Contact Information
Registered Office/ Head Office:
Ashford Laboratories Pvt. Ltd.,
31/36, 5th Floor, Dheeraj Heritage,
S. V. Road, Santacruz (West),
Mumbai (Bombay) - 400 054. India.
Tele- fax: + 91 22 6675 8866
Email:info@ashfordlab.com

Japan Office:
Ashford Laboratories,
4-11-24-1402 Fukae Kitamachi,
Higashi Nada Ku, Kobe 658-0013,
Japan.
Tele- fax: +81 0784 122579
Email:japan@ashfordlab.com
Paraford™ (Paracetamol 10mg/ ml, solution for infusion) Paracetamol Solution for Infusion, 50ml/ 100ml
      Qualitative and Quantitative Composition       Pharmaceutical Form       Clinical Particulars       Pharmacological Properties       Pharmaceutical Particulars
TOP QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 10 mg paracetamol
One 50 ml vial contains 500 mg paracetamol
One 100 ml vial contains 1000 mg paracetamol
One 100 ml bag contains 1000 mg paracetamol
Excipients: Sodium 0.04 mg/ml

TOPPHARMACEUTICAL FORM
Solution for infusion. The solution is clear and slightly yellowish.

TOPCLINICAL PARTICULARS
Therapeutic indications
Paraford is indicated for the short-term treatment of moderate pain, especially following surgery and for the short-term treatment of fever, when administration by intravenous route is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible.

Posology and method of administration

Intravenous route. The 100 ml vial or 100 ml bag 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.

Posology
 
Adolescents and adults weighing more than 50 kg

AParacetamol 1 g per administration, i.e. one 100 ml vial or one 100 ml bag, up to four times a day.
The minimum interval between each administration must be 4 hours.
The maximum daily dose must not exceed 4 g.

 
Children weighing more than 33 kg (approximately 11 years old), adolescents and adults weighing less than 50 kg

Paracetamol 15 mg/kg per administration, i.e. 1.5 ml solution per kg up to four times a day.
The minimum interval between each administration must be 4 hours.
The maximum daily dose must not exceed 60 mg/kg (without exceeding 3 g)

 
Children weighing more than 10 kg (approximately 1 year old) and weighing less than 33 kg

Paracetamol 15 mg/kg per administration, i.e. 1.5 ml solution per kg up to four times a day.
The minimum interval between each administration must be 4 hours.
The maximum daily dose must not exceed 60 mg/kg (without exceeding 2 g)

 
Term newborns infants, infants, toddlers and children weighing less than 10 kg (up to approximately 1 year old)

Paracetamol 7.5 mg/kg per administration, i.e. 0.75 ml solution per kg up to four times a day.
The minimum interval between each administration must be 4 hours.
The maximum daily dose must not exceed 30 mg/kg.
No safety and efficacy data are available for premature neonates

Severe renal insufficiency
It is recommended, when giving paracetamol to patients with severe renal impairment (creatinine clearance 30 mL/min), to increase the minimum interval between each administration to 6 hours
In adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration: The maximum daily dose must not exceed 3 g
Method of administration
The paracetamol solution is administered as a 15-minute intravenous infusion.

Text for the 50ml and 100ml vials
Use a 0.8 mm needle and vertically perforate the stopper at the spot specifically indicated.

Text for the 50ml vials
Paraford of 50ml vial can also be diluted in a 0.9% sodium chloride solution or 5% glucose solution up to one tenth. In this case, use the diluted solution within the hour following its preparation (infusion time included).

Text for the 50ml and 100ml vials
As for all solutions for infusion presented in glass vials, 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 perfusion applies particularly for central route infusion, in order to avoid air embolism.
Contraindications

PARAFORD is contraindicated
 
in patients with hypersensitivity to paracetamol or to propacetamol hydrochloride (prodrug of paracetamol) or to one of the excipients.

 
in cases of severe hepatocellular insufficiency.


Special warnings and precautions for use

Warnings
It is recommended to use a suitable analgesic oral treatment as soon as this administration route is possible. In order to avoid the risk of overdose, check that other medicines administered do not contain either paracetamol or propacetamol.

