Ceftriaxone Kalceks

Package leaflet: Information for the user

Ceftriaxone Kalceks 1 g powder for solution for injection/infusion

ceftriaxone
Generic medicine
Read all of this leaflet carefully before you are given this medicine 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.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Ceftriaxone Kalceks is and what it is used for

Ceftriaxone Kalceks 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.
Ceftriaxone Kalceks is used to treat the following 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.

This medicine 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 a 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 need to know before you are given Ceftriaxone Kalceks

Do not be given Ceftriaxone Kalceks 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, monobactams or 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, or a severe rash that develops rapidly.

• you are allergic to lidocaine and Ceftriaxone Kalceks is to be administered by intramuscular injection.

Ceftriaxone Kalceks 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 calcium-containing product intravenously.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Ceftriaxone Kalceks if:

• you have recently received or are about to receive products containing calcium;
• you have recently had diarrhoea after taking an antibiotic; you have 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 are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering of the lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes 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”).

If you are due to have a blood or urine test
If you are given Ceftriaxone Kalceks for a prolonged period, you may need to have regular blood tests. Ceftriaxone Kalceks may affect the results of urine sugar tests and a blood test known as the Coombs test.
If you are due to have these types of tests, inform the person taking your sample that you have been given Ceftriaxone Kalceks.
If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems that may give inaccurate glucose readings during treatment with ceftriaxone. If such systems are used, check the instructions for use and inform your doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

Children
Talk to your doctor, pharmacist or nurse before Ceftriaxone Kalceks is given to a child if the child has recently received or is about to receive intravenously a product containing calcium.

Other medicines and Ceftriaxone Kalceks
Tell 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 to treat infections, particularly eye infections);
• medicines used to prevent blood clots.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, ask your doctor for advice before receiving this medicine.
Your doctor will assess the benefits of treatment with Ceftriaxone Kalceks for you and the possible risks to the baby.

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

Ceftriaxone Kalceks contains sodium
This medicine contains 83 mg of sodium (a component of common table salt) per vial.
This is equivalent to 4.15% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Ceftriaxone Kalceks is administered

Ceftriaxone Kalceks is generally administered by a doctor or a nurse. Ceftriaxone Kalceks will be prepared by a doctor, pharmacist, or nurse and must not be mixed or co-administered with calcium-containing injections.
Ceftriaxone Kalceks 1 g powder for injectable solution/infusion can be administered via intravenous infusion or by direct intramuscular injection.

Usual dose
Your doctor will determine the correct dose of Ceftriaxone Kalceks 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 kidney and liver function. The number of days or weeks during which you will receive Ceftriaxone Kalceks 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 either as a single daily dose or as 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 Ceftriaxone Kalceks once daily per kg of the child's body weight, depending on the severity and type of infection. If the child has a severe infection, the 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 the daily dose exceeds 2 g, it may be given 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.

Neonates (0–14 days of life):

• 20–50 mg of Ceftriaxone Kalceks 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 Ceftriaxone Kalceks you need and will closely monitor you, depending on the severity of your liver or kidney disease.

If you are given more Ceftriaxone Kalceks than you should
If you are accidentally given more ceftriaxone than prescribed, contact your doctor or the nearest hospital immediately.

If you miss a dose of Ceftriaxone Kalceks
If you miss an injection, it should be administered as soon as possible. However, if it is almost time for the next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for a forgotten dose.

If you stop treatment with Ceftriaxone Kalceks
Do not stop taking Ceftriaxone Kalceks 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 will experience them.
With this medicine, you may experience the following side effects:

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have a severe allergic reaction, contact a doctor 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 occurring in the context of allergic reactions, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, contact a doctor immediately.
Signs may include:

• severe rash developing 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, blood test abnormalities (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 Ceftriaxone Kalceks for spirochete infections such as Lyme disease;
• acute generalized exanthematous pustulosis (AGEP), which presents as a widespread, red, scaly rash with bumps under the skin and pustules, accompanied by fever. The most common sites are skin folds, trunk and upper limbs.

