TAKHZYRO lanadelumab 300mg/2mL solution for injection vial

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

lanadelumab, Quantity: 300 mg

Доступна з:

Takeda Pharmaceuticals Australia Pty Ltd

Фармацевтична форма:

Injection, solution

Склад:

Excipient Ingredients: citric acid monohydrate; water for injections; dibasic sodium phosphate dihydrate; polysorbate 80; histidine; sodium chloride

Адміністрація маршрут:

Subcutaneous

Одиниць в упаковці:

1

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (C1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years and older.

Огляд продуктів:

Visual Identification: Colourless to slightly yellow solution, appearing clear or slightly opalescent.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Статус Авторизація:

Registered

Дата Авторизація:

2019-01-30

Характеристики продукта

TAKHZYRO PI V5.0 (CCDS V5)
1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION - TAKHZYRO
® (LANADELUMAB)
SUBCUTANEOUS INJECTION
1
NAME OF THE MEDICINE
Lanadelumab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ready-to-use solution, for subcutaneous injection only.
TAKHZYRO is a sterile, preservative-free solution supplied in a
single-dose pre-filled syringe
or a single-dose vial.
Each pre-filled syringe or vial contains 300 mg of lanadelumab in 2 mL
solution.
_Excipient with known effect: _
Each mL of solution contains 3.45 mg (0.150 mmol) of sodium.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
The solution is colourless to slightly yellow, appearing either clear
or slightly opalescent.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
TAKHZYRO is indicated for routine prevention of recurrent attacks of
hereditary angioedema
(C1-esterase-inhibitor deficiency or dysfunction) in patients aged 12
years and older.
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
TAKHZYRO therapy should be initiated under supervision of a physician
experienced in the
care of patients with hereditary angioedema (HAE).
DOSAGE
The recommended starting dose is 300 mg lanadelumab every 2 weeks. In
patients who are
stably attack free on treatment, a dose reduction of 300 mg
lanadelumab every 4 weeks may be
considered, especially in patients with low weight.
_Elderly: _
Limited information is available on patients above 65 years of age.
Available data indicates
that no dose adjustment is required for patients above 65 years of
age.
▼

TAKHZYRO PI V5.0 (CCDS V5)
2
_Hepatic impairment: _
No studies have been conducted in patients with hepatic impairment.
_ _
_Renal impairment: _
No studies have been conducted in patients with renal impairment.
_ _
_Paedia