Setriox

Package leaflet: Information for the patient

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

Ceftriaxone (as ceftriaxone sodium)
Lidocaine (as lidocaine hydrochloride)
Generic medicine
Please read carefully this leaflet 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 dangerous.
• If you experience any side effect, including 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 administered
4. Possible side effects
5. How to store SETRIOX
6. Contents of the pack and other information

1. What SETRIOX is and what it is used for

SETRIOX contains the active substance 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 bones and joints.
• of the skin or soft tissues.
• of the blood.
• of the heart.

It may 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 SETRIOX

Do not receive SETRIOX 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 breathing or swallowing difficult, sudden swelling of hands, feet and ankles, or a severe rash that develops rapidly.
• you are allergic to lidocaine and SETRIOX is to be administered by intramuscular injection.
• you have a heart conduction disorder causing low blood pressure and slowed heart rate (complete atrioventricular block).
• you have a 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 certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or is to receive intravenous treatment with a product containing calcium.

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

• you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels detectable in blood tests, increased levels of a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious 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 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 have other illnesses, such as haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin, weakness or shortness of breath).
• you are on a low-sodium diet.
• you suffer from loss of muscle function and weakness (myasthenia gravis).
• you suffer from seizures (epilepsy).
• you have any heart condition, especially if it affects your heart rate.
• you have breathing problems.
• you suffer from porphyria (a rare inherited disease affecting the skin and nervous system).

If you are to undergo blood or urine tests
If you are given SETRIOX for a prolonged period, you may need to have regular blood tests. SETRIOX 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 SETRIOX.

If you are diabetic or require monitoring of blood glucose levels, you must not use certain blood glucose monitoring systems, as they may give inaccurate readings during treatment with ceftriaxone. If such systems are used, check the instructions for use and inform your doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

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

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

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, 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).

Several medicines may interact with lidocaine, leading to altered effects. These include:

• medicines used to treat infections (clarithromycin, erythromycin).
• medicines used to treat stomach ulcers (e.g. cimetidine).
• strong painkillers such as codeine and meperidine (narcotic or opioid medicines).
• medicines used to treat irregular heart rate (e.g. mexiletine, tocainide).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will assess the benefits of treatment with SETRIOX for you and the potential risks for your baby.

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

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

3. How SETRIOX is administered

SETRIOX is generally administered by a doctor or a nurse via an injection given directly into a muscle. SETRIOX will be prepared by a doctor, pharmacist, or nurse and must not be mixed or co-administered with injections containing calcium.
Usual dose
Your doctor will determine the correct dose of SETRIOX 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 SETRIOX 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 will 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 SETRIOX once daily per kg of the child's body weight, depending on the severity and type of infection. If you have a severe infection, your doctor will 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 life):

• 20–50 mg of SETRIOX 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 SETRIOX you will need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more SETRIOX than you should
If you are accidentally given more SETRIOX than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of SETRIOX
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 give a double dose (two injections together) to make up for the missed dose.
If you stop treatment with SETRIOX
Do not stop taking SETRIOX 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 everyone gets them.
With this medicine, you may experience the following side effects:
Treatment with ceftriaxone, especially in elderly patients with severe renal insufficiency or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation, and seizures.

Severe allergic reactions (frequency not known, cannot be estimated from the available data)
If you have a severe allergic reaction, seek medical attention 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.

Severe skin reactions (frequency not known, cannot be estimated from the available data)
If you develop a severe skin reaction, inform a 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 as 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 in the body (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, usually resolving spontaneously. These symptoms may occur shortly after starting treatment with SETRIOX 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 decreased leukocytes and increased eosinophils) and platelets (decreased thrombocytes).
• 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., oral 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 SETRIOX was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function test results (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 raised itchy welts (urticaria), possibly affecting large areas of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid accumulation).
• Chills.

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 destruction of red blood cells (haemolytic anaemia).
• Severe decrease in white blood cell count (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.
• Problems with the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and clay-coloured stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. Pain during urination or reduced urine output may occur.
• False positive Coombs test (a blood test to detect blood-related problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• SETRIOX may interfere with certain types of blood glucose tests; please consult your doctor.

Following accidental intravascular injection of lidocaine during intramuscular administration of
SETRIOX i.m., additional side effects may occur, which may include:
Not known (frequency cannot be estimated from the available data)

• Changes in heart rate and rhythm.
• Low blood pressure.
• Slowed heart rate (less than 60 beats per minute).
• Interruption of normal blood circulation due to cardiac arrest and reduced 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, seizures or epileptic fits, deep unconsciousness (coma).
• Blurred vision, double vision, or temporary loss of vision.
• Feeling unwell (nausea or vomiting).
• Breathing difficulties.
• Reduced respiratory rate or possible cessation of breathing.
• Unusual drowsiness or daytime fatigue, or fainting.

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 SETRIOX

Keep this medicine out of the sight and reach of children.
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.
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 when stored at a temperature equal to or below 25°C.
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.
Do not dispose of any medicine via 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 SETRIOX contains
The active substance is ceftriaxone.
One vial of powder contains: ceftriaxone disodium 3.5 H2O 1.193 g, equivalent to ceftriaxone 1 g;
One solvent vial: aqueous solution of 1% lidocaine.
Description of the appearance of SETRIOX and pack contents
1 vial of powder + 1 vial of solvent (3.5 ml).
Marketing Authorization 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)