Eraxitron: detailed information

Package leaflet: Information for the patient

Eraxitron 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use

Ceftriaxone sodium
Generic medicine
Please read this leaflet carefully before you are given this medicine 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Eraxitron is and what it is used for
What you need to know before you are given Eraxitron
How Eraxitron is administered
Possible side effects
How to store Eraxitron
Contents of the pack and other information

1. What Eraxitron is and what it is used for

Eraxitron is an antibiotic that contains the active substance ceftriaxone sodium. It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Eraxitron is administered by injection into a muscle (intramuscular use).
Eraxitron is used:

to treat severe infections of confirmed or suspected Gram-negative bacterial origin, particularly those caused by "difficult" bacteria;
to treat severe infections of confirmed or suspected mixed bacterial origin, including Gram-negative bacteria resistant to commonly used antibiotics.

In particular, this medicine is used in debilitated patients and/or those with reduced immune defenses (immunocompromised).
It is also used to prevent infections during surgical procedures.

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

Eraxitron must not be administered to you if:

you are allergic to ceftriaxone sodium or to any of the other ingredients of this medicine (listed in section 6);
you are allergic to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams, and carbapenems). Possible signs of an allergic reaction include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of the hands, feet, and ankles, and a severe rash that develops rapidly;
you are allergic to lidocaine and Eraxitron is to be administered by intramuscular injection (see "Warnings and precautions");
you have previously experienced a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, carbapenems, and monobactams). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of the hands, feet, and ankles, chest pain, and a severe rash that develops rapidly.

Eraxitron must not be administered to children in the following cases:

the child is premature;
the child is a hyperbilirubinemic newborn, i.e. suffers from elevated bilirubin (a substance produced in the liver) in the blood;
the child is a premature newborn up to 41 weeks of life (gestational weeks + weeks of life);
the child is a newborn (up to 28 days of life) and has certain blood disorders (hypoalbuminemia or acidosis), or jaundice (yellowing of the skin or whites of the eyes), or must receive intravenously (via intravenous route) a product containing calcium (see "Children" and "How Eraxitron is administered");
the child (over 28 days of life) must receive intravenously a product containing calcium.

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

you have recently received or are about to receive products containing calcium. Eraxitron must not be mixed with such products (see "How Eraxitron is administered");
you are on a low-sodium diet;
you have recently had diarrhoea after taking an antibiotic;
you 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 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 levels of liver enzymes detectable in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 "Possible side effects").

If you need to undergo blood or urine tests
If you are given Eraxitron for a prolonged period, you may need to have regular blood tests. Eraxitron may affect the results of urine sugar tests and a blood test known as the Coombs test.
If you are due to have tests, inform the person taking your sample that you have been given Eraxitron.
If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems that may inaccurately measure blood glucose during treatment with ceftriaxone. If such systems are used, check the instructions for use and inform your doctor, pharmacist, or nurse. Alternative analytical methods should be used if necessary.

If lidocaine is used as a diluent
If lidocaine is used as the solvent, the solution must only be administered by intramuscular injection.
The solution containing lidocaine must never be administered intravenously (by intravenous injection) or to patients allergic to lidocaine.

Children
Talk to your doctor, pharmacist, or nurse before Eraxitron is administered to a child if:
the child has recently received or is about to receive intravenously a product containing calcium.

Other medicines and Eraxitron
Inform 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, as they may interact with ceftriaxone:

an antibiotic called an aminoglycoside; an antibiotic called chloramphenicol (used to treat infections, particularly eye infections);
a medicine used to treat cancer called amsacrine;
an antibiotic called vancomycin;
a medicine called fluconazole (used to treat fungal infections);
oral contraceptives.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will assess the benefits of treatment with Eraxitron for you and the potential risks for the unborn or breastfed child.

Driving and using machines
Eraxitron may cause dizziness. If you experience dizziness, do not drive or operate machinery.

Eraxitron contains sodium
This medicine contains 82.91 mg of sodium (a main component of table salt) per vial.
This is equivalent to 4.15% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Eraxitron is administered

Eraxitron is generally administered by a doctor or nurse via an injection given directly into a muscle. Eraxitron will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with injections containing calcium (see "Warnings and precautions").
As with all antibiotic therapies, treatment with Eraxitron should generally continue for at least 2–3 days after fever has resolved or until complete recovery from the bacterial infection has been confirmed.
Recommended dose
Your doctor will determine the appropriate dose of Eraxitron 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 degree of kidney and liver function. The number of days or weeks during which you will receive Eraxitron depends on the type of infection you have.
Adults, elderly patients, and children over 12 years of age with a body weight equal to or greater than 50 kilograms (kg):

The recommended dose is 1 g once daily (every 24 hours). If you have a severe infection or an infection caused by moderately sensitive microorganisms, your doctor may administer a higher dose (up to 4 g daily given as a single solution).

Neonates and children from 21 days to 12 years of age with a body weight less than 50 kilograms (kg):

The recommended dose is 20–80 mg per kg of body weight per day;
Children with a body weight equal to or greater than 50 kg should receive the adult recommended dose.

