Ceftriaxone Qilu 1 g powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ceftriaxone Qilu 1 g powder for solution for injection and for infusion EFG

ceftriaxone (as ceftriaxone sodium)

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before using Ceftriaxone Qilu

3. How to use Ceftriaxone Qilu

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 for adults and children (including newborn babies). It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not keep or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Ceftriaxone is used to treat infections of:

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

Ceftriaxone may be used:

• to treat certain sexually transmitted infections (gonorrhea and syphilis).
• to treat patients with low levels of white blood cells (neutropenia) who have fever due to a bacterial infection.
• to treat chest infections in adults with chronic bronchitis.
• to treat Lyme disease (transmitted by ticks) in adults and children, including newborns from 15 days of age.
• to prevent infections during surgery.

You should consult a doctor if you worsen or do not improve.

2. What you need to know before using Ceftriaxone Qilu

Do not use Ceftriaxone Qilu:

• if you are allergic to ceftriaxone or to 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 other similar antibiotics (such as cephalosporins, carbapenems, or monobactams); signs of such a reaction include sudden swelling of the throat or face making it difficult to breathe or swallow, sudden swelling of hands, feet, and ankles, chest pain, or a rapidly spreading, severe skin rash.
• if you are allergic to lidocaine and you are to receive ceftriaxone by intramuscular injection.

Ceftriaxone Qilu must not be given to newborn babies if:

• the baby is premature.
• the baby 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 if the baby is to receive a calcium-containing product by intravenous injection.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Ceftriaxone:

• if you have recently received or are about to receive any product containing calcium.
• if you have recently had diarrhoea after antibiotic treatment; if you have ever had intestinal problems, particularly colitis (inflammation of the intestine).
• if you have had liver or kidney problems (see section 4).
• if you have gallstones or kidney stones.
• if you have had other illnesses, for example, haemolytic anaemia (a decrease in your red blood cells that may cause your skin to appear pale yellow and lead to weakness and shortness of breath).
• if you are on a low-sodium diet.
• if you experience or have experienced a combination of any of the following symptoms: rash, skin redness, blistering of the lips, eyes, and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels seen in blood tests, an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions; see also section 4 "Possible side effects").

If you need blood or urine tests

If you are to receive ceftriaxone for a prolonged period, you may need to have regular blood tests. Ceftriaxone may affect the results of urine glucose (glucosuria) tests and of a blood test called the Coombs test. If you are having tests:

• tell the person taking the sample that you have received ceftriaxone.

If you are diabetic or need to monitor your blood glucose (glycaemia), you should not use certain glucose monitoring systems that may give inaccurate glucose readings during treatment with ceftriaxone. If you use such a system, consult the user instructions and speak with your doctor, pharmacist, or nurse. Alternative testing methods should be used if necessary.

Children

Before your child receives ceftriaxone, consult your doctor, pharmacist, or nurse if:

• they have recently received or are scheduled to receive a calcium-containing product by intravenous injection.

Use of Ceftriaxone Qilu with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 to treat infections, especially of the eyes).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Your doctor will assess the expected benefits of treatment with ceftriaxone against any potential risks to your baby.

Driving and use of machines

Ceftriaxone may cause dizziness. If you feel dizzy, do not drive or operate tools or machinery. Talk to your doctor if you experience this symptom.

Ceftriaxone Qilu contains sodium

1 g vial: this medicine contains 82.8 mg of sodium (the main component of table salt used in cooking) per vial. This corresponds to 4.14% of the maximum daily recommended dietary intake of sodium for adults, which should be taken into account in patients on low-sodium diets.

3. How to take Ceftriaxone Qilu

Ceftriaxone is usually administered by a doctor or a nurse. It can be given:

• by intravenous infusion, or
• by direct injection into a vein, or
• by intramuscular injection.

Ceftriaxone is prepared for administration by a doctor, pharmacist, or nurse. It must not be mixed or administered simultaneously with other injectable products containing calcium.

Recommended dose

Your doctor will decide the correct dose of ceftriaxone for you. The dose depends on the type and severity of the infection, whether you are already receiving other antibiotics, your body weight and age, as well as the condition of your liver and kidneys. The number of days or weeks you will receive ceftriaxone depends on the type of infection you have.

Adults, elderly patients, and children aged 12 years and older weighing 50 kg or more:

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

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

• 50 to 80 mg of ceftriaxone per kg of body weight once daily, depending on the type and severity of the infection. If the infection is severe, your doctor may prescribe a higher dose, 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 administered either as a single daily dose or as two separate doses.
• Children weighing 50 kg or more should receive the adult dose.

