BIXON 1 Г/3,5 МЛ Порошок и раствор для инъекционного раствора

Содержание инструкции

1. BIXON 1 g/ 3.5 ml powder and solvent for injectable solution for intramuscular use
   1. What BIXON is and what it is used for
   2. What you need to know before you are given BIXON
   3. How BIXON is administered
   4. Possible side effects
   5. How to store BIXON
   6. Contents of the pack and other information

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

Ceftriaxone (as ceftriaxone disodium)
Lidocaine (as lidocaine hydrochloride)
“Generic medicine”

Read this leaflet carefully before you are given this medicine as 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 BIXON is and what it is used for
• 2. What you need to know before you are given BIXON
• 3. How BIXON is given
• 4. Possible side effects
• 5. How to store BIXON
• 6. Contents of the pack and other information

1. What BIXON is and what it is used for

BIXON is 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. Bixon is
administered by injection into a muscle in a solution containing lidocaine, which reduces the
pain associated with the injection.
Bixon 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 can be administered:

• to treat specific sexually transmitted infections (gonorrhea and syphilis).
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have a 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 life.
• to prevent infections during surgery.

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

You must not be given Bixon if:

• you are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6).
• you have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include a sudden swelling of the throat or face, which can make it difficult to breathe or swallow, a sudden swelling of hands, feet and ankles, and a severe skin rash that develops rapidly.
• you are allergic to lidocaine and Bixon is to be given to you by injection into a muscle.
• you suffer from an abnormality in the propagation of the heart impulse that causes a decrease in blood pressure and a slowing of the heart rate (complete atrioventricular block).
• you suffer from a condition of reduced blood volume (hypovolemia).

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

• the child is premature.
• the child is a newborn (up to 28 days of life) and has some blood problems or jaundice (yellowing of the skin or the white of the eye) or must receive a product containing calcium through a vein.

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

• you have recently received or are about to receive products containing calcium.
• you have recently had problems with diarrhea after taking an antibiotic. You have had problems with your intestines, in particular colitis (inflammation of the intestine).
• you suffer from problems with the liver or kidneys (see section 4).
• you have gallstones or kidney stones.
• you have other diseases, for example hemolytic anemia (a reduction in red blood cells that can make the skin pale yellow and cause weakness or shortness of breath).
• you are following a low-sodium diet.
• you suffer from loss of muscle function and weakness (myasthenia gravis).
• you suffer from seizures (epilepsy).
• you suffer from any heart problem, especially if this affects your heart rate.
• you have breathing problems.
• you suffer from porphyria (a rare hereditary disease that affects the skin and nervous system)
• you develop or have developed in the past 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 and an increase in a type of white blood cells (eosinophilia) and enlarged 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 Bixon for a prolonged period, you may need to have regular
blood tests. Bixon 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 Bixon.

If you are diabetic or need monitoring of blood glucose levels, you should not use some
blood glucose monitoring systems that may detect blood glucose incorrectly during treatment with ceftriaxone. If you are using such systems, check the
instructions for use and inform your doctor, pharmacist or nurse. If necessary, alternative analytical methods must be used.

Children
Talk to your doctor, pharmacist or nurse before giving Bixon to your child if:

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

Other medicines and BIXON
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). Several drugs can interact with lidocaine, resulting in altered effects. These drugs include:
• medicines used to treat infections (clarithromycin, erythromycin).
• medicines used to treat stomach ulcers (e.g. cimetidine).
• powerful painkillers such as codeine and pethidine (narcotic or opioid drugs).
• medicines used to treat irregular heartbeat (e.g. mexiletine, tocainide).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
The doctor will assess the benefits that treatment with Bixon would bring and the possible risks to
the child.

Driving and operating machinery
BIXON can cause dizziness. If you feel dizzy, do not drive and do not use tools or machinery.
Contact your doctor if you experience these symptoms.

Contains sodium
Bixon 1 g/3.5 ml contains 82.91 mg of sodium (the main component of table salt) per
1 g vial. This is equivalent to 4.1% of the recommended maximum daily intake with the
diet of an adult.

3. How BIXON is administered

Bixon is generally administered by a doctor or nurse via an injection
performed directly into a muscle. Bixon will be prepared by a doctor, pharmacist or a
nurse and will not be mixed, nor will it be administered simultaneously with injections containing
calcium.

Usual dose
The doctor will determine the right dose of Bixon 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 Bixon will depend on the type of infection you have.

Adults, elderly and children 12 years of age and over 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 you have a severe infection, the doctor will administer a higher dose (up to 4 g per day). If your dose

daily is greater than 2 g, you may take it as a single dose once a day or as two
separate doses.

