CEFTRIAXONE 1 G Proszek do sporządzania roztworu do wstrzykiwań/infuzji

Treść ulotki

1. Ceftriaxone Kalceks 1 g powder for injectable solution/for infusion
   1. What is Ceftriaxone Kalceks and what is it 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

Ceftriaxone Kalceks 1 g powder for injectable solution/for infusion

ceftriaxone

Equivalent medicine

Read 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, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. 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 given
• 4. Possible side effects
• 5. How to store Ceftriaxone Kalceks
• 6. Contents of the pack and other information

1. What is Ceftriaxone Kalceks and what is it 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 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.

This medicine 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 Ceftriaxone Kalceks

You must not be given Ceftriaxone Kalceks 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, monobactams or 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, and a severe skin rash that
  develops rapidly.

sudden swelling of the throat or face, which can make it difficult to breathe or swallow, a
sudden swelling of hands, feet and ankles, and a severe skin rash that
develops rapidly.

• you are allergic to lidocaine and Ceftriaxone Kalceks must be given to you by injection into a muscle.

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 life) and has some blood problems or jaundice (yellowing of the skin or the white of the eye) or must receive a product containing calcium through a vein.

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 problems with diarrhoea after taking an antibiotic. You have had problems with your intestines, in particular colitis (inflammation of the intestine);
• you have problems with your liver or kidneys (see section 4);
• you have gallstones or kidney stones;
• you have other illnesses, for example hemolytic anemia (a reduction in red blood cells that can make the skin pale yellow and cause weakness or shortness of breath);
• you are on a low-sodium diet;
• you experience or have experienced in the past any combination of the following symptoms: skin rash, skin redness, blisters 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 Ceftriaxone Kalceks for a prolonged period, you may need to have
regular blood tests. Ceftriaxone Kalceks can affect the results of urine tests for sugar and a blood test known as the Coombs test.
If you are about to have this type of tests, tell the person taking your sample that you
have been given Ceftriaxone Kalceks.
If you are diabetic or need monitoring of blood glucose levels, you should not use some
blood glucose monitoring systems that may detect blood glucose incorrectly during treatment with ceftriaxone. If you use such systems, check the instructions for
use and inform your doctor, pharmacist or nurse. If necessary, alternative analytical methods must be used.

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

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, 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);
• medicines to prevent blood clots

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor for advice before receiving this medicine.
The 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 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.

Ceftriaxone Kalceks contains sodium
This medicine contains 83 mg of sodium (the main component of table salt) per vial.
This is equivalent to 4.15% of the recommended maximum daily intake of salt with the diet of 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 will not be mixed, nor will it be
administered simultaneously with injections containing calcium.
Ceftriaxone Kalceks 1 g powder for injectable solution/for infusion can be administered
via intravenous infusion or via an injection directly into a muscle.

Usual dose
The 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 weight and
age, the degree of function of your kidneys and liver. The number of days or weeks
during which you receive Ceftriaxone Kalceks will depend on the type of infection you have.

Adults, elderly and children aged 12 years or over 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 serious infection, the doctor will administer a higher dose (up to 4 g per day). If your daily dose is greater 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 less than 50 kg:

• 50-80 mg Ceftriaxone Kalceks once a day for each kg of the child's body weight depending on the severity and type of infection. If you have a serious infection, the doctor will prescribe a higher dose starting from 100 mg for each kg of body weight up to a maximum of 4 g per day. If your daily dose is greater 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 Ceftriaxone Kalceks 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 for 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
Ceftriaxone Kalceks you need and will monitor you carefully, depending on the severity
of the liver and kidney disease.

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

If you forget to take Ceftriaxone Kalceks
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 Ceftriaxone Kalceks
Do not stop taking Ceftriaxone Kalceks unless your doctor tells you to. If you have
any doubts about using 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.
You may experience the following side effects with this medicine:

Serious allergic reactions (frequency not known, cannot be estimated from available data)
If you have a severe allergic reaction, tell your doctor immediately.
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.

