EFTRY 1 G/3.5 ML Proszek i rozpuszczalnik do roztworu do wstrzykiwań

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

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

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

1. What EFTRY is and what it is used for

EFTRY 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.
EFTRY 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 EFTRY

Do not receive EFTRY 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 EFTRY is to be given to you by injection into a muscle.

EFTRY should 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 EFTRY 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 intestine)
• you have gallstones or kidney stones
• you have other illnesses, 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 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 problems with your liver or kidneys (see section 4)

If you are going to have a blood or urine test
If you are given EFTRY for a prolonged period, you may need to have regular
blood tests. EFTRY 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 EFTRY.

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

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

Other medicines and EFTRY
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 with
breast milk, ask your doctor for advice before taking this medicine.
The doctor will assess the benefits that treatment with EFTRY would bring you and the possible risks to the baby.

Driving and operating machinery
EFTRY 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.

Eftry 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 maximum recommended daily intake of salt with the diet of an adult.

3. How EFTRY is administered

EFTRY is generally administered by a doctor or nurse via an injection given
directly into a muscle. EFTRY 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 right dose of EFTRY 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
EFTRY will depend on the type of infection you have.

Adults, the 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 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 EFTRY 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 EFTRY 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 EFTRY
you will need and will monitor you closely, depending on the severity of the liver and
kidney disease.

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

If you forget to take EFTRY
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 EFTRY
Do not stop taking EFTRY 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 everybody gets them.
With this medicine you may experience the following side effects:

Serious allergic reactions (frequency not known, the frequency 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 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, the frequency cannot be estimated from the available data)
If you experience a serious skin reaction, seek medical attention 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 tends to resolve spontaneously. These symptoms occur shortly after starting treatment with EFTRY 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).
• 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 or burning sensation along the vein where EFTRY 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).
• 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.

Treatment with ceftriaxone, especially in elderly patients with severe kidney failure or nervous system diseases, can occasionally cause a decrease in consciousness, abnormal movements, agitation and convulsions.

Frequency not known (the frequency cannot be estimated from 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 that can cause pain, nausea and 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).
• EFTRY 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 EFTRY

Keep this medicine out of sight and reach of children.
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.
From a microbiological point of view, the product should be used immediately after reconstitution. 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 below 25°C.
They may vary in colour from pale yellow to amber depending on the concentration and storage period; this characteristic does not affect the efficacy or tolerability of the medicine.
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 EFTRY contains

The active ingredient is: ceftriaxone disodium 1193 mg (equivalent to 1000 mg of Ceftriaxone)
The other ingredients are: Lidocaine hydrochloride 35 mg and water for injections q.s. to 3.5 ml

Description of appearance and package contents
Powder and solvent for injectable solution

Marketing Authorisation Holder
Dymalife Pharmaceutical Srl – Via Bagnulo 95 80063 Piano di Sorrento (NA)

Manufacturer
Officina Farmaceutica Mitim S.r.l. – Via Cacciamali 34-36-38 – 25125 Brescia
Esseti Farmaceutici S.r.l. – Via Campobello 15 – 00071 – Pomezia – Roma