Doses higher than the recommended entails risk for very serious liver damage. Clinical symptoms and signs of liver damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis) are usually first seen after two days of drug administration with a peak seen usually after 4 - 6 days. Treatment with antidote should be given as soon as possible

This medicinal product contains less than 1 mmol sodium (23mg) per 100ml of Paraford, i.e. essentially "sodium free".

Text for the 50ml and 100ml vials
As for all solutions for infusion presented in glass vials, a close monitoring is needed notably at the end of the infusion
Precautions for use
Paracetamol should be used with caution in cases of
 
hepatocellular insufficiency,

 
severe renal insufficiency (creatinine clearance 30 mL/min)

 
chronic alcoholism,

 
chronic malnutrition (low reserves of hepatic gluthatione),

 
dehydration.


Overdose

There is a risk of liver injury (including fulminant hepatitis, hepatic failure,cholestatic hepatitis, cytolytic hepatitis), particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition and in patients receiving enzyme inducers. Overdosing may be fatal in these cases.

 
Symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor, abdominal pain. Overdose, 7.5 g or more of paracetamol in a single administration in adults and 140 mg/kg of body weight in a single administration in children, causes hepatic cytolysis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with decreased prothrombin levels that may appear 12 to 48 hours after administration. Clinical symptoms of liver damage are usually evident initially after two days, and reach a maximum after 4 to 6 days. Emergency measures

 
Immediate hospitalisation.

 
Before beginning treatment, take a tube of blood for plasma paracetamol assay, as soon as possible after the overdose.

 
The treatment includes administration of the antidote, N-acetylcysteine (NAC), by the i.v. or oral route, if possible before the 10th hour. NAC can, however, give some degree protection even after 10 hours, but in these cases prolonged treatment is given.

 
Symptomatic treatment.

 
Hepatic tests must be carried out at the beginning of treatment and repeated every 24 hours. In most cases hepatic transaminases return to normal in one to two weeks with full restitution of liver function. In very severe cases, however, liver transplantation may be necessary.

TOPPHARMACOLOGICAL PROPERTIES Pharmacodynamic properties
Pharmacotherapeutic group: OTHER ANALGESICS AND ANTIPYRETICS, ATC code: N02BE01

The precise mechanism of the analgesic and antipyretic properties of paracetamol has yet to be established; it may involve central and peripheral actions.

PARAFORD provides onset of pain relief within 5 to 10 minutes after the start of administration. The peak analgesic effect is obtained in 1 hour and the duration of this effect is usually 4 to 6 hours.

PARAFORD reduces fever within 30 minutes after the start of administration with a duration of the antipyretic effect of at least 6 hours.

TOPPHARMACEUTICAL PARTICULARS List of excipients
Cysteine hydrochloride monohydrate, Disodium phosphate dihydrate, Hydrochloric acid, Mannitol, Sodium hydroxide, Water for injection

Incompatibilities

PARAFORD should not be mixed with other medicinal products.

Shelf life

2 years.

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Text for the 50ml vial
If diluted in 0.9% sodium chloride or 5% glucose, the solution should also be used immediately. However, if the solution is not used immediately, do not store for more than 1 hour (infusion time included).

Special precautions for storage

Do not store above 30°C. Do not refrigerate or freeze.

Text for the 100ml bag
For the 100 ml bag, store the immediate packaging in the outer, aluminium overpackaging. Following the opening of the overpackaging, the product must be used immediately.

Nature and contents of container

Text for the 50ml and 100ml vials
50 ml and 100 ml Type II clear glass vial with bromobutyl stopper and a aluminium/plastic Flip-Off cap.

Pack size: pack of 12 vials. Text for the 100ml bag
The 100 ml bag is a multilayer, plastic bag (PP and polyolefin) packed in an oxygen-proof, aluminium overpackaging.

Special precautions for disposal and other handling

Text for the 50ml and 100ml vials
Use a 0.8 mm needle and vertically perforate the stopper at the spot specifically indicated.
Before administration, the product should be visually inspected for any particulate matter and discoloration. For single use only. Any unused solution should be discarded.

The diluted solution should be visually inspected and should not be used in presence of opalescence, visible particulate matters or precipitate.

Text for the 100ml bag
There is a potential presence of moisture between the bag and the outer packaging as a result of the sterilization process. It does not impact the quality of the solution.

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