Name of the drug
Ceftriaxone
framed
Please read this leaflet carefully before using this medicine as it contains important information for you.
· Keep this leaflet. You might 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 give this to anyone else. It could harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any adverse effects not mentioned in this leaflet. See section 4.
What does this booklet contain ?
1. What is CEFTRIAXONE SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM) and in which cases is it used?
2. What should you know before using CEFTRIAXONE SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM)?
3. How to use CEFTRIAXONE SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM)?
4. What are the possible side effects?
5. How to store CEFTRIAXONE SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM)?
6. Package contents and other information.
1. WHAT IS CEFTRIAXONE SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM) AND WHAT IT IS USED FOR? Return to the top of the page
Pharmacotherapeutic group: antibacterial for systemic use, third generation cephalosporins, ATC code: J01DA04.
CEFTRIAXONE SUN is an antibiotic indicated for adults and children (including neonates). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
CEFTRIAXONE SUN is used to treat infections:
brain (meningitis);
· lungs ;
middle ear;
the abdomen and the wall of the abdomen (peritonitis);
urinary tract and kidneys;
bones and joints;
· skin and soft tissues;
· some blood
· of the heart.
It can be given for:
· treat specific sexually transmitted infections (gonorrhoea and syphilis);
treat patients with low white blood cell count (neutropenia) and fever, suspected to be caused by bacteria;
- treat acute exacerbations in adults with chronic bronchitis;
treat Lyme disease (due to tick bites) in adults and children, including newborn babies from 15 days of age;
prevent infections related to surgery.
2. BEFORE YOU USE CEFTRIAXONE SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM)? Return to the top of the page
Never use CEFTRIAXONE SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM):
if you are allergic to ceftriaxone or to any of the other ingredients of this medication mentioned 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 which may cause difficulty in breathing or swallowing, sudden swelling of the hands, feet and ankles, and a severe rash that develops rapidly;
if you are allergic to lidocaine and need to use CEFTRIAXONE SUN by injection into a muscle.
CEFTRIAXONE SUN should not be used in the following cases:
· Premature;
Newborn babies (up to 28 days old) with certain blood problems or jaundice (yellowing of the skin or whites of the eyes) or if a product containing calcium needs to be injected into the vein.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using CEFTRIAXONE SUN.
if you have recently used or are about to use products that contain calcium;
if you have recently had diarrhea after taking an antibiotic. If you have ever had bowel problems, especially colitis (bowel inflammation);
if you suffer from liver or kidney problems (see section 4)
if you have gallstones or kidney stones;
if you have other conditions, such as haemolytic anemia (decrease in your red blood cells, which can make your skin pale yellow and give you 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, redness, blistering of the lips, eyes and mouth, peeling skin, high fever, flu-like symptoms, increased levels of liver enzymes in blood tests and increase in a type of white blood cells (eosinophilia) and swelling of the lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).
If you need to do a blood or urine test
If you are using Ceftriaxone SUN for a long time you may need regular blood tests. Ceftriaxone SUN may affect the results of urine tests that screen for the presence of sugar in the urine, and of a blood test called the Coombs test. If you need to test:
Tell the person taking the sample that you have taken Ceftriaxone SUN.
If you have diabetes or require blood sugar monitoring, you should not use certain blood sugar monitoring devices that may incorrectly assess your blood sugar while you are receiving ceftriaxone.
If you use this type of device, check the instructions for use and inform your doctor, pharmacist or nurse. Alternative methods of measurement can be used if necessary.
Children
Talk to your doctor, pharmacist or nurse before giving CEFTRIAXONE SUN to your child if:
he/she has recently taken or is due to take a product containing calcium to be injected into the vein.
Sodium
This medicine contains sodium. This medicinal product contains 83 mg of sodium per 1.193 g vial. To be taken into account in patients controlling their dietary sodium intake.
Other medicines and CEFTRIAXONE SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM)
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, if you are taking any of the following medicines, tell your doctor or pharmacist:
a type of antibiotic called an aminoglycoside;
an antibiotic called chloramphenicol (used to treat infections, especially of the eye).
CEFTRIAXONE SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM) with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
The doctor will assess the benefits of treatment with CEFTRIAXONE SUN and the risks for your baby.
Athletes
Not applicable.
