PARACETAMOL BAXTER

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamolo Baxter 10 mg/ml solution for infusion

Generic medicine
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Paracetamolo Baxter is and what it is used for
2. What you need to know before using Paracetamolo Baxter
3. How to use Paracetamolo Baxter
4. Possible side effects
5. How to store Paracetamolo Baxter
6. Contents of the pack and other information

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

This medicinal product contains the active substance paracetamol and is an analgesic (relieves pain) and an antipyretic (reduces fever).
Term newborns, infants, young children and children (weighing less than or equal to 33 kg)
Use the 50 ml vial.
Adults, adolescents and children (weighing more than 33 kg)
Use the 100 ml vial.
It is indicated for the short-term treatment of moderate pain, particularly following surgical procedures, and for the short-term treatment of fever.

2. What you need to know before using Paracetamol Baxter

Do not use Paracetamol Baxter:

• if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to propacetamol hydrochloride. This is another analgesic which is converted by the body into paracetamol;
• if you have severe liver disease.

Warnings and precautions
Consult your doctor or pharmacist before using Paracetamol Baxter if any of the following apply:

• if you could take analgesics orally instead, as this is the recommended route of administration;
• if you have liver or kidney disease or if you drink excessive amounts of alcohol;
• if you are taking other medicines containing paracetamol;
• in case of malnutrition or dehydration;
• if you have glucose-6-phosphate dehydrogenase deficiency. This is a blood disorder.

Other medicines and Paracetamol Baxter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Paracetamol Baxter may affect other medicines and be affected by them:

• other medicines containing paracetamol or propacetamol, to avoid exceeding the recommended daily dose (see section 3 "How to use Paracetamol Baxter");
• probenecid: a reduction in the paracetamol dose may be necessary;
• salicylamide, an anti-inflammatory medicine;
• oral anticoagulants. Monitoring of the anticoagulant effect may be required;
• medicines that induce liver enzymes: close monitoring of the paracetamol dose is necessary to avoid liver damage.

Paracetamol Baxter and alcohol
Limit alcohol consumption during treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy
If necessary, Paracetamol Baxter may be administered during pregnancy. You will be given the lowest possible dose to relieve pain or fever. Contact your doctor if pain or fever does not subside.
Breastfeeding
Paracetamol Baxter may be used during breastfeeding.
Driving and using machines
Paracetamol Baxter does not impair the ability to drive or operate machinery.
Paracetamol Baxter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.

3. How to use Paracetamol Baxter

For intravenous use.
Paracetamol will be administered to you by a healthcare professional as an infusion into one of your veins.
The dose will be individually adjusted by the physician according to your body weight and general condition. The dosage is based on the patient's body weight and general health status.

Full-term neonates, infants, young children and children (body weight less than or equal to 33 kg)
Use the 50 ml vial. Refer to the table below for volume according to body weight.

Adults, adolescents and children (body weight greater than 33 kg)
Use the 100 ml vial. Refer to the table below for volume according to body weight.

Dosage
For the recommended dose, refer to the table below.

• The minimum interval between each administration must be at least 4 hours.
• The minimum interval between each administration in patients with severe renal impairment must be at least 6 hours.
• No more than 4 doses should be administered within 24 hours.
• The medicine is administered as a 15-minute intravenous infusion.
• Before administration, the medicine must be visually inspected by healthcare professionals. Paracetamol Baxter must not be used if particulate matter or discoloration is observed, as these are signs of deterioration.

* Preterm neonates: Safety and efficacy data in preterm neonates are not available.
**Patients with lower body weight will require smaller volumes.
*** Maximum daily dose: The maximum daily paracetamol dose reported in the table above applies to patients who are not taking other products containing paracetamol, and must be adjusted accordingly taking such products into account.

Renal impairment:
In patients with renal impairment, the interval between each administration should be adjusted.

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

Paracetamol in solution is administered as a 15-minute intravenous infusion.

If you feel that the effect of this medicine is too strong or too weak, consult your doctor.

If you receive more Paracetamol Baxter than you should
Overdose is unlikely, as this medicine will be administered by a healthcare professional. Your doctor will ensure that you do not receive doses exceeding the recommended dose for your case.

An overdose of Paracetamol Baxter is potentially fatal due to irreversible liver damage. Severe liver damage may occur even if you are otherwise in good health.
To prevent liver damage, it is essential to receive medical treatment as soon as possible. The shorter the time interval between the infusion and the initiation of antidote treatment (the fewer hours possible), the greater the likelihood of avoiding liver injury.

In case of overdose, symptoms generally appear within the first 24 hours and may include: nausea, vomiting, anorexia, pallor, abdominal pain, and risk of liver injury. Seek immediate medical attention if you or your child receive an excessive dose of this medicine, even if you or your child appear to be in good condition. This is because an excessive dose of paracetamol may cause delayed but severe liver damage.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Rare (may affect fewer than 1 in 1,000 patients):
The following may occur:

• malaise;
• drop in blood pressure;
• changes in laboratory test results: abnormal increase in liver enzyme levels detected in blood tests. In this case, inform your doctor, as regular blood tests may be required thereafter.

