GAMUNEX®-C SOLUTION FOR INFUSION 10%

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Human Normal Immunoglobulin

Saatavilla:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC-koodi:

J06BA02

Lääkemuoto:

INJECTION, SOLUTION

Koostumus:

Human Normal Immunoglobulin 0.1g /mL

Antoreitti:

INTRAVENOUS, SUBCUTANEOUS

Prescription tyyppi:

Prescription Only

Valmistaja:

GRIFOLS THERAPEUTICS LLC

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2016-01-26

Valmisteyhteenveto

FULL PRESCRIBING INFORMATION
GAMUNEX®-C, [IMMUNE GLOBULIN INJECTION (HUMAN), 10%
CAPRYLATE/CHROMATOGRAPHY PURIFIED]
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE
• THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS, INCLUDING
GAMUNEX-C. RISK
FACTORS
MAY
INCLUDE:
ADVANCED
AGE,
PROLONGED
IMMOBILIZATION,
HYPERCOAGULABLE
CONDITIONS, HISTORY OF VENOUS OR ARTERIAL THROMBOSIS, USE OF
ESTROGENS, INDWELLING
CENTRAL VASCULAR CATHETERS, HYPERVISCOSITY, AND CARDIOVASCULAR RISK
FACTORS. THROMBOSIS
MAY OCCUR IN THE ABSENCE OF KNOWN RISK FACTORS. (_SEE WARNINGS AND
PRECAUTIONS_ [5.4],
_PATIENT COUNSELING INFORMATION_ [17])
• FOR PATIENTS AT RISK OF THROMBOSIS, ADMINISTER GAMUNEX-C AT THE
MINIMUM DOSE AND
INFUSION RATE PRACTICABLE. ENSURE ADEQUATE HYDRATION IN PATIENTS
BEFORE ADMINISTRATION.
MONITOR FOR SIGNS AND SYMPTOMS OF THROMBOSIS AND ASSESS BLOOD
VISCOSITY IN PATIENTS
AT RISK FOR HYPERVISCOSITY. (_SEE DOSAGE AND ADMINISTRATION_ [2.5], _
WARNINGS AND_
_PRECAUTIONS_ [5.4])
• RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROSIS, AND
DEATH MAY OCCUR WITH
IMMUNE
GLOBULIN
INTRAVENOUS
(IGIV)
PRODUCTS
IN
PREDISPOSED
PATIENTS.
PATIENTS
PREDISPOSED TO RENAL DYSFUNCTION INCLUDE THOSE WITH ANY DEGREE OF
PRE-EXISTING RENAL
INSUFFICIENCY, DIABETES MELLITUS, AGE GREATER THAN 65, VOLUME
DEPLETION, SEPSIS,
PARAPROTEINEMIA, OR PATIENTS RECEIVING KNOWN NEPHROTOXIC DRUGS.
• RENAL DYSFUNCTION AND ACUTE RENAL FAILURE OCCUR MORE COMMONLY IN
PATIENTS RECEIVING
IGIV PRODUCTS CONTAINING SUCROSE.(1) GAMUNEX-C DOES NOT CONTAIN
SUCROSE.
• FOR PATIENTS AT RISK OF RENAL DYSFUNCTION OR FAILURE, ADMINISTER
GAMUNEX-C AT THE
MINIMUM CONCENTRATION AVAILABLE AND THE MINIMUM INFUSION RATE
PRACTICABLE.
(_SEE_
_WARNINGS AND PRECAUTIONS _[5.2])
1 INDICATIONS AND USAGE
GAMUNEX-C is an immune globulin injection (human) 10% liquid that is
indicated for the
treatment of:
1.1 PRIMARY HUMORAL IMMUNODEFICIENCY (PI)
GAMUNEX-C is indicated as replacement therapy of primary humoral
immunodeficiency. This
includes, but is not limited to, co