Diaxone

Package leaflet: Information for the patient

Diaxone

“1 g/3.5 ml powder and solvent for injectable solution for intramuscular use” vial + solvent vial of 3.5 ml
Ceftriaxone (as ceftriaxone sodium)
“Equivalent medicine”
Please read all of this leaflet carefully before this medicine is administered to you because it contains important information for you.

• Keep this leaflet. 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. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Diaxone is and what it is used for

Diaxone contains the active substance ceftriaxone, 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.
Diaxone is used to treat infections:

• of the brain (meningitis).
• of the lungs.
• of the middle ear.
• of the abdomen and abdominal wall (peritonitis).
• of the urinary tract and kidneys.
• of the bones and joints.
• of the skin or soft tissues.
• of the blood.
• of the heart.

It may also be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis).
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have fever due to 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 surgery.

2. What you need to know before you are given Diaxone

Do not be given Diaxone if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have previously had a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include sudden swelling of the throat or face, which may make it difficult to breathe or swallow, sudden swelling of hands, feet and ankles, chest pain, or a severe rash that develops rapidly.
• you are allergic to lidocaine and Diaxone is to be administered by intramuscular injection.

Diaxone must not be given to children in the following cases:

• the child is premature.
• the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or needs to receive a product containing calcium through a vein.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Diaxone if:

• you have recently received or are about to receive products containing calcium.
• you have recently had diarrhoea after taking an antibiotic, or have had intestinal problems, particularly colitis (inflammation of the intestine).
• you have liver or kidney problems (see section 4).
• you have gallstones or kidney stones.
• you have other diseases, such as haemolytic anaemia (a type of anaemia involving destruction of red blood cells, which may cause pale yellow skin, weakness or shortness of breath).
• you are on a low-sodium diet.
• you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering on lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels detectable in blood tests, 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 need to have blood or urine tests
If you are given Diaxone for a prolonged period, you may need to have regular blood tests. Diaxone may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are about to undergo testing:

• inform the person taking your sample that you have been given Diaxone.

Children
Talk to your doctor, pharmacist or nurse before Diaxone is given to a child if:

• the child has recently received or is about to receive a product containing calcium through a vein.

Other medicines and Diaxone
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• an antibiotic called an aminoglycoside.
• an antibiotic called chloramphenicol (used to treat infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Your doctor will assess the benefits of treatment with Diaxone for you and the possible risks to the baby.

Driving and using machines
Diaxone may cause dizziness. If you feel dizzy, do not drive or operate tools or machinery. Contact your doctor if you experience these symptoms.

3. How Diaxone is administered

Diaxone is usually administered by a doctor or nurse via an injection given directly into a muscle. Diaxone will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered at the same time as injections containing calcium.

Usual dose
Your doctor will determine the appropriate dose of Diaxone for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the extent of your kidney and liver function. The number of days or weeks during which you will receive Diaxone will depend on the type of infection you have.

Adults, elderly patients, and children aged 12 years and older with a body weight equal to or greater than 50 kilograms (kg):

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor may administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given either as a single daily dose or as two separate doses.

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

• 50–80 mg of Diaxone once daily per kg of the child's body weight, depending on the severity and type of infection. If the infection is severe, your doctor may prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose exceeds 2 g, it may be given either as a single daily dose or as two separate doses.
• Children with a body weight equal to or greater than 50 kg should receive the usual adult dose.

Newborns (0–14 days of age):

• 20–50 mg of Diaxone once daily per kg of the newborn's body weight, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the newborn's body weight.

Patients with liver or kidney problems
You may be given a different dose than the usual one. Your doctor will decide the amount of Diaxone you need and will monitor you closely, depending on the severity of your liver or kidney disease.

If you are given more Diaxone than you should have
If you are accidentally given more Diaxone than prescribed, contact your doctor or the nearest hospital immediately.

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

If you stop treatment with Diaxone
Do not stop taking Diaxone unless instructed by your doctor. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

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

With this medicine, you may experience the following side effects:

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have a severe allergic reaction, seek immediate medical advice.
Signs may include:

• Sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.
• Sudden swelling of the hands, feet and ankles.
• Chest pain occurring in the context of an allergic reaction, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome).

Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, seek immediate medical advice.
Signs may include:

• Severe rash developing rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, elevated liver enzymes, abnormalities in blood tests (eosinophilia), swollen 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, which may cause fever, chills, headache, muscle pain and rash, which usually resolves spontaneously. These symptoms may occur shortly after starting treatment with Diaxone for spirochete infections such as Lyme disease.

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Abnormalities in white blood cells (such as reduced white blood cells and increased eosinophils) and platelets (reduced platelet count).
• Soft stools or diarrhoea.
• Changes in blood test results for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. thrush).
• Decreased number of white blood cells (granulocytopenia).
• Reduced number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Diaxone was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (increased blood creatinine).

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

• Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with hives (urticaria), which may cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid accumulation).
• Chills. Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation and seizures.

Not known (frequency cannot be estimated from the available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anaemia characterised by the breakdown of red blood cells (haemolytic anaemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Seizures.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
• Inflammation of the mouth lining (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Gallbladder and/or liver problems which may cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and pale stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or your urine output may decrease.
• False positive Coombs test (a test to detect blood problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Diaxone may interfere with certain types of blood glucose tests; please consult your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diaxone

From a microbiological standpoint, the product should be used immediately after reconstitution.
If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user.
The chemical and physical stability of the medicinal product after reconstitution has been demonstrated for 24 hours between +2°C and +8°C, and for 6 hours when the product is stored at a temperature below 25°C.
Solutions may vary in colour from pale yellow to amber, depending on concentration and storage duration; this characteristic does not affect the efficacy or tolerability of the medicinal product.

6. Package contents and other information

What Diaxone contains
One vial of powder contains:
Active substance: Ceftriaxone disodium 3.5 H₂O, 1.93 g equivalent to Ceftriaxone 1 g;
One solvent vial contains: aqueous solution of 1% lidocaine.
Description of the appearance of Diaxone and contents of the package
DIAXONE 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use:
1 vial of powder + 1 solvent vial of 3.5 ml
Marketing Authorization Holder
EURO-PHARMA S.r.l. – Via Garzigliana, 8 - Torino
Manufacturer
ESSETI Farmaceutici S.r.l., Via Campobello, 15 – 00071 Pomezia (Roma)