CEFTRIAXONE KALCEKS 1 g POWDER FOR SOLUTION FOR INJECTION AND INFUSION

2. What you need to know before you are given Ceftriaxone Kalceks

You should not be given Ceftriaxone Kalceks if:

• you are allergic to ceftriaxone or any of the other ingredients of this medication (listed in section 6);
• you have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, monobactams, or carbapenems). Signs include sudden swelling of the throat or face that can make it difficult to breathe or swallow, sudden swelling of the hands, feet, and ankles, chest pain, and severe rash that appears suddenly.
• you are allergic to lidocaine and are going to be given Ceftriaxone Kalceks as an intramuscular injection.

Ceftriaxone Kalceks should not be given to babies if:

• they are premature;
• they are newborns (up to 28 days of age) and have certain blood problems or jaundice (yellow skin or eyes) or are going to be given a product containing calcium intravenously.

Warnings and precautions

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

• you have recently received or are going to receive products containing calcium;
• you have had problems with lidocaine;
• you have recently had diarrhea after using an antibiotic;
• you have had intestinal disorders, particularly colitis (inflammation of the large intestine);
• you have liver or kidney problems (see section 4);
• you have gallstones or kidney stones;
• you have other diseases, such as hemolytic anemia (a decrease in red blood cells that can cause pale skin and weakness or difficulty breathing);
• you are on a low-sodium diet;
• you experience or have experienced a combination of any of the following symptoms: rash, skin redness, blisters on the lips, eyes, and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia) and swelling of the lymph nodes (signs of severe skin reactions, see also section 4 "Possible side effects").

If you need a blood or urine test

If you are given Ceftriaxone Kalceks for a long time, you may need to have regular blood tests. Ceftriaxone Kalceks can affect the results of urine glucose tests and a blood test called the Coombs test.

If you are going to have these tests, inform the person taking the blood sample that you are being given Ceftriaxone Kalceks.

If you are diabetic or need to monitor your blood sugar levels, you should not use some glucose testing systems, as they may give incorrect results while you are being given ceftriaxone. If you use these systems, check the instructions and ask your doctor, pharmacist, or nurse. If necessary, alternative testing methods will be used.

Children

Consult your doctor, pharmacist, or nurse before Ceftriaxone Kalceks is given to your child if they have recently been given a product containing calcium intravenously.

Other medicines and Ceftriaxone Kalceks

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Especially tell your doctor or pharmacist if you are taking any of the following medicines:

• a group of antibiotics known as aminoglycosides;
• an antibiotic called chloramphenicol (used especially to treat eye infections);
• medicines used to prevent blood clots.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Your doctor will assess the benefits of treating you with Ceftriaxone Kalceks against the 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. Talk to your doctor if you experience these symptoms.

Ceftriaxone Kalceks contains sodium

Ceftriaxone Kalceks 1 g powder for solution for injection and infusion

This medicine contains 83 mg of sodium (a major component of cooking/table salt) in each vial. This is equivalent to 4.15% of the maximum recommended daily sodium intake for an adult.

Ceftriaxone Kalceks 2 g powder for solution for injection and infusion

This medicine contains 166 mg of sodium (a major component of cooking/table salt) in each vial. This is equivalent to 8.3% of the maximum recommended daily sodium intake for an adult.

3. How Ceftriaxone Kalceks is used

Ceftriaxone Kalceks is usually given by a doctor or nurse. The doctor, pharmacist, or nurse will reconstitute Ceftriaxone Kalceks and will not mix or administer it simultaneously with injections containing calcium.

Ceftriaxone Kalceks 1 g powder for solution for injection and infusion can be administered as a drip (intravenous infusion) or as an injection directly into a vein or muscle.

Ceftriaxone Kalceks 2 g powder for solution for injection and infusion can be administered as a drip (intravenous infusion) or as an injection into a muscle.

Recommended dose

Your doctor will decide the correct dose of Ceftriaxone Kalceks for you. The dose will depend on the severity and type of infection; whether you are being given other antibiotics; your weight and age; and whether your kidneys and liver are working properly. The number of days or weeks you are given Ceftriaxone Kalceks will depend on the type of infection you have.

Adults, elderly people, and children from 12 years with a body weight of 50 kg or more:

• 1 to 2 g, once a day, depending on the severity and type of infection. If you have a severe infection, your doctor may increase the dose (up to 4 g, once a day). If the daily dose is more than 2 g, it may be given as a single dose per day or divided into two separate doses.

Newborns, infants, and children from 15 days to 12 years with a body weight less than 50 kg:

• 50 to 80 mg of Ceftriaxone Kalceks per kg of the child's body weight, once a day, depending on the severity and type of infection. If you have a severe infection, your doctor may increase the dose to 100 mg per kg of body weight, up to a maximum of 4 g, once a day. If the daily dose is more than 2 g, it may be given as a single dose per day or divided into two separate doses.
• Children who weigh 50 kg or more should receive the usual adult dose.

