Ceftriaxone Qilu

Package leaflet: Information for the patient

Ceftriaxone Qilu 1 g powder for solution for injection or infusion, 2 g powder for solution for injection or infusion

Ceftriaxone (as ceftriaxone sodium)
Generic Medicine
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people. Even if their symptoms are the same as yours, it could be harmful.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Ceftriaxone Qilu is and what it is used for
2. What you need to know before being administered Ceftriaxone Qilu
3. How Ceftriaxone Qilu is administered
4. Possible side effects
5. How to store Ceftriaxone Qilu
6. Contents of the pack and other information

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

Ceftriaxone is an antibiotic administered to adults and children (including newborns). It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxone 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 or soft tissues.
• of the blood.
• of the heart.

It may also be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis).
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have fever due to 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 15 days of age.
• to prevent infections during surgery.

Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before you are given Ceftriaxone Qilu

Do not be given Ceftriaxone Qilu if:

• You are allergic to ceftriaxone.
• 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 make breathing or swallowing difficult, sudden swelling of hands, feet and ankles, and a severe rash that develops rapidly.
• You are allergic to lidocaine and Ceftriaxone is to be administered by intramuscular injection.

Ceftriaxone Qilu must not be given to children in the following cases:

• The child is premature.
• The child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or needs to receive a calcium-containing product intravenously.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Ceftriaxone if:

• You have recently received or are about to receive calcium-containing products.
• You have recently had diarrhoea after taking an antibiotic. You have had intestinal problems, particularly colitis (inflammation of the intestine).
• You have liver or kidney problems.
• You have gallstones or kidney stones.
• You have other diseases, such as haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin and lead to weakness or shortness of breath).
• You are on a low-sodium diet.

If you are due to have a blood or urine test
If you are given ceftriaxone for a prolonged period, you may need to have regular blood tests. Ceftriaxone may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are about to have tests:

• Inform the person taking your sample that you have been given Ceftriaxone.

If you are diabetic or require monitoring of blood glucose levels, certain blood glucose monitoring systems should not be used, as they may give inaccurate glucose readings while you are taking ceftriaxone. If you use such systems, check the instructions for use and inform your doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

Children
Talk to your doctor, pharmacist or nurse before giving Ceftriaxone to a child if:

• The child has recently received or is about to receive intravenously a product containing calcium.

Other medicines and Ceftriaxone Qilu
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• An antibiotic called an aminoglycoside.
• An antibiotic called chloramphenicol (used in the treatment of infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Your doctor will assess the benefits that treatment with ceftriaxone would provide you against the possible risks to the baby.

Driving and using machines
Ceftriaxone may cause dizziness. If you feel dizzy, do not drive and do not operate tools or machinery.
Contact your doctor if you experience these symptoms.

Ceftriaxone Qilu contains sodium.
1 g vial: this medicine contains 82.8 mg of sodium (the main component of table/cooking salt) per vial. This is equivalent to 4.14% of the maximum recommended daily intake of sodium for an adult.
2 g vial: this medicine contains 165.6 mg of sodium (the main component of table/cooking salt) per vial. This is equivalent to 8.28% of the maximum recommended daily intake of sodium for an adult.

3. How Ceftriaxone Qilu is administered

Ceftriaxone is generally administered by a doctor or nurse. It may be given

• as an intravenous infusion (IV infusion), or
• as an injection directly into a vein, or
• into a muscle.

Ceftriaxone is prepared by a doctor, pharmacist, or nurse and will not be mixed with injections containing calcium, nor will it be administered simultaneously with such injections.
Recommended dose
Your doctor will determine the correct dose of ceftriaxone for you. The dose will depend on the severity and type of infection, whether you are taking other antibiotics at the same time, your body weight and age, and how well your kidneys and liver are functioning. The number of days or weeks during which you will receive ceftriaxone will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years or older with a body weight equal to or greater than 50 kilograms (kg):

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor may administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.

Newborns, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:

• 50–80 mg of ceftriaxone per kg of the child's body weight once daily, depending on the severity and type of infection. If you have a severe infection, your doctor may prescribe a higher dose of up to 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.
• Children with a body weight equal to or greater than 50 kg should receive the standard adult dose.

Newborns (0–14 days of life):

• 20–50 mg of ceftriaxone per kg of the newborn's body weight once daily, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the newborn's body weight.

