Ceftriaxon-mip i.v./i.m 1 g

Leaflet attached to the packaging: patient information

Ceftriaxon-MIP i.v./i.m. 1 g, powder for solution for injection/infusion

Ceftriaxon-MIP i.v. 2 g, powder for solution for infusion

Ceftriaxone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• 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-MIP and what is it used for
• 2. Important information before using Ceftriaxon-MIP
• 3. How to use Ceftriaxon-MIP
• 4. Possible side effects
• 5. How to store Ceftriaxon-MIP
• 6. Contents of the packaging and other information

1. What is Ceftriaxon-MIP and what is it used for

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

Ceftriaxon-MIP 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,
• the bones and joints,
• the skin and soft tissues,
• the blood,
• 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-MIP

When not to use Ceftriaxon-MIP:

• 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-MIP by intramuscular injection.

Ceftriaxon-MIP must not be used in small children if:

• the child is premature,
• the child is a newborn (up to 28 days old) and has certain blood disorders or jaundice (yellowing of the skin and/or eyes) or is to receive a product containing calcium intravenously.

Warnings and precautions

Before starting treatment with Ceftriaxon-MIP, you should discuss it with your doctor, pharmacist, or nurse if:

• the patient has or has had any of the following symptoms: rash, skin redness, blisters around the mouth, eyes, or genital area, 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"),
• the patient has recently received or is about to receive a product containing calcium,
• the patient has recently had diarrhea after antibiotic treatment,
• the patient has had intestinal problems, especially colitis (inflammation of the colon),
• 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 pallor and weakness or shortness of breath),
• the patient is on a low-sodium diet.

In case of blood or urine tests

If the patient is receiving Ceftriaxon-MIP for a long time, regular blood tests may be necessary. Ceftriaxon-MIP may affect the results of urine sugar tests and a blood test called the Coombs test. If the patient is having tests:

• the person taking the sample should be informed that the patient is receiving Ceftriaxon-MIP.

Children

Before giving Ceftriaxon-MIP to a child, you should discuss it with a doctor, pharmacist, or nurse if:

• the child has recently received or is to receive a product containing calcium intravenously.

Ceftriaxon-MIP and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or 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 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 treatment with Ceftriaxon-MIP for the mother and the risks for the baby.

Driving and using machines

Ceftriaxon-MIP may cause dizziness. If the patient feels dizzy, they should not drive or use any tools or machines. The patient should inform their doctor if they experience such symptoms.

Ceftriaxon-MIP contains sodium

Ceftriaxon-MIP i.v./i.m. 1 g:

The medicine contains 83 mg (3.6 mmol) of sodium (the main component of common salt) per 1 g. This corresponds to 4.15% of the maximum recommended daily intake of sodium in the diet for adults.

Ceftriaxon-MIP i.v. 2 g:

The medicine contains 166 mg (7.2 mmol) of sodium (the main component of common salt) per 2 g. This corresponds to 8.3% of the maximum recommended daily intake of sodium in the diet for adults.

This should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.

Preparation of the medicine for administration - see the section "Information intended exclusively for healthcare professionals" at the end of the leaflet. When calculating the total sodium content in the prepared dilution of the medicine, the sodium from the diluent should be taken into account. For accurate information on the sodium content in the solution used to dilute the medicine, the patient information leaflet of the diluent should be consulted.

3. How to use Ceftriaxon-MIP

Ceftriaxon-MIP is usually administered by a doctor or nurse. It can be given as an intravenous infusion (drip) or as an injection directly into a vein or into a muscle. Ceftriaxon-MIP is prepared by a doctor, pharmacist, or nurse and will not be mixed or administered at the same time as solutions containing calcium.

Usual dose

The doctor will decide what dose of Ceftriaxon-MIP 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-MIP depends on the type of infection.

Adults, elderly, and children over 12 years old and weighing at least 50 kg

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

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

• 50 to 80 mg of Ceftriaxon-MIP per kg of body weight once a day, depending on the severity and type of infection. In cases of severe infection, the doctor will use a higher dose, up 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, the medicine can be administered in one dose or in two separate doses.
• Children weighing 50 kg or more should receive the usual adult dose.

Newborns up to 14 days old

• 20 to 50 mg of Ceftriaxon-MIP per kg of 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 body weight.

Patients with liver or kidney problems

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

Overdose of Ceftriaxon-MIP

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

Missed dose of Ceftriaxon-MIP

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

Stopping treatment with Ceftriaxon-MIP

The patient should not stop treatment with Ceftriaxon-MIP unless their doctor tells them to. If the patient has any further doubts about the use of this medicine, they should consult their doctor or nurse.

4. Possible side effects

Like all medicines, Ceftriaxon-MIP 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 the available data)

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

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 - frequency cannot be estimated from the available data)

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

Symptoms may include:

• 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);
• 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 drug 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 Ceftriaxon-MIP for infections caused by spirochetes, such as Lyme disease.

