10 mg / ml solution for infusion
paracetamol
What Paracetamol B. Braun is and what it is used for
This medicine is a painkiller (analgesic) and an antipyretic (antipyretic).
It is used for
- short-term treatment of moderate pain, especially after surgery
- short-term treatment of fever.
Paracetamol contained in Paracetamol B. Braun may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Paracetamol B. Braun
Do not use Paracetamol B. Braun
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic (hypersensitive) to propacetamol (another painkiller that is converted to paracetamol in your body)
- if you have severe liver disease.
Warnings and cautions
Talk to your doctor before receiving Paracetamol B. Braun.
Take special care with Paracetamol B. Braun
- if you have liver disease or serious kidney disease, or in chronic alcohol abuse
- if you are taking any other medicines containing paracetamol. In that case, your doctor will adjust the dose one
- in case of nutritional disorders (starvation, malnutrition) or dehydration
- if you have a genetically caused deficiency of enzyme et glucose -6-phosphate dehydrogenase (favism)
Tell your doctor before treatment if any of the above apply to you.
Prolonged or frequent use of Paracetamol B. Braun in infusion form is not recommended. It is recommended that you use this medicine only until you can take painkillers through your mouth again.
Your doctor will make sure that the highest recommended dose is not exceeded. This can otherwise lead to serious liver damage.
Other drugs and Paracetamol B. Braun
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:
- the drug probenecid (used to treat gout ): the paracetamol dose may need to be reduced.
- analgesics containing salicylamide: dose one may need to be adjusted.
- drugs that activate liver enzymes: strict paracetamol dose control is required to avoid liver damage.
- anticoagulants ( anticoagulants ): the effect of these medicines may need to be monitored more closely.
This medicinal product contains paracetamol and this must be taken into account when taking other medicinal products containing paracetamol or propacetamol, to avoid overdose (see section 3).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
If necessary, Paracetamol B. Braun can be used during pregnancy. However, you should use the lowest possible dose that relieves your pain and/or fever and use the medicine for the shortest possible time. Contact a doctor if the pain and/or fever do not decrease or if you need to take the medicine more often.
Breast-feeding
Paracetamol B. Braun can be used during breastfeeding.
Paracetamol B. Braun contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. is almost sodium-free.
How to use Paracetamol B. Braun
The recommended dose is
Your doctor will adjust the dose individually for you based on your body weight and general condition.
Method of administration
You will be given this medicine by a doctor as a drip into a vein ( intravenous use). This usually takes about 15 minutes. You will be under close supervision during and especially towards the end of infusion one.
If you have the impression that the effect of Paracetamol B. Braun is too strong or too weak, talk to your doctor.
If you take more Paracetamol B. Braun than you should
Overdose is unlikely as the drug is given by healthcare professionals.
Your doctor will make sure that the highest recommended dose is not exceeded.
In case of overdose, symptoms usually appear within the first 24 hours and include nausea, vomiting, anorexia (loss of appetite), pale skin, and abdominal pain. These symptoms may be signs of liver damage.
If you think you may have an overdose, tell your doctor immediately. Seek medical attention immediately in case of overdose, even if you feel well to avoid the risk of serious and permanent liver damage. If necessary, you can get an antidote.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can be serious. If you get any of them, stop taking Paracetamol B. Braun and see a doctor immediately:
Very rare (affects up to 1 in 10,000 people)
- allergic reactions of varying severity, from skin reactions such as hives to allergic shock
- very rare cases of severe skin reactions
- Abnormally low levels of certain blood cells ( platelets, white blood cells ) may occur.
Other side effects include:
Rare (affects up to 1 in 1,000 people)
- altered laboratory values: abnormally high levels of liver enzymes found in blood samples
- drop in blood pressure
- feeling sick
No known frequency (can not be calculated from the available data)
- reddening of the skin, hot flashes, or itching
- abnormally fast heartbeat
Frequent side effects at the injection site have been reported during clinical trials (pain and burning).
How to store Paracetamol B. Braun
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 carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Store the packaging in the outer carton. Sensitive to light.
Contents of the pack and other information
Content declaration
The active substance is paracetamol.
1 ml contains 10 mg paracetamol .
Each 10 ml ampoule contains 100 mg of paracetamol .
Each 50 ml bottle contains 500 mg of paracetamol.
Each 100 ml bottle contains 1000 mg of paracetamol.
Other ingredients are:
Mannitol, sodium citrate dihydrate, concentrated acetic acid (for pH adjustment), water for injections.
What the medicine looks like and the contents of the pack
Paracetamol B. Braun is a clear and colorless or slightly pink to the orange solution. Perceptions of color may vary.
Paracetamol B. Braun is supplied in plastic bottles of 50 ml or 100 ml or plastic ampoules 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
34209 Melsungen
Germany
Manufacturer
B. Braun Medical SA
Carretera de Terrassa 121
08191 Rubí
Barcelona
Spanien
Further information on this medicine can be obtained from the representative of the marketing authorization holder:
Sweden
B. Braun Medical AB
Box 110
182 12 Danderyd