Pa Injection Solution for injection 150

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

paracetamol

Available from:

Lincoln Pharmaceuticals Limited, INDIA

ATC code:

Other analgesics and antipyretics

INN (International Name):

paracetamol

Dosage:

150

Pharmaceutical form:

Solution for injection

Manufactured by:

LINCOLN PHARMACEUTICALS LIMITED, INDIA

Product summary:

Physical description: Clear colourless solution; Local technical representative: Heko Pharmacy Limited (7718)

Authorization status:

Registered/Compliant

Authorization date:

2022-01-10

Summary of Product characteristics

SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paracetamol Injection 150 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol BP
This product contains Paracetamol 150 mg/ml solution for injection
_For the full list of excipients, see section 6.1. _
3.
PHARMACEUTICAL FORM
IM/IV
A clear colourless solution.
4.
CLINICAL PARTICULARS
1.
THERAPEUTIC INDICATIONS
Paracetamol 150 mg/ml solution for injection is indicated for the mild
to moderate pain, pyrexia
(pyrexia with discomfort in children).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Paracetamol 150 mg/ml solution for injection based in 10 mg/kg body
weight, to be given via slow
IV push or via deep IM injection, every 4-6 hours a day, or
approximately as follows:
METHOD OF ADMINISTRATION: Paracetamol 150 mg/ml solution for injection
may be given 4-6 hours
via slow IV push or via deep IM injection while symptoms persist, but
not to exceed 5 doses in
each 24-hr period for not >5 days unless otherwise directed by a
physician.
3.
CONTRAINDICATIONS
It is contraindicated in patients with known hypersensitivity to
Paracetamol to any of the excipients
of the formulation. In cases of severe hepatocellular insufficiency.
4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
_Hepatic injury:_ Administration of Paracetamol in doses higher than
recommended may result in
hepatic injury, including the risk of severe hepatotoxicity and death.
Do not exceed the maximum
recommended daily dose of paracetamol.
Use caution when administering paracetamol in patients with hepatic
impairment or active hepatic
disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g.,
due to dehydration or blood
loss), or severe renal impairment (creatinine clearance ≤ 30
mL/min).
Patients should take precaution if your baby is less than 4 weeks old,
consult and take advice to
your physician or pharmacist before giving them paracetamol 150 mg/ml
solution for injection in
particular if the baby is given other medicines that contain propylene
glycol or alcohol.
_AGE GRO