizziness;

· urge to vomit or vomit;

· pruritus (itching);

· pain or burning along the vein into which this medication was given; pain at the injection site;

· high temperature (fever);

· Abnormal result of a blood test that measures kidney function (increase in blood creatinine).

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

· Inflammation of the large intestine (colon). Signs can include diarrhea, usually with blood and mucus, stomach pain and fever.

· difficulty breathing (bronchospasm);

· skin rash (urticaria) which may cover a large part of the body with itching and swelling;

· blood or sugar in the urine;

· edema (fluid retention);

· Chills.

Treatment with ceftriaxone, particularly in elderly patients with severe kidney or nervous system problems, may in rare cases lead to impaired consciousness, abnormal movements, agitation and convulsions.

Not known (effects whose frequency cannot be estimated from the available data)

· A minor infection that may not be treatable with an already prescribed antibiotic

· A form of anemia in which red blood cells are destroyed (haemolytic anaemia)

· Significant decrease in the number of certain white blood cells (agranulocytosis);

· Cramps;

· dizziness (head spinning);

· Inflammation of the pancreas (pancreatitis). Signs can include severe abdominal pain that spreads to your back.

· inflammation of the lining of the mouth (stomatitis);

· Inflammation of the tongue (glossitis). Signs can include swelling, redness, and soreness of the tongue;

· gallbladder problemsand/or liver that can causepain, nausea, vomiting, yellowish skin, itching, abnormally dark urine and clay-colored stools;

· Neurological condition that can affect newborns with severe jaundice (kernicterus);

· Kidney problems due to ceftriaxone calcium deposits, which can cause painful urination or small urine production;

· false-positive Coombs test (a test that detects certain blood problems);

· false positive result for galactosemia (abnormal accumulation of a sugar called galactose);

· This medicine can affect the results of some types of tests that measure the amount of sugar in the blood. Ask your doctor.

Declaration of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to side effects not mentioned in this leaflet. You can also report side effects directly through the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

By reporting side effects, you help provide more information about the safety of the medicine.

5. HOW TO STORE CEFTRIAXONE VIATRIS 1 g powder for solution for injection?

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 bottle. The expiration date refers to the last day of that month.

This medicine should be stored at a temperature not exceeding 25°C.

The solution must be used immediately after reconstitution. However, its stability has been demonstrated for 8 hours at a temperature not exceeding +25 °C and 24 hours at a temperature between +4 °C and +8 °C.

Don't throw medicine down the drainor withTrash. Ask your pharmacist how to throw away medicines you no longer use. These measures help protect the environment.

6. PACKAGING CONTENT AND OTHER INFORMATION

What CEFTRIAXONE VIATRIS 1 g powder for solution for injection contains

· The active ingredient is:

Ceftriaxon-Natrium (1193 mg Ceftriaxon-Natrium ou 1000 mg Ceftriaxon-Base)

What Ceftriaxone Viatris looks like and contents of the pack

This medicine is in the form of a powder to be made up into a solution for injection. Box of 1, 10 and 30 vial(s).

10 ml bottle (type I or II glass) with stopper (halobutyl) with aluminum cap; Box of 1, 10 or 30.

15 ml vial (type I glass) with stopper (bromobutyl) with aluminum cap; box of 10.

license holder

VIATRIS HEALTH

1 RUE-DE-TULIN

69007 LYON

homologation operator

VIATRIS HEALTH

1 RUE-DE-TULIN

69007 LYON

Manufacturer

WESSLING HUNGARY LTD.

ANONYMOUS U. 6

1045 BUDAPEST

HUNGARY

MITIM S.R.L.

VIA CACCIAMALI, 34-38

25125 BRESCIA

ITALY

Drug names in member states of the European Economic Area

Not applicable.

The last date this notice was revised is:

To be completed later by the holder

Others

Detailed information about this medicine is available on the ANSM (France) website.

The following information is intended for healthcare professionals only:

perfusion: Dissolve 2 g of ceftriaxone in 40 ml of water for injections or in 40 ml of one of the following solutions for infusion: sodium chloride 0.9%; 0.45% + 2.5% glucose; 5% glucose; 10% glucose; 6% dextran in 5% glucose; Hydroxyethyl Starch 6-10%.

HEALTH EDUCATION COUNCIL

WHAT TO KNOW ABOUT ANTIBIOTICS?

Antibiotics are effective in fighting infections caused by bacteria. They are not effective against viral infections.

Furthermore, your doctor has decided to prescribe you this antibiotic because it is precisely adapted to your case and your current illness.

Bacteria have the ability to survive or multiply despite the effects of an antibiotic. This phenomenon is called resistance: it makes certain antibiotic treatments ineffective.

Resistance increases due to overuse or inappropriate use of antibiotics.

You run the risk of encouraging the emergence of resistant bacteria, delaying your healing or even making this medicine ineffective, if you do not do the following:

· to dose to be taken,

· intake times,

· and the duration of treatment.

To keep this medicine working:

1- Only use an antibiotic if your doctor prescribes it for you.

2- Strictly follow your prescription.

3- Do not reuse an antibiotic without a prescription, even if you think you are fighting an apparently similar illness.

4- Never give your antibiotic to someone else, it may not be suitable for your illness.

5- At the end of your treatment, return all open packages to your pharmacist for the correct and proper disposal of this medicine.