NANOGEN | Solution for infusion PACEPHENE (Paracetamol 10mg/mL)

PACEPHENE 500 mg

Each vial of solution for infusion (50 mL) contains:

Active ingredients: Paracetamol………500 mg

Excipients: Mannitol, Sodium metabisulfite, Disodium hydrogen phosphate dodecahydrate, Sodium hydroxide, Citric acid monohydrate, Water for injections.

PACEPHENE 1000 mg

Each vial of solution for infusion (100 mL) contains:

Active ingredients: Paracetamol………1000 mg

Excipients: Mannitol, Sodium metabisulfite, Disodium hydrogen phosphate dodecahydrate, Sodium hydroxide, Citric acid monohydrate, Water for injections.

Pharmaceutical form: solution for infusion

Description: The solution for infusion is clear, colorless, or almost colorless, without any particles, packed in transparent glass vials, capped with rubber stoppers and plastic-aluminum caps.

pH: 5.0 – 6.0

Osmolarity: 330 – 370 mOsmol/Kg

THERAPEUTIC INDICATIONS

Paracetamol 10 mg/mL Solution for Infusion 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 use

The 50 mL vial is adapted to term newborn infants, infants, toddlers, and children weighing less than 33 Kg.

The 100 mL vial is restricted to adults, adolescents, and children weighing more than 33 Kg.

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 (creatinine clearance ≤ 30 mL/min) must be at least 6 hours.

In adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition, dehydration: the maximum daily dose must not exceed 3 g.

CONTRAINDICATIONS

• In patients with hypersensitivity to paracetamol or to propacetamol hydrochloride (prodrug of paracetamol) or o any of the excipients.

• In cases of severe hepatocellular insufficiency.

STORAGE & SHELF LIFE

STORAGE: In a cool dry place, the temperature does not exceed 30oC, protect from light, do not freeze or refrigerate.

SHELF LIFE: 24 months from manufacturing date.

Specification: Manufacturer’s

MANUFACTURED BY

NANOGEN LAMDONG PHARMACEUTICAL MANUFACTURING COMPANY LIMITED

Lot BII-11, BII-12, BII-13, BII-14, Phu Hoi Industrial Park, Phu Hoi Commune, Duc Trong District, Lam Dong Province, VIETNAM.

NANOGEN | Solution for infusion PACEPHENE (Paracetamol 10mg/mL)