Paracetamol baxter

Patient Information Leaflet

Paracetamol Baxter, 10 mg/mL, solution for infusion
Paracetamolum
Please read all of this leaflet carefully before using this medicine, because it
contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

Table of contents

1. What Paracetamol Baxter is and what it is 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 pack and other information

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

Paracetamol Baxter contains the active substance paracetamol and belongs to a group of medicines called analgesics (relieves pain) and antipyretics (reduces fever).
Newborns, infants, young children and children (with body weight less than or equal to 33 kg)
Use the 50 mL vial.
Adults, adolescents and children (with body weight above 33 kg)
Use the 100 mL vial.
This 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:

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

Warnings and precautions
Before starting treatment with Paracetamol Baxter, speak with your
doctor, pharmacist or nurse if:

• instead of intravenous administration, the patient could take oral analgesics, as this is the recommended route of administration;
• the patient has impaired liver or kidney function, or if the patient abuses alcohol;
• the patient is taking other medicines containing paracetamol;
• the patient is undernourished or dehydrated;
• the patient has glucose-6-phosphate dehydrogenase deficiency. This is a blood disorder.

During treatment with Paracetamol Baxter, inform the doctor immediately if:
If the patient has serious conditions, including severe kidney dysfunction 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). Cases of a serious condition called metabolic acidosis (a disturbance in blood and body fluids) have been reported in patients who take
paracetamol regularly over a prolonged period or who take paracetamol together
with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.
Paracetamol Baxter with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 exceed the recommended daily dose (see section 3. "How to use Paracetamol Baxter");
• probenecid: a lower dose of paracetamol may be required;
• salicylamide, an anti-inflammatory medicine;
• oral anticoagulants: monitoring of the anticoagulant effect may be required;
• medicines that induce liver enzymes: strict control of the paracetamol dose is necessary to avoid liver damage;
• flucloxacillin (an antibiotic) due to a serious disturbance in blood and body fluids (called metabolic acidosis), which requires urgent treatment (see section 2).

Paracetamol Baxter and alcohol
Alcohol consumption should be limited during treatment with this medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Pregnancy
If necessary, Paracetamol Baxter may be administered during pregnancy. The patient will be given the lowest possible dose that relieves pain or reduces fever. If pain or fever persists, the patient should contact her doctor.
Breastfeeding
Paracetamol Baxter may be administered to breastfeeding patients.
Driving and operating machinery
Paracetamol Baxter has no influence on the ability to drive or operate machinery.
Paracetamol Baxter contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".

3. How to use Paracetamol Baxter

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

Newborns, infants, young children and children (with body weight less than or equal to 33 kg)
Use the 50 mL vial. The dosing table below provides volume according to body weight.

Adults, adolescents and children (with body weight above 33 kg)
Use the 100 mL vial. The dosing table below provides volume according to body weight.

Dosage
Recommended doses are given in the table below.

• The minimum interval between consecutive doses must be at least 4 hours.
• The minimum interval between consecutive doses 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 should be given intravenously over 15 minutes.
• Before administration, the product should be visually inspected by medical personnel. Paracetamol Baxter must not be used if particulate matter is present or if the solution has changed colour, as these are signs of degradation or spoilage of the medicinal product.

* Premature infants: Safety and efficacy data are lacking in premature infants.
**Patients with lower body weight will require smaller volumes.
*** Maximum daily dose: The maximum daily dose of paracetamol listed in the table above applies to patients not taking other medications containing paracetamol.
If the patient is taking such medications, this dose must be adjusted accordingly.
Renal impairment:
In patients with impaired renal function, the interval between doses should be adjusted.
Hepatic impairment
In patients with chronic or actively compensated liver disease, hepatocellular insufficiency, chronic alcohol abuse, chronic malnutrition (low hepatic glutathione reserves), dehydration, Gilbert's syndrome, or with body weight below 50 kg: the maximum daily dose must not exceed 3 g.
Paracetamol solution is administered as a 15-minute intravenous infusion.
If the patient feels that the medicine's effect is too strong or too weak, they should speak with their doctor.
Administration of a higher than recommended dose of Paracetamol Baxter
Overdose is unlikely because the medicine is administered by a healthcare professional. The physician will ensure that the patient does not receive a dose higher than recommended.
Paracetamol Baxter overdose is potentially fatal due to
irreversible liver damage. There is a risk of severe liver damage,
even if the patient feels well.
To avoid liver damage, it is essential to receive treatment as early as possible .
The shorter the interval between the infusion and the initiation of antidote administration (the
minimum possible number of hours), the greater the likelihood of preventing liver damage .
In cases of overdose, symptoms usually appear within the first 24 hours and may include: nausea, vomiting, anorexia, pallor, abdominal pain, and risk of liver damage. The physician should be informed immediately if an excessive dose has been administered or given to a child, even if the patient's or child's condition appears normal, because excessive amounts of paracetamol may cause delayed, severe liver damage.
If there are any further doubts regarding the use of this medicine, consult a physician, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.

Uncommon (may affect up to 1 in 1,000 people)
The following adverse reactions may occur:

• weakness;
• low blood pressure;
• changes in laboratory test results: increased liver enzyme activity detected during routine blood testing. In such a case, you should inform your doctor, as follow-up tests may be required at a later time.

