Patient Information Leaflet

Paracetamol B. Braun, 10 mg/ml, solution for infusion
paracetamol
Please read all of this leaflet carefully before use, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
If you experience any adverse reactions while taking this medicine, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

What Paracetamol B. Braun is and what it is used for
Important information before using Paracetamol B. Braun
How to use Paracetamol B. Braun
Possible side effects
How to store Paracetamol B. Braun
Contents of the pack and other information

1. What Paracetamol B. Braun is and what it is used for

This is an analgesic (relieves pain) and antipyretic (reduces fever) medicine.
It is used for:

short-term treatment of mild to moderate pain, particularly in the postoperative period,
short-term treatment of fever.

2. Important information before using Paracetamol B. Braun

When not to use Paracetamol B. Braun

if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
if the patient has a known hypersensitivity to propacetamol (another analgesic drug, metabolized in the body to paracetamol)
if the patient has severe liver disease.

Warnings and precautions
Before starting treatment with Paracetamol B. Braun, consult a doctor.
When to exercise special caution when using Paracetamol B. Braun

if the patient has liver disease or severe kidney disease, or if the patient chronically abuses alcohol
if the patient is taking other medicines containing paracetamol. In such cases, the doctor will adjust the dose
in cases of nutritional disorders (malnutrition) or dehydration
if the patient has genetically determined glucose-6-phosphate dehydrogenase (G-6-PD) deficiency (favism)

Please inform the doctor before starting treatment if any of the above conditions apply to the patient.
During treatment with Paracetamol B. Braun, immediately inform the doctor if the patient develops serious conditions, including severe kidney dysfunction, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), 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 receiving paracetamol regularly over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Prolonged or frequent use of paracetamol is not recommended. This medicine should be used only until the patient can resume oral analgesic therapy.
The doctor will ensure that the patient does not receive a dose higher than recommended. Excessive dosing may lead to severe liver damage.
Paracetamol B. Braun and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
This is particularly important if the patient is taking:

probenecid (a medicine used in the treatment of gout): a dose reduction of paracetamol may be necessary;
analgesics containing salicylamide: dose adjustment may be required;
medicines that induce liver enzymes: close monitoring of the paracetamol dose is necessary to avoid liver damage;
any anticoagulant medicines (blood thinners): more careful monitoring of their effect may be needed;
flucloxacillin (an antibiotic) due to the serious risk of a disturbance in body fluids and blood (called metabolic acidosis), which requires urgent treatment (see section 2).

This medicine contains paracetamol, which should be taken into account if the patient is taking other medicines containing paracetamol or propacetamol, to avoid overdose (see section 3).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.

Pregnancy Paracetamol B. Braun may be administered to pregnant women if necessary. The lowest effective dose providing adequate pain relief or fever reduction should be used, and the medicine should be taken for the shortest possible duration. If pain is not relieved or fever does not subside, or if increased dosing frequency is required, consult a doctor.
Breastfeeding Paracetamol B. Braun may be used during breastfeeding.

Paracetamol B. Braun contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per package; therefore, it is considered "sodium-free".

3. How to use Paracetamol B. Braun

Recommended dose:
The doctor will determine the dose and the appropriate bottle size for each patient based solely on the patient's
body weight.
Method of administration
This medicine is administered by a doctor as an intravenous infusion (intravenous administration). This takes about 15 minutes.
Careful and continuous monitoring of the patient is required during the infusion, especially towards the end of the infusion.
If the patient feels that the effect of Paracetamol B. Braun infusion solution is too strong or too weak, this should be reported to the doctor.
Use of a higher than recommended dose of Paracetamol B. Braun
Overdose is unlikely because the medicine is administered by a healthcare professional.
The doctor will ensure that the patient does not receive a dose higher than recommended.
In case of overdose, symptoms usually occur within the first 24 hours and include: nausea, vomiting, anorexia (loss of appetite), pallor, abdominal pain. These symptoms may indicate liver damage.
If the patient suspects an overdose, this should be reported to the doctor immediately. In case of overdose, immediate medical assistance is required, even if the patient feels well, due to the risk of severe and irreversible liver damage. If necessary, the patient will be given an antidote.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may be serious. If any of these occur, discontinue use of Paracetamol B. Braun immediately and consult a doctor without delay:
Very rare (may affect up to 1 in 10,000 people)

