Medaxone 1 g powder for injection and for infusion EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Medaxone 1 g Powder for Solution for Injection and for Infusion EFG

Ceftriaxone

Read this entire leaflet carefully before you start using this medicine, because 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are possible adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Medaxone is and what it is used for

Medaxone is an antibiotic administered to adults and children (including newborns). It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

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 also be used:

• To treat certain sexually transmitted infections (gonorrhoea and syphilis).
• To treat patients with low white blood cell counts (neutropenia) who have 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 procedures.

2. What you need to know before using Medaxone

Do not use Medaxone:

• If you are allergic to ceftriaxone or any of the other components of this medicine (listed in section 6).
• If you have previously had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems, or monobactams). Signs include, among others, sudden swelling of the throat or face that may make it difficult to breathe or swallow, sudden swelling of the hands, feet, and ankles, chest pain, and sudden onset of a severe rash.
• If you are allergic to lidocaine and Medaxone is to be administered as an intramuscular injection.

Medaxone must not be given to babies:

• If the baby is premature.
• If the newborn is up to 28 days old and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or if they are to receive intravenous products containing calcium.

Warnings and precautions

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

• If you are experiencing or have previously experienced a combination of any of the following symptoms: rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, elevated liver enzyme levels shown in blood tests, 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 have recently received or are about to receive products containing calcium.
• If you have recently had diarrhoea after taking an antibiotic, or if you have ever had 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 suffer from other diseases, such as haemolytic anaemia (a deficiency of red blood cells that may give the skin a pale yellow tinge and cause weakness or shortness of breath).
• If you are on a low-sodium diet.

If you are having blood or urine tests

If you are receiving ceftriaxone for a prolonged period, you may need regular blood tests.

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

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

If you are diabetic or need to monitor your blood glucose levels, you should not use certain blood glucose monitoring systems that may give inaccurate results while you are receiving ceftriaxone. If you use such systems, check the instructions and consult your doctor, pharmacist, or nurse.

Alternative testing methods should be used if necessary.

Children

Talk to your doctor, pharmacist, or nurse before Medaxone is given to your child if:

• They have recently received intravenous products containing calcium.

Using Medaxone with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• 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, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will assess the benefit of treatment with ceftriaxone for you and the potential risk to your baby.

Driving and using machines

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

Consult your doctor if you experience these symptoms.

3. How to use Medaxone

Medaxone is normally administered by a doctor or nurse.

It may be given as

• an intravenous infusion (drip) or as an injection directly into a vein, or
• into a muscle.

The doctor, pharmacist, or nurse will reconstitute Medaxone, and it must not be mixed or administered simultaneously with injections containing calcium.

Recommended dose

Your doctor will decide 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 you will receive Medaxone will depend on the type of infection you have.

Adults, elderly, and children aged 12 years and older with a body weight of 50 kilograms (kg) or more:

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

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

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

Newborns (0–14 days):

• 20–50 mg of ceftriaxone per kg of body weight once daily, depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg per kg of body weight of the infant.

Patients with liver or kidney problems

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

If you use more Medaxone than you should

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

If you forget to use Medaxone

If you miss an injection, it should be given as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not administer a double dose (two injections at the same time) to make up for the missed dose.

If you stop using Medaxone

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 disorders, may rarely cause decreased consciousness, abnormal movements, agitation, and seizures.

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, among others:

• Sudden swelling of the face, throat, lips, or mouth, which may make it difficult to breathe or swallow.
• Sudden swelling of the hands, feet, and ankles.
• Chest pain in the context of allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome).

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

If you experience a severe skin reaction, inform your doctor immediately.

Signs may include:

• A severe rash appearing suddenly, with blisters or peeling skin 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)

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

Uncommon (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).
• Reduction in red blood cells (anemia).
• Problems with blood clotting. Signs may include, among others, easy bruising and joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Pruritus (itching).
• Pain or burning sensation at the site where ceftriaxone was administered. Blisters, bruising, deep redness or rash, burning sensation, pain, irritation, itching, skin hardening, or swelling at the injection site.
• High temperature (fever).
• Abnormalities in kidney function tests (increased blood creatinine).