Newborns (0 to 14 days)

• 20 to 50 mg of Ceftriaxone Kalceks per kg of the child's body weight, once a day, depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg per kg of the baby's weight.

People with liver and kidney problems

You may be given a different dose than usual. Your doctor will decide how much Ceftriaxone Kalceks you need and will closely monitor you depending on the severity of the liver and kidney disease.

If you are given more Ceftriaxone Kalceks than you should

If you accidentally receive a higher dose than prescribed, go to your doctor or the nearest hospital immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you miss a dose of Ceftriaxone Kalceks

If you miss an injection, you should receive it as soon as possible. However, if it is close to the time of your next injection, skip the missed dose. Do not give a double dose (two injections at the same time) to make up for the missed dose.

If you stop using Ceftriaxone Kalceks

Do not stop using Ceftriaxone Kalceks unless your doctor tells you to. If you have any further questions on 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.

This medicine can cause the following side effects:

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

If you have a severe allergic reaction, tell a doctor immediately.

Signs may include:

• sudden swelling of the face, throat, lips, or mouth, which 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 can be a symptom of an allergy-induced heart attack (Kounis syndrome).

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

If you have a severe skin rash, tell a doctor immediately.

Signs may include:

• a severe rash that develops quickly, with blisters or peeling of the skin and possibly blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).

• a combination of any of the following symptoms: widespread rash, high body temperature, elevated liver enzyme values, blood abnormalities (eosinophilia), swelling of the 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 causes fever, chills, headache, muscle pain, and rash, usually self-limiting. This occurs shortly after starting treatment with ceftriaxone for infections with spirochetes such as Lyme disease.
  • Acute Generalized Exanthematous Pustulosis (AGEP) appears as a widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. The most common location is mainly in skin folds, trunk, and upper limbs.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• abnormalities in white blood cells (decrease in leukocytes and increase in eosinophils) and platelets (decrease in thrombocytes).
• soft stools or diarrhea.
• alteration of blood test results related to liver activity.
• skin rash.

Uncommon (may affect up to 1 in 100 people)

• fungal infections (e.g., candidiasis).
• decrease in the number of white blood cells (granulocytopenia).
• decrease in the number of red blood cells (anemia).
• blood clotting problems. Signs may include easy bruising and pain and swelling of the joints.
• headache.
• dizziness.
• nausea or vomiting.
• itching (pruritus).
• pain or burning sensation in the vein where Ceftriaxone Kalceks was administered. Pain at the injection site.
• high temperature (fever).
• alteration of kidney-related test results (increase in blood creatinine).

Rare (may affect up to 1 in 1,000 people)

• inflammation of the large intestine (colon). Signs include diarrhea, usually with blood or mucus, stomach pain, and fever.
• treatment with ceftriaxone, particularly in elderly patients with severe kidney problems or nervous system problems, can rarely cause decreased consciousness, abnormal movements, agitation, and convulsions.
• difficulty breathing (bronchospasm).
• lumpy skin rash (hives) that can cover a large area of the body, with itching and swelling.
• blood or sugar in the urine.
• swelling (edema).
• chills.

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

• secondary infection that does not respond to the previously prescribed antibiotic.
• a form of anemia in which red blood cells are destroyed (hemolytic anemia).
• sharp decrease in white blood cells (agranulocytosis).
• seizures.
• vertigo (feeling that everything is spinning).
• inflammation of the pancreas (pancreatitis). Signs include severe stomach pain that spreads to the back.
• inflammation of the mucous membrane that lines the mouth (stomatitis).
• inflammation of the tongue (glossitis). Signs include swelling, redness, and pain in the tongue.
• problems with the gallbladder or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, dark urine, and clay-colored stools.
• neurological disorder that can occur in newborns with severe jaundice (kernicterus).
• skin inflammation and redness (erythema multiforme).
• kidney problems caused by the precipitation of ceftriaxone calcium. You may experience pain when urinating or urinate a small amount.
• false positive result in the Coombs test (test to determine certain blood disorders).
• false positive result in the galactosemia test (abnormal accumulation of the sugar galactose).
• Ceftriaxone Kalceks may interfere with some types of blood glucose tests. Consult your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftriaxone Kalceks

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage temperature.

Store the vials in the outer packaging to protect them from light.

After reconstitution with lidocaine hydrochloride 10 mg/ml (1%) solution for intramuscular injection

The chemical and physical stability in use has been demonstrated for 6 hours at 25 °C.

From a microbiological point of view, unless the method of reconstitution prevents the risk of microbial contamination, the medicine should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.

After reconstitution for intravenous injection

The chemical and physical stability in use has been demonstrated for 48 hours between 2 and 8 °C and 12 hours at 25 °C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at a temperature of 2 to 8 °C, unless the reconstitution has been carried out under controlled and validated aseptic conditions.

After reconstitution for intravenous infusion

The reconstituted solution should be diluted immediately after reconstitution.

