Ceftriaxon aptapharma

Package leaflet: Information for the patient

Ceftriaxon AptaPharma, 1 g, powder for solution for injection/infusion
Ceftriaxon AptaPharma, 2 g, powder for solution for injection/infusion
Ceftriaxonum
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Ceftriaxon AptaPharma is and what it is 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 pack and other information

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

Ceftriaxon AptaPharma is an antibiotic used in adults and children (including newborns). It works by 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),
• the lungs,
• the middle ear,
• the abdomen and abdominal wall (peritonitis),
• the urinary tract and kidneys,
• bones and joints,
• the skin and soft tissues,
• the blood,
• the heart.

This medicine may also be used:

• to treat certain sexually transmitted infections (gonorrhoea and syphilis),
• to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection,
• to treat chest infections in adults with chronic bronchitis,
• to treat Lyme disease (a tick-borne illness) in adults and children, including newborns from day 15 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 rapidly developing 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 infants,
• 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 who are to receive intravenous medicines containing calcium.

Warnings and precautions
Before starting treatment with Ceftriaxon AptaPharma, discuss with your doctor, pharmacist or
nurse if:

• the patient has recently received or is about to receive medications containing calcium;
• the patient has recently had diarrhoea after antibiotic treatment. The patient has ever had intestinal problems, especially colitis (inflammation of the large intestine);
• the patient has problems with the liver or kidneys (see section 4);
• the patient has gallstones or kidney stones;
• the patient has other diseases such as haemolytic anaemia (reduction in red blood cells, causing paleness, weakness or shortness of breath);
• the patient is on a low-sodium diet;
• the patient currently has or has previously had any of the following symptoms: rash, redness of the skin, blisters around the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme activity observed in blood tests, increased number of a certain type of white blood cells (eosinophilia), and enlarged lymph nodes (symptoms of severe skin reactions, see also section 4 “Possible side effects”).

Regarding blood or urine tests
If the patient is receiving Ceftriaxon AptaPharma for a prolonged period, regular blood tests may be necessary.
Ceftriaxon AptaPharma may affect the results of blood and urine glucose tests and the Coombs test.
If the patient is undergoing testing, inform the person collecting the sample that the patient is receiving Ceftriaxon AptaPharma.
If the patient has diabetes or needs to monitor blood glucose levels, do not use tests that may inaccurately measure blood glucose levels during treatment with ceftriaxone. If monitoring blood glucose levels, check the instructions and inform the doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

Children
Before giving Ceftriaxon AptaPharma to a child, discuss with the doctor, pharmacist or
nurse if the child has recently received or is about to receive intravenous products containing calcium.

Ceftriaxon AptaPharma with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, tell the doctor or pharmacist if the patient is taking any of the following medicines:

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

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
The doctor will assess the benefits of treatment with Ceftriaxon AptaPharma for the mother and the risks for the child.

Driving and using machines
Ceftriaxon AptaPharma may cause dizziness. If the patient experiences dizziness, he/she should not drive or operate any tools or machinery. Inform the doctor if such symptoms occur.

Ceftriaxon AptaPharma contains sodium
Ceftriaxon AptaPharma 1 g, powder for solution for injection/infusion
The medicine contains approximately 82.8 mg of sodium (the main component of table salt) in each 1 g, equivalent to 4.15% of the maximum recommended daily dietary sodium intake for adults.
Ceftriaxon AptaPharma 2 g, powder for solution for injection/infusion
The medicine contains approximately 165.6 mg of sodium (the main component of table salt) in each 2 g, equivalent to 8.3% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Ceftriaxon AptaPharma

Ceftriaxon AptaPharma is usually administered by a doctor or nurse.
It may be given as:

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

Ceftriaxon AptaPharma is prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with calcium-containing solutions.
Typical dosage
Your doctor will decide the appropriate dose of Ceftriaxon AptaPharma for you. The dose depends on the severity and type of infection; whether you are taking other antibiotics; your age and body weight; and your liver and kidney function. The number of days or weeks you will receive Ceftriaxon AptaPharma depends on the type of infection.
Adult patients, elderly patients, and adolescents aged 12 years and older with body weight
greater than or equal to 50 kg:

• 1 to 2 g once daily, depending on the severity and type of infection. In severe infections, the doctor may use a higher dose (up to 4 g once daily). If the daily dose exceeds 2 g, the medicine may be given as a single dose or in two separate doses.

