Ceftriaxon Aptapharma

Leaflet accompanying the packaging: patient information

Ceftriaxon AptaPharma, 1 g, powder for solution for injection/infusion

Ceftriaxon AptaPharma, 2 g, powder for solution for injection/infusion

Ceftriaxone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ceftriaxon AptaPharma and what is it used for
• 2. Important information before using Ceftriaxon AptaPharma
• 3. How to use Ceftriaxon AptaPharma
• 4. Possible side effects
• 5. How to store Ceftriaxon AptaPharma
• 6. Contents of the packaging and other information

1. What is Ceftriaxon AptaPharma and what is it used for

Ceftriaxon AptaPharma is an antibiotic used in adults and children (including newborns). Its action is based on killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Ceftriaxon AptaPharma 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 and soft tissues,
• of the blood,
• of the heart.

This medicine can be used:

• to treat certain sexually transmitted infections (gonorrhea and syphilis),
• to treat patients with a low white blood cell count (neutropenia) who have a fever caused by a bacterial infection,
• to treat chest infections in adults with chronic bronchitis,
• to treat Lyme disease (a disease transmitted by ticks) in adults and children, including newborns from the 15th day of life,
• to prevent infections during surgery.

2. Important information before using Ceftriaxon AptaPharma

When not to use Ceftriaxon AptaPharma:

• if the patient is allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems, monobactams). Symptoms of such a reaction include: sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of the hands, feet and ankles, chest pain and a rapidly spreading severe rash;
• if the patient is allergic to lidocaine and is to receive Ceftriaxon AptaPharma by intramuscular injection.

Ceftriaxon AptaPharma must not be used in:

• premature babies,
• full-term newborns (up to 28 days of age) who have certain blood disorders or jaundice (yellowing of the skin or whites of the eyes) or are to receive calcium intravenously.

Warnings and precautions

Before starting treatment with Ceftriaxon AptaPharma, the patient should discuss with their doctor, pharmacist or nurse if:

• the patient has recently received or is about to receive calcium-containing products;
• the patient has recently had diarrhea after antibiotic treatment. The patient has had intestinal problems, particularly colitis (inflammation of the large intestine);
• the patient has liver or kidney problems (see section 4);
• the patient has gallstones or kidney stones;
• the patient has other diseases, such as hemolytic anemia (reduced red blood cell count, which can cause paleness, weakness or shortness of breath);
• the patient is on a low-sodium diet;
• the patient has or has had any of the following symptoms: rash, skin redness, blisters around the mouth, eyes or mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme activity in blood tests and increased white blood cell count (eosinophilia) and swollen lymph nodes (symptoms of severe skin reactions, see also section 4 "Possible side effects").

In case of blood or urine tests

If the patient is receiving Ceftriaxon AptaPharma for a long time, regular blood tests may be necessary. Ceftriaxon AptaPharma may affect the results of blood sugar tests and urine tests, known as the Coombs test. If the patient is having tests, they should inform the person taking the sample that they are taking Ceftriaxon AptaPharma.

If the patient has diabetes or needs to control their blood sugar levels, they should not use tests that may incorrectly measure blood sugar levels while taking ceftriaxone. If the patient is monitoring their blood sugar levels, they should check the instructions and tell their doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

Children

Before giving Ceftriaxon AptaPharma to a child, the doctor, pharmacist or nurse should be consulted if the child has recently received or is about to receive a calcium-containing product intravenously.

Ceftriaxon AptaPharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

In particular, the patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• an antibiotic belonging to the aminoglycoside group,
• an antibiotic called chloramphenicol (used to treat infections, especially eye infections).

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a baby, they should consult their doctor before using this medicine.

The doctor will assess the benefits of treating the patient with Ceftriaxon AptaPharma and the risks to the baby.

Driving and using machines

Ceftriaxon AptaPharma may cause dizziness. If the patient feels dizzy, they should not drive or operate any tools or machines. They should inform their doctor if they experience such symptoms.

