Paracetamol Baxter

Leaflet accompanying the packaging: information for the user

Paracetamol Baxter, 10 mg/mL, solution for infusion

Paracetamol

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Paracetamol Baxter and what is it used for
• 2. Important information before using Paracetamol Baxter
• 3. How to use Paracetamol Baxter
• 4. Possible side effects
• 5. How to store Paracetamol Baxter
• 6. Contents of the packaging and other information

1. What is Paracetamol Baxter and what is it used for

Paracetamol Baxter contains the active substance paracetamol and belongs to a group of pain-relieving (pain-relieving) and antipyretic (fever-reducing) medicines.

Newborns, infants, small children, and children (with a body weight of 33 kg or less)

Use a vial containing 50 mL.

Adults, adolescents, and children (with a body weight over 33 kg)

Use a vial containing 100 mL.
The medicine is used for the short-term treatment of moderate pain, especially after surgical procedures, and for the short-term treatment of fever.

2. Important information before using Paracetamol Baxter

When not to use Paracetamol Baxter:

Warnings and precautions

Before starting treatment with Paracetamol Baxter, the patient should talk to their doctor, pharmacist, or nurse if:

• the patient can take oral pain-relieving medicines instead of intravenous administration, as this is the recommended route of administration;
• the patient has liver or kidney function disorders, or if the patient abuses alcohol;
• the patient is taking other medicines containing paracetamol;
• the patient is malnourished or dehydrated;
• the patient has a glucose-6-phosphate dehydrogenase deficiency. This is a blood disease.

During treatment with Paracetamol Baxter, the patient should immediately inform their doctor if:

If the patient has severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). There have been reports of a severe disease called metabolic acidosis (a blood and fluid disorder) in patients who have taken paracetamol regularly for a long time or have taken paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea (nausea) and vomiting.

Paracetamol Baxter and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Paracetamol Baxter may affect other medicines, and other medicines may interfere with its action:

• other medicines containing paracetamol or propacetamol; therefore, do not take more than the recommended daily dose (see section 3. "How to use Paracetamol Baxter");
• probenecid: a lower dose of paracetamol may be necessary;
• salicylamide, an anti-inflammatory medicine;
• oral anticoagulants: it may be necessary to monitor the effect of the anticoagulant;

the medicine;

• medicines that activate liver enzymes: to avoid liver damage, strict control of the paracetamol dose is necessary.
• flucloxacillin (an antibiotic) due to a serious blood and fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

Paracetamol Baxter with alcohol

While taking this medicine, the patient should limit their alcohol consumption.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Pregnancy

If necessary, Paracetamol Baxter can be administered during pregnancy. The patient will be given the lowest possible dose to relieve pain or reduce fever. If pain or fever persists, the patient should contact their doctor.

Breastfeeding

Paracetamol Baxter can be administered to breastfeeding patients.

Driving and using machines

Paracetamol Baxter does not affect the ability to drive or use machines.

Paracetamol Baxter contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per vial, which means it is considered "sodium-free".

3. How to use Paracetamol Baxter

For intravenous administration.
Paracetamol will be administered by a healthcare professional as an intravenous infusion.
The doctor will adjust the dose individually for each patient. The dose depends on the patient's body weight and overall health.

Newborns, infants, small children, and children (with a body weight of 33 kg or less)

Use a vial containing 50 mL. The following table shows the dosing schedule based on body weight.

Adults, adolescents, and children (with a body weight over 33 kg)

Use a vial containing 100 mL. The following table shows the dosing schedule based on body weight.

Dosing

The recommended doses are listed in the table below.

• The minimum interval between consecutive administrations of the medicine must be at least 4 hours.
• The minimum interval between consecutive administrations of the medicine in patients with severe kidney function disorders must be at least 6 hours.
• Do not administer more than 4 doses in 24 hours.
• The medicine is administered intravenously over 15 minutes.
• Before administration, the product should be visually inspected by medical personnel. Do not use Paracetamol Baxter if there are solid particles or a change in the color of the solution in the vial. These are signs of degradation or spoilage of the medicine.