Neonates (0–14 days of life):

The recommended dose is 20–50 mg per kg of body weight once daily;
The maximum daily dose must not exceed 50 mg per kg of body weight of the neonate.

Premature infants:

The maximum recommended dose is 50 mg per kg of body weight once daily.

Prevention of infections during surgery:

The recommended dose to prevent postoperative infections is a single dose of 1 g, administered one hour before surgery.

Patients with liver or kidney problems:
You may be given a different dose than usual. Your doctor will decide the amount of Eraxitron you need and will closely monitor you, depending on the severity of your liver or kidney disease.
Administration method for intramuscular solution
To administer the intramuscular injection:

dissolve the contents of the vial with the solution from the ampoule (1% lidocaine solution);
deeply inject the resulting extemporaneous solution into the buttock, alternating buttocks with subsequent injections;
Do not administer the lidocaine solution intravenously.
If you are given more Eraxitron than you should
If you are accidentally given more Eraxitron than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of Eraxitron
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for a missed dose.
If you stop treatment with Eraxitron
Do not stop taking Eraxitron unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

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
If you experience a severe allergic reaction, contact your doctor immediately.
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 during allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

Severe skin reactions (not known, frequency cannot be estimated from available data)
If you develop a severe skin reaction, inform your doctor immediately.
Signs may include:

Severe rash that develops rapidly, with blistering or skin peeling and possible mouth blisters (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 occur shortly after starting ERAXITRON treatment for spirochete infections such as Lyme disease.

Other possible side effects:

loose stools or diarrhea;
nausea;
vomiting;
inflammation of the oral mucosa (stomatitis);
inflammation of the tongue (glossitis). Signs include swelling, redness, and irritation of the tongue;
thickening of bile;
increase in a type of white blood cells (eosinophilia);
decrease in all white blood cells (leukopenia);
decrease in the number of a type of white blood cells (granulocytopenia);
decrease in the number of red blood cells (hemolytic anemia);
decrease in the number of platelets (thrombocytopenia);
skin rash (exanthema or rash);
allergic dermatitis;
itching;
skin rash with wheals associated with itching and swelling (urticaria);
edema (fluid accumulation);
headache;
dizziness and vertigo;
gallbladder problems that may cause pain, nausea, and vomiting;
increased levels of liver enzymes;
blood or sugar in urine (hematuria or glycosuria);
low urine output (oliguria);
abnormal kidney function tests (increased blood creatinine);
genital infection (genital mycosis);
fever;
chills;
anaphylactic or anaphylactoid reactions, for example, contraction of the muscles lining the airways making breathing difficult (bronchospasm);
severe and in some cases fatal adverse reactions in premature infants and neonates up to 28 days of age treated with ceftriaxone and calcium administered intravenously (calcium-ceftriaxone salt deposits observed post-mortem in the lungs and kidneys);
severe infections caused by microorganisms not sensitive to ceftriaxone (such as Candida, fungi, or other resistant microorganisms);
inflammation of the large intestine (colon). Signs include diarrhea, often with blood and mucus, stomach pain, and fever (pseudomembranous colitis);
pain or burning sensation along the vein if Eraxitron was administered intravenously;
pain at the injection site;
kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or your urine output may decrease;
gallbladder and/or liver problems, mainly in patients treated with doses of Eraxitron higher than the standard recommended dose, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and clay-colored stools (frequency not known);
inflammation of the pancreas (pancreatitis). Signs include severe stomach pain radiating to the back;
blood clotting problems;
False positive Coombs test result (a test to detect blood problems);
False positive result for galactosemia (an abnormal accumulation of the sugar galactose);
Eraxitron may interfere with certain types of tests to measure blood glucose; check with your doctor;
severe decrease in the number of white blood cells (agranulocytosis) (frequency not known);
Treatment with ceftriaxone, especially in elderly patients with severe renal failure or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation, and seizures;
Problems with the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and clay-colored stools (frequency not known).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You may 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 Eraxitron

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 that month.
The expiry date applies to the product in its original, undamaged packaging, correctly stored.
This medicine does not require any special storage conditions.
Chemical and physical stability during use of the reconstituted product has been demonstrated for 24 hours if stored between +2°C and +8°C, and for 6 hours if stored at a temperature below 25°C.
From a microbiological standpoint, the medicine should be used immediately after reconstitution. If not used immediately, the period and conditions of storage prior to use are the responsibility of the user and must not exceed the times indicated above for chemical and physical stability during use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Eraxitron contains

The active substance is ceftriaxone sodium. One vial of powder contains 1.193 g of ceftriaxone sodium (equivalent to 1 g of ceftriaxone).
The other component (solvent vial) is 1% aqueous lidocaine solution. One solvent vial contains 3.5 ml of 1% aqueous lidocaine solution.

Eraxitron must not be mixed with other medicinal products in the same syringe.
Description of the appearance of Eraxitron and contents of the pack
1 vial of powder + 1 solvent vial of 3.5 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
I.B.N. SAVIO S.r.l. - Via del Mare, 36 - Pomezia (RM).
Manufacturer
Anfarm Hellas S.A. - Schimatari Viotias (Greece).
ACS DOBFAR SpA - Teramo-Italy
ACS DOBFAR SpA - Verona-Italy