Ceftriaxone Sala 2 g powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ceftriaxone Sala 2 g powder for solution for injection and for infusion EFG

Read all of this 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 and must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

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:

• for the treatment of specific sexually transmitted infections (gonorrhea and syphilis).

• for the treatment of patients with low levels of white blood cells (neutropenia) who have fever due to a bacterial infection.

• for the treatment of 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 using 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 severe and rapid skin rash.
• if you are allergic to lidocaine and you are to receive ceftriaxone by intramuscular injection.

Ceftriaxone must not be given 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 whites of the eyes), or if they are to be given a product containing calcium by intravenous infusion.

Warnings and precautions

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

• if you have recently received or are scheduled to receive any product containing calcium.
• if you have recently had diarrhea after 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, 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 a blood test called the Coombs test. If you are undergoing 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:

• calcium-containing intravenous products have recently been administered or are planned to be administered.

Other medicines and Ceftriaxona Sala

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• an antibiotic known as 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 plan 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. Speak with your doctor if you experience this symptom.

Ceftriaxona Sala contains sodium

This medicine contains 165.6 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 8.28% 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 direct injection into a vein, or
• by injection 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 a 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, with 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 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 the one recommended. Your doctor will decide how much ceftriaxone you need and will closely monitor you based on the severity of your kidney or liver disease.

If you use more Ceftriaxone Sala than you should

If, by mistake, you receive a higher dose than prescribed, contact your doctor 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 administer 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 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 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 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 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 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 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, often with blood and mucus, stomach pain, and fever.
• Difficulty breathing (bronchospasm).
• Hives (urticaria), which may cover large areas 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 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 used 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 (blood sugar tests); consult your doctor.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (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: The physical and chemical stability in use has been demonstrated for up to 8 hours at 25°C and 24 hours under refrigeration (between 2–8°C).

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

6. Contents of the pack and other information

Composition of Ceftriaxone Sala

The active substance is ceftriaxone (as ceftriaxone sodium).

Each vial contains 2 g of ceftriaxone (as ceftriaxone sodium).

Once reconstituted with 40 ml of an appropriate solution (see Administration method below), the concentration of the solution is 50 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The powder vial contains no other components (excipients).

Appearance of the product and pack contents

It is presented in a glass vial, closed with a rubber stopper and sealed with a 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

Administration method

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. The information provided in the Technical Data Sheet or Summary of Product Characteristics of lidocaine must be taken into account.

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 administered by infusion. In neonates, intravenous infusions should last 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.

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) 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 a 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 medicinal product other than a 1.06% hydrochloride lidocaine solution (for intramuscular injection only). See Administration method.

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 Dosage and Administration method sections 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 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 further 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.

Mixtures of beta-lactam antibacterial agents (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.