PARACETAMOL BAXTER 10 mg/mL SOLUTION FOR INFUSION

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

This medicine contains the active substance paracetamol. It is an analgesic (pain reliever) and an antipyretic (fever reducer).

Newborns, infants, and children (weight less than or equal to 33 kg)

Use the vial containing 50 ml.

Adults, adolescents, and children (weight greater than 33 kg)

Use the vial containing 100 ml.

It is indicated for the short-term treatment of moderate pain, especially after surgery, and for the short-term treatment of fever.

2. What you need to know before you use Paracetamol Baxter

Do not use Paracetamol Baxter:

• if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to propacetamol hydrochloride (another pain reliever that is converted to paracetamol in your body);
• if you have severe liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to receive Paracetamol Baxter:

• if you can take pain relievers orally, as this is the recommended route of administration;
• if you have reduced kidney or liver function, or if you abuse alcohol;
• if you are taking other medicines that contain paracetamol;
• in cases of malnutrition or dehydration;
• if you have a deficiency of glucose-6-phosphate dehydrogenase (a blood disorder).

During treatment with Paracetamol Baxter, inform your doctor immediately if:

If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Other medicines and Paracetamol Baxter

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines. Paracetamol Baxter may interact with other medicines:

• other medicines that contain paracetamol or propacetamol, therefore do not take more than the recommended daily dose (see section 3 "How to use Paracetamol Baxter");
• probenecid: it may be necessary to reduce the dose of paracetamol;
• salicylamide, an anti-inflammatory;
• oral anticoagulants. It may be necessary to monitor the anticoagulant effect;
• medicines that activate liver enzymes: in these cases, it is necessary to strictly control the dose of paracetamol to avoid liver damage.
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that requires urgent treatment (see section 2).

Paracetamol Baxter and alcohol

Limit your alcohol intake during treatment with this medicine.

Pregnancy and breastfeeding

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

Pregnancy

If necessary, Paracetamol Baxter can be used during pregnancy. You will be given the lowest possible dose that reduces pain or fever. Contact your doctor if the pain or fever does not decrease.

Breastfeeding

Paracetamol Baxter can be used during breastfeeding.

Driving and using machines

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

Paracetamol Baxter contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially "sodium-free".

3. How to use Paracetamol Baxter

By intravenous route.

A healthcare professional will administer the paracetamol by infusion in one of your veins.

Your doctor will adjust the dose individually for you based on your body weight and clinical situation.

Newborns, infants, and children (weight less than or equal to 33 kg)

Use the vial containing 50 ml. See the following table for volumes based on body weight.

Adults, adolescents, and children (weight greater than 33 kg)

Use the vial containing 100 ml. See the following table for volumes based on body weight.

Administration

See the recommended dose in the following table.

• The minimum interval between each administration must be at least 4 hours.
• The minimum interval between each administration in patients with severe kidney failure must be at least 6 hours.
• No more than 4 doses should be administered in 24 hours.
• The medicine will be administered in a vein for 15 minutes.
• Before administration, healthcare professionals will visually inspect it. Paracetamol Baxter should not be used if discoloration or particles are observed, which are signs of product deterioration.

*Preterm newborns:There are no safety and efficacy data for preterm newborns.

**Patients with lower weight will require smaller volumes.

***Maximum daily dose:The maximum daily dose of paracetamol indicated in the table above refers to patients who are not taking other medicines that contain paracetamol. The dose should be adjusted accordingly if the patient is taking these other medicines.

Kidney failure:

In patients with kidney failure, the interval between each administration should be adjusted.

Liver failure:

In patients with active compensated or chronic liver disease, hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), dehydration, Gilbert's syndrome, weight less than 50 kg: the maximum daily dose should not exceed 3 g.

The paracetamol solution is administered as an intravenous infusion for 15 minutes.

If you think the effect of this medicine is too strong or too weak, tell your doctor.

If you receive more Paracetamol Baxter than you should

Overdose is unlikely to occur, as it will be a healthcare professional who administers the medicine. Your doctor will make sure you do not receive a higher dose than recommended.

An overdose of Paracetamol Baxter is potentially fatal due to irreversible liver damage.There is a risk of severe liver damage, even if you feel well.

To avoid liver damage, it is essential to receive medical treatmentas soon as possible. The shorter the interval between infusion and start of treatment with the antidote (the fewer hours), the higher the probability of avoiding liver damage.

In case of overdose, symptoms usually appear within the first 24 hours and include: nausea, vomiting, anorexia, pallor, abdominal pain, and risk of liver damage. Consult your doctor immediately if you or your child receive too much medicine, even if you or your child feel well. This is because too much paracetamol can cause severe liver damage in a delayed manner.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

May include:

• Discomfort.
• Decrease in blood pressure.

Changes in laboratory test results: abnormally high levels of liver enzymes in blood tests. If this occurs, consult your doctor as regular monitoring of blood parameters may be necessary.

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

May include:

• A severe skin rash or allergic reaction may occur. Stop treatment immediately and inform your doctor.
• Other changes in laboratory test results have been observed, which have required regular monitoring of blood parameters: abnormally low levels of some blood cells (platelets, white blood cells), which can cause nosebleeds or bleeding gums.
• Very rare cases of severe skin reactions have been reported.

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

• Cases of skin redness, flushing, itching, and abnormally rapid heartbeats have been reported.
• Cases of pain and burning sensation at the injection site have been reported.
• A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any 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 Paracetamol Baxter

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

Do not administer this medicine after the expiry date stated on the carton and on the vial label after EXP. The expiry date refers to the last day of the month stated.

Do not refrigerate or freeze.