* Premature infants:there are no data on the safety and efficacy of Paracetamol Baxter in premature infants.
** Patients with a lower body weight will require smaller volumes.
*** Maximum daily dose:the maximum daily dose of paracetamol listed in the table above applies to patients who are not taking other medicines containing paracetamol. If the patient is taking such medicines, this dose should be adjusted accordingly.
Renal impairment:
In patients with renal impairment, the interval between consecutive administrations should be modified according to the following scheme:

Administration of the paracetamol solution by intravenous infusion lasting 15 minutes.

If the patient thinks that the effect of the medicine is too strong or too weak, they should talk to their doctor.

Using a higher dose of Paracetamol Baxter than recommended

Overdose is unlikely because the medicine is administered by a healthcare professional. The doctor will ensure that the patient does not receive a higher dose of the medicine than recommended.
Overdose of Paracetamol Baxter can be potentially fatal due to irreversible liver damage.There is a risk of serious liver damage, even if the patient feels well.
To avoid liver damage, it is essential to receive treatment as soon as possible.The sooner the treatment is started, the higher the likelihood of preventing liver damage..
In cases of overdose, symptoms usually appear within the first 24 hours and include: nausea, vomiting, loss of appetite, pallor, abdominal pain, and risk of liver damage. The patient should immediately inform their doctor if they have taken or given too much medicine to a child, even if the patient or child seems to be fine, because too much paracetamol can cause delayed, serious liver damage.
In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Paracetamol Baxter can cause side effects, although not everybody gets them.

Rare (may affect up to 1 in 1000 people)

The following side effects may occur:

• weakness;
• low blood pressure;
• changes in laboratory test results: increased liver enzyme activity detected during a blood test. In this case, the patient should inform their doctor, as further tests may be necessary.

Very rare (may affect up to 1 in 10,000 people)

The following side effects may occur:

• a severe skin rash or allergic reaction may occur. Treatment should be discontinued, and the doctor informed.
• other changes in laboratory test results requiring regular monitoring of blood parameters: a decrease in the number of certain types of blood cells (platelets, white blood cells), which can lead to nosebleeds or gum bleeding;
• very rare cases of severe skin reactions have been reported.

Unknown frequency (cannot be estimated from the available data)

• Reports of redness of the skin, redness of the face, itching, and abnormal rapid heartbeat.
• Reports of pain and burning sensation at the injection site.
• A serious disease that can make the blood more acidic (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform 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:
Jerozolimskie Avenue 181C,
02-222 Warsaw
phone: +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, more information can be collected on the safety of this medicine.

5. How to store Paracetamol Baxter

The medicine should be stored out of sight and reach of children.
The medicine should not be administered after the expiry date stated on the carton and vial after "EXP". The expiry date refers to the last day of the month stated.
Do not store in a refrigerator or freeze.
Any unused product or waste material should be disposed of in accordance with local requirements.

6. Contents of the packaging and other information

What Paracetamol Baxter contains

The active substance of the medicine is paracetamol.
1 mL of the solution contains 10 mg of paracetamol.
Each vial containing 50 mL of the solution contains 500 mg of paracetamol.
Each vial containing 100 mL of the solution contains 1000 mg of paracetamol.
The other ingredients are: cysteine hydrochloride monohydrate, disodium phosphate, concentrated hydrochloric acid (for pH adjustment), mannitol, sodium hydroxide (for pH adjustment), water for injections.

What Paracetamol Baxter looks like and contents of the pack

Paracetamol Baxter is a clear, colorless to slightly yellowish solution without visible solid particles.
The medicine is available in:

• 50 mL of the solution in a 100 mL glass vial (type II) with a chlorobutyl rubber stopper and a red aluminum flip-off cap in a cardboard box.
• 100 mL of the solution in a 100 mL glass vial (type II) with a chlorobutyl rubber stopper and a blue aluminum flip-off cap in a cardboard box.

