Skip to Content

UK Edition. Click here for US version.

PARACETAMOL UNI-PHARMA 10 MG/ML SOLUTION FOR INFUSION

Active substance(s): PARACETAMOL

View full screen / Print PDF » Download PDF ⇩
Transcript
Paracetamol
UNI-PHARMA

10 mg/ml Solution for Infusion
Paracetamol

PAC K AG E L E A F L E T: I N F O R M AT I O N F O R T H E U S E R
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.
• 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. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Paracetamol Uni-Pharma is and what it is used for
2. What you need to know before you use Paracetamol Uni-Pharma
3. How to use Paracetamol Uni-Pharma
4. Possible side effects
5. How to store Paracetamol Uni-Pharma
6. Contents of the pack and other information
1. What Paracetamol Uni-Pharma is and what it is used for
This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers
fever).
It is indicated for the short-term treatment of moderate pain, especially
following surgery, and for the short-term treatment of fever.
2. What you need to know before you use Paracetamol Uni-Pharma
Do not use Paracetamol Uni-Pharma
• if you are allergic (hypersensitive) 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 for
infusion and a precursor of paracetamol)
• if you suffer from a severe liver disease.
Warnings and precautions
Talk to your doctor before using Paracetamol Uni-Pharma
• use a suitable analgesic oral treatment as soon as this administration route is
possible.
• if you suffer from a liver or kidney disease, or from alcohol abuse,
• if you are taking other medicines containing paracetamol,
• in cases of nutrition problems (malnutrition) or dehydration.
Inform your doctor before treatment if any of the above mentioned conditions

apply to you.
Other medicines and Paracetamol Uni-Pharma
Tell your doctor if you are taking have recently taken or might take any other
medicines.
• This medicine contains paracetamol and this must be taken into account if
other medicines containing paracetamol or propacetamol are taken, in order
not to exceed the recommended daily dose. Inform your doctor if you are taking
other medicines containing paracetamol or propacetamol.
• A dose reduction should be considered if you are also talking Probenecid.
• Please inform your doctor or pharmacist if you are taking oral anticoagulants.
Closer check-ups of the effect of the anticoagulant might be necessary.
Pregnancy and breast-feeding
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.
Paracetamol Uni-Pharma can be used during pregnancy. You should use the
lowest possible dose that reduces your pain and/or your fever and use it for the
shortest time possible. Contact your doctor if the pain and/or fever are not
reduced or if you need to take the medicine more often.
Paracetamol Uni-Pharma may be used during breast-feeding.
Paracetamol Uni-Pharma contains sodium
This medicinal product contains less than 10.9 mmol sodium (250 mg) per 100
ml of Paracetamol Uni-Pharma. To be taken into consideration by patients on a
controlled sodium diet.
3. How to use Paracetamol Uni-Pharma
• 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 Uni-Pharma 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.
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.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
In rare cases (may affect up to 1 in 1,000 people):
• malaise (a feeling of being unwell),
• drop in blood pressure
• changes in laboratory test results such as abnormally high levels of liver
enzymes found during blood checks. Should this occur, inform your doctor as
regular blood checks may be required later.
Very rare cases (may affect up to 1 in 10,000 people),
• of serious skin reactions have been reported
• of allergic reaction may occur.
Stop the treatment immediately and inform your doctor.
Other changes in laboratory test results have been observed which have
resulted in regular blood checks: abnormally low levels of some types of blood
cells (platelets, white cells), possibly leading to bleeding from the nose or gums.
Should this occur, inform your doctor.
Cases of redness of the skin, flushing, itching and abnormally rapid beating of
the heart have been reported.
Cases of pain and burning sensation at injection site have been reported.
Additional side effects in children and adolescents
Please read the above section for side effects. There are no additional side effects
that are specific to children and adolescents.
Reporting of side effects
If you get any side effects, talk to your doctor. 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 Uni-Pharma
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 label after
EXP.
The expiry date refers to the last day of that month.

