GLASSIA

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

ALPHA-1-ANTITRYPSIN ( AAT)

Disponible desde:

KAMADA LTD, ISRAEL

Código ATC:

B02AB02

formulario farmacéutico:

SOLUTION FOR INFUSION

Composición:

ALPHA-1-ANTITRYPSIN ( AAT) 1 G / 50 ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricado por:

KAMADA LTD, ISRAEL

Área terapéutica:

ALFA1 ANTITRYPSIN

indicaciones terapéuticas:

Alpha1-Proteinase Inhibitor (Human), GLASSIA® is indicated for chronic augmentation and maintenance therapy in individuals with congenital deficiency of alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT) deficiency and clinical evidence of emphysema.

Fecha de autorización:

2016-07-31

Información para el usuario

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
_______________
13-07-2014
________
םש
רישכת
תילגנאב
רפסמו
םושירה
_
GLASSIA 146-60-33208
______
םש
לעב
םושירה
_________
KAMADA LTD
______________________________
דבלב תורמחהה טורפל דעוימ הז ספוט
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
DOSAGE AND
ADMINISTRATION
ADMINISTRATION
Administer GLASSIA
®
at room
temperature through an appropriate
intravenous administration set at a rate not
greater than 0.04 mL/kg body weight per
minute.The recommended dosage of 60
mg/kg takes approximately 60-80 minutes
to infuse.
You may then resume the infusion at
a rate tolerated by the patient
.
ADMINISTRATION
Administer GLASSIA
®
at room temperature through an
appropriate intravenous administration set at a rate not to exceed
0.2 mL/kg body weight per minute, and as determined by the
response and comfort of the patient. The recommended dosage of
60 mg/kg at a rate of 0.2 mL/kg/min will take approximately 15
minutes to infuse.
Resume the infusion at a rate tolerated by the patient, except in the
case of severe reaction.
WARNINGS AND
PRECAUTIONS
IF ANAPHYLACTIC OR
SEVERE ANAPHYLACTOID
REACTIONS OCCUR,
DISCONTINUE THE INFUSION
IMMEDIATELY.
Discontinue the infusion if hypersensitivity symptoms occur
and administer appropriate emergency treatment.
TRANSMISSIBLE
INFECTIOUS
AGENTS
Because this product is made from human
plasma, it may carry a risk of transmitting
infectious agents, such as viruses, and
theoretically, the Creutzfeldt-Jakob
disease (CJD) agent.
There is also the possibility that unknown
infectious agents may be present in such
products
.
The physician should weigh the risks
and benefits of the use of this
product and discuss the risks and
benefits with the patient.
Because this product is made from human plas

Ficha técnica

GLASSIA
®
FULL PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
GLASSIA
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alpha-1-antitrypsin (AAT) 1 g/50 ml
_ _
_Excipient with known effect: _
_ _
Sodium Content : This medicinal product contains about 200mg sodium
per bottle of 50 ml,
equivalent to 10 % of the WHO recommended maximum daily intake of 2 g
sodium for adult.
For the full list of excipients, see section 14.
3.
PHARMACEUTICAL FORM
Solution for infusion
4.
INDICATIONS AND USAGE
Alpha
1
-Proteinase Inhibitor (Human), GLASSIA is indicated for chronic
augmentation and
maintenance therapy in individuals with congenital deficiency of alpha
1
-proteinase inhibitor
(Alpha
1
-PI), also known as alpha
1
-antitrypsin (AAT) deficiency and clinical evidence of
emphysema.
•
The effect of augmentation therapy with GLASSIA or any Alpha
1
-PI product on
pulmonary exacerbations and on the progression of emphysema in Alpha
1
-PI deficiency
has not been conclusively demonstrated in randomized, controlled
clinical trials.
•
Clinical data demonstrating the long-term effects of chronic
augmentation and
maintenance therapy of individuals with GLASSIA are not available.
•
GLASSIA is not indicated as therapy for lung disease in patients in
whom severe Alpha
1
-
PI deficiency has not been established.
5
DOSAGE AND ADMINISTRATION
For intravenous use only.
5.1 Dosage
•
Administer 60 mg/kg body weight of GLASSIA once weekly by intravenous
infusion.
•
Dose ranging studies using efficacy endpoints have not been performed.
5.2 Preparation
1.
Use aseptic technique.
2.
Allow the product to reach room temperature prior to infusing and
administer within three
hours of entering the vials.
3.
Inspect the vial of GLASSIA. The solution should be clear and
colorless to yellow-green
and may contain a few protein particles. Discard if the product is
cloudy.
4.
The product is suitable for infusion directly from the vial or pooled
into an empty sterile
container for intravenous infusion.
5.
Use a vented spike (not supplied) to wit