After dilution for intravenous infusion

The chemical and physical stability in use has been demonstrated for 48 hours between 2 and 8 °C and 12 hours at 25 °C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at a temperature of 2 to 8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions.

Do not use this medicine after the expiry date which is stated on the label of the vial and on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ceftriaxone Kalceks

• The active substance is ceftriaxone.

Ceftriaxone Kalceks 1 g powder for solution for injection and infusion

Each vial contains 1 g of ceftriaxone (as ceftriaxone sodium).

Ceftriaxone Kalceks 2 g powder for solution for injection and infusion

Each vial contains 2 g of ceftriaxone (as ceftriaxone sodium).

Appearance of Ceftriaxone Kalceks and Package Contents

Almost white or yellowish powder.

Ceftriaxone Kalceks 1 g powder for solution for injection and infusion

It is presented in a colorless glass vial closed with a gray bromobutyl rubber stopper covered with an aluminum cap and a dark blue plastic cap of the flip-off type.

Ceftriaxone Kalceks 2 g powder for solution for injection and infusion

It is presented in a colorless glass vial closed with a gray bromobutyl rubber stopper covered with an aluminum cap and an orange plastic cap of the flip-off type.

The vials are packaged in cardboard boxes.

Presentation: individual package of 1 vial or clinical package of 10 vials.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS KALCEKS

Krustpils iela 71E,

Riga, LV-1057,

Latvia

Tel.: +371 67083320

E-mail: [email protected]

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder

Grindeks Kalceks España, S.L.

c/ José Abascal, 58 2º dcha

28003 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area 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/infuziju šķiduma 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

Date of last revision of this leaflet: May 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

Consult the Summary of Product Characteristics or Package Leaflet for more information on prescribing information.

Method of administration

Ceftriaxone Kalceks 1 g powder for solution for injection and infusion can be administered as an intramuscular injection, slow intravenous injection, and intravenous infusion.

Ceftriaxone Kalceks 2 g powder for solution for injection and infusion can be administered as an intramuscular injection and intravenous infusion.

Incompatibilities

Based on bibliographic publications, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, and aminoglycosides.

This medicine should not be mixed with other medicines, except for those mentioned below.

In particular, diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) should not be used to reconstitute ceftriaxone powder in vials or for subsequent dilution of the reconstituted contents for intravenous administration, as a precipitate may form. Ceftriaxone should not be mixed or administered simultaneously with solutions containing calcium, including total parenteral nutrition solutions.

If treatment consists of a combination of another antibiotic and ceftriaxone, do not administer in the same syringe or infusion solution.

For single use only.

See the storage conditions for reconstituted and diluted solutions in section 5.

Compatibility has been demonstrated with the following solutions:

• water for injections;
• lidocaine hydrochloride 10 mg/ml (1%) solution (only for intramuscular use);
• 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%) solution with glucose 25 mg/ml (2.5%).

Intramuscular injection

For intramuscular injection, 1 g of ceftriaxone is dissolved in 3.5 ml of a 1% lidocaine hydrochloride solution, or 2 g of ceftriaxone is dissolved in 7 ml of a 1% lidocaine hydrochloride solution.

The solution should be administered as a deep intramuscular injection. Doses greater than 1 g should be divided and injected at more than one injection site. For doses greater than 2 g, intravenous administration should be used. Intramuscular administration should be considered when the intravenous route is not possible or is less suitable for the patient.

Ceftriaxone Kalceks should not be mixed with other medicines in the same syringe, except for the 1% lidocaine hydrochloride solution (only for intramuscular injection).

Since lidocaine is used as a solvent, the resulting solution should never be administered intravenously.

Intravenous injection

For intravenous injection, 1 g of ceftriaxone is dissolved in 10 ml of water for injections. The injection should be administered directly into a vein or through an infusion catheter 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 or 2 g of ceftriaxone is dissolved, and if necessary, further diluted with one of the compatible calcium-free solutions mentioned above (except lidocaine hydrochloride solution, as lidocaine solutions should never be administered intravenously).

The concentration of ceftriaxone in the final solution for intravenous infusion is 48 mg/ml:

*First, the powder is reconstituted in 20 ml of compatible diluent. The reconstituted solution is further diluted with 20 ml of compatible diluent to achieve a concentration of 48 mg/ml using the appropriate administration device (e.g., infusion pump, infusion bag).

It is recommended to flush the intravenous infusion line after each administration with a 9 mg/ml (0.9%) sodium chloride injection solution to ensure administration of the full dose.

The infusion should be administered over at least 30 minutes.

In neonates, intravenous doses should be administered over approximately 60 minutes to reduce the risk of bilirubin encephalopathy.

The solution has a coloration ranging from slightly yellowish to yellow-brown after reconstitution/dilution, depending on the storage time, concentration, and diluent used, but this does not affect the efficacy of the medicine.

Reconstituted and diluted solutions should be inspected visually before use. They should only be used if the solutions are clear and free of particles. The reconstituted product is for single use, and any unused solution should be discarded.

This medicine may pose a risk to the environment.

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.