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PARACETAMOL 10 MG/ML SOLUTION FOR INFUSION

Active substance(s): PARACETAMOL

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781/12621265/0615

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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as
yours.
• 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.

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

1. What Paracetamol is and what it is used for
This medicine is an analgesic (it relieves pain) and an antipyretic (it
lowers fever).
It is used for
• short-term treatment of moderate pain, especially following surgery.
• short-term treatment of fever.

2. What you need to know before you use Paracetamol
Do not use Paracetamol
• if you are allergic to paracetamol or to any of the other ingredients
of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to propacetamol (another analgesic, being converted to paracetamol in your body)
• if you suffer from a severe liver disease.

Warnings and precautions
Talk to your doctor before you receive Paracetamol
Take special care with Paracetamol
• if you suffer from liver or severe kidney disease, or from chronic
alcohol abuse
• 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)
or dehydration
• if you suffer from a genetically caused disorder of the enzyme glucose-6-phosphatedehydrogenase (favism)
Inform your doctor before treatment if any of the above mentioned
conditions apply to you.
Prolonged or frequent use of paracetamol is discouraged. It is recommended that this medicine should only be used until you are able to
take pain killers by mouth again.
Your doctor will assure not to give you doses higher than recommended. This may lead to severe liver damage.

Other medicines and Paracetamol
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
This is especially important if you are taking:
• a medicine called probenecid (used to treat gout): reduction of the
paracetamol dose may be required.
• painkillers containing salicylamide: adjustment of the dose may be
required.
• medicines that activate liver enzymes: strict control of the paracetamol dose is required in order to avoid liver damage.
• any blood thinning medicines (anticoagulants): a more careful control of the effect of these medicines may be necessary.
This medicine contains paracetamol and this must be taken into account if other medicines containing paracetamol or propacetamol are
taken, in order to avoid overdose (see section 3).

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor for advice before taking
this medicine.
• Pregnancy
Tell your doctor if you are pregnant or you think you may be pregnant.
Paracetamol may be used during pregnancy. However, in this case the
doctor must evaluate if the treatment is advisable.
• Breast-feeding
Paracetamol may be used during breast-feeding.

Paracetamol contains Sodium
This medicine contains less than 1 mmol (23 mg ) sodium, this means it
is essentially sodium free.

3. How to use Paracetamol
The recommended dose is:
The dose will be individually adjusted by your doctor, based on your
weight and general condition.

Method of administration
This medicine will be given to you by a doctor through a drip into a
vein (intravenous use). This usually takes about 15 minutes. You will be
closely monitored during and especially towards the end of the infusion.
If you have the impression that the effect of Paracetamol solution for
infusion is too strong or too weak, talk to your doctor.

If you are given more Paracetamol than you should
Overdose is unlikely as you will be given this medicine by a healthcare
professional.
Your doctor will assure not to give you doses higher than recommended.
In overdose cases, symptoms generally appear within the first 24 hours
and comprise: feeling sick, being sick, anorexia (loss of appetite), pasty
skin and abdominal pain. These symptoms could reflect liver injury.

4. Possible side effects

Lätus

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

The following side effects may be serious. If any of them occur, stop Paracetamol and seek medical attention immediately:

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GB__781
Paracetamol 10 mg/ml
781/12621265/0615
GIF (EP, MPw)
Standort Rubi

Very rare (may affect up to 1 in 10 000 people)
• allergic reactions of varying severity, ranging from skin reactions like
nettle rash to allergic shock
• abnormally low levels of some types of blood cells (platelets, white
cells) can occur.

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
enzymes found during blood checks
• drop in blood pressure
• malaise
Not known (frequency cannot be estimated from the available
data)
• redness of the skin, flushing or itching
• abnormally rapid beating of the heart
Frequent side effects at injection site have been reported during clinical trials (pain and burning sensation).

G 150676

Reporting of side effects
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
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Paracetamol
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
packaging after “EXP”. The expiry date refers to the last day of that
month.
Do not store above 30 °C.
Keep the container in the outer carton in order to protect from light.

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What is in this leaflet:

schwarz

Dokument = 210 x 594 mm
2 Seiten

6. Contents of the pack and other information
What Paracetamol contains:
The active substance is paracetamol.
One ml contains 10 mg paracetamol.
Each 10 ml ampoule contains 100 mg paracetamol.
Each 50 ml bottle contains 500 mg paracetamol.
Each 100 ml bottle contains 1000 mg paracetamol.
The other ingredients are:
Mannitol, sodium citrate dihydrate, acetic acid glacial (for pH adjustment), water for injections.

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

Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Phone: +49/5661/71-0
Fax: +49/5661/71-4567

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

This leaflet was last revised in 06/2015.

If you think you may have been given an overdose, tell a doctor immediately. 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.

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If you have any further questions on the use of this product ask your
doctor or pharmacist.

B|BRAUN
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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 administration is possible.
Dosing based on patient weight (please see the dosing table here below)
10 ml ampoule
Patient weight

Dose
per administration

Volume per
administration

Maximum volume of
Paracetamol (10 mg/ml)
per administration based
on upper weight limits
of group (ml)***

Maximum daily dose**

≤ 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
administration

Maximum volume of
Paracetamol (10 mg/ml)
per administration based
on upper weight limits
of group (ml)***

Maximum daily dose**

> 10 kg to
≤ 33 kg

15 mg/kg

1.5 ml/kg

49.5 ml

60 mg/kg
not exceeding 2 g

Patient weight

Dose
(per administration)

Volume per
administration

Maximum volume of
Paracetamol (10 mg/ml)
per administration based
on upper weight limits
of group (ml)***

Maximum daily dose**

> 33 kg and
≤ 50 kg

15 mg/kg

1.5 ml/kg

75 ml

60 mg/kg
not exceeding 3 g

> 50 kg with additional
risk factors for hepatotoxicity

1g

100 ml

100 ml

3g

> 50 kg and no additional
risk factors for hepatotoxicity

1g

100 ml

100 ml

4g

100 ml bottle

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
increase the minimum interval between each administration to 6 hours.

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* 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.

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 combination 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 infusions, in order to avoid air embolism.
Shelf life after first opening
The infusion should commence immediately after connecting the container to the giving set.

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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.

B|BRAUN B. Braun Melsungen AG
34209 Melsungen
Germany

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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