Prospecto: Information for the Patient

Medaxone 1 g Powder for Injection and Infusion EFG

Ceftriaxone

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribedonlyto you, and you should not give it to others even iftheyhave the same symptomsas you,as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this prospect. See section4.

Medaxone is an antibiotic administered to adults and children (including newborns). It acts by eliminating the bacteria that cause infections. It belongs to a group of medications known as cefalosporins.

Medaxone 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.

It may be administered:

• To treat some sexually transmitted infections (gonorrhea and syphilis).
• To treat patients with white blood cell deficiency (neutropenia) who have a fever due to a bacterial infection.
• To treat chest infections in adults with chronic bronchitis.
• To treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age.
• To prevent infections during surgical interventions.

Do not use Medaxone:

• If you are allergic to ceftriaxone or any of the other components of this medication (listed in section6).
• If you have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems, or monobactams). Symptoms include, among others, sudden inflammation of the throat or face that may make it difficult to breathe or swallow, sudden inflammation of the hands, feet, and ankles, and severe sudden onset rash.
• If you are allergic to lidocaine and will be administered ceftriaxone in the form of an intramuscular injection.

Medaxone should not be administered to infants:

• If the infant is premature.
• If the infant is newborn (up to 28 days) and has certain blood problems or jaundice (yellow skin or white of the eyes) or will be administered in a vein a product containing calcium.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Medaxone:

• Have experienced 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, elevated 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 have been administered recently or will be administered products containing calcium.
• If you have had diarrhea after taking an antibiotic recently. Have had any intestinal problems, especially colitis (inflammation of the large intestine).
• If you have liver or kidney problems (see section 4).
• If you have gallstones or kidney stones.
• If you have other diseases, such as hemolytic anemia (deficiency of red blood cells that can give the skin a yellowish pale color and cause weakness or shortness of breath).
• If you are on a low-sodium diet.

If you are to have blood or urine tests

If you are administered ceftriaxone for a prolonged period, you may need to have blood tests regularly.

Ceftriaxone may affect the results of blood glucose tests and a blood test called the Coombs test. If you are to have tests:

• Inform the person taking the sample that you are being administered ceftriaxone.

If you are diabetic or need to control your blood glucose level, do not use some blood glucose monitoring systems that may give incorrect results while you are being administered ceftriaxone. If you use these systems, check the instructions and consult your doctor, pharmacist, or nurse.

Alternative analysis methods should be used if necessary.

Children

Consult your doctor, pharmacist, or nurse before administering Medaxone to your child if:

• Recently administered in a vein a product containing calcium.

Use of Medaxone with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Specifically, inform your doctor or pharmacist if you are taking any of the following medications:

• A group of antibiotics known as aminoglycosides.
• An antibiotic called chloramphenicol (used to treat infections, especially eye infections).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Your doctor will assess the benefits of ceftriaxone treatment for you and the risk to your child.

Driving and operating machinery

Ceftriaxone may cause dizziness. If you feel dizzy, do not drive or operate tools or machinery.

Consult your doctor if you experience these symptoms.

Medaxone is usually administered by a doctor or a nurse.

It can be administered in the form of

• intravenous infusion (drip) or direct injection into a vein or
• into a muscle.

The doctor, pharmacist, or nurse reconstitutes Medaxone and it should not be mixed or administered simultaneously with injections containing calcium.

Recommended dose

Your doctor will decide on the correct dose of Medaxone for you. The dose will depend on the severity and type of infection, whether you are receiving other antibiotics, your weight and age, and whether your kidneys and liver are functioning properly.

The number of days or weeks that you will receive Medaxone will depend on the type of infection you have.

Adults, elderly, and children 12 years of age or older with a body weight of 50 kg or more:

• 1 to 2g once a day depending on the severity and type of infection. If the infection is severe, your doctor will increase the dose (up to 4 g once a day). If the daily dose is greater than 2g, it may be administered once a day or divided into two doses.

Newborns, infants, and children between 15 days and 12 years of age with a body weight less than 50 kg:

• 50-80 mg of ceftriaxone per kg of child's weight once a day depending on the severity and type of infection. If the infection is severe, your doctor will increase the dose up to 100 mg per kg of body weight up to a maximum of 4 g once a day. If the daily dose is greater than 2g, it may be administered once a day or divided into two doses.
• Children weighing 50 kg or more should receive the usual adult dose.

