Prospecto: information for the patient

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

ceftriaxone (in the form of ceftriaxone sodium)

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See section 4.

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

2.What you need to know before starting to use Ceftriaxona Qilu

3.How to use Ceftriaxona Qilu

4.Possible adverse effects

1. Storage of Ceftriaxona Qilu

6.Contents of the package and additional information

Ceftriaxone is an antibiotic for adults and children (including newborn babies). It works by eliminating the bacteria causing infections. It belongs to a group of medicines called cephalosporins.

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
• the bones and joints
• the skin and soft tissues
• the blood
• the heart

Ceftriaxone can be used:

• to treat specific sexually transmitted infections (gonorrhea and syphilis).
• to treat patients with low white blood cell counts (neutropenia) who have fever due to 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.

Do not use Ceftriaxona Qilu:

• if you are allergic to ceftriaxona or any of the other components of this medication (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 inflammation of the throat or face that makes it difficult to breathe or swallow, sudden swelling of the hands, feet, and ankles, chest pain, or a severe skin rash.
• if you are allergic to lidocaína and are to receive ceftriaxona by intramuscular injection.

Ceftriaxona Qilu should not be administered to babies if:

• the baby is premature.
• the baby is a newborn (up to 28 days old) and has certain blood problems or jaundice (yellowing of the skin or white of the eye) or is to be administered a product containing calcium via a vein.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Ceftriaxona:

• if you have recently received or are to receive a product containing calcium.
• if you have recently had diarrhea after antibiotic treatment; if you have ever had intestinal problems, particularly colitis (inflammation of the intestine).
• if you have liver or kidney problems (see section 4).
• if you have gallstones or kidney stones.
• if you have other diseases, for example, hemolytic anemia (decrease in red blood cells that can make your skin pale yellow and cause 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, blisters on the lips, eyes, and mouth, skin peeling, high fever, flu-like symptoms, elevated liver enzyme levels observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlargement of lymph nodes (signs of severe skin reactions, see also section 4 "Possible side effects")

If you need a blood or urine test

If you are to receive ceftriaxona for a long time, you may need to have blood tests periodically. Ceftriaxona may affect the result of a urine glucose test and a blood test called the Coombs test. If you are having tests:

• inform the person taking the sample that you have received ceftriaxona.

If you are diabetic or need to control your blood glucose level (glucemia), do not use certain glucose control systems that may give incorrect glucose values while you are being treated with ceftriaxona. If you use such a system, consult the instructions for use and talk to your doctor, pharmacist, or nurse. If necessary, alternative testing methods should be used.

Children

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

• recently received a product containing calcium via a vein or is to be administered one.

Use of Ceftriaxona Qilu with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• a type of antibiotic called aminoglucoside.
• an antibiotic called cloranfenicol (used to treat infections, especially of the eyes).

Pregnancy, breastfeeding, and fertility

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

Your doctor will evaluate the expected benefits of treatment with ceftriaxona against the risks to your baby.

Driving and operating machinery

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

Ceftriaxona Qilu contains sodium

1 g vial: this medication contains 82.8 mg of sodium (the main component of table salt) in each vial. This is equivalent to 4.14% of the maximum recommended daily sodium intake in the adult diet, which should be taken into account in patients on low-sodium diets.

Usually, a doctor or nurse administers ceftriaxone. It can be administered:

• in intravenous infusion or
• directly into a vein or
• into a muscle

A doctor, pharmacist, or nurse prepares ceftriaxone for administration. It should not be mixed or administered simultaneously with other injected products containing calcium.

Recommended dose

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

Adults, elderly patients, and children 12 years of age or older with a weight of 50 kg or more:

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

Newborns, infants, and children 15 days to 12 years of age with a weight less than 50 kg:

• 50 to 80 mg of ceftriaxone per kilogram of the child's weight once a day, depending on the type and severity of the infection. If the infection is severe, your doctor will prescribe a higher dose, up to 100 mg per kilogram of weight per day, with a maximum of 4 g per day. If your daily dose is greater than 2 g, it may be administered as a single daily dose or as two separate doses.
• Children weighing 50 kg or more should receive the recommended dose for adults.