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 related to liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g., candidiasis).
• 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 Ceftriaxone Kalceks 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.
• Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation and seizures.
• Breathing difficulties (bronchospasm).
• Rash with wheals (urticaria), which may cover a large area 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 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.
• Problems with the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and clay-coloured stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Inflammation and redness of the skin (erythema multiforme).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
• False positive Coombs test result (a test to detect blood problems).
• False positive test result for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone Kalceks may interfere with certain types of tests to measure blood glucose; please consult your doctor.

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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Ceftriaxone Kalceks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and on the label of the
vial, after "Exp." or "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Keep the vials in the outer packaging to protect the medicine from light.

After reconstitution with lidocaine hydrochloride 10 mg/ml (1%) solution for intramuscular injection
Chemical and physical in-use stability has been demonstrated for 6 hours at 25 °C.
From a microbiological standpoint, unless the reconstitution method excludes the risk of
microbiological contamination, the product should be used immediately. If not used
immediately, the duration and conditions of in-use storage are the responsibility of the user.

After reconstitution for intravenous injection
Chemical and physical in-use stability has been demonstrated for 48 hours at 2–8 °C and for
12 hours at 25 °C.
From a microbiological standpoint, the product should be used immediately. If not used
immediately, the duration of in-use storage and storage conditions prior to use are the responsibility of the user and, under normal circumstances, should not exceed 24 hours at 2–8 °C, unless reconstitution was carried out under controlled and validated aseptic conditions.

After reconstitution for intravenous infusion
The reconstituted solution must be diluted immediately after reconstitution.

After dilution for intravenous infusion
Chemical and physical in-use stability has been demonstrated for 48 hours at 2–8 °C and for
12 hours at 25 °C.
From a microbiological standpoint, the product should be used immediately. If not used
immediately, the duration of in-use storage and storage conditions prior to use are the responsibility of the user and, under normal circumstances, should not exceed 24 hours at 2–8 °C, unless dilution was carried out under controlled and validated aseptic conditions.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone Kalceks contains

• The active substance is ceftriaxone.

Each vial contains 1 g of ceftriaxone (as ceftriaxone sodium).
Description of the appearance of Ceftriaxone Kalceks and contents of the pack
Almost white or slightly yellowish powder.
The powder is contained in a colourless glass vial, closed with a grey bromobutyl rubber stopper, covered by an aluminium seal and a dark blue plastic flip-off cap.
Vials are packed in a cardboard box.
Pack sizes: 1 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia
This medicinal product is authorised in the European Economic Area Member States under the
following names:
Finland Ceftriaxone Kalceks 1 g, 2 g injektio-/infuusiokuiva-aine liuosta varten
Austria, Germany Ceftriaxon Kalceks 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Ceftriaxon Kalceks 2 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Czech Republic, Italy, Poland Ceftriaxone Kalceks
Belgium Ceftriaxone Kalceks 1 g, 2 g poeder voor oplossing voor injectie/infusie
Ceftriaxone Kalceks 1 g, 2 g poudre pour solution injectable/pour perfusion
Ceftriaxone Kalceks 1 g, 2 g Pulver zur Herstellung einer
Injektions-/Infusionslösung
Croatia Ceftriakson Kalceks 1 g, 2 g prašak za otopinu za injekciju/infuziju
Denmark, Norway Ceftriaxon Kalceks
France CEFTRIAXONE KALCEKS 1 g poudre pour solution injectable/pour perfusion
CEFTRIAXONE KALCEKS 2 g poudre pour solution injectable/pour perfusion
Hungary Ceftriaxone Kalceks 1 g és 2 g por oldatos injekcióhoz vagy infúzióhoz
Ireland Ceftriaxone 1 g, 2 g powder for solution for injection/infusion
Latvia Ceftriaxone Kalceks 1 g, 2 g pulveris injekciju/infūziju šķīduma pagatavošanai
Lithuania Ceftriaxone Kalceks 1 g, 2 g milteliai injekciniam ar infuziniam tirpalui
Netherlands Ceftriaxon Kalceks 1 g, 2 g poeder voor oplossing voor injectie/infusie
Slovakia Ceftriaxone Kalceks 1 g, 2 g prášok na injekčný/infúzny roztok
Slovenia Ceftriakson Kalceks 1 g, 2 g prašek za raztopino za injiciranje/infundiranje
Spain Ceftriaxona Kalceks 1 g, 2 g polvo para solución inyectable y para perfusión

