Ceftriaxone Sala 1 g powder for injection and for infusion EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Ceftriaxone Sandoz 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.

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 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 surgical procedures.

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

2. What you need to know before starting to use Ceftriaxone Sala

Do not use Ceftriaxone Sala

• 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 this 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 rapid and severe skin rash.

• if you are allergic to lidocaine and are due to receive ceftriaxone by intramuscular injection.

Ceftriaxone 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 calcium-containing intravenous products are to be administered.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting ceftriaxone:

• if you have recently received or are going to receive any product containing calcium.
• if you have recently had diarrhea following treatment with antibiotics; 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, hemolytic anemia (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 are experiencing 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 levels of liver enzymes, 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 a blood or urine test

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

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

If you are diabetic or need to monitor your blood glucose level (glycemia), you should not use certain glucose monitoring systems that may provide inaccurate estimated glucose values while you are being treated 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 been given intravenous medication containing calcium or are scheduled to receive such medication.

Other medicines and Ceftriaxona Sala

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:

• a type of 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 might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Your doctor will evaluate the expected benefits of treatment with ceftriaxone against the 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.

Ceftriaxona Sala contains sodium

This medicine contains 82.8 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 4.14% of the maximum daily recommended sodium intake for an adult.

3. How to use Ceftriaxone Sala

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

• by intravenous infusion or
• by injection directly 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 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 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 adolescents aged 12 years and older with a body weight of 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 as a single daily dose or as two separate doses.

Newborns, infants, and children from 15 days to 12 years of age with body weight below 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 as a single daily dose or as two separate doses.
• Children weighing 50 kg or more should receive the adult recommended 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 receive a different dose than recommended. Your doctor will decide how much ceftriaxone you need and will closely monitor you based on the severity of your liver or kidney disease.

If you use more Ceftriaxone Sala 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 medication and the amount ingested.

If you forget to use Ceftriaxone Sala

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 receive a double dose (two injections at the same time) to make up for a missed dose.

If you stop using Ceftriaxone Sala

Do not stop receiving ceftriaxone unless your doctor tells you to do so.

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 experiences 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 a heart attack triggered by allergy (Kounis syndrome).

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

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

Symptoms may include:

• A severe rash that develops rapidly, with blisters or skin peeling and possibly mouth blisters (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 levels, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other 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 spirochetal 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 indicating 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 ill.
• Itching.
• Pain or burning sensation at the site or vein where this 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), which may cover large areas of the body, accompanied by 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 nervous system 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 a previously prescribed antibiotic.
• Hemolytic anemia (a type of anemia involving destruction of red blood cells).
• Agranulocytosis (severe decrease in white blood cells).
• Seizures.
• Dizziness (sensation of spinning).
• 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 in newborns with severe jaundice (bilirubin encephalopathy - kernicterus).
• Kidney disorders caused by calcium-ceftriaxone deposits. 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 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 type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (Website: www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftriaxone Sala

Keep this medicine out of the reach and sight of children.

Store below 25°C. Keep in the original packaging to protect from light.

Before reconstitution: Do not use this medicine after the expiry date stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.

After reconstitution: Physical and chemical stability in use has been demonstrated for up to 8 hours at 25°C and 24 hours in the refrigerator (between 2–8°C).

From a microbiological standpoint, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the times and conditions for storage of the solution prior to administration are the responsibility of the user and normally should not exceed the shorter of the times indicated above for chemical and physical stability in use.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ceftriaxone Sala

The active substance is ceftriaxone (as ceftriaxone sodium).

Each vial contains 1 g of ceftriaxone (as ceftriaxone sodium).

Once reconstituted with 10 ml of water for injections, the concentration of the solution is 100 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The powder vial contains no other components (excipients).

Appearance of the product and contents of the pack

It is presented in a glass vial, closed with a rubber stopper and sealed with an aluminium cap.

It is available in cardboard boxes containing 1 vial of powder or in clinical packs of 100 vials of powder.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIO REIG JOFRE, S.A.
Gran Capitán, 10 – 08970
Sant Joan Despí (Barcelona),
Spain

Date of the most recent revision of this leaflet: April 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.gob.

This information is intended for healthcare professionals only

Method of administration

Intramuscular administration

For intramuscular administration, use commercial presentations that include a vial of lidocaine as solvent.

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

Intravenous administration

Ceftriaxone may 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 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 appropriate for the patient. Intravenous administration should be used for doses exceeding 2 g.

Concentrations for intravenous injection: 100 mg/ml
Concentrations for intravenous infusion: 50 mg/ml

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 precipitation of ceftriaxone-calcium.

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 precipitate may form. Precipitation of ceftriaxone-calcium may also occur if ceftriaxone is mixed with calcium-containing solutions in the same intravenous 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

For post-reconstitution stability of the vial, see section 5.

Ceftriaxone must not be mixed in the same syringe with any drug other than a 1.06% hydrochloride lidocaine solution (for intramuscular injection only). See Method of administration.

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: 0.9% sodium chloride, 5% glucose, 10% glucose, 5% glucose in 0.9% sodium chloride, or sterile water for injection. The infusion should be administered over at least 30 minutes.

Refer to the sections Dosage and Method of administration for further information.

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 mentioned in the section Instructions for use. In particular, 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 precipitate may form. Ceftriaxone and calcium-containing solutions, including total parenteral nutrition, must not be mixed or administered simultaneously.

Mixtures of beta-lactam antibiotics (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If administered simultaneously, they must be given at separate sites. Do not mix them in the same syringe or vial.