Audited Supplier
Composition:
1 vial of 100ml contains: Active ingredient.......................................................paracetamol 1g
Excipients..................................................................Mannitol
Cysteine
Disodium phosphate
Sodium chloride
Water for Injection
Hydrochloride acid
Indications:
Paracetamol is a sterile Solution for Infusion. One single vial contains 1g paracetamol (acetaminophen) per 100ml in Water for Injection.Paracetamol is only administrated to treat pain and fever, for adults,teenagers and children over 33kg of weight (about 11 years old). It is prescribed in use in short-term therapy for moderate pain, especially after operating and use in short-term therapy for fever.
The 100 ml bottle is restricted to adults, adolescents and children weighing more than 33 kg.
The 50 ml bottle is restricted to toddlers and children weighing more than 10 kg and up to 33 kg.
The 10 ml ampoule is restricted to term newborn infants, infants and toddlers weighing up to 10 kg.
Posology:
The dose to be administered and the bottle size to be used depend exclusively on the patient`s weight. 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 section 6.6) or a syringe driver must be used.
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 B. Braun (10 mg/ml) per administration based on upper weight limits of group (ml)*** | Maximum daily dose** |
≤ 10 kg* | 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 B. Braun (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 B.Braun (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 hepatotoxicity | 1 g | 100 ml | 100 ml | 3 g |
> 50 kg and no additional risk factors for hepatotoxicity | 1 g | 100 ml | 100 ml | 4 g |
* Preterm newborn infants:
No safety and efficacy data are available for premature newborn infants (see also section 5.2)
** 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 (See section 5.2).
Adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration:
The maximum daily dose must not exceed 3000 mg (see section 4.4).
Method of administration
Take care when prescribing and administering Paracetamol B.Braun to avoid dosing errors due to confusion between milligram (mg) and millilitre (ml), which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Take care to ensure the dose is measured and administered accurately. |
Intravenous use.
The paracetamol solution is administered as a 15-minute intravenous infusion.
Package: packaged in glass bottle
Shelf life: 3 years from manufacturing date.
Storage: Paracetamol should be stored at a temperature below 25°c. Do not store in refrigerator or freezer.
Specification:
In-House
Paracetamol should not be administered after the expiry date.
Keep medicines out of reach of children!