Other possible side effects

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1000 people)

• inflammation of the colon (colitis); symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever,
• ceftriaxone treatment - especially in elderly patients with severe kidney or nervous system disorders - may rarely cause decreased consciousness, abnormal movements, agitation, and seizures,
• breathing difficulties (bronchospasm),
• bulging rash (hives), which may cover 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 the 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,
• severe dizziness (vertigo),
• 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,
• problems related to the gallbladder and/or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, extremely 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 ceftriaxone salt; 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 galactosemia test result (a test that detects abnormal accumulation of galactose in the body),
• Ceftriaxon-MIP 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, pharmacist, 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-MIP

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

Store at a temperature not exceeding 30°C.

The prepared solution can be stored for 24 hours in the refrigerator (2°C-8°C).

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-MIP contains

• The active substance is ceftriaxone. Ceftriaxon-MIP i.v./i.m. 1 g: 1 vial contains 1 g of ceftriaxone in the form of ceftriaxone sodium (1.193 g). Ceftriaxon-MIP i.v. 2 g: 1 vial contains 2 g of ceftriaxone in the form of ceftriaxone sodium (2.386 g).
• The medicine does not contain any other ingredients.

What Ceftriaxon-MIP looks like and contents of the pack

The vials contain a white to yellowish powder.

Vials made of glass with a bromobutyl rubber stopper and an aluminum flip-off cap in a cardboard box.

1 vial

5 vials

10 vials

25 vials

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

MIP Pharma Polska Sp. z o.o.

ul. Orzechowa 5

80-175 Gdańsk

Tel.: 58 303 93 62

Fax: 58 322 16 13

Email: info@mip-pharma.pl

Manufacturer

Chephasaar, Chemisch-pharmazeutische Fabrik GmbH

Mühlstrasse 50

D-66386 St. Ingbert

Germany

Date of last revision of the leaflet:

• 02.04.2024

Information intended exclusively for healthcare professionals:

Ceftriaxon-MIP can be administered by intravenous infusion lasting at least 30 minutes (recommended administration method) or by slow intravenous injection lasting 5 minutes or by deep intramuscular injection. Intravenous injection in a manner interrupted over a longer period than 5 minutes should be performed preferably in large veins. In infants and children under 12 years old, intravenous doses of 50 mg/kg or more should be administered by infusion. In newborns, intravenous doses should be administered over a period longer than 60 minutes to reduce the risk of bilirubin encephalopathy.

Intramuscular injections should be administered to an appropriate depth within a relatively large muscle; do not administer more than 1 g per injection site. Intramuscular administration should be considered when intravenous administration is not possible or is less appropriate for the patient. Doses greater than 2 g should be administered intravenously.

Intravenous administration of solutions using lidocaine as a solvent should never be performed. The information provided in the Summary of Product Characteristics for lidocaine should be taken into account.

Ceftriaxone is contraindicated in newborns (up to 28 days old) who require (or are expected to require) intravenous treatment with calcium-containing solutions, including continuous infusions containing calcium, such as parenteral nutrition solutions, due to the risk of precipitation of calcium ceftriaxone salt.

Due to the risk of precipitation, calcium-containing diluents (e.g., Ringer's solution or Hartmann's solution) should not be used to dissolve ceftriaxone in vials or to further dilute the prepared solution for intravenous administration. Ceftriaxone calcium salt may also precipitate when ceftriaxone is mixed with a calcium-containing solution in the same intravenous administration set. Therefore, ceftriaxone should not be mixed or administered simultaneously with calcium-containing solutions.

For preoperative prophylaxis of surgical site infections, ceftriaxone should be administered 30-90 minutes before the surgical procedure.

Method of preparation of the solution for intravenous infusion

Ceftriaxon-MIP i.v./i.m. 1 g or Ceftriaxon-MIP i.v. 2 g can be administered by intravenous infusion lasting at least 30 minutes. The contents of 1 vial of Ceftriaxon-MIP i.v./i.m. 1 g or Ceftriaxon-MIP i.v. 2 g should be dissolved in 40 ml of one of the following intravenous infusion solutions, which do not contain calcium:

• water for injection
• 0.9% sodium chloride solution
• 0.45% sodium chloride solution + 2.5% glucose solution
• 5% glucose solution
• 10% glucose solution
• 6% dextran solution in 5% glucose solution
• infusion solutions containing hydroxyethyl starch (6-10%)

Method of preparation of the solution for intravenous injection

The contents of 1 vial of Ceftriaxon-MIP i.v./i.m. 1 g should be dissolved in 10 ml of water for injection and injected directly into a vein.

Method of preparation of the solution for intramuscular injection

The dry substance of 1 g should be dissolved in 3.5 ml of injection solution - 1% 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.

The solutions have a yellowish color. This characteristic of the active substance does not affect the efficacy and tolerability of the medicinal product.

The prepared solution in the vial is intended for single use. It is recommended to use the solution immediately after preparation.