Paracetamol 10 Mg/Ml Solution For Infusion
1
Version:V002/15/10/2015/PL20117/0204
Supersedes:V001/16/03/2012/PL20117/0204
Package leaflet: Information for the user
Paracetamol 10 mg/ml solution for infusion
Read all of this leaflet carefully before
you start taking 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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Paracetamol solution for infusion is and what it is used for
2. What you need to know before you use Paracetamol solution for infusion
3. How to use Paracetamol solution for infusion
4. Possible side effects
5. How to store Paracetamol solution for infusion
6. Contents of the pack and other information
1. What Paracetamol solution for infusion is and what it is used for
This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers fever).
The 100 ml vial is restricted to adults, adolescents and children weighing more than 33 kg.
The 50 ml vial is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg.
It is indicated for the short-term treatment ofmoderate pain, especiallyfollowing surgery, and for the short-term treatment of fever.
2. What you need to know before you use Paracetamol solution for . infusion
Do not use Paracetamol solution for infusion
• if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to propacetamol (another analgesicfor infusion and a precursor of paracetamol).
• if you suffer from a severe liver disease.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Paracetamol solution for infusion
• if you suffer from a liver or kidney disease, orfrom alcohol abuse,
• if you are taking other medicines containing paracetamol,
• in cases of nutrition problems (malnutrition) or dehydration.
• if you suffer from Gilbert's syndrome (familial non-haemolytic jaundice)
• use a suitable analgesic oral treatment as soon as this administration route is possible.
Other medicines and Paracetamol solution for infusion
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 (see section “How to use paracetamol solution forinfusion”). Inform your doctor if you are taking other medicines containing paracetamol or propacetamol.
A dose reduction should be considered for concomitant treatment with 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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Inform your doctor if you are pregnant. Paracetamol solution for infusion may be used during pregnancy. However, in this case the doctor must evaluate if the treatment is advisable.
Breast-feeding
Paracetamol Solution for infusion may be used during breast-feeding.
Paracetamol solution for infusion contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml of Paracetamol solution for infusion, i.e. essentially "sodium free".
3. How to use Paracetamol solution for infusion
Intravenous use.
The 100 ml vial is restricted to adults, adolescents and children weighing more than 33 kg.
The 50 ml vial is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg.
For the 50 ml and 100 ml vial, close monitoring is needed before the end of infusion.
Dose
The dose calculation should be based only on the patient's weight (see also below the dosing table overview).
Adolescents and adults weighing more than 50 ko:
1g of paracetamol per administration, i.e. a 100 ml vial or 100 ml bag, up to 4 times a day.
Leave an interval of at least 4 hours between administrations.
The maximum dose must not exceed 4 g of paracetamol per day, taking into account all the medicines containing paracetamol or propacetamol.
Children weighing more than 33 kg, adolescents and adults weighing less than 50 kg:
15 mg/kg paracetamol peradministration, i.e. 1.5 ml solution per kg, up to 4 times a day.
Leave an interval of at least 4 hours between administrations.
The maximum dose must not exceed 60 mg paracetamol per kilo and per day (without exceeding 3 g), taking into account all the medicines containing paracetamol or propacetamol.
Children weighing more than 10 kg and weighing less than 33 kg:
15 mg/kg paracetamol peradministration, i.e. 1.5 ml solution per kg, up to 4 times a day.
Leave an interval of at least 4 hours between administrations.
The maximum dose must not exceed 60 mg paracetamol per kilo and per day (without exceeding 2 g), taking into account all the medicines containing paracetamol or propacetamol.
Term newborn infants , infants, toddlers and children weighing less than 10 ko:
7.5 mg/kg paracetamol per administration, i.e. 0.75 ml solution per kg up to 4 times a day.
Leave an interval of at least 4 hours between administrations.
The maximum dose must not exceed 30 mg paracetamol per kg and per day, taking into account all the medicines containing paracetamol or propacetamol.
Tell your doctor or pharmacist if you are No safety and efficacy data are available
taking, have recently taken or might take for premature neonates,
any other medicines.
