Paracetamol Infusion 1g/100ml

Model NO.: 1g/100ml Specification.: 1g/100ml Registration: Dossiers Could Be Available Specification: 1g/100ml HS Code: 3004909099 Product: Glutathione for Injection Package.: 1bottle/Box Trademark: REX Origin: China Pracetamol infusion

Specification: 1g/100ml
Packing: 1bottle/box
Indications:
It's for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever.
The 100ml bottle or 100ml bag is restricted to adults, adolescents and children weighing more than 33kg.
CTD dossiers could be available.

1. WHAT Paracetamol 10 mg/ml, solution for infusion IS AND WHAT IT IS USED FOR
This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers fever).
One 50ml bottle contains 500mg paracetamol.
One 100ml bottle contains 1g paracetamol.

The 100 ml bottle is restricted to adults, adolescents and children weighing more than 33 kg.
The 50 ml is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg.
It is indicated for the short-term treatment of moderate pain, especially following surgery, and for the short-term 
treatment of fever.

2. BEFORE YOU USE Paracetamol 10 mg/ml, solution for infusion
Do not use Paracetamol 10 mg/ml, solution for infusion
? If you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of Paracetamol
? If you are allergic (hypersensitive) to propacetamol (another analgesic for infusion and a precursor of paracetamol)
? If you suffer from a severe liver disease.
Pregnancy and breast-feeding
Pregnancy
Inform your doctor if you are pregnant. Paracetamol may be used during pregnancy. However, in this case the doctor 
must evaluate if the treatment is advisable.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Paracetamol may be used during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

3. HOW TO USE Paracetamol 10 mg/ml, solution for infusion
Intravenous use.
The 100 ml bottle or 100 ml bag is restricted to adults, adolescents and children weighing more than 33 kg.
The 50 ml is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg.
For the 50ml and 100ml bottle, a close monitoring is needed before the end of infusion.
Dosage
Dosing based on patient weight (please see the dosing table here below)

* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn infants.
** Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4 hours. No
more than 4 doses to be given in 24 hours.
The minimum interval between each administration in patients with severe renal
Insufficiency must be at least 6 hours
*** 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.

The paracetamol solution is administered as a 15-minute intravenous infusion.

4. HOW TO STORE Paracetamol 10 mg/ml, solution for infusion
Keep out of the reach and sight of children.
Do not use Paracetamol 10 mg/ml, solution for infusion after the expiry date which is stated on the packaging after EXP.
Do not store above 30°C. Do not refrigerate or freeze.

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