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

6. Container Content and Additional Information

Composition of Paracetamol Baxter

The active ingredient is paracetamol.

One ml of solution for infusion contains 10 mg of paracetamol.

Each 50 ml vial contains 500 mg of paracetamol.

Each 100 ml vial contains 1,000 mg of paracetamol.

The other components are: mannitol (E421), L-cysteine hydrochloride monohydrate (E920), disodium phosphate (E339), sodium hydroxide (for pH adjustment) (E524), hydrochloric acid (for pH adjustment) (E507), water for injectable preparations.

Appearance of the Product and Container Content

Paracetamol Baxter is a clear, particle-free solution, colorless to slightly yellowish.

This medicinal product is presented in glass vials, with red (for 50 ml vials) and blue (for 100 ml vials) aluminum flip-off caps and seals.

Paracetamol Baxter is presented in packs of 25 vials.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Baxter Holding B.V.

Kobaltweg 49

3542 CE Utrecht

Netherlands

Manufacturer

Bieffe Medital S.P.A

Via Nuova Provinciale

23034-Grosotto (SO), Italy

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

Austria: Paracetamol Baxter 10 mg/ml Infusionslösung

Germany: Paracetamol Baxter 10 mg/ml Infusionslösung

Belgium: Paracetamol Baxter 10 mg/ml solution pour perfusion

France: Paracetamol Baxter 10 mg/ml solution pour perfusion

Luxembourg: Paracetamol Baxter 10 mg/ml solution pour perfusion

Greece: Paracetamol/Baxter 10 mg/ml Δι?λυμα για ?γχυσηs

Cyprus: Paracetamol/Baxter 10 mg/ml Δι?λυμα για?γχυση

Denmark: Paracetamol Baxter 10 mg/ml infusionsvæske, opløsning

Finland: Paracetamol Baxter 10 mg/ml infuusioneste, liuos

Ireland: Paracetamol 10 mg/ml Solution for Infusion

United Kingdom: Paracetamol 10 mg/ml Solution for Infusion

Italy: Paracetamolo Baxter

Netherlands: Paracetamol Baxter 10 mg/ml oplossing voor infusie

Portugal: Paracetamol Baxter

Norway: Paracetamol Baxter

Spain: Paracetamol Baxter 10 mg/ml solución para perfusión EFG

Sweden: Paracetamol Baxter 10 mg/ml infusionsvätska, lösning

Iceland: Paracetamol Baxter 10 mg/ml innrennslislyf, lausn

Poland: Paracetamol Baxter

Date of Last Revision of this Leaflet: February 2025

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

This information is intended only for healthcare professionals:

INFORMATION FOR HEALTHCARE PROFESSIONALS

Summary of information on dosage, dilution, administration, and conservation of Paracetamol Baxter 10 mg/ml, solution for infusion EFG. Consult the Summary of Product Characteristics or Package Leaflet for full prescribing information.

Intravenous route.

Newborns, infants, and children (weight less than or equal to 33 kg)

Use the 50 ml vial.

Adults, adolescents, and children (weight greater than 33 kg)

Use the 100 ml vial.

As with all infusion solutions presented in glass vials, it should be remembered that they must be carefully monitored, especially at the end of the infusion, regardless of the administration route. This monitoring at the end of the infusion should be performed especially when the infusion is through a central route, in order to avoid gas embolisms.

Administration

Information prior to dose preparation

• The minimum interval between each administration should be at least 4 hours.
• The minimum interval between each administration in patients with severe renal impairment should be at least 6 hours.
• No more than 4 doses should be administered in 24 hours.
• The paracetamol solution is administered by intravenous infusion over 15 minutes (if you need more information, consult the "Method of administration" section below the volume table).
• The diluted solution should be visually inspected and should not be used if opalescence, visible particles, or precipitate are observed.

RISK OF MEDICATION ERRORS

Be careful to avoid administration errors due to possible confusion between milligrams (mg) and milliliters (ml), as this could lead to accidental overdose and death (see section 4.2 of the Summary of Product Characteristics).

Dosage according to patient weight (please consult the posology table below)

*Preterm newborns:There are no safety and efficacy data available for preterm newborns.

**Patients with lower weight will require smaller volumes.

***Maximum daily dose:The maximum daily dose indicated in the table above refers to patients who are not receiving other medications containing paracetamol and should be adjusted taking into account these other medications.

Renal impairment:

The minimum interval between each administration in patients with renal impairment should be modified according to the following guideline:

Hepatic impairment

In patients with active compensated or chronic liver disease, hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), dehydration, Gilbert's syndrome, weight less than 50 kg: the maximum daily dose should not exceed 3 g.

Method of administration

Patients with a weight less than or equal to 10 kg:

• The glass vial of paracetamol should not be hung as for an infusion due to the small volume of medication administered to this population.
• The volume to be administered should be withdrawn from the vial and may be administered undiluted or diluted in a 0.9% sodium chloride solution or a 5% glucose solution up to one-tenth (one volume of Paracetamol in nine volumes of diluent) and administered over 15 minutes.
• A 5 or 10 ml syringe should be used to measure the appropriate dose based on the child's weight and desired volume. The volume administered to this weight group should not exceed 7.5 ml per dose.
• The user should consult the dosing recommendations in the Summary of Product Characteristics of the medicinal product.

To withdraw the solution, use a 0.8 mm (21 gauge) needle and puncture the stopper vertically at the indicated point. For single use only. Any unused solution should be discarded.

The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.

Validity period after dilution

The chemical and physical stability of the product in use has been demonstrated for 48 hours at 20-25°C.

From a microbiological point of view, the medicinal product should be administered immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless the dilution has taken place in controlled and validated aseptic conditions.