Ceftriaxon AptaPharma contains sodium

Ceftriaxon AptaPharma, 1 g, powder for solution for injection/infusion

The medicine contains about 82.8 mg of sodium (the main component of common salt) per 1 g, which is 4.15% of the maximum recommended daily intake of sodium in the diet for adults.

Ceftriaxon AptaPharma, 2 g, powder for solution for injection/infusion

The medicine contains about 165.6 mg of sodium (the main component of common salt) per 2 g, which is 8.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ceftriaxon AptaPharma

Ceftriaxon AptaPharma is usually given by a doctor or nurse.

It can be given:

• as a drip (intravenous infusion) or by injection directly into a vein or
• into a muscle.

Ceftriaxon AptaPharma is prepared by a doctor, pharmacist or nurse, and will not be mixed or given at the same time as solutions containing calcium.

Usual dose

The doctor will decide what dose of Ceftriaxon AptaPharma is suitable for the patient. The dose depends on the severity and type of infection; whether the patient is taking other antibiotics; the patient's age and weight; the patient's liver and kidney function. The number of days or weeks the patient will receive Ceftriaxon AptaPharma depends on the type of infection.

Adult patients, elderly patients and adolescents from 12 years of age and weighing 50 kg or more:

• From 1 to 2 g once a day, depending on the severity and type of infection. In case of severe infection, the doctor will use a higher dose (up to 4 g once a day). If the daily dose is higher than 2 g, the medicine can be given in one dose or in two separate doses.

Newborns, infants and children from the 15th day of life to 12 years of age and weighing less than 50 kg:

• From 50 to 80 mg of Ceftriaxon AptaPharma per kilogram of the child's weight once a day, depending on the severity and type of infection. In case of severe infection, the doctor will use a higher dose, up to 100 mg per kilogram of the child's weight, up to a maximum of 4 g once a day. If the daily dose is higher than 2 g, the medicine can be given in one dose per day or in two separate doses.
• Children weighing 50 kg or more should receive the usual adult dose.

Newborns (0-14 days):

• From 20 to 50 mg of Ceftriaxon AptaPharma per kilogram of the child's weight once a day, depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg per kilogram of the newborn's weight.

Patients with liver or kidney problems

The patient may receive a different dose than usual. The doctor will determine what dose of Ceftriaxon AptaPharma is suitable for the patient and will closely monitor their condition depending on the severity of liver and kidney disease.

Using a higher dose of Ceftriaxon AptaPharma than recommended

In case of accidental administration of a dose higher than prescribed by the doctor, the patient should contact their doctor or the nearest hospital immediately.

Missing a dose of Ceftriaxon AptaPharma

If the patient misses an injection, they should receive it as soon as possible. However, if it is close to the time of the next injection, they should not take the missed dose. They should not take a double dose (two injections at the same time) to make up for the missed dose.

Stopping treatment with Ceftriaxon AptaPharma

The patient should not stop using Ceftriaxon AptaPharma unless their doctor tells them to. If the patient has any further doubts about using this medicine, they should consult their doctor or nurse.

4. Possible side effects

Like all medicines, Ceftriaxon AptaPharma can cause side effects, although not everybody gets them.

The following side effects may occur during treatment with this medicine.

Severe allergic reactions (frequency not known - cannot be estimated from available data)

In case of a severe allergic reaction, the patient should tell their doctor immediately.

Symptoms 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 associated with an allergic reaction, which can be a sign of a heart attack caused by an allergy (Kounis syndrome).

Severe skin reactions (frequency not known - cannot be estimated from available data)

In case of a severe skin reaction, the patient should tell their doctor immediately.

