TERIPIN-S Solution for Injection 1mg8.5mL

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

TERLIPRESSIN ACETATE

Boleh didapati daripada:

Eucogen Pharma Sdn. Bhd.

INN (Nama Antarabangsa):

TERLIPRESSIN ACETATE

Unit dalam pakej:

8.5mL x 5 Ampoules

Dikeluarkan oleh:

HANLIM PHARMA.CO.,LTD

Ciri produk

【Appearance】
Colorless and transparent injection in a colorless and transparent
ampoule
【Composition】
Each ampoule (8.5 mL) contains
- Active ingredient: Terlipressin Acetate
--------------------------------------------------------------------------------
1.0 mg
(0.85 mg as Terlipressin)
- Inactive Ingredients: Acetic acid anhydride, sodium acetate
trihydrate, sodium chloride and water for injection
【Indications】
- Bleeding oesophageol varices.
- Treatment of type 1 hepatorenal syndrome, characterized by
spontaneous acute renal insufficiency, in patient
suffering from severe cirrhosis with ascites.
【Dosage and Administration】
Bleeding oesophageol varices
Adults: Initially an i.v. injection of 1.7 mg terlipressin is given
every 4 hours. The treatment should be maintained
until bleeding has been controlled for 24 hours, but up to a maximum
of 48 hours. After the initial dose, the dose
can be adjusted to 0.85mg terlipressin i.v. every 4 hours in patients
with body weight < 50 kg or if adverse effects
occur.
Type 1 hepatorenal syndrome
2.55 to 3.4 mg of terlipressin every 24 hours as 3 or 4
administrations.
In the absence of any reduction of the serum creatinine after 3 days
of treatment, cessation of Teripin-S Injection
treatment is advised.
In the other cases, Teripin-S Injection treatment is to be pursued
until the obtaining either of a serum creatinine
less than 130 μmol/litre or of a drop of at least 30 % in the serum
creatinine with respect to the value measured
at the time of diagnosis of hepatorenal syndrome.
The standard average duration of treatment is 10 days.
【Method of Administration】
I.V. Injection
【Caution】
1. Warning
Cut ampoule injections carefully to minimize glass fragments, as
fragments of glass can be mixed
in while cutting the container and cause adverse effects. Take special
caution when using with chil-
dren and the elderly and infirm.
【Contraindications】
Contraindicated in pregnancy.
Hypersensitivity to terlipressin acetat