Newborns, infants, and children aged from day 15 to 12 years with body weight below 50 kg:

• 50 to 80 mg of Ceftriaxon AptaPharma per kg of body weight once daily, depending on the severity and type of infection. In severe infections, the doctor may use a higher dose, up to 100 mg per kg of body weight, with a maximum of 4 g once daily. If the daily dose exceeds 2 g, the medicine may be given as a single daily dose or in two separate doses.
• Children with body weight of 50 kg or more should receive the usual adult dose.

Newborns (aged 0–14 days):

• 20 to 50 mg of Ceftriaxon AptaPharma per kg of body weight once daily, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of body weight of the newborn.

Patients with impaired liver or kidney function
Patients may receive a dose different from the usual. The doctor will determine the appropriate dose of Ceftriaxon AptaPharma and will closely monitor the patient depending on the severity of liver or kidney disease.
Accidental overdose of Ceftriaxon AptaPharma
If a larger than recommended dose is accidentally administered, contact your doctor or nearest hospital immediately.
Missed dose of Ceftriaxon AptaPharma
If a dose is missed, it should be administered as soon as possible. However, if it is almost time for the next dose, do not administer the missed dose. Do not take a double dose (two injections at the same time) to make up for a missed dose.
Stopping Ceftriaxon AptaPharma treatment
Do not stop using Ceftriaxon AptaPharma unless instructed by your doctor. If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions described below may occur during treatment with this medicine.

Severe allergic reactions (frequency unknown – cannot be estimated from available data)
If a severe allergic reaction occurs, inform your doctor immediately.
Symptoms may include:

• sudden swelling of the face, throat, lips or mouth; this may make breathing or swallowing difficult;
• sudden swelling of hands, feet and ankles;
• chest pain associated with an allergic reaction, which may be a sign of an allergy-induced heart attack (Kounis syndrome).

Severe skin reactions (frequency unknown – cannot be estimated from available data)
If a severe skin reaction occurs, inform your doctor immediately.
Symptoms of such a reaction may include:

• rapidly developing severe rash, with blisters or peeling 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, abnormal blood test results (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome);
• Jarisch-Herxheimer reaction causing fever, chills, headache, muscle pain and skin rash, usually self-limiting; this reaction may occur shortly after starting treatment with Ceftriaxon AptaPharma for infections caused by spirochetes, such as Borrelia burgdorferi (Lyme disease).

Treatment with ceftriaxone – especially in elderly patients with serious renal or neurological disorders – may rarely cause decreased level of consciousness, abnormal movements, agitation and seizures.

Other possible adverse reactions:

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

• abnormalities in white blood cells (such as decreased leukocyte count and increased eosinophil count) and platelets (decreased platelet count);
• loose stools or diarrhoea;
• changes in blood test results assessing liver function;
• rash.

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

• fungal infections (e.g. candidiasis);
• decreased white blood cell count (granulocytopenia);
• decreased red blood cell count (anaemia);
• problems with blood clotting; symptoms may include easy bruising, as well as joint pain and swelling;
• headache;
• dizziness;
• nausea or vomiting;
• itching;
• pain or burning along the vein into which Ceftriaxon AptaPharma was administered; pain at the injection site;
• high body temperature (fever);
• abnormal kidney function test result (increased blood creatinine concentration).

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

• inflammation of the large intestine (colitis); symptoms include diarrhoea, usually with blood and mucus, abdominal pain and fever;
• breathing difficulties (bronchospasm);
• raised itchy rash (urticaria), which may affect large parts of the body, itching and swelling;
• presence of blood or glucose in urine;
• oedema (fluid retention);
• chills.