Patients with liver or kidney problems
You may be given a different dose than the recommended one. Your doctor will decide how much ceftriaxone you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are accidentally given too much Ceftriaxone Qilu
If you are accidentally given more ceftriaxone than prescribed, contact your doctor or the nearest hospital immediately.
If you forget to take Ceftriaxone Qilu
If you miss a dose of this medicine, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not receive a double dose (two injections together) to make up for a missed dose.
If you stop treatment with Ceftriaxone Qilu
Do not stop taking ceftriaxone unless instructed to do so by your doctor.
If you have any questions about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

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

Serious side effects

Severe allergic reactions (frequency not known, cannot be estimated from the available data)
If you have a severe allergic reaction, contact your doctor immediately.
Signs may include:

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

Severe skin rashes (frequency not known, cannot be estimated from the available data)
If you develop a severe skin rash, contact your doctor immediately.

• Signs may include a severe rash that develops rapidly, with blistering or peeling of the skin, and possibly blisters in the mouth.

Other side effects

Common (may affect up to 1 in 10 people)

• Abnormalities in white blood cells (such as reduced leukocytes and increased eosinophils) and platelets (reduced thrombocytes).
• Soft stools or diarrhoea.
• Changes in blood test results indicating liver function abnormalities.
• Skin rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. candidiasis).
• Decreased number of white blood cells (granulocytopenia).
• Reduced number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation at or along the vein where this medicine was administered.
• Pain at the injection site.
• High temperature (fever).
• Abnormal kidney function test results (increased blood creatinine).

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

• Inflammation of the large intestine (colitis). Signs include diarrhoea, often with blood and mucus, stomach pain and fever.
• Breathing difficulties (bronchospasm).
• Skin rash with raised red patches (urticaria), possibly covering large areas of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid retention).
• Chills.

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

• Secondary infection that may not respond to the prescribed antibiotic.
• A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Seizures.
• Vertigo (spinning sensation).
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
• Inflammation of the mucous membrane of the mouth (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Gallbladder problems that may cause pain, nausea and vomiting.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. This may cause pain when urinating, or reduced urine output.
• False positive Coombs test result (a test to detect blood problems).
• False positive test result for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone may interfere with certain types of tests used to measure glucose in the blood; please check with your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly via the national reporting system at:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceftriaxone Qilu

• Your doctor or pharmacist is responsible for the storage of ceftriaxone. They are also responsible for properly disposing of any unused ceftriaxone.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton or vial. The expiry date refers to the last day of the month.
• Do not store above 25 °C; keep the vial in the outer packaging to protect it from light.

Chemical and physical in-use stability has been demonstrated for 6 hours at 225 °C and for 24 hours at 2–8 °C.
From a microbiological standpoint, unless the method of opening precludes the risk of microbial
contamination, the product should be used immediately. If not used immediately, the conditions and duration of in-use storage are the responsibility of the user.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist to dispose of
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone Qilu contains
The active substance in ceftriaxone powder for injectable solution or for infusion is ceftriaxone.
1 g: each vial contains ceftriaxone sodium, equivalent to 1 g of ceftriaxone.
2 g: each vial contains ceftriaxone sodium, equivalent to 2 g of ceftriaxone.
Each gram of ceftriaxone sodium contains approximately 3.6 mmol (82.8 mg) of sodium.
There are no other components in ceftriaxone.

Description of the appearance of Ceftriaxone Qilu and contents of the pack

• Ceftriaxone is a powder for injectable solution or for infusion. It is a crystalline powder, almost white or slightly yellow in colour. It is supplied in a glass vial. After reconstitution, the solution ranges in colour from pale yellow to yellow, depending on storage duration, concentration, and diluent used; however, this does not affect the efficacy of the active substance. Only clear solutions free from visible particles should be used.
• Prior to administration to the patient, ceftriaxone is constituted into a solution by adding sterile liquid to the vial. The correct dose is then withdrawn from the vial. It may be administered to the patient either as an injection or added to an infusion bag, which is delivered through a tube into a vein.
• Pack sizes: supplied in packs of 1, 10, and 100 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
QILU PHARMA SPAIN S.L.
Paseo de la Castellana 40,
8th floor, 28046-Madrid
Spain
Manufacturer:
KYMOS PHARMA SERVICES, S.L.
Ronda de Can Fatjo,
7B (Parque Tecnológico del Vallès),
Cerdanyola del Vallès, 08290
Barcelona, Spain

This medicinal product is authorised in the EEA Member States under the following names:
United Kingdom: Ceftriaxone 1 g powder for solution for injection/infusion
Ceftriaxone 2 g powder for solution for injection/infusion
Germany: Ceftriaxon Qilu 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Ceftriaxon Qilu 2 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Spain: Ceftriaxona Qilu 1 g, polvo para solución inyectable y para perfusión
Ceftriaxona Qilu 2 g, polvo para solución inyectable y para perfusión
Finland: Ceftriaxon Qilu 1 g injektio-/infuusiokuiva-aine liuosta varten
Ceftriaxon Qilu 2 g injektio-/infuusiokuiva-aine liuosta varten
Ceftriaxon Qilu 1 g pulver till injektions-/infusionsvätska, lösning
Ceftriaxon Qilu 2 g pulver till injektions-/infusionsvätska, lösning
France: Ceftriaxone Qilu 1 g, poudre pour solution injectable/pour perfusion
Ceftriaxone Qilu 2 g, poudre pour solution injectable/pour perfusion
Italy: Ceftriaxone Qilu
Sweden: Ceftriaxone Qilu 1 g pulver till injektions-/infusionsvätska, lösning
Ceftriaxone Qilu 2 g pulver till injektions-/infusionsvätska, lösning