The following information is intended exclusively for physicians or healthcare professionals:
Refer to the Summary of Product Characteristics for complete prescribing information.
Route of administration
Ceftriaxone Kalceks 1 g powder for injectable solution/for infusion can be used for intramuscular injection, slow intravenous injection, and intravenous infusion.
Incompatibilities
Based on reports in the literature, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole, and aminoglycosides.
This medicinal product must not be mixed with other medicinal products except those mentioned below.
In particular, diluents containing calcium (such as Ringer's solution, Hartmann's solution) must not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration, as precipitate may form.
Ceftriaxone must not be mixed or co-administered with calcium-containing solutions, including total parenteral nutrition.
If combination therapy with another antibiotic and ceftriaxone is planned, administration must not occur through the same syringe or in the same infusion solution.
For single use only.
See section 5 for storage conditions of reconstituted and diluted solutions.
Compatibility has been demonstrated with the following solutions:

• Water for injections;
• Lidocaine hydrochloride 10 mg/ml (1%) solution (for intramuscular injection only);
• Sodium chloride 9 mg/ml (0.9%) solution;
• Glucose 50 mg/ml (5%) solution;
• Glucose 100 mg/ml (10%) solution;
• Sodium chloride 4.5 mg/ml (0.45%) and glucose 25 mg/ml (2.5%).

Intramuscular injection
For intramuscular injection, 1 g of ceftriaxone is dissolved in 3.5 ml of 1% lidocaine hydrochloride solution.
The solution must be administered by deep intramuscular injection. Doses exceeding 1 g should be divided and injected at more than one site. For doses above 2 g, intravenous administration should be used.
Intramuscular injections should be performed only when intravenous administration is not feasible or is less appropriate for the patient.
Ceftriaxone Kalceks must not be mixed with other drugs in the same syringe, except with 1% lidocaine hydrochloride solution (for intramuscular injection only).
Since the solvent used is lidocaine, the resulting solution must never be administered intravenously.
Intravenous injection
For intravenous injection, 1 g of ceftriaxone is dissolved in 10 ml of water for injections. The injection is administered directly into a vein or via an intravenous infusion line over 5 minutes.
The concentration of ceftriaxone in the final solution for intravenous injection is 93 mg/ml.
Intravenous infusion
For intravenous infusion, 1 g of ceftriaxone is dissolved and, if necessary, further diluted with one of the above-mentioned calcium-free compatible solutions (excluding lidocaine hydrochloride solution, as lidocaine solutions must never be administered intravenously).
The concentration of ceftriaxone in the final solution for intravenous infusion is 48 mg/ml:

It is recommended to flush the intravenous infusion line after each administration with sodium chloride 9 mg/ml (0.9%) injection solution to ensure complete delivery of the dose.
The infusion must be administered over at least 30 minutes.
In neonates, intravenous doses should be administered over 60 minutes to minimize the risk of bilirubin encephalopathy.
The color of the solution after reconstitution/dilution ranges from slightly yellowish to brownish yellow, depending on storage duration, concentration, and solvent used; however, this does not affect the efficacy of the medicinal product.
Reconstituted/diluted solutions must be visually inspected before use. Only clear solutions free from visible particles should be used. The reconstituted product is for single use only, and any unused solution must be discarded.
This medicinal product may pose a risk to the environment.
Unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with local regulations.