Newborns (0–14 days):

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

Patients with liver or kidney problems

If you have impaired kidney or liver function, you may require a different dose than the one recommended. Your doctor will determine the appropriate dose of ceftriaxone for you and will closely monitor you based on the severity of your liver or kidney disease.

If you use more Ceftriaxone Qilu than you should

If you accidentally receive a higher dose than prescribed, contact your doctor immediately or go to the nearest hospital as soon as possible.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to use Ceftriaxone Qilu

If you miss a dose of this medicine, it should be administered as soon as possible. However, if it is almost time for the next injection, skip the missed dose. Do not administer a double dose (two injections at once) to make up for a missed dose.

If you stop using Ceftriaxone Qilu

Do not stop receiving ceftriaxone unless instructed by your doctor. If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

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

If you experience a severe allergic reaction, inform your doctor immediately.

Signs may include:

• Sudden swelling of the face, throat, lips, or mouth, which may cause difficulty breathing or swallowing.
• Sudden swelling of hands, feet, and ankles.
• Chest pain in the context of allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome).

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

If you develop a severe skin reaction, inform a doctor immediately.

Symptoms may include:

• A severe rash that develops rapidly, with blisters or peeling skin and possibly blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• A combination of any of the following symptoms: widespread rash, high body temperature, elevated liver enzyme levels, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction causing fever, chills, headache, muscle pain, and skin rash, which is usually self-limiting. This occurs shortly after starting ceftriaxone treatment for spirochete infections such as Lyme disease.

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people)

• Abnormal white blood cell counts (e.g., decreased white blood cell count and increased eosinophils) and platelets (decreased platelet count).
• Loose stools or diarrhea.
• Changes in blood test results assessing liver function.
• Skin rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g., oral candidiasis).

• Decreased white blood cell count (granulocytopenia).

• Decreased red blood cell count (anemia).

• Blood clotting problems. Signs may include frequent bruising, as well as joint pain and swelling.

• Headache.

• Dizziness.

• Feeling unwell or sick.

• Itching (pruritus).

• Pain or burning sensation at the site or vein where the medicine was injected. Pain at the injection site.

• High temperature (fever).

• Impaired 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, stomach pain, and fever.
• Difficulty breathing (bronchospasm).
• Hives (urticaria) that may cover large parts of the body, with itching and swelling.
• Blood or sugar in the urine.
• Edema (swelling due to fluid accumulation).
• Chills.
• Treatment with ceftriaxone, particularly in elderly patients with severe kidney problems or neurological disorders, may rarely cause decreased consciousness, abnormal movements, agitation, and seizures.

Frequency not known (cannot be estimated from available data)

• Secondary infection that may not have responded to previously prescribed antibiotic treatment.
• Hemolytic anemia (a type of anemia involving destruction of red blood cells).
• Agranulocytosis (severe decrease in white blood cells).
• Seizures.
• Dizziness (sensation of lightheadedness).
• Inflammation of the pancreas (pancreatitis). Signs may include severe stomach pain radiating to the back.
• Inflammation of the mucous membrane lining the mouth cavity (stomatitis).
• Inflammation of the tongue (glossitis). Signs may include swelling, red discoloration, and pain of the tongue.
• Problems with the gallbladder or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, abnormally dark urine, and clay-colored stools.
• Neurological disorder that may occur in newborns with severe jaundice (bilirubin encephalopathy - kernicterus).
• Kidney problems caused by deposits of calcium-ceftriaxone. You may experience pain when urinating or reduced urine output.
• False positive Coombs test result (a test to detect certain blood abnormalities).
• False positive galactosemia test result (abnormal accumulation of galactose in the blood).
• Ceftriaxone may interfere with certain blood glucose tests; consult your doctor.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftriaxone Qilu

• Storage of ceftriaxone is the responsibility of your doctor or pharmacist, who will also ensure the proper disposal 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 indicated.
• Do not store above 25 °C. Keep the vial in the cardboard carton to protect it from light.

Physical and chemical stability in use 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 excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the duration and conditions of storage are the user's responsibility.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines or their packaging, consult your pharmacist. This helps protect the environment.

6. Contents of the container and other information

Composition of Ceftriaxone Qilu

The active substance in Ceftriaxone for injectable solution and for infusion is ceftriaxone.

1 g: each vial contains ceftriaxone sodium equivalent to 1 g of ceftriaxone.

Each gram of ceftriaxone sodium contains approximately 3.6 mmol (82.8 mg) of sodium.

Ceftriaxone contains no other excipients.