Dosing based on patient weight (please Paracetamol solution for infusion with see the dosing table below) food, drink and alcohol
Limit the use of alcohol during treatment with this medicine.
|
Patient weight |
Single dose |
Maximum daily dose1 |
|
<10 kg2 |
7.5 mg/kg paracetamol per administration, i.e. 0.75 ml solution per kg |
• Uptofourtimesaday • The minimum interval between each administration must be 4 hours • The maximum daily dose must not exceed 30 mg/kg (i.e. 3 ml/kg) |
|
>10kg and < 33 kg |
15 mg/kg paracetamol per administration, i.e. 1.5 ml solution per kg |
• Uptofourtimesaday • The minimum interval between each administration must be 4 hours • The maximum daily dose must not exceed 60 mg/kg (i.e. 6 ml/kg; maximum daily dose 2 g (i.e. 200 ml) |
|
> 33 kg and < 50 kg |
15 mg/kg paracetamol per administration, i.e. 1.5 ml solution per kg |
• Uptofourtimesaday • The minimum interval between each administration must be 4 hours • The maximum daily dose must not exceed 60 mg/kg (maximum daily dose 3g, i.e. 300 ml) |
|
> 50 kg |
1g paracetamol per administration, i.e. one 100 ml vial |
• Uptofourtimesaday • The minimum interval between each administration must be 4 hours • The maximum daily dose must not exceed 4 g (i.e. 400 ml) |
Patients with seriously reduced functioning ofthe kidney function:
It is recommended to reduce the dose and increase the minimum interval between each administration to 6 hours. The dose will depend on yourweight and your general condition. Your doctorwill calculate your bodyweight and will determine the dose you should receive.
Method of administration
The paracetamol solution is administered in intravenous infusion over 15 minutes.
For the 50 ml and 100 ml vials, a 0.8 mm needle has to be used and the stopper vertically perforated at the spot specifically indicated.
In children, the volume of solution to be infused is 1.5 ml per kg per administration.
It can also be diluted in 9 mg/ml sodium chloride (0.9%) or 50 mg/ml glucose (5%) up to one tenth.
The diluted solution should be visually inspected and must not be used if opalescence, visible particulate matter or precipitate are found.
If you have the impression that the effect of Paracetamol solution for infusion is too strong or too weak, talk to your doctor.
This product should only be used until you are able to take painkillers by mouth again.
Ifyou use more Paracetamol solution for infusion than you should, talk to your doctor or pharmacist immediately.
Because irreversible liver damage may be possible, immediate hospitalisation and treatment with an antidote are necessary.
In overdose cases, symptoms generally appear within the first 24 hours and comprise:
• nausea,
• vomiting,
• anorexia,
• pallor,
• abdominal pain and
• a risk of liver injury.
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
If you have any further questions on the use of this product ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons), the following may occur:
• a malaise,
• a drop in blood pressure or changes in laboratory test results: abnormally high levels of hepatic enzymes found during blood checks. Should this occur, inform your doctor as regular blood checks may be required later.
In very rare cases (less than 1 out of 10,000 persons, including isolated reports), the following may occur:
• a serious skin rash or allergic reaction may occur. Stop the treatment immediately and inform your doctor.
In isolated cases, other changes in laboratory test results have been observed which have necessitated regular blood checks: abnormally low levels of some types of blood cells (platelets, white cells), possibly leading to bleeding from the nose orgums. Should this occur, inform your doctor.
The following cases have been reported:
• rednessoftheskin,
• flushing,
• itching and
• abnormally rapid beating of the heart.
Cases of pain and burning sensation at injection site have been reported.
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 pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 solution for infusion
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.
This medicinal product does not require any special storage conditions.
Do not refrigerate or freeze.
For the 50 ml vial, after dilution in 9 mg/ml sodium chloride (0.9%) or 50 mg/ml glucose (5%): do not store for more than 1 hour (infusion time included).
Before administration, the product should be inspected visually. Do not use Paracetamol solution for infusion if you notice any particulate matter and discoloration.
For single use only. The product should be used immediately after opening. Any unused solution should be discarded.
Do not use this medicine if you notice any visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. 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 10 mg/ml, solution for infusion contains
• The active substance is paracetamol. One ml contains 10 mg paracetamol.
• The other ingredients (excipients) are mannitol, cysteine hydrochloride monohydrate, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, water for injections.
What Paracetamol 10 mg/ml, solution for infusion looks like and contents of the pack
Vials of 50 ml and 100 ml.
Each vial (100 ml) contains 1000 mg paracetamol.
Each vial (50 ml) contains 500 mg paracetamol.
Paracetamol 10 mg/ml solution for infusion is a clear and colourless or slightly yellowish solution.
Paracetamol 10 mg/ml solution for infusion vials are supplied in packs of 1 or 12 vials. Not all pack sizes or presentations may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester
LE3 0PA
UK
Manufacturers
Atlantic Pharma - Produgoes
Farmaceuticas S.A.
Rua da Tapada Grande, 2, Abrunheira, 2710 - 089 Sintra, Portugal
Tecnimede Sociedade-Tecnico-Medicinal, S.A.
Quinta da Cerca, Caixaria,
2564-187 Dois Portos, Portugal
This leaflet was last revised in October 2015
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.
Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn infants.