The following information is intended for healthcare professionals only:
Posology
The polypropylene bag containing 100 ml is restricted to adults, adolescents
and children weighing more than 33 kg.
The volume to be administered must not exceed the determined
dose.
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)
*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 increase the minimum
interval between each administration to 6 hours.
In adults with hepatocellular insufficiency, chronic alcoholism, chronic
malnutrition (low reserves of hepatic glutathione), dehydration:
The maximum daily dose must not exceed 3 g.
Method of administration
The paracetamol solution is administered as a 15-minute intravenous infusion.
In children, the volume of solution to be infused is 1.5 ml per kg per
administration
For single use. The overwrap should be removed shortly before use. The
product should be used immediately after opening. Any unused solution
should be discarded.
Shelf -life after first opening
Chemical and physical in-use stability has been demonstrated for 24 hours at
25°C without overwrapping.
From a microbiological point of view, unless the method of opening precludes
the risk of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the
responsibility of the user.
Before administration, the product should be visually inspected for any
particulate matter and discoloration. Do not use this medicine if you notice any
particulate matter and discoloration. There could be a potential presence of
moisture between the bag and the outer packaging as a result of the
sterilisation process. This does not impact the quality of the solution.

Patient
Weight

Dose
Volume
per
per
administration administration

This medicinal product does not require any special temperature storage
conditions. Do not refrigerate or freeze. Keep the bag in the outer carton to
protect the product from light.
Do not throw away any medicines via wastewater. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What Paracetamol Uni-Pharma contains
• The active substance is paracetamol. One ml contains 10 mg paracetamol.
• The other ingredients are: hydroxypropylbetadex, disodium edetate, sodium
chloride, sodium dihydrogen phosphate dihydrate (E339), disodium hydrogen
phosphate dihydrate (E339) and water for injections.
What Paracetamol Uni-Pharma looks like and contents of the pack
Paracetamol Uni-Pharma is a clear to slightly yellowish solution
Paracetamol Uni-Pharma is supplied in 100ml polypropylene bags equipped
with an infusion site, consisting of a tube sealed with a rubber stopper and an
aluminium cap. The bags are overwrapped with an aluminium foil, a metalized
film or with a polyethylene - based multilayer film and are available in packs of
1 x 100 ml, 10 x 100 ml, 20 x 100 ml or 50 x 100 ml bags. Not all pack sizes may
be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
14th km National Road 1, GR-145 64 Kifissia - Greece
Manufacturer
SALF SpA Laboratorio Farmacologico
Via Marconi 2, 24069 Cenate Sotto (Bergamo), Italy
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
14th km National Road 1, GR-145 64 Kifissia - Greece
This medicinal product is authorised in the Member States of the EEA
under the following names:
Italy: Exopon 10 mg/ml Solution for Infusion
Netherlands: Apotel 10 mg/ml Solution for Infusion
Spain: Apotel 10 mg/ml Solution for Infusion
France: Apotel 10 mg/ml Solution for Infusion
Germany: Exopon 10 mg/ml Solution for Infusion
Portugal: Paracetamol Uni-Pharma 10 mg/ml Solution for Infusion
Denmark: Apotel 10 mg/ml Solution for Infusion
Sweden: Exopon 10 mg/ml Solution for Infusion
United Kingdom: Paracetamol Uni-Pharma 10 mg/ml Solution for Infusion
This leaflet was last revised in 11/2015

Maximum volume of
Paracetamol Uni-Pharma
per administration based
on upper weight limits of
group (mL)**

Maximum Daily Dose *

>33 kg to
≤ 50 kg

15mg / kg

15mg / kg

75 mL

60mg/kg
not exceeding 3g

>50 kg with
additional risk
factors for
hepatotoxicity

1g

100 mL

100 mL

3g

>50 kg with no
additional risk
factors for
hepatotoxicity

1g

100 mL

100 mL

4g

11.2015 U131186
UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
14th km National Road 1, 145 64 Kifissia, Greece
Tel.: +30-210-80 72 512, Fax:+30- 210-80 78 907, e-mail: unipharma@uni-pharma.gr, www.uni-pharma.gr

Expand view ⇕

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.

Hide