Appearance of the product and contents of the container

• Ceftriaxone is a powder for injectable solution and for infusion. It is a crystalline powder of almost white or yellowish color. It is supplied in a glass vial. After reconstitution, the solution may range in color from pale yellow to yellow, depending on storage time, concentration, and diluent used; however, this does not affect the efficacy of the active substance. The solution should only be used if it is clear and free from particles.
• Before administration to the patient, a solution is prepared by adding a sterile liquid to the vial. The correct dose is then withdrawn from the vial. It can be administered to the patient either by injection or added to an infusion bag containing a solution for intravenous infusion, which is delivered through a small tube inserted into a vein.
• Ceftriaxone Qilu is available in pack sizes of 1, 10, and 100 vials. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th floor, 28046 - Madrid,

Spain

Manufacturer

KYMOS, S.L.

Ronda de Can Fatjó,

7B (Parc Tecnològic del Vallès),

Cerdanyola del Vallès, 08290

Barcelona, Spain

MIAS Pharma Limited

Suite 2, Stafford House, Strand Road,

Portmarnock, Co. Dublin,

Ireland

Tillomed Malta Ltd.

Malta Life Sciences Park, LS2.01.06 Industrial Estate,

San Gwann, SGN 3000,

Malta

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 – Barcelona

Spain

Tel.: +34 93 342 78 90

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

United Kingdom	:	Ceftriaxone 1 g powder for solution for injection/infusion
Germany	:	Ceftriaxon Qilu 1 g powder for solution for injection/infusion
Spain	:	Ceftriaxone Qilu 1 g powder for injectable solution and for perfusion EFG
France	:	Ceftriaxone Qilu 1 g, powder for injectable solution/for perfusion
Italy	:	Ceftriaxone Qilu
Croatia	:	Ceftriakson Qilu 1 g powder for injection/infusion solution
Hungary	:	Ceftriaxone Qilu 1 g powder for solution for injection or infusion
Slovenia	:	Ceftriakson Qilu 1 g powder for solution for injection/infusion

Date of the last revision of this leaflet: May 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.es/

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This information is intended for healthcare professionals only:

INFORMATION FOR HEALTHCARE PROFESSIONALS

Ceftriaxone Qilu 1 g powder for injectable solution and for infusion EFG

ceftriaxone (as ceftriaxone sodium)

Refer to the full prescribing information in the Technical Data Sheet or the Summary of Product Characteristics.

Administration method

Intramuscular administration

Ceftriaxone may be administered via deep intramuscular injection. For intramuscular injections, a relatively large muscle mass should be selected for the injection site, and no more than 1 g should be injected at a single site.

Since the solvent used is lidocaine, the resulting solution must never be administered intravenously. The information provided in the Summary of Product Characteristics or Technical Data Sheet for lidocaine must be taken into account.

Intravenous administration

Ceftriaxone may be administered by intravenous infusion over a minimum of 30 minutes (preferred route) or by slow intravenous injection over 5 minutes. Intermittent intravenous injections should be administered over 5 minutes, preferably into large veins. Intravenous doses of 50 mg/kg or higher in infants and children up to 12 years of age should be given by infusion. In neonates, intravenous doses should be administered over approximately 60 minutes to reduce the risk of bilirubin encephalopathy. Intramuscular administration should be considered when the intravenous route is not feasible or less suitable for the patient. Intravenous administration should be used for doses exceeding 2 g.

Ceftriaxone is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with intravenous solutions containing calcium, including continuous infusions containing calcium such as parenteral nutrition, due to the risk of ceftriaxone-calcium precipitation.

Diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) must not be used to reconstitute ceftriaxone vials or for further dilution of a reconstituted vial for intravenous administration, as a precipitate may form. Ceftriaxone-calcium precipitation may also occur if ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously.

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

Instructions for use

Physicochemical stability in use 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 excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage period and conditions are the responsibility of the user.

Ceftriaxone must not be mixed in the same syringe with any medicinal product other than a 1.06% lidocaine hydrochloride solution (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 via deep intramuscular injection. Doses exceeding 1 g should be divided and injected at more than one site.

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 catheter.

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 the Dosage and Administration method sections 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

According to specialized literature, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, aminoglycosides, and labetalol.

Solutions containing ceftriaxone must not be mixed or combined with other compounds, except those specified in the Instructions for use section. In particular, diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) must not be used to reconstitute ceftriaxone vials or for subsequent dilution of a reconstituted vial for intravenous administration, as a precipitate may form. Ceftriaxone and calcium-containing solutions, including total parenteral nutrition, must not be mixed or administered simultaneously.

If combination therapy with ceftriaxone and another antibiotic is planned, administration must not be performed using the same syringe or in the same infusion solution.