Newborns (0-14 days)

• 20 to 50 mg of ceftriaxone per kilogram of the child's weight once a day, depending on the type and severity of the infection.
• The maximum daily dose should not exceed 50 mg per kilogram of the baby's weight.

Patients with liver or kidney problems

If you have impaired kidney or liver function, you may receive a different dose than recommended. Your doctor will decide how much ceftriaxone you need and will closely monitor you according to the severity of the liver or kidney disease.

If you take more Ceftriaxona Qilu than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Ceftriaxona Qilu

If you forget a dose of this medication, take it as soon as you remember. However, if it is almost time for the next injection, skip the missed dose. Do not receive a double dose (two injections at once) to compensate for a missed dose.

If you interrupt treatment with Ceftriaxona Qilu

Do not stop receiving Ceftriaxona unless your doctor tells you to. If you have any other questions about the use of this medication, ask your doctor or nurse.

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

Severe side effects

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

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

The signs may be:

• Sudden inflammation of the face, throat, lips, or mouth, which may cause difficulty breathing or swallowing.
• Sudden inflammation of hands, feet, and ankles.
• Chest pain in the context of allergic reactions, which may be a symptom of allergic-induced myocardial infarction (Kounis syndrome).

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

If you have a severe skin reaction, inform your doctor immediately.

The symptoms may include:

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

Other possible side effects:

Frequent (may affect up to 1 in 10 people)

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

Rare (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. The signs may include frequent petechiae, 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 this medicine was injected. Pain at the injection site.
• Elevated body temperature (fever).
• Altered kidney function (increased serum creatinine).

Rare (may affect up to 1 in 1000 people)

• Colitis (inflammation of the large intestine). The signs may include diarrhea, often with blood and mucus, abdominal pain, and fever.
• Difficulty breathing (bronchospasm).
• Rash (urticaria) that may cover a large area of the body, with itching and swelling.
• Blood or sugar in the urine.
• Swelling (edema).
• Chills.
• The ceftriaxone treatment, particularly in elderly patients with severe kidney problems or neurological problems, rarely may cause decreased consciousness, abnormal movements, agitation, and seizures.

Unknown frequency (cannot be estimated from available data)

• Secondary infection that may not have responded to a previously prescribed antibiotic.
• Hemolytic anemia (a type of anemia with destruction of red blood cells).
• Agranulocytosis(severe decrease in white blood cells).
• Seizures.
• Dizziness (vertigo).
• Pancreatitis (inflammation of the pancreas). The signs may include severe abdominal pain that radiates to the back.
• Stomatitis (inflammation of the mucous membrane lining the oral cavity).
• Glossitis (inflammation of the tongue). The signs may include swelling, redness, and pain of the tongue.
• Problems with the gallbladder or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, dark-colored urine, and clay-colored stools.
• Neurological disorder that may occur in newborns with severe jaundice (bilirubin encephalopathy-kernicterus).
• Renal disorders caused by ceftriaxone calcium deposits. You may experience pain while urinating or have a decreased urine output.
• Falsely positive Coombs test (a test for detecting some blood abnormalities).
• Falsely positive galactosemia (abnormal accumulation of galactose in the blood).
• Ceftriaxone may interfere with some glucose tests (blood sugar), consult your doctor.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• The conservation of ceftriaxone is the responsibility of your doctor or pharmacist, who will also be in charge of properly disposing of unused ceftriaxone.
• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box or vial. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 25 °C. Keep the vial in the cardboard box to protect it from light.

Physical and chemical stability has been demonstrated in use for 6 hours at 25 °C and for 24 hours at 2-8 °C.

From a microbiological point of view, and unless the opening method allows for the elimination of the risk of microbial contamination, the product must be used immediately. If not used immediately, the period and storage conditions are the responsibility of the user.

Medications should not be thrown down the drain or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Ceftriaxone Qilu Composition

The active ingredient of Ceftriaxone powder for solution for injection and 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 does not include other components.

