MEDAXONE 2 g POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Medaxone 2 g Powder for Solution for Injection and Infusion EFG

Ceftriaxone

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Medaxone is and what it is used for

Medaxone is an antibiotic that is administered to adults and children (including newborns). It works by eliminating 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 the flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away 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.
• Bones and joints.
• Skin and soft tissues.
• Blood.
• Heart.

It can be administered:

• To treat certain sexually transmitted infections (gonorrhea and syphilis).
• To treat patients with a low white blood cell count (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 procedures.

2. What you need to know before you use Medaxone

Do not use Medaxone:

• 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 similar antibiotics (such as cephalosporins, carbapenems, or monobactams). Signs include sudden swelling of the throat or face that can make it difficult to breathe or swallow, sudden swelling of the hands, feet, and ankles, and severe rash that appears suddenly.
• If you are allergic to lidocaine and are going to be administered ceftriaxone as an intramuscular injection.

Medaxone should not be administered to babies:

• If the baby is premature.
• If the baby is a newborn (up to 28 days) and has certain blood problems or jaundice (yellow skin or eyes) or is going to be administered a product containing calcium intravenously.

Warnings and precautions

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

• 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 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 recently been administered or are going to be administered products containing calcium.
• If you have recently had diarrhea after taking an antibiotic. You have 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 hemolytic anemia (red blood cell deficiency that can give the skin a pale yellow tint and cause weakness or shortness of breath).
• If you are on a low-sodium diet.

If you are going to have blood or urine tests

If you are administered ceftriaxone for a long time, you may need to have regular blood tests.

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

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

If you are diabetic or need to control your blood sugar levels, you should not use certain blood sugar testing 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.

In case of necessity, alternative analysis methods should be used.

Children

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

• They have recently been administered a product containing calcium intravenously.

Using Medaxone with other medicines

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

In particular, tell 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 or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

Driving and using machines

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

Consult your doctor if you experience these symptoms.

3. How to use Medaxone

Medaxone is usually administered by a doctor or nurse.

It can be administered as

• a drip (intravenous infusion) or
• into a muscle.

Your doctor, pharmacist, or nurse will reconstitute Medaxone and will not mix or administer it 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 being administered other antibiotics, your weight and age, and whether your kidneys and liver are working properly.

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

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

• 1 to 2 g 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 more than 2 g, it may be administered once a day or divided into two doses.

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

• 50-80 mg of ceftriaxone per kg of the 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 more than 2 g, it may be administered once a day or divided into two doses.
• Children who weigh 50 kg or more should receive the usual adult dose.

Newborns (0-14 days)

• 20-50 mg of ceftriaxone per kg of the baby'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 be administered 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 use 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 miss an injection, you should receive it as soon as possible. However, if it is almost time for your next injection, 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.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

This medicine may cause the following side effects:

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

Severe allergic reactions (frequency not known: cannot be estimated from the 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 can make it difficult to breathe or swallow.
• Sudden swelling of the hands, feet, and ankles.

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

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

Signs may include:

• A severe rash that appears suddenly, 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 rash, high body temperature, elevated liver enzyme levels, blood abnormalities (eosinophilia), increased lymph node size, 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 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 cells (decreased leukocytes and elevated eosinophils) and platelets (decreased thrombocytes).
• Soft stools or diarrhea.
• Changes in liver function test results.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g., oral thrush or genital fungal infections).
• Decreased number of certain white blood cells (granulocytopenia).
• Reduced number of red blood cells (anemia).
• Blood clotting problems. Signs may include easy bruising and pain and swelling of the joints.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching (pruritus).
• Pain or burning sensation at the injection site. Blisters, bruising, deep redness, rash, burning sensation, pain, irritation, itching, hardening of the skin, or swelling at the injection site.
• High temperature (fever).
• Abnormalities in kidney function tests (elevated creatinine in blood).

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, itchy rash (hives) that can cover a large area of the body, itching, and swelling.
• Blood or sugar in the urine.
• Swelling (edema).
• Chills.
• Infection at the injection site.

Frequency not known (cannot be estimated from the available data)

• Secondary infection that does not respond to the previously prescribed antibiotic.
• A form of anemia in which red blood cells are destroyed (hemolytic anemia).
• Severe decrease in white blood cells (agranulocytosis).
• Convulsions.
• Dizziness (vertigo, a feeling that everything is spinning).
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain that spreads to the back.
• Inflammation of the mucous membrane that lines the mouth (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness, and soreness of the tongue.
• Bile duct or liver problems, which can cause pain, nausea, vomiting, yellowing of the skin, itching, abnormal urine, and pale-colored stools.
• A neurological disorder that can occur in newborns with severe jaundice (bilirubin encephalopathy).
• Kidney problems caused by the precipitation of ceftriaxone-calcium. You may experience pain when urinating or urinate less often.
• False-positive result in the Coombs test (test to determine certain blood problems).
• False-positive result in the galactosemia test (test for abnormal accumulation of the sugar galactose).
• Ceftriaxone may interfere with some types of blood glucose tests - please consult your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 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 storage time and conditions before use are the responsibility of the user and normally should not exceed 24 hours at 2°C - 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

Composition of Medaxone

• The active ingredient is ceftriaxone. Each vial contains 2 g of ceftriaxone in the form of ceftriaxone sodium.
• The other components are: none.

Appearance of the product and container contents

Medaxone 2 g is a crystalline powder that is almost white or yellowish, slightly hygroscopic.

Medaxone 2 g is supplied in transparent type I glass vials with a nominal capacity of 20 ml, sealed with a bromobutyl rubber stopper and aluminum cap, in a box with a package insert.

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

Only some package 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 on 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 last revision of this package insert: July 2024

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This information is intended only for healthcare professionals:

Consult the summary of product characteristics for the complete technical data sheet.

Method of administration

Intramuscular injection

Medaxone can be administered by deep intramuscular injection. 2 g of ceftriaxone should be dissolved in 7 ml of 1% lidocaine injection.

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

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

Intravenous infusion

Medaxone can be administered by intravenous infusion over at least 30 minutes (preferred route).

2 g of ceftriaxone should be dissolved in 40 ml of one of the following calcium-free solutions.

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. Intramuscular administration should be considered when the intravenous route is not possible or is less appropriate for the patient. For doses greater than 2 g, intravenous administration should 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) should 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 can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration catheter. Therefore, ceftriaxone 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 surgery.

Instructions for use

Recently prepared solutions are recommended. These maintain their potency for at least 6 hours at 25°C or 24 hours at 2-8°C.

Intramuscular injection:

2 g of ceftriaxone should be dissolved in 7 ml of 1% lidocaine injection.

The solution can be administered by deep intramuscular injection. Doses greater than 1 g should be divided and injected at more than one site.

Ceftriaxone should not be mixed in the same syringe with any other medicinal product except 1% lidocaine injection (only for intramuscular injection).

Lidocaine solutions should not be administered intravenously.

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

The infusion should be administered over at least 30 minutes.

Concentrations for intravenous infusion: 50 mg/ml

Disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.

Incompatibilities:

Based on published literature, ceftriaxone is incompatible 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". In particular, diluents containing calcium (such as Ringer's solution or Hartmann's solution) should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration, as a precipitate may form. Ceftriaxone should not be mixed or administered simultaneously with calcium-containing solutions, including total parenteral nutrition.