Very rare (may affect up to 1 in 10,000 people)
The following adverse reactions may occur:

• severe skin rash or allergic reaction may occur. Treatment must be stopped immediately and your doctor should be informed.
• other changes in laboratory test results requiring regular monitoring of blood parameters have been observed: reduction in the number of certain types of blood cells (platelets, white blood cells), which may result in nosebleeds or bleeding gums;
• very rare cases of serious skin reactions have been reported.

Unknown (frequency cannot be estimated from the available data)

• Cases of skin redness, facial flushing, itching, and abnormally rapid heartbeat have been reported.
• Cases of pain and burning sensation at the injection site have been reported.
• Serious condition which may cause blood to become more acidic (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Paracetamol Baxter

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the carton and vial after "EXP". The expiry date refers to the last day of the stated month.
Do not store in the refrigerator and do not freeze.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.

6. Contents of the pack and other information

What Paracetamol Baxter contains
The active substance is paracetamol.
1 mL of solution contains 10 mg of paracetamol.
Each vial containing 50 mL of solution contains 500 mg of paracetamol.
Each vial containing 100 mL of solution contains 1000 mg of paracetamol.
The other ingredients are: cysteine hydrochloride monohydrate, disodium phosphate, hydrochloric acid concentrated (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, colourless to slightly yellowish solution free from visible solid particles.
The medicine is available as:
50 mL of solution in a vial made of transparent type II glass with a capacity of 100 mL, closed with a chlorobutyl rubber stopper and a red flip-off aluminium cap, packed in a cardboard box.
100 mL of solution in a vial made of transparent type II glass with a capacity of 100 mL, closed with a chlorobutyl rubber stopper and a blue flip-off aluminium cap, packed in a cardboard box.
Paracetamol Baxter is supplied in packs containing 25 vials.

Marketing Authorisation Holder
Baxter Holding B.V.
Kobaltweg 49
3542 CE Utrecht
The Netherlands
Telephone: +31 30 248 8911

Manufacturer
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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Information intended exclusively for healthcare professionals:
INFORMATION FOR HEALTHCARE WORKERS
Summary of information on dosing, dilution, administration, and
storage of the medicinal product Paracetamol Baxter, 10 mg/mL, infusion solution.
Full product information is contained in the Summary of Product Characteristics.
Intravenous administration.
Newborns, infants, young children and children (with body weight less than or equal to 33 kg)
Use the 50 mL vial.
Adults, adolescents and children (with body weight above 33 kg)
Use the 100 mL vial.
As with all infusion solutions in glass vials, close monitoring of the infusion is essential, especially towards the end, regardless of the route of administration. Monitoring at the end of the infusion is particularly important for infusions administered via a central venous catheter to avoid air embolism.
Dosing
Information prior to dose preparation

• The minimum interval between consecutive doses must be at least 4 hours.
• The minimum interval between consecutive doses 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 (detailed information is provided in the section “Method of administration” below the dosing table).
• The diluted solution should be inspected visually and must not be used if opalescence, visible solid particles, or precipitate are present.

RISK OF MEDICATION ERRORS DURING ADMINISTRATION
Extreme caution must be exercised to avoid dosing errors resulting from confusion
between milligrams (mg) and millilitres (mL), which may lead to accidental
overdose and death (see section 4.2 SmPC).
Dosing based on patient body weight (see dosing table below)

* Premature infants: lack of safety and efficacy data regarding use in
premature infants.
**Patients with lower body weight will require smaller volumes to be administered.
*** Maximum daily dose: the maximum daily dose of paracetamol listed in the
table above applies to patients not taking other medicinal products containing
paracetamol and should be appropriately adjusted taking into account such
medicinal products.
Renal function impairment:
In patients with renal function impairment, the minimum interval between doses
should be adjusted according to the scheme below:

Liver impairment
In patients with chronic or compensated active liver disease, hepatocellular insufficiency, chronic alcoholism, chronically undernourished patients (low hepatic glutathione reserves), dehydrated patients, patients with Gilbert's syndrome, and patients weighing less than 50 kg: the maximum daily dose must not exceed 3 g.
Administration method
Patients with body weight ≤ 10 kg:

• Due to the small infusion volume 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 may be given undiluted or diluted in 0.9% sodium chloride solution or 5% glucose solution to a maximum of one-tenth of the total volume (one volume of paracetamol, nine volumes of diluent) and administered as an infusion over 15 minutes.
• A syringe with a capacity of 5 or 10 mL should be used to measure the dose appropriate to the child's body weight and required volume. The volume administered in this weight group should never exceed 7.5 mL per dose.
• The user should consult the dosing recommendations provided in the product's summary of characteristics. To withdraw the solution, use a needle with a diameter of 0.8 mm (21-gauge), inserted vertically at the designated site on the stopper. For single use only. Any unused portions of the solution must be discarded. Any unused medicinal product or waste material must be disposed of in accordance with local regulations.

Stability after dilution
Chemical and physical stability of the prepared solution has been demonstrated for 48 hours at 20–25 °C.
From a microbiological standpoint, the product should be used immediately. If the product is not used immediately, the responsibility for storage duration and conditions prior to use lies with the user and generally should not exceed 24 hours at 2 to 8 °C, unless the dilution was carried out under controlled and validated aseptic conditions.