Eftry

Package leaflet: Information for the patient

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

CEFTRIAXONE (as sodium ceftriaxone)
Generic medicine
Please read this leaflet carefully before this medicine is administered to you, 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 EFTRY is administered to you
3. How EFTRY is administered
4. Possible side effects
5. How to store EFTRY
6. Package contents 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 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 should know before being given EFTRY

Do not be given EFTRY 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 EFTRY is to be administered by intramuscular injection.

EFTRY 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 is to receive a product containing calcium through a vein.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before being given EFTRY if:

• 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 gallstones or kidney stones
• you have other diseases, for example 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 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 EFTRY for a prolonged period, you may need to have regular blood tests. EFTRY may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are about to undergo tests:

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

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

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

Other medicines and EFTRY
Inform 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 might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Your doctor will evaluate the benefits that treatment with EFTRY would provide you and the possible risks for the baby.

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

EFTRY contains sodium
This medicine contains 82.8 mg of sodium (a main component of table salt) per 1 g vial. This corresponds to 4.14% of the maximum recommended daily dietary intake of sodium for 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 must not be mixed or co-administered with calcium-containing injections.
Usual dose
Your doctor will determine the correct dose of EFTRY 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 function 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, 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 may administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.

Neonates, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:

• 50–80 mg of EFTRY 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 your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.
• Children with a body weight equal to or greater than 50 kg should receive the usual adult dose.

Neonates (0–14 days of life)

• 20–50 mg of EFTRY once daily per kg of the neonate’s body weight, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the neonate’s body weight.

Patients with liver or kidney problems
You may be given a different dose from the usual one. Your doctor will decide the amount of EFTRY you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more EFTRY than you should
If you are accidentally given more EFTRY than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of EFTRY
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 administer a double dose (two injections together) to make up for the missed dose.
If you stop EFTRY treatment
Do not stop taking EFTRY 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 everybody gets them.
With this medicine, you may experience the following side effects:

Severe allergic reactions (frequency unknown; cannot be estimated from the available data)
If you have a severe allergic reaction, seek medical advice 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.
• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

Severe skin reactions (frequency unknown; cannot be estimated from the available data)
If you experience a severe skin reaction, seek medical advice immediately.
Signs may include:

• severe rash developing rapidly, with blistering or peeling of the skin and possible formation of blisters 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 (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 EFTRY 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 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. 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 EFTRY was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (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 raised lumps (urticaria), which may cover a large area of the body, associated with itching and swelling.
• Sugar or blood in the urine.
• Oedema (fluid retention).
• Chills.

Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation and seizures.
Frequency not known (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 the number of white blood cells (agranulocytosis).
• Seizures.
• Dizziness.
• 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.
• Gallbladder and/or liver problems that may cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and pale 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 a reduced amount of urine produced.
• False positive Coombs test (a blood test to detect blood-related problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• EFTRY may interfere with certain types of blood glucose tests; please consult your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell 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 EFTRY

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
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 below 25°C.
The solution may vary in colour from pale yellow to amber, depending on concentration and storage duration; this characteristic does not affect the drug's efficacy or tolerability.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information What EFTRY contains

The active substance is: ceftriaxone disodium 1193 mg (equivalent to 1000 mg of ceftriaxone)
The other components are: lidocaine hydrochloride 35 mg and water for injections q.s. to 3.5 ml
Description of the appearance and contents of the pack
Powder and solvent for injectable solution
Marketing Authorization 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