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Paracetamol 10mg/ml Solution for Infusion

Read all of this leaflet carefully before you are given this Take special care with Paracetamol 10mg/ml Solution for
medicine. Infusion
• Keep this leaflet. You may need to read it again. • Use a suitable oral pain killer as soon as possible.
• If you have any further questions, ask your doctor, nurse or • If you suffer from a liver disease, severe kidney disease or from
pharmacist. alcohol abuse.
• If you are taking other medicines containing paracetamol.
• This medicine has been prescribed for you. Do not pass it on • In cases of nutrition problems (malnutrition) or dehydration.
to others. It may harm them, even if their symptoms are the Inform your doctor before treatment if any of the above mentioned
same as yours. conditions apply to you.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or Taking other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have
pharmacist. recently taken any other medicines, including medicines obtained
without a prescription or herbal medicines and natural products.
In this leaflet: Take particular care if you are taking the following medicines while
1 W under treatment with Paracetamol 10mg/ml Solution for Infusion:
 hat Paracetamol 10mg/ml Solution for Infusion is • other paracetamol-containing products, in order not to exceed the
and what it is used for recommended daily dose.
2 B efore you use • probenecid.
• oral anticoagulants. More check-ups to look at the effect of the
3 H ow to use anticoagulant might be needed.
4 P ossible side effects
5 H Pregnancy and breast-feeding
 ow to store Inform your doctor or nurse if you are pregnant, may be pregnant or
6  F
 urther information are breast-feeding. Paracetamol 10mg/ml Solution for Infusion may
be used during pregnancy, however, the doctor must evaluate if the
treatment is advisable.
1 What Paracetamol 10mg/ml Solution for Infusion is Ask your doctor, nurse or pharmacist for advice before taking any
and what it is used for medicine.
Paracetamol 10mg/ml Solution for Infusion is used as an analgesic
(relieves pain) and an antipyretic (lowers fever). Important information about some of the ingredients of
It is used for: Paracetamol 10mg/ml Solution for Infusion
• short-term treatment of moderate pain, especially following surgery This medicinal product contains 4.32 mmol sodium per dose. To be
• short-term treatment of fever. taken into consideration by patients on a controlled sodium diet.

2 Before you use 3 How to use


For intravenous use (injection into a vein).
Do not use Paracetamol 10mg/ml Solution for Infusion
if you: The 50ml vial is restricted to term newborn infants, infants, toddlers
• are allergic (hypersensitive) to paracetamol or any of the other and children weighing less than 33kg.
ingredients of Paracetamol 10mg/ml Solution for Infusion. An The 100ml vial is restricted to adults, adolescents and children
allergic reaction may include a rash, itching, difficulty breathing or weighing more than 33kg.
swelling of the face, lips, throat or tongue.
• are allergic (hypersensitive) to propacetamol (another analgesic Dosage
similar to paracetamol). Do not give anything else containing paracetamol while
• suffer from severe liver disease. using this medicine.
The dose you will be given will be decided by the doctor and will
depend on your weight, liver and kidney function.

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BBBA1153 Continued over page

The following information is intended for medical or healthcare professionals only:


Paracetamol 10mg/ml Solution for Infusion
The 50ml vial is restricted to term newborn infants, infants, toddlers and children weighing less than 33kg.
The 100ml vial is restricted to adults, adolescents and children weighing more than 33kg.
Dosage
Dosing based on patient weight (please see table below):
Patient weight Dose per Volume per Maximum volume of Maximum Daily Dose **
administration administration paracetamol, solution
for infusion (10mg/
mL) per administration
based on upper weight
limits of group (mL)***
≤10kg * 7.5mg/kg 0.75mL/kg 75mL 30mg/kg
> 10kg to ≤33kg 15mg/kg 1.5mL/kg 49.5mL 60mg/kg not exceeding 2g

> 33kg to ≤50kg 15mg/kg 1.5mL/kg 75mL 60mg/kg not exceeding 3g


>50kg with additional 1g 100mL 100mL 3g
risk factors for
hepatotoxicity
> 50kg and no 1g 100mL 100mL 4g
additional risk factors
for hepatotoxicity

