CEFTRIAXONE REIG JOFRE 1g POWDER AND SOLUTION FOR INTRAMUSCULAR INJECTION

2. What you need to know before you use Ceftriaxone Reig Jofre

Do not use Ceftriaxone Reig Jofre

• 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, severe allergic reaction to penicillin or other similar antibiotics (such as cephalosporins, carbapenems, or monobactams); signs of this reaction are like 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, 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 the 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 that contains 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, a type of white blood cell (eosinophilia), and swollen 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 going to receive ceftriaxone for a long time, you may need to have periodic blood tests. Ceftriaxone can affect the results 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 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.

Other medicines and Ceftriaxone Reig Jofre

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

Ceftriaxone Reig Jofre contains sodium

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

3. How to use Ceftriaxone Reig Jofre

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 with other injected products that contain 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 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 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 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 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 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 Reig Jofre 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 Reig Jofre

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. Do not receive a double dose (two injections at the same time) to make up for a missed dose.

If you stop treatment with Ceftriaxone Reig Jofre

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 peeling of the skin 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), swollen 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.
• Pain or burning sensation at the injection site. Pain at the injection site.
• High temperature (fever).
• Altered kidney function (increased creatinine in the 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 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 (feeling like the room 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, abnormally dark urine, and clay-colored stools.
• A neurological disorder that can occur in newborns with severe jaundice (bilirubin encephalopathy - kernicterus).
• Kidney problems caused by deposits of ceftriaxone calcium. 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. This includes any 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 Reig Jofre

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: The 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, 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 24 hours between 2-8°C, unless the reconstitution has been carried out under controlled and validated aseptic conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to 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 Reig Jofre

The active ingredient is ceftriaxone (as ceftriaxone sodium).

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

Once the vial is reconstituted with 3.5 ml of the lidocaine solution contained in the ampoule, the concentration of the solution is 285.71 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The powder vial has no other components (excipients).

The ampoule of solvent contains 4 ml of 1% lidocaine solution corresponding to 40 mg of lidocaine hydrochloride.

Appearance of the Product and Container Content

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

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

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 Route

Intramuscular Administration

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

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

Intravenous Administration

The solvent provided with this medication, containing lidocaine, cannot be used for intravenous administration.

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 administration 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 the surgical procedure.

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 medication other than a 1% lidocaine hydrochloride solution (for intramuscular injection only).

Intramuscular injection: 1 g of ceftriaxone should be dissolved with 3.5 ml of the 1% lidocaine hydrochloride solution provided in the ampoule. The solution should be administered by deep intramuscular injection. Doses greater than 1 g should be divided and injected in more than one place.

Lidocaine solutions should not be administered intravenously.

Consult the Dosageand Administration Routesections 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. They should not be mixed in the same syringe or vial.