CEFTRIAXONE QILU 1 g POWDER FOR INJECTION AND INFUSION SOLUTION

2. What you need to know before you use Ceftriaxone Qilu

Do not use Ceftriaxone Qilu:

• 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 other similar antibiotics (such as cephalosporins, carbapenems, or monobactams); signs of such a reaction are sudden swelling of the throat or face that makes breathing or swallowing difficult, sudden swelling of hands, feet, and ankles, chest pain, or a severe and rapid skin rash.
• if you are allergic to lidocaine and are going to receive ceftriaxone by intramuscular injection.

Ceftriaxone Qilu must not be administered to babies if:

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

Warnings and precautions

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

• if you have recently received or are going 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 had liver or kidney problems (see section 4).
• if you have gallstones or kidney stones.
• if you have had other diseases, for example, hemolytic anemia (a decrease in your 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, increased liver enzyme levels observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and an increase in lymph node size (signs of severe skin reactions, see also section 4 "Possible side effects")

If you need a blood or urine test

If you are going to receive ceftriaxone for a long time, you may need to have regular blood tests. Ceftriaxone can affect the results of a urine test for sugar (glucosuria) and 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 control your blood sugar levels, you should not use certain blood sugar control systems that may give incorrect glucose estimates while you are being treated with ceftriaxone. If you use such a system, consult the instructions for use and talk to your doctor, pharmacist, or nurse. If necessary, alternative test methods should be used.

Children

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

• your child has recently been given or is going to be given a product containing calcium in a vein.

Using Ceftriaxone Qilu with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Particularly, tell your doctor or pharmacist if you are taking any of the following medicines:

• a type of antibiotic called 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 have a baby, ask your doctor for advice before taking this medicine.

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

Driving and using machines

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

Ceftriaxone Qilu contains sodium

Vial of 1 g: this medicine contains 82.8 mg of sodium (the main component of cooking salt) per vial. This is equivalent to 4.14% of the maximum recommended daily intake of sodium in the adult diet, 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 nurse. It can be administered:

• by intravenous infusion or
• by direct injection into a vein or
• into a muscle

Ceftriaxone is prepared for administration by a doctor, pharmacist, or nurse. It must not be mixed or administered at the same time as other injectable products containing calcium.

Recommended dose

Your doctor will decide 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 the condition of your liver and kidneys. The number of days or weeks you will receive ceftriaxone will depend on the type of infection.

Adults, elderly patients, and children from 12 years of age 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 more than 2 g, it may be administered as a single dose per day or as two separate doses.

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

• 50 to 80 mg of ceftriaxone per kg 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 kg of weight up to a maximum of 4 g per day. If your daily dose is more than 2 g, it may be administered as a single dose per day or as two separate doses.
• Children with a weight of 50 kg or more should receive the recommended adult dose.

Newborns (0-14 days)

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

Patients with liver or kidney problems

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

If you use more Ceftriaxone Qilu than you should

If you receive a higher dose than prescribed by mistake, 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use 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 the next injection, skip the missed injection. You should not receive a double dose (two injections at the same time) to make up for a missed dose.

If you stop using Ceftriaxone Qilu

Do not stop receiving Ceftriaxone unless your doctor tells you to. If you have any further questions on the use of this medicine, ask 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, tell your doctor immediately.

The signs may be:

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

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

If you have a severe skin reaction, inform a 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 SJS and TEN).
• A combination of any of the following symptoms: widespread skin rash, high body temperature, elevated liver enzyme values, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which causes fever, chills, headache, muscle pain, and skin rash, usually self-limiting. This occurs shortly after starting treatment with ceftriaxone for infections with spirochetes such as Lyme disease.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Abnormalities in 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 liver function test results.
• 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. The signs may include frequent bruising, as well as pain and swelling of the joints.
• Headache.
• Dizziness.
• Feeling unwell or sick.

• Itching (pruritus).
• Pain or burning sensation at the injection site. Pain at the injection site.
• High temperature (fever).
• Abnormal kidney function (increased blood creatinine).

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

• Inflammation of the large intestine (colon). The signs may include diarrhea, usually with blood and mucus, stomach pain, and fever.
• Difficulty breathing (bronchospasm).
• Hives (urticaria) that can cover a large area of the body, with itching and swelling.
• Blood or sugar in the urine.
• Swelling (edema).
• Chills.
• Treatment with ceftriaxone, particularly in elderly patients with severe kidney problems or nervous system problems, can rarely cause decreased consciousness, abnormal movements, agitation, and convulsions.

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

• Secondary infection that may not have responded to previous antibiotic treatment.
• Hemolytic anemia (a form 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 stomach pain that radiates to the back.
• Stomatitis (inflammation of the mucous membrane lining the mouth).
• Glossitis (inflammation of the tongue). The signs may include swelling, redness, and pain in the tongue.
• Problems with the gallbladder or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, dark urine, and clay-colored stools.
• A neurological disorder that can occur in newborns with severe jaundice (bilirubin encephalopathy - kernicterus).
• Kidney problems caused by ceftriaxone calcium deposits. You may have pain when urinating or a decreased amount of urine.
• A false-positive result in the Coombs test (a test to detect certain blood abnormalities).
• A false-positive result for 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 side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es.

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

5. Storage of Ceftriaxone Qilu

• The storage of ceftriaxone is the responsibility of your doctor or pharmacist, who will also be responsible for 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 which is stated on the carton or vial. The expiry date is the last day of the month stated.
• Do not store above 25°C. Keep the vial in the carton to protect it from light.

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

From a microbiological point of view, unless the opening method allows the risk of microbial contamination to be ruled out, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Ceftriaxone Qilu

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.

Product Appearance and Container Content

• Ceftriaxone is a powder for solution for injection and infusion. It is a crystalline powder of almost white or yellowish color. It is presented in a glass vial. The solution presents a pale yellow to yellow coloration after reconstitution, depending on the storage time, concentration, and diluent used, but this does not affect the efficacy of the active ingredient. The solution should only 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. Then, the correct dose is extracted from the vial. It can be administered to the patient either by injection or added to an infusion solution bag 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 marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

floor 8, 28046 - Madrid,

Spain

Manufacturer

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

Tel.: + 34 93 342 78 90

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

Date of last revision of this leaflet:May 2024

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

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This information is intended only for healthcare professionals:

INFORMATION FOR HEALTHCARE PROFESSIONALS

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

ceftriaxone (as ceftriaxone sodium)

Consult the complete prescribing information in the Summary of Product Characteristics or the Package Leaflet.

Method of Administration

Intramuscular administration

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

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

Intravenous administration

Ceftriaxone can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 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 be administered over approximately 60 minutes to reduce the risk of bilirubin encephalopathy. Intramuscular administration should be considered when the intravenous route is not possible or is less suitable for the patient. For doses greater than 2 g, intravenous administration 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 parenteral nutrition, due to the risk of ceftriaxone-calcium precipitation.

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

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

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

Ceftriaxone should 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 by deep intramuscular injection. Doses greater than 1 g should be divided and injected at more than one site.

Lidocaine solutions should 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 through 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, or hydroxyethyl starch 6-10% for infusion. The infusion should be administered over at least 30 minutes.

Consult the sections Dosageand Method of Administrationfor more information.

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

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 incompatible with amsacrine, vancomycin, fluconazole, aminoglycosides, and labetalol.

Solutions containing ceftriaxone should not be mixed or added to other compounds, except those mentioned in the Instructions for Usesection. In particular, diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) should 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 solutions containing calcium, including total parenteral nutrition, should not be mixed or administered simultaneously.

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.