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BBBA1153

Paracetamol IV 10mg/ml Solution for Infusion PIL - UK


approved for print/date Colours Non Printing Colours
Item no: BBBA1153
1. Black 1.
Originator: C.Grant Dimensions: 150 x 315
Origination Date: 15/08/17 Min Body Text Size: 7pt 2. 2.
Revision Date: 29/08/17 Supplier: Neogen 3. 3.
Revised By: C.Grant 4.
Proof Round
02 Technical Date sent: 15/08/17
5.
6.
UK-Eire-Artwork-Support@Actavis.com Approval Date received: 29/08/17

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.
Patient Dose per Volume Maximum volume of Maximum Tell your doctor or nurse if you experience the following side effects:
weight adminis- per paracetamol, solu- Daily Rare (occurs in less than 1 in 1,000 patients):
tration adminis- tion for infusion (10 Dose ** • a general feeling of being unwell (malaise)
tration mg/mL) per admin- • a drop in blood pressure
istration based on • changes in liver enzymes found during blood checks. Should this
upper weight limits occur, inform your doctor as regular blood checks may be required
of group (mL)*** later.
≤10kg * 7.5mg/kg 0.75mL/kg 7.5mL 30mg/kg Very Rare (occurs in less than 1 in 10,000 patients):
> 10kg to 15mg/kg 1.5mL/kg 49.5mL 60mg/kg • very rare cases of serious skin reactions have been reported.
≤33kg not exceed- Not Known (cannot be estimated from available data):
ing 2g • other changes in laboratory test results which may result in regular
> 33kg to 15mg/kg 1.5mL/kg 75mL 60mg/kg blood checks: abnormally low levels of some types of blood cells
≤50kg not exceed- (platelets, white cells) can occur, possibly leading to bleeding from
ing 3g the nose or gums.
>50kg with 1g 100mL 100mL 3g If any of the side effects gets serious, or if you notice any
additional side effects not listed in this leaflet, please tell your doctor or
risk factors pharmacist.
for hepato-
Reporting of side effects
toxicity
If you get any side effects, talk to your doctor or pharmacist. This
> 50kg 1g 100mL 100mL 4g includes any possible side effects not listed in this leaflet. You can also
and no report side effects directly via the Yellow Card Scheme Website:
additional www.mhra.gov.uk/yellowcard
risk factors
for hepato- By reporting side effects you can help provide more information on the
toxicity safety of this medicine.
* Pre-term newborn infants: No safety and efficacy data are available 5 How to store
for pre-term newborn infants.
Keep out of the sight and reach of children.
**Maximum daily dose: The maximum daily dose as presented in Do not use Paracetamol 10mg/ml Solution for Infusion after the expiry
the table above is for patients that are not receiving other paracetamol date which is stated on the label and carton after EXP. The expiry date
containing products and should be adjusted accordingly taking such refers to the last day of that month.
products into account. Store below 30ºC. Protect from light. Store in the original package. Do
***Patients weighing less will require smaller volumes. not refrigerate or freeze.
The minimum interval between each administration must be at Medicines should not be disposed of via wastewater or household
least 4 hours. waste. Ask your pharmacist how to dispose of medicines no longer
The minimum interval between each administration in patients required. These measures will help to protect the environment.
with severe renal insufficiency must be at least 6 hours. 6  Further information
No more than 4 doses to be given in 24 hours.
In patients weighing 50kg or less or with risk factors, you will be What Paracetamol 10mg/ml Solution for Infusion contains
given a maximum dose of 3g per day. • The active substance is paracetamol.
• One ml contains 10mg paracetamol.
If you are given more Paracetamol 10mg/ml Solution for Infusion • Each 50ml vial contains 500mg paracetamol.
than you should • Each 100ml vial contains 1000mg paracetamol in 100ml.
Talk to a doctor at once if you are given too much of this medicine • The other ingredients are: cysteine hydrochloride monohydrate,
even if you feel well. This is because too much paracetamol can disodium phosphate dihydrate, hydrochloric acid (1M) (for pH-
cause delayed, serious liver damage. Contact your doctor, nurse or adjustment), sodium hydroxide (1M) (for pH-adjustment), mannitol,
pharmacist immediately if you experience the following symptoms of water for injections.
an overdose within the first 24 hours: feeling or being sick, weight loss,
pale skin (pallor) or abdominal pain. What Paracetamol 10mg/ml Solution for Infusion looks
If you forget to use Paracetamol 10mg/ml Solution for Infusion like and contents of the pack
If you forget to use Paracetamol 10mg/ml Solution for Infusion, pain Vials 50ml and 100ml.
or fever is likely to return. Do not take a double dose to make up for Paracetamol 10mg/ml Solution for Infusion is a clear solution.
forgotten individual doses. The vials are packed in carton boxes. Each box contains:
50ml: 10 vials
If you have any further questions on the use of Paracetamol 10mg/ml 100ml: 10 vials
Solution for Infusion, ask your doctor, nurse or pharmacist.
Marketing Authorisation Holder
4 Possible side effects Accord Healthcare Limited, Sage House , 319 Pinner Road,
Like all medicines, Paracetamol 10mg/ml Solution for Infusion can North Harrow, Middlesex, HA1 4HF, United Kingdom
cause side effects, although not everybody gets them. Manufacturer
Contact your doctor or nurse and stop treatment immediately SM Farmaceutici SRL, Zona industrial – 85050 Tito, Potenza, Italy
if you experience an allergic reaction with symptoms such as This leaflet was last revised in August 2017
swelling of the face, lips, tongue and throat, difficulty breathing or
swallowing or a skin rash.
If you would like a
leaflet with larger
text, please contact
01271 385257

