NILSON 1 G/3.5 ML Порошок и раствор для инъекционного раствора

Содержание инструкции

1. What is NILSON and what it is used for
2. What you need to know before you are given NILSON
3. How NILSON is administered
4. Possible side effects
5. How to store NILSON
6. Package contents and other information

NILSON 1 g powder and solvent for injectable solution for intramuscular use
Ceftriaxone (as ceftriaxone sodium)

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

1. What is NILSON and what it is used for

NILSON contains the active ingredient ceftriaxone which is an antibiotic administered to adults and children
(including newborns). It works by killing 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 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 a surgical procedure.

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

Do not be given NILSON 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, chest painand a severe skin rash that develops rapidly
• you are allergic to lidocaine and NILSON needs to be given to you by injection into a muscle.

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 life) and has some blood problems or jaundice (yellowing of the skin or the white of the eye) or needs to receive a product containing calcium through a vein.

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 problems with diarrhoea after taking an antibiotic. You have had problems with your intestines, in particular colitis (inflammation of the intestines)
• 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 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 increased type of white blood cells (eosinophilia) and swollen lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”)
• you have problems with your liver or kidneys (see section 4).

If you are going to have a blood or urine test
If you are given NILSON for a prolonged period, you may need to have regular
blood tests. NILSON can affect the results of urine tests for 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 NILSON.

Children
Talk to your doctor, pharmacist or nurse before NILSON is given to the child if:

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

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, 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).

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 NILSON would bring you and the possible risks to the baby.

Driving and operating machinery
NILSON 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.

3. How NILSON is administered

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

Usual dose
The doctor will determine the correct dose of NILSON 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 function of your kidneys and liver. The number of days or weeks during which you will receive NILSON will depend on the type of infection you have.

Adults, elderly and children aged 12 years 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 more 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 NILSON 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 more 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 NILSON 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 NILSON you need and will monitor you closely, depending on the severity of the liver and kidney disease.

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

If you forget to take NILSON
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 NILSON
Do not stop taking NILSON unless your doctor tells you to. If you have any doubts about the use of this medicine, consult 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:

Serious allergic reactions (frequency not known, the frequency cannot be estimated based on the available data)
If you have a severe allergic reaction, seek immediate medical attention.
Signs may include:

• Chest pain 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 can make it difficult to breathe or swallow
• sudden swelling of the hands, feet and ankles.

Severe skin reactions (frequency not known, the frequency cannot be estimated based on the available data)
If you experience a severe skin reaction, seek immediate medical attention.
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 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 in 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 NILSON to treat infections from spirochetes such as Lyme disease.

Treatment with ceftriaxone, especially in elderly patients with severe kidney failure or nervous system disorders, can rarely cause a decrease in consciousness, abnormal movements, agitation and convulsions.
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).
• Decreased number of white blood cells (granulocytopenia).
• Decreased 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 NILSON 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). Signs include diarrhea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Skin 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 estimated 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). 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.
• 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 Coombs test (a test to detect blood problems).
• A false positive test for galactosemia (an abnormal accumulation of galactose sugar).
• NILSON may interfere with some types of tests to measure blood glucose; check with your doctor.

Reporting of side effects
If you get any side effects, even 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 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 which is stated on the pack after Scad.
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. Package contents and other information

What NILSON 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 contains: 1% aqueous lidocaine solution.

Description of the appearance of NILSON and package contents
Powder and solvent for injectable solution for intramuscular use.
Pack of 1 vial of 1 g + 1 solvent vial of 3.5 ml

Marketing authorisation holder and manufacturer
DYMALIFE PHARMACEUTICAL S.R.L.
Via Bagnulo, 9580063Piano di Sorrento (Na)

Manufacturer responsible for batch release
ESSETI FARMACEUTICI S.r.l.
Via Campobello n. 15, 00040 Pomezia (RM)