Zoster Immunoglobulin-VF

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Zoster immunoglobulin, human 100 IU/mL (Immunoglobulin ex NZ)

Available from:

CSL Behring (NZ) Ltd

INN (International Name):

Zoster immunoglobulin, human 100 IU/mL (Immunoglobulin ex NZ)

Dosage:

200 IU/2mL

Pharmaceutical form:

Granules for injection

Composition:

Active: Zoster immunoglobulin, human 100 IU/mL (Immunoglobulin ex NZ) Excipient: Glycine

Units in package:

Vial, glass, 200 IU

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

CSL Behring (Australia) Pty Ltd

Therapeutic indications:

Zoster Immunoglobulin-VF is indicated for prophylaxis against varicella in patients who meet all four of the criteria listed below: 1. One of the following underlying illnesses or conditions: a. Neoplastic disease (leukaemia or lymphoma) b. Congenital or acquired immunodeficiency c. Immunosuppressive therapy with steroids or antimetabolites. 2. One of the following types of exposure to chickenpox or shingles patients: a. Household contact b. Playmate contact (> 1 hour play indoors) c. Hospital contact (in same 2 to 4 bedroom or adjacent beds in a large ward) d. Newborn contact (newborn of mother who had onset of chickenpox < 5 days before delivery or within 48 hours after delivery) e. Premature infant (> 28 weeks gestation) whose mother lacks a prior history of chickenpox f. Premature infant (< 28 weeks gestation or < 1000g) regardless of maternal history. 3. Negative or unknown prior history of chickenpox. 4. If Zoster Immunoglobulin-VF can be administered within 96 hours after exposure. Zoster Immunoglobulin-VF, Normal Immunoglobulin-VF (immunoglobulin for intramuscular use) or plasma are of no value in the treatment of established varicella or zoster infection. High levels of circulating antibody do not prevent dissemination of infection. Zoster Immunoglobulin-VF is not indicated for prophylactic use in immunodeficient children or adults when there is a history of varicella, unless the patient's immunosuppressed status is that which is associated with bone marrow transplantation.

Product summary:

Package - Contents - Shelf Life: Vial, glass, - 200 IU - 156 weeks from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

1992-07-09

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Zoster Immunoglobulin-VF NZ DS 13.00
Page
1
of
9
1 PRODUCT NAME
Zoster Immunoglobulin-VF 200 IU, solution for intramuscular injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Zoster Immunoglobulin
Zoster Immunoglobulin-VF is a sterile solution containing 160 mg/mL
human plasma protein of
which at least 98% is immunoglobulin G (IgG) with antibodies to
varicella-zoster virus of at least
200 IU/vial.
Zoster Immunoglobulin-VF contains less than 0.5 mg/mL immunoglobulin A
(IgA).
Zoster Immunoglobulin-VF is manufactured from human plasma donated by
New Zealand’s
voluntary and non-remunerated donors.
Zoster Immunoglobulin-VF contains 22.5 mg/mL of glycine.
Zoster Immunoglobulin-VF 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
Zoster Immunoglobulin-VF is indicated for prophylaxis against
varicella in patients who meet all four
of the criteria listed below:
1.
One of the following underlying illnesses or conditions:
a.
Neoplastic disease (leukaemia or lymphoma).
b.
Congenital or acquired immunodeficiency.
c.
Immunosuppressive therapy with steroids or antimetabolites.
2.
One of the following types of exposure to chickenpox or shingles
patients:
a.
Household contact.
b.
Playmate contact (>1 hour play indoors).
c.
Hospital contact (in same 2 to 4 bedroom or adjacent beds in a large
ward).
d.
Newborn contact (newborn of mother who had onset of chickenpox <5 days
before delivery
or within 48 hours after delivery).
e.
Premature infant (≥28 weeks gestation) whose mother lacks a prior
history of chickenpox.
f.
Premature infant (<28 weeks gestation or ≤1000 g) regardless of
maternal history.
NEW ZEALAND DATA SHEET
Zoster Immunoglobulin-VF NZ DS 13.00
Page
2
of
9
3.
Negative or unknown prior history of chickenpox.
4.
If Zoster Immunoglobulin-VF can be administered within 96 hours after
exposure.
Zoster Immu