Eptifibatide Viatris

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Eptifibatide 0.75 mg/mL (75 mg in 100 mL)

から入手可能:

Viatris Limited

INN（国際名）:

Eptifibatide 0.75 mg/mL (75 mg in 100 mL)

投薬量:

0.75 mg/mL

医薬品形態:

Solution for infusion

構図:

Active: Eptifibatide 0.75 mg/mL (75 mg in 100 mL) Excipient: Citric acid monohydrate Sodium hydroxide Water for injection

処方タイプ:

Prescription

製:

Plantex Ltd

適応症:

Indicated for patients undergoing non-urgent, percutaneous coronary intervention (PCI) with coronary stenting for the reduction of death, myocardial infarction, urgent revascularisation and the need for acute antithrombotic rescue therapy. Indicated for the reduction of death and myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction. Indicated in patients who are managed with standard medical therapies and/or with percutaneous coronary intervention. Eptifibatide is intended for use with aspirin, heparin or clopidigrel.

製品概要:

Package - Contents - Shelf Life: Vial, glass, 100 ml type I with rubber closure and crimp seal in printed carton - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

承認日:

2015-11-12

製品の特徴

Page 1 of 20
NEW ZEALAND DATA SHEET
EPTIFIBATIDE VIATRIS
1. PRODUCT NAME
Eptifibatide Viatris 75 mg/100 mL (0.75 mg/mL) solution for infusion.
Eptifibatide Viatris 20 mg/10 mL (2 mg/mL) solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Eptifibatide Viatris is a clear, colourless solution containing the
acetate salt of the active ingredient,
eptifibatide, a synthetic cyclic heptapeptide containing six amino
acids, including one cysteine
amide and one mercaptopropionyl (desamino cysteinyl) residue.
The BOLUS INJECTION is a single dose 10 mL vial containing
eptifibatide 20 mg (2 mg/mL) and the
SOLUTION FOR INTRAVENOUS INFUSION is a single dose 100 mL vial
containing eptifibatide 75 mg
(0.75 mg/mL).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eptifibatide Viatris is formulated as a sterile clear, colourless
solution for injection in two dosage
administration forms, bolus injection and intravenous infusion.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Eptifibatide
Viatris
is
indicated
for
patients
undergoing
non-urgent
percutaneous
coronary
intervention (PCI) with intracoronary stenting for the reduction of
death, myocardial infarction,
urgent revascularisation and the need for acute antithrombotic rescue
therapy.
Eptifibatide Viatris is indicated for the reduction of death and
myocardial infarction in patients
presenting with unstable angina or non-Q-wave myocardial infarction
(chest pain with ST-segment
depression > 0.5 mm or definitive T-wave inversion > 1 mm or transient
ST-segment elevation
> 0.5 mm of less than 30 minutes or persistent ST-segment elevation >
0.5 mm not requiring
reperfusion therapy or thrombolytic agents, or chest pain in patients
without persistent ST-segment
elevation with CK-MB greater than the upper limit of normal).
Eptifibatide Viatris is indicated in patients who are managed with
standard medical therapies
and/or with percutaneous coronary intervention.
Patients with unstable angina (UA) or non-Q-wave myocardial infarction
(NQMI)