Newborns (0-14 days)

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

Patients with liver and kidney problems

You may receive a different dose than usual. Your doctor will decide how much Medaxone you need and will closely monitor you depending on the severity of the liver and kidney disease.

If you take more Medaxone than you should

If you accidentally receive a higher dose than prescribed, go to your doctor or the nearest hospital immediately.

If you forget to use Medaxone

If you forget a dose, you should receive it as soon as possible. However, if it is almost time for your next dose, omit the missed dose. Do not administer a double dose (two injections at the same time) to compensate for the missed dose.

If you interrupt treatment with Medaxone

Do not stop using ceftriaxone unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

This medicine may cause the following side effects:

Treatment with ceftriaxone, particularly in elderly patients with severe kidney problems or nervous system problems, rarely may cause decreased consciousness, abnormal movements, agitation, and seizures.

Severe allergic reactions (frequency unknown: cannot be estimated from available data)

Inform your doctor immediately if you experience a severe allergic reaction.

The signs may include:

• Sudden inflammation of the face, throat, lips, or mouth, which may make it difficult to breathe or swallow.
• Sudden inflammation of the hands, feet, and ankles.

Severe skin reactions (frequency unknown: cannot be estimated from available data)

Inform your doctor immediately if you experience a severe skin reaction.

The signs may include:

• Severe rash that appears suddenly, with blisters or skin peeling, and possibly with blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SSJy NET).
• A combination of any of the following symptoms: generalized skin rash, high body temperature, elevated liver enzyme values, blood abnormalities (eosinophilia), enlarged lymph nodes, and organ damage (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, which is usually self-limiting. This occurs shortly after starting ceftriaxone treatment for infections caused by spirochetes such as Lyme disease.

Other possible side effects:

Frequent (may affect up to 1 in 10 people)

• Abnormalities in white blood cells (decreased leukocytes and elevated eosinophils) and platelets (decreased thrombocytes).
• Soft stools or diarrhea.
• Changes in liver function test results.
• Rash.

Rare (may affect up to 1 in 100 people)

• Fungal infections (e.g., oral candidiasis or genital fungal infections).
• Decreased number of certain white blood cells (granulocytopenia).
• Reduced number of red blood cells (anemia).
• Bleeding problems. The signs may include, among others, easy bruising and joint pain.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching (pruritus).
• Pain or burning sensation at the site where ceftriaxone was administered. Blisters, bruises, deep redness, or rash, burning sensation, pain, irritation, itching, skin hardening, or swelling at the injection site.
• High body temperature (fever).
• Abnormalities in kidney function test results (elevated creatinine in blood).

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

• Colitis, which may cause diarrhea, often with blood or mucus, abdominal pain, and fever.
• Difficulty breathing (bronchospasm).
• Severe rash (hives) that may cover a large area of the body, itching, and swelling.
• Blood or sugar in the urine.
• Swelling (edema).
• Chills.
• Injection site infection

Frequency unknown (cannot be estimated from available data)

• Secondary infection that does not respond to the previously prescribed antibiotic.
• A type of anemia in which red blood cells are destroyed (hemolytic anemia).
• Severe decrease in white blood cells (agranulocytosis).
• Seizures.
• Dizziness (vertigo).
• Pancreatitis, which may cause severe abdominal pain that radiates to the back.
• Stomatitis, which may cause inflammation of the mucous membrane that lines the mouth.
• Glossitis, which may cause inflammation of the tongue, characterized by swelling, redness, and itching.
• Bile duct or liver problems, which may cause pain, nausea, vomiting, yellowing of the skin, itching, dark-colored urine, and clay-colored stools.
• Neurological disorder that may occur in newborns with intense jaundice (bilirubin encephalopathy).
• Renal problems caused by ceftriaxone calcium precipitation. You may experience pain while urinating or urinating in small amounts.
• Falsely positive Coombs test result (analysis to determine certain blood disorders).
• Falsely positive galactosemia test result (abnormal accumulation of galactose sugar).
• Ceftriaxone may interfere with certain types of blood glucose tests - please consult your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date refers to the last day of the month indicated.

This medication does not require any special storage temperature. Keep the vial in the outer box to protect it from light.

The reconstituted solution should preferably be used immediately. Physical and chemical stability has been demonstrated during use for 6 hours at 25°C and 24 hours at 2°C - 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the time and storage conditions before use are the responsibility of the user and should normally not exceed 24 hours at 2°C - 8°C, unless reconstitution was performed in controlled and validated aseptic conditions.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. These measures are intended to protect the environment.

