Tetanus Immunoglobulin-VF

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

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

제공처:

CSL Behring (NZ) Ltd

INN (International Name):

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

복용량:

250 IU

약제 형태:

Solution for injection

구성:

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

패키지 단위:

Vial, glass, 1x250IU, 250 IU

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

CSL Behring (Australia) Pty Ltd

치료 징후:

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.

제품 요약:

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

승인 날짜:

1992-07-09

제품 특성 요약

NEW ZEALAND DATA SHEET
Tetanus Immunoglobulin-VF NZ DS 13.00
Page
1
of
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