781/12621265/0716

Package Leaflet: Information for the user

Paracetamol 10 mg/ml solution for infusion

Paracetamol

Read all of this leaflet carefully, before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
schwarz
• 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.

Dokument = 210 x 594 mm
2 Seiten
What is in this leaflet:
4. Possible side effects
1. What Paracetamol is and what it is used for Lätus
2. What you need to know before you use Paracetamol Like all medicines, this medicine can cause side effects, although not
3. How to use Paracetamol everybody gets them.
4. Possible side effects
5. How to store Paracetamol The following side effects may be serious. If any of them 7727

6. Contents of the pack and other information occur, stop Paracetamol and seek medical attention imme-
diately:
Very rare (may affect up to 1 in 10 000 people) GB__781
1. What Paracetamol is and what it is used for • allergic reactions of varying severity, ranging from skin reactions like Paracetamol 10 mg/ml
nettle rash to allergic shock 781/12621265/0716
This medicine is an analgesic (it relieves pain) and an antipyretic (it • very rare cases of serious skin reactions GIF (EP, MPw)
lowers fever). • abnormally low levels of some types of blood cells (platelets, white Standort Rubi
It is used for cells) can occur.
• short-term treatment of moderate pain, especially following surgery.
• short-term treatment of fever. Other side effects include: Font size: 9,25 pt.
Rare (may affect up to 1 in 1 000 people)
• changes in laboratory test results: abnormally high levels of liver
2. What you need to know before you use Paracetamol enzymes found during blood checks G 150676
Do not use Paracetamol • drop in blood pressure
• malaise
• if you are allergic to paracetamol or to any of the other ingredients
of this medicine (listed in section 6) Not known (frequency cannot be estimated from the available
• if you are allergic (hypersensitive) to propacetamol (another analge- data)
sic, being converted to paracetamol in your body) • redness of the skin, flushing or itching
• if you suffer from a severe liver disease. • abnormally rapid beating of the heart
Frequent side effects at injection site have been reported during clini-
Warnings and precautions cal trials (pain and burning sensation).
Talk to your doctor before you receive Paracetamol
Do not take anything else containing paracetamol while taking this
Reporting of side effects
medicine. If you get any side effects talk to your doctor or pharmacist. This
­includes any possible side effects not listed in this leaflet. You can also
Take special care with Paracetamol
report side effects directly via the Yellow Card Scheme at:
• if you suffer from liver or severe kidney disease, or from chronic
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
alcohol abuse
provide more information on the safety of this medicine.
• if you are taking other medicines containing paracetamol. In this
case your doctor will adjust your dose
• in cases of nutrition problems (states of underfeeding, malnutrition) 5. How to store Paracetamol
or dehydration
• if you suffer from a genetically caused disorder of the enzyme glu- Keep this medicine out of the sight and reach of children.
cose-6-phosphatedehydrogenase (favism) Do not use this medicine after the expiry date which is stated on the
Inform your doctor before treatment if any of the above mentioned packaging after “EXP”. The expiry date refers to the last day of that
conditions apply to you. month.
Prolonged or frequent use of paracetamol is discouraged. It is recom- Do not store above 30 °C.
mended that this medicine should only be used until you are able to Keep the container in the outer carton in order to protect from light.
take pain killers by mouth again.
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Your doctor will assure not to give you doses higher than recommend-
ed. This may lead to severe liver damage.
6. Contents of the pack and other information
What Paracetamol contains:
Other medicines and Paracetamol
The active substance is paracetamol.
Tell your doctor or pharmacist if you are taking, have recently taken or One ml contains 10 mg paracetamol.
might take any other medicines. Each 10 ml ampoule contains 100 mg paracetamol.
