Paracetamol 10 Mg/Ml Solution For Infusion
Out of date information, search another741/12612520/1014
_ PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
|
Approval for Printing BlBRAUN Melsungen AG | |
|
Approved for Printing |
□ |
|
Approved for Printing when corrected |
□ |
|
New draft required |
□ |
|
Date |
Signature |
|
Name in capital letters | |
What is in this leaflet:
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
schwarz
Dokument = 210 x 594 mm 2 Seiten
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 glu-cose-6-phosphatedehydrogenase (favism)
Inform your doctor before treatment if any of the above mentioned conditions apply to you.
As common practice in infusion therapy your doctor will observe you for the occurrence of allergic reactions to the active ingredient or to the excipients (e.g. hydroxyl ethyl starch) (see also section 'Possible side effects').
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
4. Possible side effects
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:
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:
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).
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/yel-lowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Latus
7924
GB__741
Paracetamol 10 mg/ml 741/12612520/1014 GIF (MP, EP)
Standort Rubi
Font size: 9 pt.
G 121568
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.
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.
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:
Hydroxyethyl starch, mannitol, sodium acetate trihydrate, 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 x 50 ml, 10 x 100 ml Not all pack sizes may be marketed.
Marketing Authorisation Holder
B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen, Germany Postal address:
34209 Melsungen, Germany Phone: +49/5661/71-0 Fax: +49/5661/71-4567
• Breast-feeding
Paracetamol may be used during breast-feeding.
Paracetamol contains Sodium
This medicinal product contains
• 12.2 mg (0.53 mmol) sodium in 10 ml,
• 61 mg (2.7 mmol) sodium in 50 ml and
• 122 mg (5.3 mmol) of sodium in 100 ml.
To be taken into account for patients on a controlled sodium diet.
Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Italy, Latvia, Luxembourg, Portugal, Slovakia, Spain, Sweden,
The Netherlands Belgium
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.
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 or pharmacist.
Austria, Germany Lithuania Romania Slovenia
Ireland, United Kingdom Poland, Norway
Paracetamol B. Braun 10 mg/ml Paracetamol B. Braun 10 mg/ml solution for infusion, oplossing voor infusie, Infusionslosung Paracetamol B. Braun 10 mg/ml Infusionslosung
Paracetamol B. Braun 10 mg/ml infuzinis tirpalas Paracetamol B. Braun 10 mg/ml solutie perfuzabila Paracetamol B. Braun 10 mg/ml raztopina za infund iranje Paracetamol 10 mg/ml solution for infusion
Paracetamol B. Braun
12612520_Paracetamol10_MP-EP-GIF210x594_GB_741.indd 1
07.10.14 06:59
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** |
|
* or O Vi |
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 |
|
100 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** |
|
> 33 kg to < 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 hepato-toxicity |
1 g |
100 ml |
100 ml |
3 g |
|
> 50 kg and no additional risk factors for hepato-toxicity |
1 g |
100 ml |
100 ml |
4 g |
* 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 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 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.
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 Melsungen AG
34209 Melsungen Germany
07.10.14 06:59
12612520_Paracetamol10_MP-EP-GIF210x594__GB_741.indd 2