Driving and using machines
CEFTRIAXONE SUN may cause dizziness. If you feel dizzy or dizzy, do not drive or use any tools or machines. If you experience these symptoms, talk to your doctor.
CEFTRIAXONE SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM) contains:
Not applicable.
3. HOW TO USE CEFTRIAXONE SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM)? Return to the top of the page
Ceftriaxone SUN is usually given by a doctor or nurse. It will be given as an injection directly into a muscle. CEFTRIAXONE SUN is prepared by the doctor, pharmacist or nurse and should not be mixed with injections containing calcium, or given at the same time as such injections.
Dosage
Your doctor will prescribe the appropriate dose of CEFTRIAXONE SUN 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 Ceftriaxone SUN depends on the type of infection you have.
Adults, elderly patients and children 12 years of age 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 2 g, you may receive it as a single dose, once a day or in two separate doses.
Newborns, infants and children aged 15 days to 12 years weighing less than 50 kg:
- 50 to 80 mg of CEFTRIAXONE SUN per kilogram of body weight of the child, 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 100 mg per kilogram body weight, up to a maximum of 4 g once a day. If your daily dose is more than 2 g, you may receive it as a single dose, once a day or in two separate doses.
Children weighing 50 kg or more should receive the usual adult dose.
Newborns (0-14 days)
- 20 to 50 mg of CEFTRIAXONE SUN per kilogram of body weight of the child, once a day, depending on the severity and type of infection.
The maximum daily dose should not exceed 50 mg per kg body weight of the child.
People with liver and kidney problems
You may take a different dose from the usual dose. Your doctor will decide the dose of CEFTRIAXONE SUN you need and will monitor you carefully depending on the severity of your liver and kidney problem.
Administration mode
Intramuscular route.
If you use more CEFTRIAXONE SUN 1 g/3.5 ml powder and solvent for solution for injection (IM) 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 CEFTRIAXONE SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM)
If you forget an injection, get the injection given to you as soon as possible. However, if the time of the next injection is very close, do not give the missed injection. Do not take a double dose (two injections at the same time) to make up for the one you missed.
If you stop using CEFTRIAXONE SUN 1 g/3.5 ml powder and solvent for solution for injection (IM)
Do not stop using CEFTRIAXONE SUN unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS? Return to the top of the page
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur with this medicine:
Severe allergic reactions (frequency not known, cannot be estimated from the available data).
If you have a severe allergic reaction, seek immediate medical attention.
Signs can include:
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 unknown, cannot be estimated from the available data).
If you have a severe rash, seek medical attention immediately.
Signs may include:
a severe rash that develops quickly, 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: widespread rash, elevated body temperature, increased liver enzymes, abnormal blood tests (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as as DRESS syndrome or systemic drug hypersensitivity syndrome with eosinophilia).
A Jarisch-Herxheimer reaction which causes fever, chills, headache, muscle pain and rash which usually resolves on its own. This occurs soon after starting treatment with ceftriaxone for spirochete infections like Lyme disease
Other possible side effects:
Common (may affect up to 1 in 10 people):
Abnormalities of white blood cells (such as a decrease in white blood cells and an increase in eosinophils) and platelets (decrease in thrombocytes);
loose stools or diarrhoea;
· Changes in the results of blood tests that measure liver function;
· Skin rash
Uncommon (may affect up to 1 in 100 people):
infection due to a fungus (eg thrush);
decrease in the number of white blood cells (granulocytopenia);
decrease in the number of red blood cells (anaemia);
Blood clotting problems. Signs can include bruising that comes on easily, as well as pain and swelling in your joints;
· Headache ;
dizziness;
Feeling sick or vomiting;
Pruritus (itching);
pain or burning sensation along the vein into which Ceftriaxone SUN was administered; pain at the injection site;
high temperature (fever);
Abnormal result of blood test that measures kidney function (increased blood creatinine).
Rare (may affect up to 1 in 1,000 people):
Inflammation of the large intestine (colon). Signs may include diarrhea usually with blood and mucus, upset stomach and fever.
Difficulty breathing (bronchospasm);
rash (hives) which may cover a large part of your body, with itching and swelling;
blood or sugar in the urine;
edema (fluid accumulation);
Chills.
