CEFTRIAXONE SALA 2 g POWDER FOR SOLUTION FOR INJECTION AND INFUSION

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

Do not use Ceftriaxone Sala

• 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 this reaction are sudden swelling of the throat or face that makes 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 are going to receive ceftriaxone by intramuscular injection.

Ceftriaxone should 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 whites of the eyes) or is going to be given a product containing calcium in a vein.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take 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, such as 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, 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 result of a urine sugar test (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 (glucose), you should not use certain glucose control systems that may give incorrect glucose estimates while you are being treated with ceftriaxone. If you use any such 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:

• they have recently been given or are going to be given a product containing calcium in a vein.

Other medicines and Ceftriaxone Sala

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 vehicles or use tools or machines. Talk to your doctor if you have this symptom.

Ceftriaxone Sala contains sodium

This medicine contains 165.6 mg of sodium (a major component of cooking/table salt) in each vial. This is equivalent to 8.28% of the maximum recommended daily sodium intake for an adult.

3. How to use Ceftriaxone Sala

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 injected 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 adolescents 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 given 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 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 up to a maximum of 4 g per day. If your daily dose is more than 2 g, it may be given 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 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 altered kidney or liver 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 Sala 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 taken.

If you forget to use Ceftriaxone Sala

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 Sala

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 rash, 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), lymph node enlargement, and involvement of other organs (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 leukocyte 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 coagulation problems. The signs may include frequent bruising, as well as pain and swelling of the joints.
• Headache.
• Dizziness.
• Feeling unwell or sick.
• Itching.
• Pain or burning sensation at the injection site or in the vein where this medicine was injected. Pain at the injection site.
• High temperature (fever).
• Altered kidney function (increased creatinine in blood).

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 with 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).
• Convulsions.
• Dizziness (feeling like your head is spinning).
• 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, abnormal urine, and clay-colored stools.
• 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 small amount of urine.
• A false-positive result in the Coombs test (a test to detect certain blood disorders).
• 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 it is possible side effects 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 Sala

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

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

Before reconstitution: Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is 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 point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage times and conditions of the solution before administration are the responsibility of the user and should not normally exceed the times indicated above for physical and chemical stability during use, whichever is shorter.

6. Container Content and Additional Information

Composition of Ceftriaxone Sala

The active ingredient is ceftriaxone (as ceftriaxone sodium).

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

Once reconstituted with 40 ml of a suitable solution (see Administrationbelow), the concentration of the solution is 50 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The powder vial has no other components (excipients).

Appearance of the Product and Container Content

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

It is presented in cardboard boxes containing 1 powder vial or in clinical packages of 100 powder vials.

Only some package 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 Last Revision of this Prospectus: April 2024

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

This information is intended only for healthcare professionals

Administration

Intramuscular Administration

For intramuscular administration, use commercial presentations that incorporate a lidocaine ampoule as a solvent.

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 Technical Data Sheet of lidocaine should be taken into account.

Intravenous Administration

Ceftriaxone can be administered by intravenous infusion for at least 30 minutes (preferred route) or by slow intravenous injection for 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 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.

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) should not be used to reconstitute ceftriaxone vials or for subsequent dilution of a reconstituted vial for intravenous administration, as a precipitate may form. Precipitation of ceftriaxone calcium 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

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

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

Lidocaine solutions should not be administered intravenously.

Intravenous injection: 1 g of ceftriaxone should be dissolved in 10 ml of water for injectable preparations. 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: 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.

Consult the Dosageand Administrationsections for more information.

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.

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