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

• Inflammation of the large intestine (colon). Signs include diarrhea, usually with blood or mucus, stomach pain, and fever.
• Difficulty breathing (bronchospasm).
• Raised rash (hives) that may cover large parts of the body, itching, and swelling.
• Blood or sugar in the urine.
• Edema (fluid accumulation).
• Chills.
• Infection at the injection site.

Frequency not known (cannot be estimated from available data)

• Secondary infection not responding to previously prescribed antibiotics.
• A form of anemia in which red blood cells are destroyed (hemolytic anemia).
• Severe decrease in white blood cells (agranulocytosis).
• Seizures.
• Vertigo (sensation that everything is spinning).
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
• Inflammation of the mucous membrane lining the mouth (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness, and soreness of the tongue.
• Gallbladder or liver problems, which may cause pain, nausea, vomiting, yellowing of the skin, itching, abnormally dark urine, and clay-colored stools.
• A neurological disorder that may occur in neonates with severe jaundice (bilirubin encephalopathy).
• Kidney problems caused by precipitation of calcium-ceftriaxone. You may experience pain when urinating or pass small amounts of urine.
• False positive result in the Coombs test (a blood test to detect certain blood disorders).
• False positive result in the galactosemia test (abnormal accumulation of the sugar galactose).
• Ceftriaxone may interfere with certain types of blood glucose tests – please consult your doctor.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medaxone

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

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

The reconstituted solution should preferably be used immediately. Physical and chemical stability has been demonstrated for up to 6 hours at 25°C and for 24 hours at 2°C - 8°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and normally should not exceed 24 hours at 2°C - 8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. These measures are intended to protect the environment.

6. Package contents and other information

Composition of Medaxone

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

Appearance of the medicinal product and contents of the container

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

Medaxone 1 g is supplied in clear type I glass vials with a nominal capacity of 10 ml, sealed with a bromobutyl rubber stopper and aluminum cap (with or without plastic flip-off seal), in a carton with package leaflet.

It is available in packs of 1, 10, 25, 50 or 100 vials.

Only certain pack sizes may be marketed.

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., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

Date of the most recent revision of this leaflet: March 2025

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This information is intended for healthcare professionals only:

Refer to the Summary of Product Characteristics for the complete technical data sheet.

Method of administration

Intramuscular injection

Medaxone may be administered by deep intramuscular injection. One gram of ceftriaxone must be dissolved in 3.5 ml of 1% lidocaine for injection.

Intramuscular injections must be administered deeply into the mass of a relatively large muscle, and no more than 1 g should be administered at each injection site.

Since lidocaine is used as the solvent, the resulting solution must never be administered intravenously.

Intravenous injection

Medaxone may be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes. Intermittent intravenous injection should preferably be administered over 5 minutes into large veins.

One gram of ceftriaxone must be dissolved in 10 ml of water for injections.

Intravenous doses of 50 mg/kg or higher in infants and children up to 12 years of age must be administered by infusion. In neonates, intravenous doses must be administered over 60 minutes to reduce the potential risk of bilirubin encephalopathy. Intramuscular administration should be considered when the intravenous route is not feasible or less appropriate for the patient. For doses exceeding 2 g, intravenous administration must be used.

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

Diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) must not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration, as a precipitate may form. Ceftriaxone-calcium precipitation may also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Therefore, ceftriaxone solutions 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

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

Intramuscular injection:

Vial size	Diluent to be added	Approximate available volume	Approximate displacement volume
1 g	3.5 ml	4.05 ml	0.55 ml

Medaxone must not be mixed in the same syringe with any drug except a 1% hydrochloric acid lidocaine solution (for deep intramuscular injection only).

Solutions containing lidocaine must not be administered intravenously.

Doses exceeding 1 g must be divided and injected at more than one site.

Intravenous injection:

Size of vial	Diluent to be added	Approximate available volume	Approximate displacement volume
1 g	10 ml	10.5 ml	0.5 ml

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

Concentrations for intravenous injection: 100 mg/ml

Concentrations for intravenous infusion: 50 mg/ml

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

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

Incompatibilities:

Based on published literature, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, aminoglycosides, and labetalol.

Solutions containing ceftriaxone must not be mixed or combined with other agents except those mentioned in the "Instructions for use." In particular, diluents containing calcium (such as Ringer's solution or Hartmann's solution) must not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration, as a precipitate may form. Ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions, including total parenteral nutrition.