GAMMAPLEX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IMMUNOGLOBULINS, NORMAL HUMAN

Available from:

KAMADA LTD, ISRAEL

ATC code:

J06BA02

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

IMMUNOGLOBULINS, NORMAL HUMAN 5 G / 100 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BIO PRODUCTS LABORATORY LIMITED (BPL), UK

Therapeutic group:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

Therapeutic area:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

Therapeutic indications:

Replacement therapy in adults, and children and adolescents in:- Primary immunodeficiency syndromes with impaired antibody production - Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed- Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation- Congenital AIDS with recurrent bacterial infectionsImmunomodulation in adults, and children and adolescents in:- Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count- Guillain Barré syndrome- Kawasaki disease

Authorization date:

2016-01-31

Patient Information leaflet

HEAD OFFICE 2 Holzman St., Science Park, P.O. Box 4081, Rehovot,
7670402, Israel | Tel. [phone] | Fax. [phone] PLANT Kibbutz Beit Kama, M.P Negev 8532500, Israel | Tel.
[phone] | Fax. [phone]
טסוגוא
8
201
,ה/דבכנ ת/חקור ,ה/אפור
:רישכתה רובע ,ןלהל טרופמכ עדימ ןוכדיע
לע עידוהל תשקבמ עדהמק תרבח
GAMMAPLEX ;
סקלפאמג
SOLUTION FOR INFUSION, I.V.
ןוישירל םאתהב םיליעפ םיביכרמ
:
IMMUNOGLOBULIN NORMAL HUMAN 5g/100 ml
:היוותה
REPLACEMENT THERAPY IN ADULTS, AND CHILDREN AND ADOLESCENTS IN:
-
Primary immunodeficiency syndromes with impaired antibody production
(see section
4.4)
-
Hypogammaglobulinaemia and recurrent bacterial infections in patients
with chronic
lymphocytic leukaemia, in whom prophylactic antibiotics have failed
-
Hypogammaglobulinaemia and recurrent bacterial infections in plateau
phase multiple
myeloma patients who have failed to respond to pneumococcal
immunisation
-
Congenital AIDS with recurrent bacterial infections
IMMUNOMODULATION IN ADULTS, AND CHILDREN AND ADOLESCENTS IN:
-
Primary immune thrombocytopenia (ITP), in patients at high risk of
bleeding or prior to
surgery to correct the platelet count
-
Guillain Barré syndrome
-
Kawasaki disease
יונישה תוהמ
םי
:
סב אפורל ןולעה ןוכדיע ףיע
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
4.4
:)בוהצב תשגדומ הרמחה(
Transfusion related acute lung injuries (TRALI)
There have been reports of TRALI i.e. noncardiogenic pulmonary oedema,
in patients
administered IVIg products.
:תואירבה דרשמ רתאבש תופורתה רגאמב
םוסרפל חלשנ ןכדועמה אפורל ןולעה
HTTPS://WWW.OLD.HEALTH.GOV.IL/UNITS/PHARMACY/TRUFOT/INDEX.ASP , לעבל הינפ י"ע ספדומ ולבקל ןתינו
המק תרבח ,םושירה 'לט( מ"עב עד
08-9406472
.)
,הכרבב
,לדונ הנינפ
הנוממ תחקור

Summary of Product characteristics

_ _
_ _
_Page 1 of 15 _
GAMMAPLEX
®
SOLUTION FOR INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
Gammaplex
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gammaplex 5 % w/v, solution for infusion.
Human normal immunoglobulin (IVIg)
One ml contains: Human normal immunoglobulin 50 mg (purity of at least
95% IgG).
Each 2.5 g vial of 50 ml contains: 2.5 g of human normal
immunoglobulin.
Each 5 g vial of 100 ml contains: 5 g of human normal immunoglobulin.
Each 10 g vial of 200 ml contains: 10 g of human normal
immunoglobulin.
Distribution of the IgG subclasses (approximate values):
IgG1
62 %
IgG2
31 %
IgG3
6 %
IgG4
1 %
The maximum IgA content is 10 micrograms
/
ml.
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Gammaplex is a colourless sterile solution for intravenous infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
REPLACEMENT THERAPY IN ADULTS, AND CHILDREN AND ADOLESCENTS IN:
-
Primary immunodeficiency syndromes with impaired antibody production
(see section 4.4)
-
Hypogammaglobulinaemia and recurrent bacterial infections in patients
with
chronic
lymphocytic
leukaemia,
in
whom
prophylactic
antibiotics
have
failed
-
Hypogammaglobulinaemia
and
recurrent
bacterial
infections
in
plateau
phase
multiple
myeloma
patients
who
have
failed
to
respond
to
pneumococcal immunisation
-
Congenital AIDS with recurrent bacterial infections
_ _
_ _
_Page 2 of 15 _
IMMUNOMODULATION IN ADULTS, AND CHILDREN AND ADOLESCENTS IN:
-
Primary
immune
thrombocytopenia
(ITP),
in
patients
at
high
risk
of
bleeding or prior to surgery to correct the platelet count
-
Guillain Barré syndrome
-
Kawasaki disease
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Replacement therapy should be initiated and monitored under the
supervision
of a physician experienced in the treatment of immunodeficiency.
Treatment
at home should be similarly supervised, with the patient fully
assessed and
trained in hospital prior to self-infusion at home.
Posology
The dose and dose regimen is depende