allergic reactions of varying severity, from skin reactions such as urticaria to anaphylactic shock
severe skin reactions
abnormally low count of certain types of blood cells (platelets, white blood cells) may occur

Other adverse reactions include:
Rare (may affect up to 1 in 1,000 people)

changes in laboratory test results: abnormally high activity of liver enzymes detected during blood tests
decreased blood pressure
malaise

Unknown (frequency cannot be estimated from the available data)

skin redness, hot flushes, or itching
abnormally rapid heartbeat
serious condition causing the blood to become more acidic (so-called metabolic acidosis), in patients with severe illness receiving paracetamol (see section 2).

During clinical trials, frequent adverse reactions at the injection site (pain and burning sensation) were reported.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
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 enables further information on the safety of the medicine to be collected.

5. How to store Paracetamol B. Braun

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store the container in the outer packaging to protect from light.

6. Contents of the package and other information

What Paracetamol B. Braun contains:
The active substance is paracetamol.
Each 1 ml contains 10 mg of paracetamol.
Each 10 ml ampoule contains 100 mg of paracetamol.
Each 50 ml bottle contains 500 mg of paracetamol.
Each 100 ml bottle contains 1000 mg of paracetamol.
The other ingredients are:
Mannitol, disodium citrate dihydrate, glacial acetic acid (for pH adjustment), water for injections.

What Paracetamol B. Braun looks like and contents of the pack
Paracetamol B. Braun infusion solution is a clear, colourless or slightly pinkish-orange solution. Perception of colour may vary.
Paracetamol B. Braun is supplied in plastic bottles of 50 ml and 100 ml or plastic ampoules of 10 ml.
Pack sizes: 20 × 10 ml, 10 × 50 ml, 10 × 100 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
B. Braun Melsungen AG
Address:
Carl-Braun-Straße 1 Correspondence address:
34212 Melsungen, Germany 34209 Melsungen, Germany
Telephone: +49/5661/71-0
Fax: +49/5661/71-4567

Manufacturer
B. Braun Medical SA
Carretera de Terrassa 121
08191 Rubí (Barcelona), Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Bulgaria, Czech Republic, Denmark, Estonia, Finland, Paracetamol B. Braun 10 mg/ml
France, Hungary, Italy, Latvia, Luxembourg,
Portugal, Slovakia, Spain, Sweden, Netherlands
Belgium Paracetamol B. Braun 10 mg/ml solution for
infusion, oplossing voor infusie, Infusionslösung
Austria, Germany Paracetamol B. Braun 10 mg/ml Infusionslösung
Lithuania Paracetamol B. Braun 10 mg/ml infuzinis tirpalas
Romania Paracetamol B. Braun 10 mg/ml solutie
perfuzabila
Slovenia Paracetamol B. Braun 10 mg/ml raztopina za
infundiranje
Ireland, United Kingdom (Northern Ireland), Malta Paracetamol 10 mg/ml solution for infusion
Norway, Poland Paracetamol B. Braun

Other sources of information
Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://www.urpl.gov

Information intended exclusively for healthcare professionals:

Dosing

The 100 ml polyethylene bottle is intended for use only in adults, adolescents, and children with a body weight above 33 kg.
The 50 ml polyethylene bottle is intended for use only in young children and children with a body weight from over 10 kg to 33 kg.
The 10 ml polyethylene ampoule is intended for use only in full-term newborns, infants, and young children with a body weight up to 10 kg.