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

• 50-80 mg Bixon once a day for each kg of the child's body weight depending on the severity and type of infection. If you have a severe infection, the doctor will prescribe a higher dose starting from 100 mg for each kg of body weight up to a maximum of 4 g per day. If your daily dose is greater than 2 g, you may take it as a single dose once a day or as two separate doses.
• children with a body weight of 50 kg or more should be administered the usual adult dose.

Newborns (0-14 days of life)

• 20-50 mg Bixon once a day for each kg of the newborn's body weight depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg for each kg of the newborn's body weight.

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

If you take more BIXON than you should
If you are accidentally given more Bixon than the prescribed dose, seek immediate
medical attention or go to the nearest hospital.

If you forget to take BIXON
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 BIXON
Do not stop taking Bixon unless your doctor tells you to. If you have any doubts
about the use of this medicine, ask 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:
Treatment with ceftriaxone, especially in elderly patients with severe kidney failure or nervous system
diseases, may rarely cause a decrease in consciousness, abnormal movements, agitation and convulsions.

Serious allergic reactions (frequency not known, cannot be estimated based on available data)
If you have a serious allergic reaction, seek immediate medical attention.
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.

Serious skin reactions (frequency not known, cannot be estimated based on available data)
If you develop a serious 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), enlarged lymph nodes and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known by the acronym DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which can cause fever, chills, headache, muscle pain and rash, which generally tends to resolve spontaneously. These symptoms occur shortly after starting treatment with Bixon for infections caused by spirochetes such as Lyme disease.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• White blood cell abnormalities (such as decreased leukocytes and increased eosinophils) and platelets (decreased thrombocytes).
• Soft stools or diarrhea.
• Changes in blood test results for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (for example, thrush).
• Decrease in the number of white blood cells (granulocytopenia).
• Decrease in the number of red blood cells (anemia).
• 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 Bixon was administered. Pain at the injection site.
• Fever.
• Abnormal values in kidney function tests (increased creatinine in the blood).

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

• Inflammation of the large intestine (colon). Signs include diarrhea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with wheals (urticaria) that can cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid retention).
• Chills.

Frequency not known (cannot be estimated based on available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anemia characterized by the destruction of red blood cells (hemolytic anemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Convulsions.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain that extends to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Gallbladder problems that can cause pain, nausea and vomiting.
• A neurological condition that can develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. Pain may occur when urinating, or the amount of urine produced may be reduced.
• A false positive Coombs test (a test to detect blood problems).
• A false positive test for galactosemia (an abnormal accumulation of galactose sugar).
• Bixon may interfere with some types of tests to measure blood glucose; check with your doctor.

After accidental injection of lidocaine into a blood vessel during intramuscular administration of Bixon i.m. other side effects may occur, which may include:

Frequency not known (cannot be estimated based on available data)

• Changes in heart rate and rhythm.
• Low blood pressure.
• Slowing of the heart rate (below 60 beats/minute).
• Interruption of normal blood circulation due to cardiac arrest and decreased blood flow.
• Loss of balance, tingling around the mouth, numbness of the tongue, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus), dizziness or lightheadedness, confusion, nervousness, involuntary rhythmic muscle contractions, convulsions or seizures, deep state of unconsciousness (coma).
• Blurred vision, double vision or temporary loss of vision.
• Feeling unwell (nausea or vomiting).
• Difficulty breathing.
• Reduced breathing rate or possible cessation of breathing.
• An unusual feeling of sleepiness or fatigue during the day or fainting.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.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 BIXON

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 package and on the label of the
vial, after “Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C. Keep the vials in the outer packaging to
protect them from light.
The chemical and physical stability during use of the reconstituted product has been demonstrated for at least 6 hours at
a temperature equal to or less than 25 °C, or 24 hours at a temperature of 2-8 °C.
From a microbiological point of view, the product must be used immediately. 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. Ask your pharmacist how to eliminate medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BIXON contains
BIXON 1 g/ 3.5 ml powder and solvent for injectable solution for intramuscular use
The active ingredients are ceftriaxone and lidocaine.
Each vial contains 1 g (gram) of ceftriaxone as ceftriaxone disodium.
Each vial contains 35 mg (milligrams) of lidocaine hydrochloride in 3.5 ml.
The displacement volume of 1 g of Bixon is 0.71 ml in a 1% lidocaine hydrochloride solution.
Adding 3.5 ml of 1% lidocaine hydrochloride solution, the final concentration of the reconstituted solution is 237.53 mg/ml.
Bixon must not be mixed with other medicines in the same syringe.

Description of the appearance of BIXON and contents of the pack
Bixon consists of a powder and solvent for injectable solution.
The powder is from white to yellowish in colour. The solvent is clear and colourless.

Marketing Authorisation Holder
Lanova Farmaceutici S.r.l. Via Conca D’oro, 212 – 00141 Rome

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via D. Alighieri, 71 - Sanremo (IM)