MEDAXONE 1 g POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

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

Medaxone should not be given 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 given a product containing calcium into a vein.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Medaxone:

• If you have experienced or are experiencing 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 seen in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 "Possible side effects").
• If you have recently been given or are going to be given products containing calcium.
• If you have recently had diarrhea after taking an antibiotic. 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 have 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 given 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 given 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 false results while you are being given ceftriaxone. If you use these systems, check the instructions and talk to your doctor, pharmacist, or nurse.

In case of need, alternative test methods should be used.

Children

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

• Your child has recently been given a product containing calcium into a vein.

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 weigh the benefits of treatment with ceftriaxone to you against the risks to your baby.

Driving and using machines

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

Talk to your doctor if you experience these symptoms.

3. How to use Medaxone

Medaxone is usually given by a doctor or nurse.

It can be given as:

• A drip (intravenous infusion) or injection directly into a vein or
• Into a muscle.

Your doctor, pharmacist, or nurse will reconstitute Medaxone and will not mix or give it at the same time as 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 given other antibiotics, your weight and age, and whether your kidneys and liver are working properly.

The number of days or weeks you are given 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 given once a day or divided into two doses.

Newborns, infants, and children from 15 days to 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 given 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.

People with liver and kidney problems

You may be given 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 have it as soon as possible. However, if it is almost time for your next injection, skip the missed dose. Do not give 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, may rarely cause decreased consciousness, abnormal movements, agitation, and convulsions.

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

If you get a severe allergic reaction, tell your doctor immediately.

Signs may include:

• 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.

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

If you get a severe skin reaction, tell 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), enlarged 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 rash, usually self-limiting. This occurs soon 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 of 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).
• Decrease in the number of certain white blood cells (granulocytopenia).
• Decrease in 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, or 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 may 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 where red blood cells are destroyed (hemolytic anemia).
• Severe decrease in white blood cells (agranulocytosis).
• Seizures.
• 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 (a test to detect certain blood problems).
• False-positive result in the galactosemia test (a test to detect abnormal galactose sugar accumulation).
• 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. This includes any possible side effects 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 which is 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 Content and Additional Information

Medaxone Composition

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

Product Appearance and Container Content

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

Medaxone 1 g is supplied in transparent type I 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 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

You can request more information about this medicine by contacting 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 last revision of this leaflet: 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.

Administration Route

Intramuscular Injection

Medaxone can be administered by deep intramuscular injection. 1 g of ceftriaxone should be dissolved in 3.5 ml of lidocaine for injection at 1%.

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 Injection

Medaxone can be administered by intravenous infusion for at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes. Intermittent intravenous injection should be administered over 5 minutes, preferably in larger veins.

1 g of ceftriaxone should be dissolved in 10 ml of water for injectable 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. 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, such as 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:

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

Lidocaine solutions should not be administered intravenously.

Doses greater than 1 g should be fractionated and injected at more than one site.

Intravenous Injection:

For IV injection, 1 g of Medaxone is 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.

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 for injection BP, sodium chloride for injection BP, 0.45% sodium chloride and 2.5% dextrose for injection BP, 6% dextran in 5% dextrose for injection BP, and 6% hydroxyethyl starch.

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 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.