ERAXITRON 1 Г/3.5 МЛ Порошок и раствор для инъекционного раствора

Содержание инструкции

1. Eraxitron 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
   1. What is Eraxitron and what it is used for
   2. What you need to know before you are given Eraxitron
   3. How Eraxitron is administered
   4. How to store Eraxitron
   5. Package contents and other information

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

Ceftriaxone sodico
Equivalent medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Eraxitron and what it is used for

Eraxitron is an antibiotic that contains the active ingredient sodium ceftriaxone. It works by killing the 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 origin from “difficult” Gram-negative bacteria;
• to treat severe infections of confirmed or suspected origin from mixed flora with the presence of Gram-negative bacteria resistant to the most common antibiotics.

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

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

Eraxitron must not be given to you if:

• you are allergic to ceftriaxone sodium or any of the other ingredients of this medicine (listed in section 6);
• you are allergic to penicillin or similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs of an allergic reaction include sudden swelling of the throat or face, which can make it difficult to breathe or swallow, sudden swelling of hands, feet and ankles, and a severe rash that develops rapidly;
• you are allergic to lidocaine and Eraxitron is to be given to you by injection into a muscle (see “Warnings and precautions”).

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

• the child is premature;
• the child is a hyperbilirubinemic newborn, i.e. suffers from an increase in bilirubin (a substance produced by the liver) in the blood;
• the child is a premature newborn up to 41 weeks of gestation (pregnancy weeks + weeks of life);
• the child is a newborn (up to 28 days of life) and has some blood problems (hypoalbuminemia or acidosis) or jaundice (yellowing of the skin or the white of the eye) or must receive a product containing calcium through a vein (intravenously) (see “Children” and “How Eraxitron is administered”);
• the child (over 28 days of life) must receive a product containing calcium through a vein.

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

• you have recently received or are about to receive products containing calcium. Eraxitron must not be mixed with these types of products (see “How Eraxitron is administered”);
• you are following a low-sodium diet;
• you have recently had problems with diarrhea after taking an antibiotic;
• you have had problems with the intestines, in particular colitis (inflammation of the intestine);
• you have problems with the liver or kidneys (see section 4);
• you have gallstones or kidney stones;
• you experience or have experienced in the past any combination of the following symptoms: rash, skin redness, blistering on lips, eyes and mouth, skin exfoliation, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).

If you are going to have a blood or urine test
If you are given Eraxitron for a prolonged period of time, you may need to undergo
regular blood tests. Eraxitron can affect the results of urine tests related to
sugar and a blood test known as the Coombs test.
If you are about to have tests, tell the person taking your sample that you have been
given Eraxitron.
If you are diabetic or need monitoring of blood glucose levels, you should not use some glucose monitoring systems that may detect blood glucose incorrectly during
treatment with ceftriaxone. If you use such systems, check the instructions for use and inform your doctor, pharmacist or nurse. If necessary, alternative analytical methods should be used.

If lidocaine is used as a diluent
If lidocaine is used as a solvent, the solution must only be administered by injection into
a muscle (intramuscularly).
The solution containing lidocaine must not, in any case, be administered by injection into a vein
(intravenously) and to patients allergic to lidocaine.

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

Other medicines and Eraxitron
Tell your doctor, pharmacist or nurse 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, as
they may interact with ceftriaxone:

• a type of antibiotic called an aminoglycoside; an antibiotic called chloramphenicol (used to treat infections, especially eye infections);
• a medicine for the treatment of cancer called amsacrine;
• a type of antibiotic called vancomycin;
• a drug called fluconazole (used to treat infections caused by fungi);
• oral contraceptives.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
The doctor will assess the benefits of treatment with Eraxitron and the possible risks to the
child.

Driving and using machines
Eraxitron can cause dizziness. If you feel dizzy, do not drive and do not use machines.

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

3. How Eraxitron is administered

Eraxitron is generally administered by a doctor or nurse via an injection performed
directly into a muscle. Eraxitron will be prepared by a doctor, pharmacist or nurse and will not be
mixed, nor will it be administered simultaneously with injections containing calcium (see “Warnings
and precautions”).
As with all antibiotic therapies, in general the administration of Eraxitron should be continued for a
minimum of 2-3 days after recovery from fever or after demonstration of complete recovery
from bacterial infection.

Recommended dose
The doctor will determine the correct dose of Eraxitron for you. The dose will depend on the severity and type of
infection, any concomitant treatment with other antibiotics, your weight and age,
the degree of functioning of your kidneys and liver. The number of days or weeks during which
you will receive Eraxitron will depend on the type of infection you have.

