Davixon

Package leaflet: Information for the patient

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

Ceftriaxone (as ceftriaxone sodium)
Lidocaine (as lidocaine hydrochloride)
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, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Davixon is and what it is used for

Davixon 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. Davixon is given by injection into a muscle, in a solution containing lidocaine, which reduces the pain associated with the injection.

Davixon 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 also be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis)
• to treat patients with a low white blood cell count (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 Davixon

Do not be given Davixon if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6)
• you have 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 it difficult to breathe or swallow, sudden swelling of hands, feet and ankles, chest pain, and a severe rash that develops rapidly
• you are allergic to lidocaine and Davixon is to be administered by intramuscular injection
• you have a heart conduction disorder causing low blood pressure and slowed heart rate (complete atrioventricular block)
• you have a condition of reduced blood volume (hypovolemia)

Davixon 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 certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or needs to receive intravenous products containing calcium

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

• you are experiencing or have previously experienced 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, increased levels of 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 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 liver or kidney problems (see section 4)
• 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 suffer from loss of muscle function and weakness (myasthenia gravis)
• you have seizures (epilepsy)
• you have any heart problems, especially if they affect your heart rate
• you have respiratory problems
• you suffer from porphyria (a rare inherited disease affecting the skin and nervous system)

If you need blood or urine tests
If you are given Davixon for a prolonged period, you may need regular blood tests. Davixon 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 collecting your sample that you have been given Davixon

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems that may inaccurately measure blood glucose during treatment with ceftriaxone. If such systems are used, check the instructions for use and inform your doctor, pharmacist, or nurse. Alternative analytical methods should be used if necessary.

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

• the child has recently received or is about to receive intravenous products containing calcium

Other medicines and Davixon
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, as they may interact with ceftriaxone:

• an antibiotic called an aminoglycoside
• an antibiotic called chloramphenicol (used to treat infections, particularly eye infections)

Various medicines may interact with lidocaine, resulting in altered effects. These include:

• medicines used to treat infections (clarithromycin, erythromycin)
• medicines used to treat stomach ulcers (e.g. cimetidine)
• strong painkillers such as codeine and meperidine (narcotic or opioid medicines)
• medicines used to treat irregular heart rate (e.g. mexiletine, tocainide)

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will evaluate the benefits that treatment with Davixon may provide you and the potential risks for the unborn or breastfed child.

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

Davixon contains sodium
Davixon 1 g/3.5 ml contains 82.8 mg of sodium (the main component of table salt) per 1 g vial. This corresponds to 4.14% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Davixon is administered

Davixon is generally administered by a doctor or nurse as an injection directly into a muscle. Davixon will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with injections containing calcium.
Usual dose
Your doctor will determine the correct dose of Davixon 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 function of your kidneys and liver. The number of days or weeks during which you will receive Davixon 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 will 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 Davixon once daily per 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 per kg of body weight, up to a maximum of 4 g per day. If your 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 equal to or greater than 50 kg should receive the usual adult dose.

Newborns (0–14 days of life):

• 20–50 mg of Davixon 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 how much Davixon you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more Davixon than you should
If you are accidentally given more Davixon than prescribed, contact your doctor or go immediately to the nearest hospital.
If you miss a dose of Davixon
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 take a double dose (two injections together) to make up for a missed dose.
If you stop treatment with Davixon
Do not stop taking Davixon unless your doctor tells you to. 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 experiences them.
You may experience the following side effects with this medicine:
Treatment with ceftriaxone, especially in elderly patients with severe renal insufficiency or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation, and seizures.

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have a severe allergic reaction, seek immediate medical attention.
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 during allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, seek immediate medical attention.
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 as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, elevated 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, usually resolving spontaneously. These symptoms may occur shortly after starting Davixon treatment 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 indicating liver function abnormalities.
• 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 Davixon 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.
• Breathing difficulties (bronchospasm).
• Rash with wheals (urticaria), possibly covering large areas 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 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 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.
• Problems that may cause pain, nausea, vomiting.
• 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 reduced urine output.
• False positive Coombs test (a blood test to detect blood-related disorders).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Davixon may interfere with certain types of blood glucose tests; please consult your doctor.

Following accidental intravascular injection of lidocaine during intramuscular administration of Davixon i.m., additional side effects may occur, which may include:
Not known (frequency cannot be estimated from the available data)

• Changes in heart rhythm and rate.
• Low blood pressure.
• Slowed heart rate (less than 60 beats/minute).
• Interruption of normal blood circulation due to cardiac arrest and reduced 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, seizures or epileptic fits, deep unconsciousness (coma).
• Blurred vision, double vision, or temporary loss of vision.
• Feeling unwell (nausea or vomiting).
• Breathing difficulties.
• Reduced respiratory rate or possible cessation of breathing.
• Unusual drowsiness or fatigue during the day or fainting.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 Davixon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label
of the vial, after Exp.
The expiry date refers to the last day of that month.
From a microbiological standpoint, the product should be used immediately. If not
used immediately, the period and conditions of storage prior to use are the
responsibility of the user and must not exceed the times indicated above for chemical and
physical stability during use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Davixon contains
The active substance is ceftriaxone.
One vial of powder contains: ceftriaxone disodium 3.5 H₂O, 1.193 g equivalent to ceftriaxone 1 g.
The excipients are:
Solvent vial: aqueous solution of 1% lidocaine.

Description of the appearance of Davixon and package contents
Powder and solvent for injectable solution for intramuscular use.
Carton pack containing 1 vial of 1 g + 1 solvent vial of 3.5 ml.

Marketing Authorization Holder
NEW RESEARCH srl,
Via Tiburtina, 1143 - 00156 Rome

Batch release responsible manufacturer
ESSETI FARMACEUTICI S.r.l.
Via Campobello n. 15, 00040 Pomezia (RM) - (complete production)
LABORATORIO FARMACEUTICO CT S.r.l.
Via Dante Alighieri, 71, 18038 Sanremo (IM) – (complete production)
LISAPHARMA S.p.A.
Via Licinio 11-15 - 22036 Erba (CO) - (solvent vial production)

July 2024