This is especially important if you are taking: Each 50 ml bottle contains 500 mg paracetamol.
• a medicine called probenecid (used to treat gout): reduction of the Each 100 ml bottle contains 1000 mg paracetamol.
paracetamol dose may be required. The other ingredients are:
• painkillers containing salicylamide: adjustment of the dose may be Mannitol, sodium citrate dihydrate, acetic acid glacial (for pH adjust-
required. ment), water for injections.
• medicines that activate liver enzymes: strict control of the paraceta-
mol dose is required in order to avoid liver damage. What Paracetamol solution for infusion looks like and con-
• any blood thinning medicines (anticoagulants): a more careful con- tents of the pack
trol of the effect of these medicines may be necessary.
Paracetamol solution for infusion is a clear and colourless to slightly
This medicine contains paracetamol and this must be taken into ac- pinkish-orangish solution. Perception may vary.
count if other medicines containing paracetamol or propacetamol are
Paracetamol is supplied in plastic bottles of 50 ml of 100 ml or a plastic
taken, in order to avoid overdose (see section 3).
ampoule of 10 ml.
Pregnancy and breastfeeding Pack sizes: 20 x 10 ml, 10 × 50 ml, 10 × 100 ml
If you are pregnant or breast-feeding, think you may be pregnant or Not all pack sizes may be marketed.
are planning to have a baby, ask your doctor for advice before taking
this medicine. Marketing Authorisation Holder
• Pregnancy B. Braun Melsungen AG
Tell your doctor if you are pregnant or you think you may be pregnant. Carl-Braun-Straße 1 Postal Address:
Paracetamol may be used during pregnancy. However, in this case the 34212 Melsungen, Germany 34209 Melsungen, Germany
doctor must evaluate if the treatment is advisable.
Phone: +49/5661/71-0
• Breast-feeding Fax: +49/5661/71-4567
Paracetamol may be used during breast-feeding.
This medicinal product is authorised in the Member States of
Paracetamol contains sodium the EEA under the following names:
This medicine contains less than 1 mmol (23 mg ) sodium, this means it Austria, Germany P aracetamol B. Braun 10 mg/ml
is essentially sodium free. Infusionslösung
Belgium Paracetamol B. Braun 10 mg/ml solution
for infusion, oplossing voor infusie,
3. How to use Paracetamol Infusionslösung
The recommended dose is: Bulgaria, Czech Republic,
The dose will be individually adjusted by your doctor, based on your Estonia, Finland, France,
weight and general condition. Italy, Luxembourg, Portugal,
Slovakia, Sweden,
Method of administration The Netherlands Paracetamol B. Braun 10 mg/ml
This medicine will be given to you by a doctor through a drip into a Ireland, United Kingdom Paracetamol 10 mg/ml solution for infusion
vein (intravenous use). This usually takes about 15 minutes. You will be Latvia Paracetamol B. Braun 10 mg/ml šķīdums
closely monitored during and especially towards the end of the infu- infūzijām
sion. Lithuania Paracetamol B. Braun 10 mg/ml infuzinis
tirpalas
If you have the impression that the effect of Paracetamol solution for
Denmark, Poland, Norway Paracetamol B. Braun
infusion is too strong or too weak, talk to your doctor.
Romania Paracetamol B. Braun 10 mg/ml solutie
If you are given more Paracetamol than you should perfuzabila
Slovenia Paracetamol B. Braun 10 mg/ml raztopina
Overdose is unlikely as you will be given this medicine by a healthcare
za infundiranje
professional.
Spain Paracetamol B. Braun 10 mg/ml solución
Your doctor will assure not to give you doses higher than recommended. para perfusión EFG
In overdose cases, symptoms generally appear within the first 24 hours
and comprise: feeling sick, being sick, anorexia (loss of appetite), pasty This leaflet was last revised in 06/2016.
skin and abdominal pain. These symptoms could reflect liver injury. If
you think you may have been given an overdose, tell a doctor imme-
diately. Immediate medical advice should be sought in the event of an
overdose, even if you feel well, to avoid risk of serious and irreversible
liver damage. If required an antidote may be given to you.
If you have any further questions on the use of this medicine ask your
doctor or pharmacist.
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B|BRAUN

