SETRIOX 1 G/3.5 ML Powder and solvent for injectable solution

Зміст інструкції

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

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

Ceftriaxone (as ceftriaxone sodium)
Lidocaine (as lidocaine hydrochloride)
Equivalent medicinal product

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 they have the same symptoms as you, 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 SETRIOX is and what it is used for
• 2. What you need to know before you are given SETRIOX
• 3. How SETRIOX is given
• 4. Possible side effects
• 5. How to store SETRIOX
• 6. Contents of the pack and other information

1. What is SETRIOX and what is it used for

SETRIOX contains the active ingredient ceftriaxone which 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. SETRIOX is administered by injection into a
muscle in a solution containing lidocaine, which reduces the pain associated with the injection.
SETRIOX 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 pre- sent with 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, in- cluding newborns from 15 days of life.
• to prevent infections during a surgical procedure.

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

You must not be given SETRIOX 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 SETRIOX is to be given to you by injection into a muscle.
• you suffer from an abnormality in the propagation of the impulse in the heart that causes a reduction in blood pressure and a slowing of the heart rate (complete atrioventricular block).
• you suffer from a state of reduced blood volume (hypovolemia).

SETRIOX 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 SETRIOX if:

• You experience or have experienced in the past any combination of the following symptoms: 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 swollen lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).
• 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 the intestine, 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 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)

If you are to undergo a blood or urine test
If you are given SETRIOX for a prolonged period, you may need to undergo regular blood tests. SETRIOX can affect the results of urine tests related to sugar and a blood test known as the Coombs test. If you are about to undergo tests:

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

If you are diabetic or need to monitor your blood glucose levels, you should not use some blood 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.

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

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

Other medicines and SETRIOX
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:

• 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 in the treatment of stomach ulcers (e.g. cimetidine).
• potent 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, are planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine.
The doctor will assess the benefits of treatment with SETRIOX for you and the possible risks to the baby.

Driving and operating machinery
SETRIOX 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.

SETRIOX contains sodium
This medicine contains 82.8 mg of sodium (the main component of table salt) per vial of 1 g. This is equivalent to 4.14% of the recommended daily intake of salt with the diet for an adult.

3. How SETRIOX is administered

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

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

Adults, elderly and children 12 years of age or older 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 daily dose 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 less than
50 kg:

• 50-80 mg SETRIOX 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 given the usual adult dose.

Newborns (0- 14 days of life)

• 20-50 mg SETRIOX 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 SETRIOX you need and will monitor you closely, depending on the severity of
liver and kidney disease.

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

If you forget to take SETRIOX
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 in-
together) to make up for the missed dose.

If you stop taking SETRIOX
Do not stop taking SETRIOX 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 everyone will experience them.
With this medicine you may experience the following side effects:
Treatment with ceftriaxone, especially in elderly patients with severe kidney failure or pa-
thologies of the nervous system, may in rare cases cause a reduction in the state of consciousness,
abnormal movements, agitation and convulsions.

Serious allergic reactions (frequency not known, the frequency cannot be defined based on the available
data)
If you have a serious allergic reaction, seek medical attention immediately.
The signs may include:

• sudden swelling of the face, throat, lips or mouth. This may make it difficult to breathe or swallow.
• sudden swelling of the hands, feet and ankles.

Serious skin reactions (frequency not known, the frequency cannot be defined based on the available data)
If you develop a serious skin reaction, inform a doctor immediately.
The 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 SETRIOX to treat infections from 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).
• Reduction in the number of red blood cells (anemia).
• Blood clotting problems. The signs include easy bruising, pain and swelling of the joints.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where SETRIOX was administered. Pain where the injection was given.
• Fever.
• Abnormal values in kidney function tests (increased creatinine in the blood).

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

• Inflammation of the large intestine (colon). The 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 (the frequency cannot be defined based on the 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). The signs include severe stomach pain that extends to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). The signs include swelling, redness and irritation of the tongue.
• 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.
• 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 result to the Coombs test (a test to detect blood problems).
• A false positive result for galactosemia (an abnormal accumulation of galactose sugar).
• SETRIOX 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 SETRIOX i.m. other side effects may occur, which may include:

Frequency not known (the frequency cannot be defined based on the available data)

• Changes in the rhythm and rate of the heart.
• Low blood pressure.
• Slowing of the heart rate (less than 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.
• Decreased 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 experience any side effects, including those 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 contribute to providing more information on the safety of this medicine.

5. How to store SETRIOX

Keep this medicine out of the sight and reach of children.
From a microbiological point of view, the product should be used immediately after re-
constitution. If not used immediately, the conditions and period of storage before
use are the responsibility of the user.
The chemical and physical stability of the medicine after reconstitution has been demonstrated for 24 hours between
+2°C and +8°C and for 6 hours for the product stored at a temperature equal to or less than 25°C.
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.
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. Contents of the pack and other information

What SETRIOX contains
The active ingredient is ceftriaxone.
One vial of powder contains: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1g; •
One solvent vial: aqueous solution of lidocaine 1%.

Description of the appearance of SETRIOX and contents of the pack
1 vial of powder + 1 solvent vial of 3.5 ml.

Marketing Authorisation Holder and Manufacturer
Eberlife Farmaceutici S.p.A.
Via G. Porzio SNC – 80143 Napoli (Na) - CDN Isola E1
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l.
Via D. Alighieri, 71 – Sanremo (IM)