Ceftriaxone treatment, especially in elderly patients with severe kidney or nervous system problems, may in rare cases cause decreased consciousness, abnormal movements, restlessness and seizures.
Not known (effects the frequency of which cannot be estimated from the available data):
A secondary infection that may not be able to be treated with an antibiotic that has already been prescribed;
A form of anemia in which red blood cells are destroyed (haemolytic anaemia);
severe fall in the number of certain white blood cells (agranulocytosis);
seizures;
dizziness (spinning head);
Inflammation of the pancreas (pancreatitis). Signs may include severe stomach pain extending into the back.
Inflammation of the lining of the mouth (stomatitis);
Inflammation of the tongue (glossitis). Signs may include swelling, redness and pain in the tongue;
Gallbladder and/or liver problems, which may cause pain, nausea, vomiting, yellowing of the skin, itching, abnormally dark colored urine and clay-coloured stools.
neurological disease that can affect newborns with severe jaundice (kernicterus);
kidney problems due to deposits of ceftriaxone calcium which may cause pain when urinating or when the amount of urine is low;
· False positive Coombs test result (a test that detects certain blood problems);
False positive result for galactosemia (abnormal accumulation of the sugar called galactose);
CEFTRIAXONE SUN may affect the results of certain types of blood sugar tests – consult your doctor.
Declaration of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any adverse effects not mentioned in this leaflet. You can also report adverse effects directly via 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 SUN 1 g/3.5 ml, powder and solvent for solution for injection (IM)? Return to the top of the page
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or vial after EXP. The expiry date refers to the last day of that month.
Before reconstitution: Do not store above +30°C.
After reconstitution: Physicochemical stability of the reconstituted product has been demonstrated for 24 hours at +25°C.
However, from a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions after reconstitution/dilution and prior to use are the responsibility of the user and should not be longer than
24 hours at a temperature between +2°C and +8°C (in the refrigerator).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION Back to top
What CEFTRIAXONE SUN 1 g/3.5 ml contains, powder and solvent for solution for injection (IM) Back to top
The active substance is:
Ceftriaxone................................................. .................................................. ....................... 1g
In the form of ceftriaxone sodium.
For 3.5 ml of reconstituted solution.
The other components are:
Solvent: lidocaine hydrochloride, water for injections.
What CEFTRIAXONE SUN 1 g/3.5 ml powder and solvent for solution for injection (IM) looks like and contents of the pack Back to top
This medication is in the form of powder and solvent for solution for injection (IM). Box of 1 bottle and 1 ampoule.
Marketing Authorization Holder Back to top
SUN PHARMA FRANCE
11/15, QUAI DION BUTTON
92800 PUTEAUX
Marketing Authorization Operator Back to top
SUN PHARMA FRANCE
11/15, QUAI DION BUTTON
92800 PUTEAUX
Manufacturer Back to top
PANPHARMA S.A.
ZI DU CLAIRAY LUTRE
35133 FERNS
Names of the medicinal product in the Member States of the European Economic Area Back to the top of the page
Not applicable.
This leaflet was last revised: Back to top
[to be completed later by the holder]
Other Back to top
Detailed information on this medicinal product is available on the ANSM (France) website.
WHAT TO KNOW ABOUT ANTIBIOTICS?
Antibiotics are effective in fighting infections caused by bacteria. They are not effective against virus infections.
Also, your doctor has chosen to prescribe this antibiotic for you because it is precisely suited to your case and your current illness.
Bacteria have the ability to survive or reproduce despite the action of an antibiotic. This phenomenon is called resistance: it renders certain antibiotic treatments inactive.
Resistance increases through the excessive or inappropriate use of antibiotics.
You risk promoting the appearance of resistant bacteria and therefore delaying your healing or even rendering this medication inactive, if you do not respect:
the dose to be taken,
the times of taking,
and the duration of treatment.
Therefore, to preserve the effectiveness of this medicine:
1- Only use an antibiotic when your doctor has prescribed it
2- Strictly respect your prescription.
3- Do not reuse an antibiotic without a medical prescription even if you think you are fighting an apparently similar disease.
4- Never give your antibiotic to another person, it may not be suitable for their disease.
5- Once your treatment is finished, bring back to your pharmacist all opened boxes for a correct and appropriate destruction of this medicine.