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 781/12621265/0716

The following information is intended for healthcare professionals only:

Posology
• The polyethylene bottle containing 100 ml is restricted to adults, adolescents and children weighing more than 33 kg.
• The polyethylene bottle containing 50 ml is restricted to toddlers and children weighing more than 10 kg and up to 33 kg.
• The polyethylene ampoule containing 10 ml is restricted to term newborn infants, infants and toddlers weighing up to 10 kg.
The volume to be administered must not exceed the determined dose. If applicable the desired volume must be diluted in a suitable solution
for infusion prior to administration (see below ‘Method of administration and dilution’) or a syringe driver must be used.
RISK OF MEDICATION ERRORS
Take care to avoid dosing errors due to confusion between milligram (mg) and milliliter (ml), which could result in accidental overdose and death.
Prolonged or frequent use is discouraged. It is recommended that a suitable analgesic oral treatment will be used as soon as this route of admin-
istration is possible.
Dosing based on patient weight (please see the dosing table here below)
10 ml ampoule
Patient weight Dose Volume per Maximum volume of Maximum daily dose**
per administration administration Paracetamol (10 mg/ml)
per administration based
on upper weight limits
of group (ml)***
≤ 10 kg* 7.5 mg/kg 0.75 ml/kg 7.5 ml 30 mg/kg

50 ml bottle
Patient weight Dose per administration Volume per Maximum volume of Maximum daily dose**
administration Paracetamol (10 mg/ml)
per administration based
on upper weight limits
of group (ml)***
> 10 kg to 15 mg/kg 1.5 ml/kg 49.5 ml 60 mg/kg
≤ 33 kg not exceeding 2 g

100 ml bottle
Patient weight Dose Volume per Maximum volume of Maximum daily dose**
(per administration) administration Paracetamol (10 mg/ml)
per administration based
on upper weight limits
of group (ml)***
> 33 kg and 15 mg/kg 1.5 ml/kg 75 ml 60 mg/kg
≤ 50 kg not exceeding 3 g
> 50 kg with additional 1g 100 ml 100 ml 3g
risk factors for hepato-
toxicity
> 50 kg and no additional 1g 100 ml 100 ml 4g
risk factors for hepato-
toxicity
* Preterm newborn infants:
No safety and efficacy data are available for premature newborn infants
** Maximum daily dose:
The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should
be adjusted accordingly taking such products into account.
*** Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4 hours.
The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.
Severe renal insufficiency:
It is recommended, when giving paracetamol to patients with severe renal impairment (creatinine clearance ≤ 30 ml/min), to reduce the dose and
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increase the minimum interval between each administration to 6 hours.

Adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration:
The maximum daily dose must not exceed 3 g (see section ‘warnings and precautions’).
Method of administration and dilution
Paracetamol can also be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion or a com-
bination of both solutions up to one tenth (one volume Paracetamol into nine volumes diluent).
For single use only. The medicine should be used immediately after opening. Any unused solution should be discarded.
As for all solutions for infusion presented in containers with air space inside, it should be remembered that close monitoring is needed notably at
the end of the infusion, regardless of administration route. This monitoring at the end of the infusion applies particularly for central route infu-
sions, in order to avoid air embolism.
Shelf life after first opening
The infusion should commence immediately after connecting the container to the giving set.
Shelf life after dilution
Chemical and physical in use stability (including infusion time) has been demonstrated for 48 hours at 23° C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior
to use are the responsibility of the user.
Before administration, the medicine should be visually inspected for any particulate matter and discolouration. Only to be used if solution is clear,
colourless or slightly pinkish-orangish (perception may vary) and the container and its closure are undamaged.
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B|BRAUN B. Braun Melsungen AG

34209 Melsungen
Germany

12621265_Paracetamol10_EP-MPw-GIF210x594__GB_781.indd 2 22.07.16 09:49