Paracetamol Baxter is supplied in packs containing 25 vials.

Marketing authorization holder

Baxter Holding B.V.
Kobaltweg 49
3542 CE Utrecht
Netherlands
Phone: +31 30 248 8911

Manufacturer

Bieffe Medital S.p.A
Via Nuova Provinciale
23034 Grosotto (SO)
Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:January 2025
------------------------------------------- TEAR OFF THE FOLLOWING PART---------------------------
Information intended for healthcare professionals only:
INFORMATION FOR HEALTHCARE PROFESSIONALS
Summary
of information
on dosing,
dilution,
administration
and
storage of Paracetamol Baxter, 10 mg/mL, solution for infusion.
The full information on the medicine is contained in the Summary of Product Characteristics.

Intravenous administration.

Newborns, infants, small children, and children (with a body weight of 33 kg or less)

Use a vial containing 50 mL.

Adults, adolescents, and children (with a body weight over 33 kg)

Use a vial containing 100 mL.
As with all solutions for infusion in glass vials, it is essential to closely monitor the infusion, especially at the end, regardless of the route of administration. Monitoring at the end of the infusion is particularly important for perfusions through a central venous catheter to avoid air embolism.

Dosing

Information before preparing the dose

• The minimum interval between consecutive administrations of the medicine must be at least 4 hours.
• The minimum interval between consecutive administrations of the medicine in patients with severe kidney function disorders must be at least 6 hours.
• Do not administer more than 4 doses in 24 hours.
• The paracetamol solution is administered by intravenous infusion over 15 minutes (detailed information is provided in the "Method of administration" section under the dosing table).
• The diluted solution should be visually inspected and not used if it is opaque, contains visible solid particles, or has an sediment.

RISK OF DOSING ERRORS

Caution should be exercised to avoid dosing errors with the medicine by confusing milligrams (mg) with milliliters (mL), which can lead to accidental overdose and death (see section 4.2 of the Summary of Product Characteristics).

Dosing based on patient body weight (see dosing table below)

* Premature infants:there are no data on the safety and efficacy of Paracetamol Baxter in premature infants.
** Patients with a lower body weight will require smaller volumes.
*** Maximum daily dose:the maximum daily dose of paracetamol listed in the table above applies to patients who are not taking other medicines containing paracetamol and should be adjusted accordingly, taking into account such medicines.
Renal impairment:
In patients with renal impairment, the interval between consecutive administrations should be modified according to the following scheme:

Liver impairment
In patients with chronic or compensated active liver disease, liver cell failure, chronic alcoholism, malnutrition (low glutathione reserve in the liver), dehydration, Gilbert's syndrome, or a body weight below 50 kg: the maximum daily dose should not exceed 3 g.

Method of administration

Patients with a body weight of ≤ 10 kg:

• Due to the small volume of the infusion administered in this population, the glass vial containing Paracetamol Baxter should not be hung.
• The volume to be administered should be withdrawn from the vial and can be administered undiluted or diluted in a 0.9% sodium chloride solution or 5% glucose solution to a maximum of one-tenth of the volume (one volume of paracetamol, nine volumes of diluent) and administered over 15 minutes.
• A 5 or 10 mL syringe should be used to measure the dose suitable for the child's body weight and the required volume. The volume administered in this weight group should never exceed 7.5 mL per dose.
• The user should consult the dosing recommendations in the Summary of Product Characteristics. To withdraw the solution, a 21-gauge (0.8 mm) needle should be used to puncture the stopper vertically at the indicated point. For single use only. Any unused solution should be discarded. Any unused product or waste material should be disposed of in accordance with local requirements.

Shelf life after dilution

Chemical and physical stability of the diluted solution has been demonstrated for 48 hours at 20–25 °C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the storage time and conditions are the responsibility of the user and are normally not longer than 24 hours at 2–8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.