Symptoms of such a reaction may include:

• a rapidly spreading severe rash, with blisters or peeling of the skin and possible blisters in the mouth [Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), also known as SJS and TEN];
• a combination of any of the following symptoms: spreading rash, high body temperature, increased liver enzyme activity, blood test abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or hypersensitivity syndrome);
• Jarisch-Herxheimer reaction causing fever, chills, headache, muscle pain and skin rash, usually self-limiting; this reaction occurs shortly after starting treatment with the medicine;

Ceftriaxon AptaPharma for infections caused by spirochetes, such as Lyme disease.

Treatment with ceftriaxone - especially in elderly patients with severe kidney or nervous system disorders - may rarely cause decreased consciousness, abnormal movements, agitation and seizures.

Other possible side effects:

Common (may occur in up to 1 in 10 patients)

• abnormalities in white blood cell count (such as decreased leukocyte count and increased eosinophil count) and platelet count (decreased platelet count),
• loose stools or diarrhea,
• changes in liver function test results,
• rash.

Uncommon (may occur in up to 1 in 100 patients)

• fungal infections (such as thrush),
• decreased white blood cell count (granulocytopenia),
• decreased red blood cell count (anemia),
• blood clotting problems; symptoms of such a reaction may include easy bruising and pain or swelling in the joints.
• headache,
• dizziness,
• nausea or vomiting,
• itching (pruritus),
• pain or burning along the vein into which Ceftriaxon AptaPharma was given; pain at the injection site,
• high body temperature (fever),
• abnormal kidney function test results (increased creatinine levels in the blood).

Rare (may occur in up to 1 in 1,000 patients)

• inflammation of the large intestine (colitis); symptoms include diarrhea, usually with blood and mucus, abdominal pain and fever,
• breathing difficulties (bronchospasm),
• hives (urticaria), which can spread over a large area of the body, itching and swelling,
• blood or sugar in the urine,
• swelling (fluid retention),
• chills.

Frequency not known (frequency cannot be estimated from available data)

• secondary infection that cannot be treated with previously prescribed antibiotics,
• a certain type of anemia in which red blood cells are destroyed (hemolytic anemia),
• significant decrease in white blood cell count (agranulocytosis),
• seizures,
• dizziness with a systemic character (feeling of spinning),
• pancreatitis; symptoms include severe abdominal pain radiating to the back.
• inflammation of the mucous membrane lining the mouth,
• inflammation of the tongue; symptoms include swelling, redness and pain in the tongue.
• problems with the gallbladder and/or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, very dark urine and clay-colored stools.
• a neurological condition that can occur in newborns with severe jaundice (kernicterus),
• kidney problems caused by the deposition of calcium salt of ceftriaxone. Symptoms may include pain when urinating or producing a small amount of urine.
• false-positive Coombs test result (a test that detects certain blood disorders),
• false-positive test result for galactosemia (a disorder characterized by the abnormal accumulation of galactose in the body),
• Ceftriaxon AptaPharma may affect the results of some glucose tests in the blood - the patient should check with their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Ceftriaxon AptaPharma

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label and carton after EXP.

The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

Store the vial in the outer packaging to protect it from light.

Solutions of Ceftriaxon AptaPharma may have a color from colorless to yellow, depending on the concentration, which does not affect their effectiveness, efficacy and tolerance.

The solution after reconstitution should be administered immediately.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ceftriaxon AptaPharma contains

The active substance of the medicine is ceftriaxone in the form of ceftriaxone sodium.

Ceftriaxon AptaPharma, 1 g, powder for solution for injection/infusion

Each vial contains 1 g of ceftriaxone (in the form of ceftriaxone sodium).

Ceftriaxon AptaPharma, 2 g, powder for solution for injection/infusion

Each vial contains 2 g of ceftriaxone (in the form of ceftriaxone sodium).

Ceftriaxon AptaPharma does not contain any excipients.

What Ceftriaxon AptaPharma looks like and contents of the pack

Ceftriaxon AptaPharma is a powder with a white to yellowish color.