The administered volume of the medicinal product must not exceed the specified dose. In such cases, the medicinal product must be diluted before administration to the desired volume with an appropriate infusion solution (see below "Method of administration and dilution") or administered using a syringe pump.
RISK OF DOSING ERRORS
Caution must be exercised to avoid dosing errors due to confusion between milligrams (mg) and millilitres (ml). Such errors may lead to unintentional overdose and patient death (see section 4.2).
The dose is determined based on the patient's body weight (see dosing table below):

10 ml vial
Patient body weight	Dose administered	Volume to be administered	Maximum total volume of a single dose of Paracetamol B. Braun (10 mg/ml solution), calculated for a patient with the maximum body weight within the given range [ml]***	Maximum daily dose**
≤ 10 kg*	7.5 mg/kg body weight	0.75 ml/kg body weight	7.5 ml	30 mg/kg body weight
50 ml bottle
Patient body weight	Dose administered	Volume to be administered	Maximum total volume of a single dose of Paracetamol B. Braun (10 mg/ml solution), calculated for a patient with the maximum body weight within the given range [ml]***	Maximum daily dose**

> 10 kg to ≤ 33 kg	15 mg/kg body weight	1.5 ml/kg body weight	49.5 ml	60 mg/kg body weight, not more than 2 g
100 ml bottle
Patient body weight	Dose administered	Volume to be administered	Maximum total volume of a single dose of Paracetamol B. Braun (10 mg/ml solution), calculated for a patient with the maximum body weight within the given range [ml]***	Maximum daily dose**
> 33 kg to ≤ 50 kg	15 mg/kg body weight	1.5 ml/kg body weight	75 ml	60 mg/kg body weight, not more than 3 g
> 50 kg with additional risk factors for hepatotoxic liver injury	1 g	100 ml	100 ml	3 g
> 50 kg without additional risk factors for hepatotoxic liver injury	1 g	100 ml	100 ml	4 g

*Premature infants:
Data on the safety and efficacy of use in premature infants are not available.
**Maximum daily dose:
The maximum daily dose indicated in the table above applies to patients who are not receiving
other medicinal products containing paracetamol. This dose should be appropriately reduced
taking into account the use of such products.
*** Smaller volumes should be administered to patients with lower body weight.
The minimum interval between individual doses must be at least 4 hours.
The minimum interval between individual doses in patients with severe renal impairment
must be at least 6 hours.
No more than 4 doses should be administered within 24 hours.
Severe renal impairment:
When administering paracetamol to patients with severe renal impairment (creatinine clearance ≤ 30
ml/min), it is recommended to reduce the dose and extend the minimum interval between
administrations to 6 hours.
Adults with hepatic impairment, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), dehydration:
The maximum daily dose must not exceed 3 g (see "Warnings and precautions").
Method of administration and dilution
Paracetamol B. Braun may also be diluted in a 9 mg/ml (0.9%) sodium chloride infusion solution or in a 50 mg/ml (5%) glucose infusion solution, or in a mixture of these solutions, at a ratio of up to 1:10 (one volume of Paracetamol B. Braun to nine volumes of diluent).
For single use only. The medicinal product should be used immediately after first opening the container. Any unused portions of the solution must be discarded.
As with all infusion solutions administered in containers containing an air space, careful monitoring is required, particularly towards the end of the infusion, regardless of the route of administration. Monitoring towards the end of the infusion is especially important for central venous infusions to avoid air embolism.
Shelf-life after first opening of the container
Infusion should begin immediately after connecting the container to the infusion set.
Shelf-life after dilution
Chemical and physical stability has been demonstrated for 48 hours after opening (including infusion time) at 23°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately after opening, the responsibility for storage conditions and duration lies with the user.
Before administration, visually inspect the solution to ensure it contains no visible particles or discoloration. The product should be used only if the solution is clear, colourless or slightly pinkish-orange, and if the container and its closure are undamaged.