Appearance of the product and contents of the pack

• Ceftriaxone is a powder for solution for injection and infusion. It is a white or yellowish crystalline powder. It is presented in a glass vial. The solution presents a pale yellow to yellow coloration after reconstitution, depending on the time of conservation, concentration, and diluent used, but this does not affect the efficacy of the active principle.Only the solution should be used if it is transparent and free of particles.
• Before administering it to the patient, a solution is prepared with ceftriaxone by adding a sterile liquid to the vial. Subsequently, the correct dose is extracted from the vial. It can be administered to the patient either by injection or by adding it to a solution bag for infusion that is administered through a small tube in a vein.
• Ceftriaxone Qilu is presented in packs of 1, 10, and 100 vials.Only some pack sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th floor, 28046 - Madrid,

Spain

Responsible for manufacturing

KYMOS, S.L.

Ronda de Can Fatjó,

7B (Parque Tecnológico 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

Phone: + 34 93 342 78 90

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

Last review date of this leaflet:May 2024

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/

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This information is intended solely for healthcare professionals:

INFORMATION FOR HEALTHCARE PROFESSIONALS

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

ceftriaxone (in the form of ceftriaxone sodium)

Consult the complete prescribing information in the Technical Dossier or the Product Characteristics Summary.

Administration

Intramuscular administration

Ceftriaxone can be administered by deep intramuscular injection. In intramuscular injections, a large muscle mass should be chosen for the injection, and no more than 1 g should be injected in the same place.

Since the solvent used is lidocaine, the resulting solution should never be administered intravenously. The information collected in the Technical Dossier or the Product Characteristics Summary should be taken into account.

Intravenous administration

Ceftriaxone can be administered by intravenous infusion of 30 minutes or more (preferred route) or by slow intravenous injection of 5 minutes. Intermittent intravenous injections should be administered over 5 minutes, preferably in large veins. Intravenous doses of 50 mg/kg or more in infants and children up to 12 years of age should be administered by infusion. In neonates, intravenous doses should have a duration of about 60 minutes to reduce the risk of bilirubin encephalopathy. Se should consider intramuscular administration when the intravenous route is not possible or less suitable for the patient. For doses greater than 2 g, the intravenous route should be used.

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 total parenteral nutrition, due to the risk of ceftriaxone-calcium precipitation.

Do not use diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) to reconstitute ceftriaxone vials or to dilute 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 line. Therefore, do not mix or administer ceftriaxone and calcium-containing solutions simultaneously.

For prophylaxis of surgical field infections, ceftriaxone should be administered 30-90 minutes before surgery.

Instructions for use

Stability and compatibility have been demonstrated for 6 hours at 25°C and for 24 hours at 2-8°C.

From a microbiological point of view, and unless the opening method allows for the exclusion of microbial contamination risk, the product should be used immediately. If not used immediately, the storage period and conditions are the responsibility of the user.

Ceftriaxone should not be mixed in the same syringe with any medication other than a 1.06% lidocaine hydrochloride solution for injection (for intramuscular use 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 in more than one place.

The resulting solutions in lidocaine should not be administered intravenously.

Intravenous injection: 1 g of ceftriaxone should be dissolved in 10 ml of water for injection. The injection should be administered over 5 minutes, directly into a vein or through an intravenous 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 (sodium chloride 0.45% and dextrose 2.5%),dextran6% in 5% dextrose for injection, orhydroxyethylstarch 6-10% for infusion. The infusion should be administered over at least 30 minutes.

Consult the sectionsPosologyandAdministrationfor more information.

The displacement value of 1 g of ceftriaxone is 0.6 ml when reconstituted with 10 ml of water for injection.

The displacement value 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 not compatible withamsacrine,vancomycin,fluconazole,aminoglycosides, orlabetalol.

Solutions containing ceftriaxone should not be mixed or added to other compounds, except those mentioned in theInstructions for usesection. In particular, do not use diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) to reconstitute ceftriaxone vials or to dilute a reconstituted vial for intravenous administration, as a precipitate may form. Do not mix or administer ceftriaxone and calcium-containing solutions simultaneously, including total parenteral nutrition solutions.

If combined treatment with ceftriaxone and another antibiotic is planned, administration should not be performed with the same syringe or in the same infusion solution.