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

• the recommended dose is 1 g once a day (every 24 hours). If you have a severe infection or in case of infections caused by moderately sensitive microorganisms, the doctor will administer a higher dose (up to 4 g per day administered in a single solution).

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

• the recommended dose is 20 - 80 mg per each kg of body weight per day;
• children with a body weight of 50 kg or more should be administered the recommended adult dose.

Newborns (0-14 days of life):

• the recommended dose is 20 - 50 mg per each kg of body weight once a day;
• the maximum daily dose should not exceed 50 mg per each kg of the newborn’s body weight.

Premature infants:

• the maximum recommended dose is 50 mg per each kg of body weight once a day.

Prevention of infections during surgery:

• the recommended dose to prevent post-operative infections is 1 g in a single dose, one hour before surgery.

People with liver and kidney problems:
You may be given a different dose than usual. The doctor will decide the amount of
Eraxitron you will need and will monitor you carefully, depending on the severity of the liver and kidney disease.

Method of administration of the solution for intramuscular use
To perform the intramuscular injection:

• 1) dissolve the contents of the vial with that of the ampoule (1% lidocaine solution);
• 2) inject the resulting solution deeply into the gluteus muscle, alternating the glutei in subsequent injections; Do not administer lidocaine solution intravenously.

If you take more Eraxitron than you should
If you are accidentally administered more Eraxitron than the prescribed dose, immediately contact
your doctor or the nearest hospital.

If you forget to take Eraxitron
If you miss an injection, you should receive it as soon as possible. However, if it is almost time to receive the next
scheduled injection, skip the missed injection. Do not take a double dose (two injections together) to
make up for the missed dose.

If you stop taking Eraxitron
Do not stop taking Eraxitron unless your doctor tells you to. If you have any doubts about the use
of this medicine, contact your doctor or nurse.

• 4. Possibleand undesirable effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You may experience the following side effects with this medicine:

Severe allergic reactions
If you have a severe allergic reaction, contact your doctor immediately.
Signs may include:

• sudden swelling of the face, throat, lips or mouth. This 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 based on available data)
If you develop a severe skin reaction, tell your doctor immediately.
Signs may include

• Severe rash that develops rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known by the acronyms SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests(eosinophilia), swollen lymph nodes and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known by the acronym DRESS or drughypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which can cause fever, chills, headache, muscle pain and rash, which generally resolves spontaneously.These symptoms occur shortly after starting treatment with Eraxitron fortreating infections with spirochetes 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 the 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).
• rash (exanthema or rash);
• allergic dermatitis;
• itching;
• rash with hives associated with itching and swelling (urticaria);
• edema (fluid retention).
• headache;
• dizziness;
• problems with the gallbladder that can cause pain, nausea and vomiting
• increased levels of liver enzymes;
• blood or sugar in the urine (hematuria or glucosuria);
• low urine production (oliguria);
• abnormal values in renal function tests (increased creatinine in the blood);
• genital infection (genital mycosis);
• fever;
• chills;
• anaphylactic or anaphylactoid reactions, for example contraction of the muscles lining the airways and making it difficult to breathe (bronchospasm);
• serious infections caused by microorganisms not sensitive to ceftriaxone (such as Candida, fungi or other resistant microorganisms);
• inflammation of the large intestine (colitis). Signs include diarrhea, often with blood and mucus, stomach pain and fever (pseudomembranous colitis);
• pain or burning sensation along the vein if Eraxitron has been administered intravenously;
• pain at the injection site.
• kidney problems caused by calcium-ceftriaxone deposits. Pain when urinating may occur, or the amount of urine produced may be reduced.
• problems with the gallbladder and/or liver, which can 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 that spreads to the back;
• blood clotting problems;
• A false positive result to the Coombs test (a test to detect blood problems).
• A false positive result for galactosemia (an abnormal accumulation of galactose sugar).
• Eraxitron can interfere with some 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, can occasionally cause a decrease in consciousness, abnormal movements, agitation and convulsions.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through 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 which is stated on the pack after “Exp”. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
This medicine does not require any particular storage conditions.
The 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 point of view, the medicine must be used immediately after
reconstitution. If not used immediately, the storage period and conditions before use
are the responsibility of the user and must not exceed the times indicated above for the chemical and
physical stability during use.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Eraxitron contains

• The active ingredient 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% lidocaine aqueous solution. One solvent vial contains 3.5 ml of 1% lidocaine aqueous solution.

Eraxitron must not be mixed with other drugs in the same syringe.

Description of the appearance of Eraxitron and package contents
1 vial of powder + 1 solvent vial of 3.5 ml.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation 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