Continued top of next column Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

* Pre-term newborn infants: No safety and efficacy data are Method of administration
available for pre-term newborn infants.
RISK OF MEDICATION ERRORS
**Maximum daily dose: The maximum daily dose as presented Take care to avoid dosing errors due to confusion between
in the table overleaf is for patients that are not receiving other milligram (mg) and millilitre (mL), which could result in
paracetamol containing products and should be adjusted accidental overdose and death.
accordingly taking such products into account.
The paracetamol solution is administered as a 15-minute
***Patients weighing less will require smaller volumes. intravenous infusion (injection into a vein).

The minimum interval between each administration must be As for all solutions for infusion presented in glass vials, it should be
at least 4 hours. remembered that close monitoring is needed notably at the end
The minimum interval between each administration in patients of the infusion, regardless of administration route. This monitoring
with severe renal insufficiency must be at least 6 hours. at the end of the infusion applies particularly for central route
No more than 4 doses to be given in 24 hours. infusions, in order to avoid air embolism.

Do not exceed the stated dose. Do not use Paracetamol 10mg/ml Solution for Infusion if you
notice any particulate matter and discolouration.
Kidney disease: For single use only. The product should be used immediately after
It is recommended when giving paracetamol to patients with opening. Any unused solution should be discarded.
severe renal impairment (creatinine clearance ≤ 30mL/min), to For the 50ml and 100ml vials, a 0.8mm needle (21 gauge needle)
increase the minimum interval between each administration to 6 has to be used and the stopper vertically perforated at the spot
hours. specifically indicated.

For the 50ml vial, it can also be diluted in 0.9% sodium chloride or
5% glucose up to one tenth (one volume paracetamol into nine
volumes diluent).
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BBBA1153 Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

Paracetamol IV 10mg/ml Solution for Infusion PIL - UK


approved for print/date Colours Non Printing Colours
Item no: BBBA1153
1. Black 1.
Originator: C.Grant Dimensions: 150 x 315
Origination Date: 15/08/17 Min Body Text Size: 7pt 2. 2.
Revision Date: 29/08/17 Supplier: Neogen 3. 3.
Revised By: C.Grant 4.
Proof Round
02 Technical Date sent: 15/08/17
5.
6.
UK-Eire-Artwork-Support@Actavis.com Approval Date received: 29/08/17

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.