Tetanus Immunoglobulin-VF

Страна: Нова Зеландія

мова: англійська

Джерело: Medsafe (Medicines Safety Authority)

Активний інгредієнт:

Tetanus immunoglobulin, human 250 [iU] (Immunoglobulin ex NZ =160mg/ml)

Доступна з:

CSL Behring (NZ) Ltd

ІПН (Міжнародна Ім'я):

Tetanus immunoglobulin, human 250 IU (Immunoglobulin ex NZ =160mg/ml)

Дозування:

250 IU

Фармацевтична форма:

Solution for injection

Склад:

Active: Tetanus immunoglobulin, human 250 [iU] (Immunoglobulin ex NZ =160mg/ml) Excipient: Glycine

Одиниць в упаковці:

Vial, glass, 1x250IU, 250 IU

Клас:

Prescription

Тип рецепту:

Prescription

Виробник:

CSL Behring (Australia) Pty Ltd

Терапевтичні свідчення:

Tetanus Immunoglobulin-VF is indicated for the passive protection of individuals who have sustained a tetanus-prone wound and who have either not been actively immunised against tetanus or whose immunisation history is doubtful. It should also be given to the fully immunised patient with a tetanus-prone wound if more than 10 years have elapsed since the last vaccine dose. In all the above instances, active immunisation with a tetanus vaccine should be commenced at the same time according to current datasheet recommendations.

Огляд продуктів:

Package - Contents - Shelf Life: Vial, glass, 1x250IU - 250 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Дата Авторизація:

1992-07-09

Характеристики продукта

NEW ZEALAND DATA SHEET
Tetanus Immunoglobulin-VF NZ DS 13.00
Page
1
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9
1 PRODUCT NAME
Tetanus Immunoglobulin-VF 250 IU, solution for intramuscular injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Tetanus Immunoglobulin
Tetanus Immunoglobulin-VF (for Intramuscular Use) is a sterile
solution containing 160 mg/mL
human plasma protein of which at least 98% is immunoglobulin G (IgG),
with a tetanus antitoxin
activity of not less than 100 IU/mL.
Tetanus Immunoglobulin-VF (for Intramuscular Use) contains less than
0.5 mg/mL
immunoglobulin A (IgA).
Tetanus Immunoglobulin-VF (for Intramuscular Use) is manufactured from
human plasma donated by
New Zealand’s voluntary and non-remunerated donors.
Tetanus Immunoglobulin-VF (for Intramuscular Use) contains 22.5 mg/mL
of glycine.
Tetanus Immunoglobulin-VF (for Intramuscular Use) contains no
preservatives.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for intramuscular injection.
The pH value of the ready-to-use solution is 6.6.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TETANUS PROPHYLAXIS
Tetanus Immunoglobulin-VF (for Intramuscular Use) is indicated for the
passive protection of
individuals who have sustained a tetanus-prone wound and who have
either not been actively
immunised against tetanus or whose immunisation history is doubtful.
It should also be given to the
fully immunised patient with a tetanus-prone wound if more than 10
years have elapsed since the last
vaccine dose. In all the above instances, active immunisation with a
tetanus vaccine should be
commenced at the same time (refer to
TABLE 1
) according to current recommendations.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Good medical care is essential in the prevention of tetanus from fresh
wounds. Thorough cleansing
and removal of all foreign and necrotic material from the site of
injury is important.
NEW ZEALAND DATA SHEET
Tetanus Immunoglobulin-VF NZ DS 13.00
Page
2
of
9
The minimum routine prophylactic dose of Tetanus Immunoglobulin-VF
(for Intramuscula