Ceftriaxone Composition

• The active ingredient is ceftriaxona. Each vial contains 1g of ceftriaxona in the form of ceftriaxona sodium.
• The other components are: none.

Appearance of the product and contents of the container

Ceftriaxone 1g is a white or yellowish crystalline powder, slightly hygroscopic.

Ceftriaxone 1g is supplied in type I transparent glass vials with a nominal capacity of 10 ml, sealed with a bromobutyl rubber stopper and an aluminum cap, in a box with a leaflet.

It is presented in boxes of 1, 10, 25, 50 or 100 vials.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Medochemie Ltd.

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Manufacturer

Medochemie Limited (Factory C)

2 Michael Erakleous street,

Agios Athanassios, Industrial Area,

4101 Agios Athanassios, Limassol,

Cyprus

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Local Representative:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

SPAIN

Last review date of this leaflet: July 2024

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This information is intended for healthcare professionals only:

See the product characteristics summary for the complete technical dossier.

Administration route

Intramuscular injection

Ceftriaxone can be administered by deep intramuscular injection. 1g of ceftriaxona should be dissolved in 3.5ml of lidocaína for injection at 1%.

Intramuscular injections should be administered deeply in a relatively large muscle mass and not more than 1g per site.

Since the solvent used is lidocaína, the resulting solution should never be administered intravenously.

Intravenous injection

Ceftriaxone can be administered by intravenous infusion for at least 30 minutes (preferred route) or by a slow intravenous injection of 5 minutes. The intermittent intravenous injection should be administered for 5 minutes preferably in the largest veins.

1g of ceftriaxona should be dissolved in 10ml of water for injection preparations.

Intravenous doses of 50 mg/kg or more in infants and children up to 12 years should be administered by infusion. In neonates, intravenous doses should be administered over 60 minutes to reduce the possible risk of bilirubin encephalopathy. The intramuscular route should be considered when the intravenous route is not possible or less appropriate for the patient. For doses greater than 2 g, the intravenous route should be used.

Ceftriaxone is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with intravenous solutions containing calcium, for example, continuous infusions containing calcium as parenteral nutrition, due to the risk of ceftriaxona-calcium precipitation.

Calcium-containing diluents (e.g. Ringer's solution or Hartmann's solution) should not be used to reconstitute ceftriaxona vials or to dilute a reconstituted vial for intravenous administration because precipitation may occur. Ceftriaxona-calcium precipitation may also occur when ceftriaxona is mixed with calcium-containing solutions in the same intravenous administration catheter. Therefore, ceftriaxona solutions and calcium-containing solutions should not be mixed or administered simultaneously.

For preoperative prophylaxis of surgical site infections, ceftriaxone should be administered 30-90 minutes before the procedure.

Instructions for use

It is recommended to use freshly prepared solutions. These solutions retain potency for at least 6 hours at 25°C or 24 hours at 2-8°C.

Intramuscular injection:

Ceftriaxone should not be mixed in the same syringe with any other medication except a solution of lidocaína hydrochloride at 1%. (Only for deep intramuscular injection).

Lidocaína solutions should not be administered intravenously.

Doses of more than 1 g should be fractionated and injected in more than one site.

Intravenous injection:

For IV injection, 1 g of Ceftriaxone should be dissolved in 10ml of water for injection preparations. The injection should be administered over 5 minutes, directly into a vein or through an intravenous catheter for infusion.

Concentrations for intravenous injection: 100 mg/ml

Concentrations for intravenous infusion: 50 mg/ml

Ceftriaxone is compatible with various intravenous infusion solutions commonly used, such as dextrose for injection BP at 5%, 10%, sodium chloride for injection BP, sodium chloride (0.45%), dextrose for injection (2.5%) BP, dextran at 6%, in dextrose for injection BP at 5%, and hydroxyethyl starch at 6%.

The disposal of residual antibiotic solution and all materials used for its administration will be carried out in accordance with local regulations.

Incompatibilities:

Based on bibliographic publications, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole, aminoglycosides, and labetalol.

Ceftriaxone solutions should not be mixed or added to other agents except those mentioned in the "Instructions for use". Specifically, calcium-containing diluents (such as Ringer's solution or Hartmann's solution) should not be used to reconstitute ceftriaxona vials or to dilute a reconstituted vial for intravenous administration because precipitation may occur. Ceftriaxone should not be mixed or administered simultaneously with solutions containing calcium, including total parenteral nutrition.