NILSON

Package leaflet: Information for the patient

NILSON 1 g powder and solvent for injectable solution for intramuscular use

Ceftriaxone (as ceftriaxone sodium)
Please read this leaflet carefully 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 NILSON is and what it is used for
2. What you need to know before being administered NILSON
3. How NILSON is administered
4. Possible side effects
5. How to store NILSON
6. Contents of the pack and other information

1. What NILSON is and what it is used for

NILSON 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.
NILSON 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 NILSON

Do not be given NILSON 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, chest pain, and a severe rash that develops rapidly
• you are allergic to lidocaine and NILSON is to be administered by intramuscular injection.

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

• the child is premature
• the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or if the child is to receive a product containing calcium intravenously.

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

• you have recently received or are about to receive products containing calcium
• you have recently had diarrhoea after taking an antibiotic, or have had intestinal problems, particularly colitis (inflammation of the intestine)
• you have gallstones or kidney stones
• you have other diseases, such as haemolytic anaemia (a reduction in red blood cells which may cause pale yellow skin, weakness or shortness of breath)
• you are on a low-sodium diet
• you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering of lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels detectable in blood tests, increase in 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 liver or kidney problems (see section 4).

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

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

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

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

Other medicines and NILSON
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 in the treatment of infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Your doctor will assess the benefits of treatment with NILSON for you and the possible risks to the unborn or breastfed child.

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

3. How NILSON is administered

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

Usual dose
Your doctor will determine the appropriate dose of NILSON 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 NILSON will depend on the type of infection you have.

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

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor may 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 NILSON once daily per kg of the child's body weight, depending on the severity and type of infection. If the infection is severe, your doctor may prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If the daily dose exceeds 2 g, it may be administered either as a single daily dose or as two separate doses.
• Children with a body weight of 50 kg or more should receive the usual adult dose.

Newborns (0–14 days of life):

• 20–50 mg of NILSON 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 NILSON you need and will monitor you closely, depending on the severity of your liver or kidney disease.

If you are given more NILSON than you should
If you are accidentally given more NILSON than prescribed, contact your doctor or go to the nearest hospital immediately.

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

If you stop treatment with NILSON
Do not stop taking NILSON 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 will experience them.
With this medicine, you may experience the following side effects:

Severe allergic reactions (not known, frequency cannot be estimated from available data)
If you have a severe allergic reaction, seek medical advice immediately.
Signs may include:

• Chest pain occurring in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome)
• 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 rashes (not known, frequency cannot be estimated from available data)
If you develop a severe skin reaction, seek medical advice immediately.
Signs may include:

• a severe rash that develops rapidly, with blistering or peeling of the skin and possibly 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 body 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 treatment with NILSON for spirochete infections such as Lyme disease.

Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation and seizures.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Abnormalities in white blood cells (such as reduced leukocytes and increased eosinophils) and platelets (reduced 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., thrush).
• Decrease in the number of white blood cells (granulocytopenia).
• Reduction in the 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 NILSON 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).
• Skin rash with wheals (urticaria), which may cover a large area 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 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 reduction in the number of white blood cells (agranulocytosis).
• Seizures.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain radiating to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Gallbladder and/or liver problems, 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. You may experience pain when urinating, or the amount of urine produced may decrease.
• False positive Coombs test (a test to detect blood problems).
• False positive result for galactosaemia (an abnormal accumulation of the sugar galactose).
• NILSON may interfere with certain types of blood glucose tests; please check with your doctor.

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 the website
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 NILSON

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging 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 NILSON 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 ampoule contains: aqueous solution of 1% lidocaine.
Description of the appearance of NILSON and package contents
Powder and solvent for injectable solution for intramuscular use.
Carton pack containing 1 vial of 1 g + 1 ampoule of 3.5 ml solvent
Marketing Authorization Holder
DYMALIFE PHARMACEUTICAL S.R.L.
Via Bagnulo, 9580063 Piano di Sorrento (Na)
Responsible manufacturer for batch release
ESSETI FARMACEUTICI S.r.l.
Via Campobello n. 15, 00040 Pomezia (RM)