FRINEG 500 mg Powder And Solvent For Injectable Solution

Зміст інструкції

1. FRINEG 500 mg/ 2 ml powder and solvent for injectable solution for intramuscular use, 1 g/ 3,5 ml powder and solvent for injectable solution for intramuscular use
   1. What is Frineg and what is it used for
   2. What you need to know before using Frineg
   3. How to use Frineg
   4. Possible side effects
   5. How to store Frineg
   6. Contents of the pack and other information

FRINEG 500 mg/ 2 ml powder and solvent for injectable solution for intramuscular use, 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 using 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 any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Frineg and what is it used for

Frineg contains the active ingredient ceftriaxone which is an antibiotic used in adults and children
(including newborns). It works by killing the bacteria that cause infections. It belongs to a group of
medicines called cephalosporins.
Frineg 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 used:

• 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 using Frineg

Do not use Frineg 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 pain and a severe skin rash that develops rapidly.
• you are allergic to lidocaine and Frineg needs 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 reduction in blood pressure and a slowing of the heart rate (complete atrioventricular block).
• you suffer from a condition of reduced blood volume (hypovolemia).

Frineg should not be used in 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 using Frineg if:

• you experience or have experienced 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 enlargement of the 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 your intestines, in particular colitis (inflammation of the intestine).
• you have problems with your 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 going to have a blood or urine test
If you use Frineg for a prolonged period, you may need to have regular blood tests. Frineg can affect the results of urine tests for sugar and a blood test known as the Coombs test.
If you are about to be tested:

• tell the person taking your sample that you have been given Frineg.

If you are diabetic or need to monitor your blood glucose levels, do not use certain 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 using Frineg in the child if:

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

Other medicines and Frineg
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).
• 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 or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before using this medicine.
The doctor will assess the benefits of treatment with Frineg and the possible risks to the child.

Driving and operating machinery
Frineg 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.

Frineg 500 mg/ 2 ml powder and solvent for solution for intramuscular injection contains
sodium
This medicine contains 41.5 mg of sodium (the main component of table salt) per vial. This is equivalent to 2% of the maximum recommended daily intake of sodium with the diet of an adult.

Frineg 1g/ 3.5 ml powder and solvent for solution for intramuscular injection contains sodium
This medicine contains 83 mg of sodium (the main component of table salt) per vial.
This is equivalent to 4% of the maximum recommended daily intake of sodium with the diet of an adult.

3. How to use Frineg

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

Usual dose
Your doctor will determine the right dose of Frineg 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 Frineg will depend on the type of infection you have.

Adults, the elderly and adolescents aged 12 years or over with a body weight of or greater than

50 kilograms (kg)

• from 1 to 2 g once a day 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 is greater than 2 g, you can 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 Frineg 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, your 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 can 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 Frineg 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.

Patients with liver and kidney problems
You may be given a different dose than usual. The doctor will decide the amount of
Frineg you will need and will keep you under close control, depending on the severity of the liver and kidney disease.

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

If you use more Frineg than you should
In case of accidental intake of an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital.

If you forget to use Frineg
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 use a double dose (two injections together)
to make up for the missed dose.

If you stop using Frineg
Do not stop using Frineg 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 everyone gets them.
Treatment with ceftriaxone, especially in elderly patients with severe kidney failure or
nervous system disorders, may in rare cases cause a decrease in consciousness,
abnormal movements, agitation and convulsions.
You may experience the following side effects with this medicine:

Serious allergic reactions (frequency not known, cannot be estimated from available data)
If you have a serious allergic reaction, seek medical attention immediately.
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.
• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

Serious skin reactions (frequency not known, cannot be estimated from 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), swollen 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 resolves spontaneously. These symptoms occur shortly after starting treatment with Frineg for infections caused by spirochetes 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 diarrhea.
• Changes in blood test results for liver function.
• Rash.

Uncommon(may affect up to 1 in 100 people)

• Fungal infections (e.g., thrush).
• Decreased number of white blood cells (granulocytopenia).
• Decreased number of red blood cells (anemia).
• Blood clotting problems. Signs include easy bruising, pain and swelling of the joints.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• 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 people)

• 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 from 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 for galactosemia (an abnormal accumulation of galactose sugar).
• Frineg 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 Frineg, other side effects may occur, which may include:

Frequency not known(cannot be estimated from available data)

• Changes in the rhythm and rate of the heart.
• 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, 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 Frineg

Keep this medicine out of the sight and reach of children.
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. The expiry date refers to the product
in intact packaging, correctly stored.
From a microbiological point of view, the product must be used immediately after
reconstitution. If not used immediately, the conditions and period of conservation 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 below 25°C.
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 Frineg contains

Frineg 500 mg/ 2 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains: ceftriaxone sodium 596.5 mg equivalent to 500 mg of ceftriaxone;
One solvent vial contains: aqueous solution of lidocaine 1%.

Frineg 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains: ceftriaxone sodium 1.193 g equivalent to 1g of ceftriaxone;
One solvent vial contains: aqueous solution of lidocaine 1%.

Description of the appearance of Frineg and contents of the pack

Frineg 500 mg/ 2 ml powder and solvent for injectable solution for intramuscular useis presented
in a box containing one vial of powder of 500 mg and one solvent vial of 2 ml.

Frineg 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
is presented in a box containing one vial of powder of 1 g and one solvent vial of 3.5 ml.

Marketing Authorisation Holder
Epifarma S.r.l.
Via San Rocco, 6
85033 Episcopia (Potenza)

Manufacturer
Laboratorio Farmaceutico CT S.r.l.
Via Dante Alighieri, 71
18038 Sanremo (IM)