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

• secondary infection not responsive to previously prescribed antibiotics;
• a type of anaemia involving destruction of red blood cells (haemolytic anaemia);
• marked decrease in white blood cell count (agranulocytosis);
• seizures;
• vertigo (spinning sensation);
• 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 of the tongue;
• disorders related to the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, very dark urine and pale stools;
• neurological condition that may occur in newborns with severe jaundice (nuclear jaundice);
• kidney problems caused by precipitation of calcium-ceftriaxone salts; may present as pain during urination or production of small amounts of urine;
• false positive Coombs test result (a test detecting certain blood disorders);
• false positive galactosaemia test result (abnormal accumulation in the body of a sugar called galactose);
• Ceftriaxon AptaPharma may affect the results of certain blood glucose tests – please consult your doctor about this.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ceftriaxon AptaPharma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following EXP.
The expiry date refers to the last day of the specified month.
This medicine does not require any special temperature storage conditions.
Store the vial in the outer packaging to protect from light.
Ceftriaxon AptaPharma solutions may vary in colour from colourless to yellow, depending on concentration; this does not affect their activity, efficacy, or tolerability.
The solution should be administered immediately after reconstitution.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Ceftriaxon AptaPharma contains
The active substance 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 (as ceftriaxone sodium).
Ceftriaxon AptaPharma, 2 g, powder for solution for injection/infusion
Each vial contains 2 g of ceftriaxone (as ceftriaxone sodium).
Ceftriaxon AptaPharma does not contain excipients.

What Ceftriaxon AptaPharma looks like and contents of the pack
Ceftriaxon AptaPharma is a powder ranging in colour from almost white to yellowish.

Pack sizes
Ceftriaxon AptaPharma, 1 g, powder for solution for injection/infusion
10 ml vial made of colourless type III glass, with a bromobutyl rubber stopper, siliconized, with an aluminium cap and a plastic flip-off seal, in a cardboard box.
Pack contains 10 vials.

Ceftriaxon AptaPharma, 2 g, powder for solution for injection/infusion
50 ml vial made of colourless type III glass, with a bromobutyl rubber stopper, siliconized, with an aluminium cap and a plastic flip-off seal, in a cardboard box.
Pack contains 5 or 10 vials.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:

Information intended exclusively for healthcare professionals

Ceftriaxon AptaPharma, 1 g, powder for solution for injection/infusion
Ceftriaxon AptaPharma, 2 g, powder for solution for injection/infusion
Ceftriaxone (as ceftriaxone sodium)
Preparation of solution for injection and infusion
Concentration for intravenous injection: 100 mg/ml
Concentration for intravenous infusion: 50 mg/ml

From a microbiological standpoint, unless the method of opening, reconstitution, or dilution excludes the risk of microbiological contamination, the prepared solution should be used immediately.
If the product is not used immediately, the user is responsible for the storage duration and conditions.

Ceftriaxon AptaPharma must not be mixed in the same syringe with any other medicinal product except 1% (10 mg/ml) lidocaine hydrochloride solution (for intramuscular injection only).
The infusion line should be flushed after each administration.

Ceftriaxon AptaPharma, 1 g, powder for solution for injection/infusion
For intravenous injection, dissolve 1 g of Ceftriaxon AptaPharma in 10 ml of water for injections. Administer over a period longer than 5 minutes, directly into the vein or via an intravenous infusion set.
For intramuscular injection, dissolve 1 g of Ceftriaxon AptaPharma 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 administered at more than one injection site.
For short intravenous infusion, dissolve 1 g of Ceftriaxon AptaPharma in 20 ml of water for injections; 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
For intravenous infusion, dissolve 2 g of Ceftriaxon AptaPharma in 40 ml of water for injections; 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 lasting at least 30 minutes.
In newborns, intravenous doses should be administered over a period longer than 60 minutes to reduce the risk of bilirubin encephalopathy.

For single use only.
A color change from pale yellow to yellow does not affect the efficacy of the product.
Only clear, particle-free solutions should be used.
Any unused product or waste material should be disposed of in accordance with local regulations.