This leaflet was last revised in 06/2018

The following information is intended for healthcare professionals only:
INFORMATION FOR HEALTHCARE PROFESSIONALS
Ceftriaxone Qilu 1 g powder for injectable solution or for infusion
Ceftriaxone Qilu 2 g powder for injectable solution or for infusion
Ceftriaxone (as ceftriaxone sodium)
Refer to the Summary of Product Characteristics for complete prescribing information.

METHOD OF ADMINISTRATION
Intramuscular administration
Ceftriaxone may be administered by deep intramuscular injection. Intramuscular injections should be given deeply into a sufficiently large muscle, and no more than 1 g should be injected at a single site.
If lidocaine is used as the solvent, the resulting solution must in no case be administered intravenously. The information provided in the Summary of Product Characteristics for lidocaine must be taken into account.

Intravenous administration
Ceftriaxone may be administered by intravenous infusion lasting at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes.
Intermittent intravenous injection should be administered over 5 minutes, preferably into larger veins. Intravenous doses of 50 mg/kg or higher in infants and children up to 12 years of age must be administered by infusion. In neonates, to reduce the potential risk of bilirubin encephalopathy, intravenous doses should be administered over 60 minutes. Intramuscular injections should be performed when intravenous administration is not feasible or is considered less appropriate for the patient. Intravenous administration must be used for doses exceeding 2 g.
Ceftriaxone is contraindicated in neonates (≤ 28 days) who require (or are likely to require) treatment with intravenous calcium-containing solutions, including continuous infusions containing calcium (e.g., for parenteral nutrition), due to the risk of calcium-ceftriaxone precipitate formation.
Diluents containing calcium (such as Ringer's solution or Hartmann's solution) must not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration, as precipitation may occur. Calcium-ceftriaxone precipitation may also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Therefore, ceftriaxone must not be mixed or co-administered with calcium-containing solutions.

For preoperative prophylaxis of surgical site infections, ceftriaxone should be administered 30–90 minutes before surgery.

Instructions for use
Chemical and physical in-use stability has been demonstrated for 6 hours at 25 °C and for 24 hours at 2–8 °C.
From a microbiological standpoint, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the conditions and duration of in-use storage are the responsibility of the user.
Ceftriaxone must not be mixed in the same syringe with any other medicinal product, except with a 1.06% solution of lidocaine hydrochloride (for intramuscular injection only).

Intramuscular injection:
1 g of Ceftriaxone should be dissolved in 3.5 ml of 1.06% lidocaine hydrochloride solution. The solution should be administered by deep intramuscular injection. Doses greater than 1 g should be divided and injected at multiple sites.
Solutions containing lidocaine must not be administered intravenously.

Intravenous injection:
1 g of Ceftriaxone should be dissolved in 10 ml of water for injections. The injection should be administered over 5 minutes, directly into a vein or via an intravenous infusion line.

Intravenous infusion:
2 g of Ceftriaxone should be dissolved in 40 ml of one of the following calcium-free solutions: 5% or 10% dextrose for injection, sodium chloride for injection, sodium chloride and dextrose for injection (0.45% sodium chloride and 2.5% dextrose), 6% dextran in 5% dextrose for injection, 6%-10% hydroxyethyl starch for infusion. The infusion should be administered over at least 30 minutes.
Refer to "Dosage" and "Method of administration" for further information.

The displacement volume of 1 g of Ceftriaxone is 0.6 ml when reconstituted with 10 ml of water for injections.
The displacement volume of 1 g of Ceftriaxone is 0.68 ml when reconstituted with 3.5 ml of 1.06% lidocaine hydrochloride solution.

Incompatibilities
Based on reports in the literature, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, aminoglycosides, and labetalol.
Solutions containing ceftriaxone must not be mixed with other agents or added to other agents, except those mentioned in "Instructions for use". In particular, diluents containing calcium (such as Ringer's solution, Hartmann's solution) must not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration, as precipitation may occur. Ceftriaxone must not be mixed or co-administered with calcium-containing solutions, including total parenteral nutrition.
If combination therapy with another antibiotic alongside ceftriaxone is intended, administration must not occur in the same syringe or in the same infusion solution.