PARACETAMOL RTU BAXTER 10 mg/mL SOLUTION FOR INFUSION

1. What is Paracetamol RTU 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). The use of this medicine is restricted to adults, adolescents, and children weighing more than 33 kg.

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 start using Paracetamol RTU Baxter

Do not use Paracetamol RTU 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 you start receiving Paracetamol RTU Baxter:

• if you can take oral pain relievers, 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 glucose-6-phosphate dehydrogenase deficiency (a blood disorder).

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

If you have severe illnesses, 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 serious 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 RTU Baxter

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines. This medicine 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 RTU 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 the blood and fluids (called metabolic acidosis) that requires urgent treatment (see section 2).

Paracetamol RTU 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 or pharmacist for advice before using this medicine.

Pregnancy

If necessary, this medicine 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

This medicine can be used during breastfeeding.

Driving and using machines

This medicine does not affect your ability to drive or use machines.

Paracetamol RTU Baxter contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per bag; i.e., it is essentially "sodium-free".

3. How to use Paracetamol RTU Baxter

Via intravenous route.

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

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

The use of this medicine is restricted to adults, adolescents, and children weighing more than 33 kg.

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.

**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 below 50 kg: the maximum daily dose should not exceed 3 g.

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

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

If you receive more Paracetamol RTU Baxter than you should

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

An overdose of this medicine can be life-threatening and cause irreversible liver damage.There is a risk of serious 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 the 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 serious liver damage in a delayed manner.

If you have any questions about the use of this medicine, 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. If this occurs, consult your doctor.
• 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 serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are 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 RTU Baxter

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

Do not administer this medicine after the expiry date stated on the label and on the bag after CAD. The expiry date is the last day of the month stated.

Do not refrigerate or freeze. Store the bag in its overbag.

For single use only. Once opened, the product should be used immediately. The solution that is not used should be discarded.

Inspect the product visually before administration. Do not use it if you observe the presence of particles and discoloration, as these are visible signs of product deterioration.

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 Contents and Additional Information

Composition of Paracetamol RTU Baxter

• The active ingredient is paracetamol.

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

Each 100 ml bag 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 Contents

Solution for infusion.

Clear solution, free from visible particles and colorless to slightly yellowish.

100 ml of solution in 100 ml polyethylene/polyamide/polypropylene (Viaflo) plastic bags, with a non-accessible false port made of polyethylene and an administration port made of polyethylene with a transparent/aluminum foil cover.

Container size: container with 40 bags.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Baxter Holding B.V.

Kobaltweg 49

3542 CE Utrecht

Netherlands

Manufacturer

Baxter Healthcare S.A.

Moneen Road, Castlebar, Co. Mayo, F23 XR63,

Ireland

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

Austria and Germany: Paracetamol Baxter Viaflo 10 mg/ml Infusionslösung im Beutel

Belgium and Luxembourg: Paracetamol Baxter 10 mg/ml Viaflo, solution pour perfusion

France: Paracetamol Viaflo 10 mg/ml solution pour perfusion

Greece and Cyprus: Paracetamol/Baxter 10 mg/ml Viaflo, δι?λυμα για ?γχυση

Denmark and Norway: Paracetamol Baxter Viaflo

Finland: Paracetamol Baxter Viaflo 10 mg/ml infuusioneste, liuos

Ireland, Malta, and United Kingdom: Paracetamol 10 mg/ml Solution for Infusion

Italy: Paracetamolo Baxter Holding BV

Netherlands: Paracetamol Baxter 10 mg/ml Viaflo oplossing voor infusie

Portugal: Paracetamol Viaflo 10 mg/ml solução para perfusão

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

Sweden: Paracetamol Baxter Viaflo 10 mg/ml infusionsvätska, lösning

Date of the Last Revision of this Leaflet: February 2025

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This information is intended solely for healthcare professionals:

INFORMATION FOR HEALTHCARE PROFESSIONALS

The following is a summary of information on the dosage and administration of Paracetamol RTU Baxter. Refer to the Summary of Product Characteristics or Package Leaflet for full prescribing information.

Intravenous Route.

The use of this medicinal product is restricted to adults, adolescents, and children weighing more than 33 kg.

Strict monitoring should be performed before the end of the infusion.

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.

RISK OF MEDICATION ERRORS

Be cautious to avoid administration errors due to possible confusion between milligrams (mg) and milliliters (ml), as this could result in accidental overdose and death (see section 4.2).

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

**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 below 50 kg: the maximum daily dose should not exceed 3 g.

Method of Administration

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

Once the outer packaging is opened, the product should be used immediately.

Before administering the product, inspect it visually for the presence of particles and discoloration. For single use.

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