Pack sizes

Ceftriaxon AptaPharma, 1 g, powder for solution for injection/infusion

A 10 ml glass vial with a bromobutyl rubber stopper, siliconized, with an aluminum cap and a plastic overcap, in a cardboard box.

The pack contains 10 vials.

Ceftriaxon AptaPharma, 2 g, powder for solution for injection/infusion

A 50 ml glass vial with a bromobutyl rubber stopper, siliconized, with an aluminum cap and a plastic overcap, in a cardboard box.

The pack contains 5 or 10 vials.

Marketing authorization holder

Apta Medica Internacional d.o.o.

Likozarjeva Ulica 6

1000 Ljubljana

Slovenia

Tel.: 00386 51 615 015

e-mail: [email protected]

Manufacturer

ACS Dobfar S.p.A

Nucleo Industriale S. Atto, S. Nicolò a Tordino

64100 Teramo

Italy

ACS Dobfar S.p.A

Via A. Fleming, 2

37135 Verona

Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:

Information intended for healthcare professionals only

Ceftriaxon AptaPharma, 1 g, powder for solution for injection/infusion

Ceftriaxon AptaPharma, 2 g, powder for solution for injection/infusion Ceftriaxone(in the form of ceftriaxone sodium) Preparation of solution for injection and infusion

Concentrations for intravenous injection: 100 mg/ml

Concentrations for intravenous infusion: 50 mg/ml

From a microbiological point of view, as long as the method of opening, reconstitution or dilution does not exclude the risk of microbiological contamination, the amount of product prepared for administration should be used immediately.

If the product is not used immediately, the user is responsible for the storage conditions and duration.

Ceftriaxon AptaPharma should not be mixed in the same syringe with any other medicinal product except 1% (10 mg/ml) lidocaine hydrochloride solution (only for intramuscular injections).

The infusion line should be flushed after each administration.

Ceftriaxon AptaPharma, 1 g, powder for solution for injection/infusion

In intravenous injection, 1 g of Ceftriaxon AptaPharma should be dissolved in 10 ml of water for injection. The injection should be given over a period of more than 5 minutes, directly into a vein or through an intravenous infusion set.

In intramuscular injection, 1 g of Ceftriaxon AptaPharma should be dissolved in 3.5 ml of 1% (10 mg/ml) lidocaine hydrochloride solution. The solution should be administered by deep intramuscular injection.

Doses greater than 1 g should be divided and injected into more than one site.

In short intravenous infusion, 1 g of Ceftriaxon AptaPharma should be dissolved in 20 ml of water for injection; 0.9% (9 mg/ml) sodium chloride; 0.45% (4.5 mg/ml) sodium chloride + 2.5% (25 mg/ml) glucose; 5% (50 mg/ml) or 10% (100 mg/ml) glucose solution; 6% (60 mg/ml) dextran in 5% (50 mg/ml) glucose or in 6-10% (60-100 mg/ml) hydroxyethyl starch.

Ceftriaxon AptaPharma, 2 g, powder for solution for injection/infusion

In intravenous infusion, 2 g of Ceftriaxon AptaPharma should be dissolved in 40 ml of water for injection; 0.9% (9 mg/ml) sodium chloride; 0.45% (4.5 mg/ml) sodium chloride + 2.5% (25 mg/ml) glucose; 5% (50 mg/ml) or 10% (100 mg/ml) glucose solution; 6% (60 mg/ml) dextran in 5% (50 mg/ml) glucose or in 6-10% (60-100 mg/ml) hydroxyethyl starch.

The product should be administered by intravenous infusion over a period of at least 30 minutes.

In newborns, intravenous doses should be administered over a period of more than 60 minutes to reduce the risk of bilirubin encephalopathy.

For single use only.

A change in color, from pale yellow to yellow, does not affect the effectiveness of the product.

Only clear solutions without visible particles should be used.

Any unused product or waste material should be disposed of in accordance with local regulations.