DIAXONE 1 G/3.5 ML Powder and solvent for injectable solution
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Інструкція із застосування DIAXONE
Зміст інструкції
Diaxone
“1g/3.5ml powder and solvent for injectable solution for intramuscular use" vial + solvent vial of
3.5 ml
Ceftriaxone (as ceftriaxone sodium)
“Generic medicine”
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. Never give it to others, even if their symptoms are the same as yours, as it could be dangerous.
- 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 Diaxone is and what it is used for
- 2. What you need to know before Diaxone is administered to you
- 3. How Diaxone is administered
- 4. Possible side effects
- 5. How to store Diaxone
- 6. Contents of the pack and other information
1. What is Diaxone and what is it used for
Diaxone 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.
Diaxone 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 Diaxone
Do not receive Diaxone 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 rash that develops rapidly.
- you are allergic to lidocaine and Diaxone is to be given to you by injection into a muscle.
Diaxone 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 certain 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 Diaxone 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 suffer from liver or kidney problems (see section 4).
- you have gallstones or kidney stones.
- you have other illnesses, for example hemolytic anemia (a form of anemia with breakdown of red blood cells, which can make the skin pale yellow and cause weakness or shortness of breath).
- you are on a low-sodium diet.
- you develop or have developed in the past any combination of the following symptoms: 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 swollen lymph nodes (signs of severe skin reactions, see also section 4 “possible side effects”).
If you are going to have a blood or urine test
If you are given Diaxone for a prolonged period, you may need to have regular
blood tests. Diaxone can affect the results of urine tests for sugar and a blood
test known as the Coombs test. If you are going to have tests:
- tell the person taking your sample that you have been given Diaxone.
Children
Talk to your doctor, pharmacist or nurse before having Diaxone 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 Diaxone
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 are 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 Diaxone would bring you and the possible risks to the
child.
Driving and operating machinery
Diaxone 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 Diaxone is administered
Diaxone is generally administered by a doctor or nurse via an injection
performed directly into a muscle. Diaxone 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 Diaxone 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 Diaxone 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 of less than 50 kg:
- 50-80 mg Diaxone 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 per 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 Diaxone 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 per 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
Diaxone you need and will monitor you carefully, depending on the severity of the liver and kidney disease.
If you take more Diaxone than you should
If you are accidentally given more Diaxone than the prescribed dose, seek immediate medical attention
or go to the nearest hospital.
If you forget to take Diaxone
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 Diaxone
Do not stop taking Diaxone 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, cannot be estimated from 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 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 experience a serious 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, 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 can cause fever, chills, headache, muscle pain and rash, which generally tends to resolve spontaneously. These symptoms occur shortly after starting treatment with Diaxone for infections caused by 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 tests 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 Diaxone was administered. 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 hives (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 renal impairment or nervous system pathologies, can rarely cause a decrease in consciousness, abnormal movements, agitation and convulsions.
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 breakdown 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).
- Diaxone 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, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system 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 Diaxone
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.
Solutions 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 drug.
6. Contents of the pack and other information
What Diaxone contains
One vial of powder contains:
active substance: Ceftriaxone bisodium 3.5 H O, 1.93 g equivalent to Ceftriaxone 1 g;
One solvent vial contains: 1% lidocaine aqueous solution.
Description of the appearance of Diaxone and contents of the pack
DIAXONE 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use:
1 vial of powder + 1 solvent vial of 3.5 ml
Marketing Authorisation Holder
EURO-PHARMA S.r.l. – Via Garzigliana, 8 - Turin
Manufacturer
ESSETI Farmaceutici S.r.l., Via Campobello, 15 – 00071 Pomezia (Rome)
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- Країна реєстрації
- Лікарська формаPowder and solvent for injectable solution, 1 G/3.5 ML
- Код АТХJ01DD04
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до DIAXONEЛікарська форма: Powder and solvent for injectable solution, 1 G /3,5 MLДіюча речовина: ЦефтриаксонВиробник: LANOVA FARMACEUTICI S.R.L.Потрібен рецептЛікарська форма: Powder and solvent for injectable solution, 1 G/3.5 MLДіюча речовина: ЦефтриаксонВиробник: PHARMACARE S.R.L.Потрібен рецептЛікарська форма: Powder and solvent for injectable solution, 500 MG/2 MLДіюча речовина: ЦефтриаксонВиробник: AESCULAPIUS FARMACEUTICI SRLПотрібен рецепт
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Часті запитання
DIAXONE потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у DIAXONE — Цефтриаксон. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
DIAXONE виробляється компанією EURO-PHARMA S.R.L.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування DIAXONE з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати DIAXONE у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Цефтриаксон) включають BIXON, KARITEX, KEFRAG. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