Very rare (may affect fewer than 1 in 10,000 patients):
The following may occur:

• severe skin rash or allergic reaction. In such cases, stop treatment immediately and inform your doctor;
• other changes in laboratory test results have been observed, requiring regular blood tests: abnormal decrease in levels of certain types of blood cells (platelets, white blood cells), possibly leading to nosebleeds or bleeding gums;
• very rare cases of serious skin reactions have been reported.

Not known (frequency cannot be estimated from the available data):

• Cases of skin redness, flushing, itching, and abnormally rapid heartbeat have been reported.
• Cases of pain and burning sensation at the site of administration have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paracetamol Baxter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label of the
vial after Exp. The expiry date refers to the last day of the month.
Do not refrigerate or freeze.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with
local applicable regulations.

6. Package contents and other information

What Paracetamol Baxter contains
The active substance is paracetamol.
1 ml 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), cysteine hydrochloride monohydrate (E920), disodium phosphate dihydrate (E339), sodium hydroxide (for pH adjustment) (E524), hydrochloric acid (for pH adjustment) (E507), water for injections.

Description of the appearance of Paracetamol Baxter and contents of the package
Paracetamol Baxter is a clear, colourless to slightly yellowish solution, free from visible particles.
This medicinal product is available in 50 ml or 100 ml glass vials, with red or blue aluminium flip-off caps, respectively.
Paracetamol Baxter is supplied in a pack containing 25 vials.

Marketing Authorisation Holder and Manufacturer
Baxter Holding B.V.
Kobaltweg 49,
3542CE Utrecht,
The Netherlands

Bieffe Medital S.P.A
Via Nuova Provinciale
23034-Grosotto (SO),
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
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FOLLOWING ----------------------------------The following information is intended exclusively for physicians and healthcare professionals:
INFORMATION FOR HEALTHCARE PROFESSIONALS
A summary of information on dosage, dilution, administration, and storage of Paracetamol Baxter 10 mg/ml, solution for infusion. Refer to the Summary of Product Characteristics for complete prescribing information.

Intravenous use.
Term neonates, infants, young children and children (weighing less than or equal to 33 kg)
Use the 50 ml vial.
Adults, adolescents and children (weighing more than 33 kg)
Use the 100 ml vial.

As with all infusion solutions contained in glass vials, close monitoring is required, especially towards the end of the infusion, regardless of the route of administration. This end-of-infusion monitoring should be particularly applied in the case of central line infusions to avoid the risk of gas embolism.

Dosage
Information prior to dose preparation

• The minimum interval between each administration must be at least 4 hours.
• The minimum interval between each administration in patients with severe renal impairment must be at least 6 hours.
• No more than 4 doses should be administered within 24 hours.
• Paracetamol solution is administered as a 15-minute intravenous infusion (for further information, see section "Method of administration" in the dosage table below).
• The diluted solution should be inspected visually and must not be used if opalescence, visible particles or precipitates are present.

RISK OF MEDICATION ERRORS
Take care to avoid dosing errors due to confusion between milligrams (mg) and millilitres (ml), which may lead to accidental overdose and death (see Summary of Product Characteristics, section 4.2).
Dosage is based on the patient's body weight (refer to the dosage table below).

* Preterm neonates: safety and efficacy data are not available for preterm neonates.
**Lower weight patients will require smaller volumes.
*** Maximum daily dose: the maximum daily dose reported in the table above refers to
patients who are not taking other products containing paracetamol, and should be adjusted accordingly
taking such products into account.
Renal impairment
In patients with renal impairment, the minimum interval between each administration must be
adjusted according to the following schedule:

Hepatic impairment
In patients with chronic active or compensated liver disease, hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), dehydration, Gilbert's syndrome, or body weight below 50 kg: the maximum daily dose must not exceed 3 g.
Method of administration
Patients weighing ≤10 kg:

• The paracetamol glass vial must not be hung as in the case of an infusion due to the small volume of product to be administered in this population.
• The volume to be administered should be withdrawn from the vial and may be given undiluted or diluted in 0.9% sodium chloride solution or 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 must be used to measure the appropriate dose according to the child's weight and desired volume. The volume administered in this weight group must never exceed 7.5 ml per dose.
• The user must refer to the dosing recommendations in the product characteristics summary.

To withdraw the solution, use a 0.8 mm (21 gauge) needle and pierce the stopper vertically at the exact point indicated. For single use only. Any unused solution must be discarded.
Any unused medicinal product and waste materials derived from it must be disposed of in accordance with local regulations.
Stability period after dilution
Chemical and physical stability during use in solutions has been demonstrated for 48 hours at 20–25 °C.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the 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 was carried out under controlled and validated aseptic conditions.