AGGRASTAT Tirofiban (as hydrochloride) 12.5mg/50mL injection vial

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

tirofiban hydrochloride, Quantity: 0.281 mg/mL (Equivalent: tirofiban, Qty 0.25 mg/mL)

Доступна с:

Correvio Australia Pty Ltd

Фармацевтическая форма:

Injection, concentrated

состав:

Excipient Ingredients: water for injections; sodium hydroxide; sodium chloride; hydrochloric acid; citric acid; sodium citrate dihydrate

Администрация маршрут:

Intravenous

Штук в упаковке:

1 X 50mL

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

AGGRASTAT, in combination with heparin, is indicated for patients with unstable angina or non-Q-wave myocardial infarction to prevent cardiac ischaemic events.

Обзор продуктов:

Visual Identification: Clear colourless solution.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Статус Авторизация:

Licence status A

Дата Авторизация:

1999-04-29

Характеристики продукта

1
AUSTRALIAN PRODUCT INFORMATION
AGGRASTAT (TIROFIBAN HYDROCHLORIDE)
CONCENTRATE FOR IV INFUSION
1
NAME OF THE MEDICINE
Tirofiban hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of the solution contains 0.281 mg of the active tirofiban
hydrochloride monohydrate
equivalent to 0.25 mg of tirofiban. The pH ranges from 5.5 to 6.5 and
may have been adjusted with
hydrochloric acid and/or sodium hydroxide
.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
AGGRASTAT Concentrate for Infusion is a clear sterile concentrated
solution for intravenous infusion
after dilution and is supplied in a 50 mL glass vial.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
AGGRASTAT, in combination with heparin, is indicated for patients with
unstable angina or non-Q-
wave myocardial infarction to prevent cardiac ischaemic events.
(See Section 4.2 Dose and method of administration and Section 5
Pharmacological properties.)
4.2
D
OSE AND METHOD OF ADMINISTRATION
THE VIAL OF AGGRASTAT (CONCENTRATE) MUST BE DILUTED PRIOR TO
ADMINISTRATION (SEE INSTRUCTIONS
FOR USE)
_AGGRASTAT is for intravenous use only using sterile equipment.
_AGGRASTAT may be co-administered
with heparin through the same line. AGGRASTAT should not be
administered in the same intravenous
line as diazepam.
AGGRASTAT is recommended for use with a calibrated infusion device.
Care should be taken to avoid
a prolonged loading infusion. Care should also be taken in calculating
the bolus dose and infusion
rates based on patient weight.
In clinical studies patients received aspirin, unless contraindicated.
2
AGGRASTAT should be administered intravenously at the initial infusion
rate of 0.4 µg/kg/min for 30
minutes. Upon completion of the initial infusion, AGGRASTAT should be
continued at a maintenance
infusion rate of 0.1 µg/kg/min. AGGRASTAT should be given with
heparin (usually an intravenous
bolus dose of 5000 U simultaneously with the start of therapy with
AGGRASTAT, then approximately
1000 U per hour titrated on