Serious skin reactions (frequency not known, cannot be estimated from available data)
If you develop a serious skin reaction, tell your doctor immediately.
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 temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs in the body (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 Ceftriaxone Kalceks to treat infections caused by spirochetes such as Lyme disease;
• acute generalized exanthematous pustulosis (AGEP) presents as a widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The most common location is the skin folds, trunk and upper extremities.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Abnormalities of white blood cells (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 Ceftriaxone Kalceks was administered. Pain where the injection was given.
• 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.
• Treatment with ceftriaxone, especially in elderly patients with severe kidney failure or nervous system disorders, can occasionally cause a decrease in consciousness, abnormal movements, agitation and convulsions.
• Difficulty breathing (bronchospasm).
• Skin rash with hives that can cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid retention).
• Chills.

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 destruction 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, which can cause pain, nausea, 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).
• Inflammation and redness of the skin (erythema multiforme).
• Kidney problems caused by calcium-ceftriaxone deposits. Pain when urinating may occur, or the amount of urine produced may be reduced.
• A false positive Coombs test (a test to detect blood problems).
• A false positive for galactosemia (an abnormal accumulation of galactose sugar).
• Ceftriaxone Kalceks 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, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through 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 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 package and on the label of the
vial, after “Scad.” or “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular 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 stability in use has been demonstrated for 6 hours at 25 °C.
From a microbiological point of view, unless the reconstitution method excludes the risk of
microbial contamination, the product must be used immediately. If not used
immediately, the in-use storage times and conditions are the responsibility of
the user.
After reconstitution for intravenous injection
Chemical and physical stability in use has been demonstrated for 48 hours at a temperature of 2-8 °C and for
12 hours at 25 °C.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the in-use storage times and conditions of storage before use
are the responsibility of the user and should not normally exceed 24 hours at 2-8 °C, unless the
reconstitution has been carried out in 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 stability in use has been demonstrated for 48 hours at a temperature of 2-8 °C and for
12 hours at 25 °C.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the in-use storage times and conditions of storage before use
are the responsibility of the user and should not normally exceed 24 hours at 2-8 °C, unless the
dilution has been carried out in controlled and validated aseptic conditions.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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
Powder of almost white or yellowish colour.
The powder is contained in a colourless glass vial, sealed with a grey bromobutyl rubber stopper
covered by an aluminium cap and a dark blue plastic snap-on cap.
The vials are packaged in a cardboard box.
Pack sizes: 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holderand Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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
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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 solution for injection/for infusion can be used for
intramuscular injection, slow intravenous injection and intravenous infusion.
Incompatibilities
Based on reports in the literature, ceftriaxone is incompatible with amsacrine,
vancomycin, fluconazole and aminoglycosides.
This medicinal product must not be mixed with other medicinal products except for those mentioned below.
In particular, diluents containing calcium (such as Ringer’s solution, Hartmann’s solution) must not
be used to reconstitute the ceftriaxone vials or to further dilute a reconstituted vial for intravenous
administration as a precipitate may form.
Ceftriaxone must not be mixed or administered concurrently with solutions containing
calcium, including total parenteral nutrition.
If combination therapy with another antibiotic is planned, administration should not be 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 higher than 1 g must be
divided and injected into more than one site. For doses higher than 2 g the intravenous route of
administration must be used. Intramuscular injections should be made when the intravenous route is not
feasible or is less appropriate for the patient.
Ceftriaxone Kalceks must not be mixed with other medicinal products in the same syringe, except
for 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 calcium-free compatible solutions listed above (except for 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 %) solution for injection to ensure delivery of the full dose.
The infusion must be administered over at least 30 minutes.
In neonates, intravenous doses must be administered over 60 minutes to minimise the risk of
bilirubin encephalopathy.

The colour of the solution after reconstitution/dilution is from slightly yellowish to yellow-brown,
depending on the storage time, concentration and solvent used, but this does not affect the efficacy of
the medicinal product.
Reconstituted/diluted solutions must be inspected visually before use. Only clear and particle-free
solutions must be used. The reconstituted product is for single use and unused solution must be
discarded.
This medicinal product may pose a risk to the environment.
Unused medicinal product and waste materials derived from such medicinal product should be disposed of
in accordance with local regulations.