HEMOFIL M ANTIHEMOPHILLIC FACTOR (HUMAN) METHOD M MONOCLONAL PURIFIED

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

FACTOR VIII (HUMAN)

Tilgjengelig fra:

TAKEDA ISRAEL LTD

ATC-kode:

B02BD02

Legemiddelform:

POWDER FOR SOLUTION FOR INJECTION

Sammensetning:

FACTOR VIII (HUMAN) 220 - 2000 IU/VIAL

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

BAXALTA US INC., USA

Terapeutisk gruppe:

COAGULATION FACTOR VIII

Terapeutisk område:

COAGULATION FACTOR VIII

Indikasjoner:

Hemophilia A - for the prevention and control of hemorrhagic episodes

Autorisasjon dato:

2023-12-31

Informasjon til brukeren

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
________
OCTOBER 22, 2013
___
םש
רישכת
תילגנאב
רפסמו
םושירה
_
ANTIHEMOPHILIC FACTOR (HUMAN) HEMOFIL M METHOD MONOCLONAL
112
94
25372
00
םש
לעב
םושירה
TEVA MEDICAL (MARKETING) LTD., HAORGIM ST 8, ASHDOD 77100
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRA-
INDICATIONS
Known
hypersensitivity
to
mouse
protein
is
a
contraindication to the use of HEMOFIL M AHF.
HEMOFIL M is contraindicated in patients with a known
hypersensitivity to the active substance, to
excipients, or to mouse proteins.
Known
hypersensitivity
to
mouse
protein
is
a
contraindication to the use of HEMOFIL M AHF.
POSOLOGY,
DOSAGE &
ADMINISTRA-
TION
The careful control of the substitution therapy is especially
important in cases of major surgery or life threatening
hemorrhages.
Although dosage can be estimated by the calculations
above, it is strongly recommended that whenever possible,
appropriate laboratory tests including serial AHF assays be
performed on the patient’s plasma at suitable intervals to
assure that adequate AHF levels have been reached and are
maintained.
Other dosage regimens have been proposed such as that of
Schimpf, et al, which describes continuous maintenance
therapy.6
INTRAVENOUS SYRINGE INJECTION
Parenteral
drug
products
should
be
inspected
for
particulate matter and discoloration prior to administration.
whenever solution and container permit
RATE OF ADMINISTRATION
Preparations of HEMOFIL M AHF can be administered
at a rate of up to 10 mL per minute with no significant
reactions .
The pulse rate should be determined before and during
administration of HEMOFIL M AHF. Should a significant
increase occur, reducing the rate of administration or
temporarily halting the in

Preparatomtale

HEMOFIL M _SPC_IL format & alignment to USPI_201120
PHYSICIANS’ PRECRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
HEMOFIL M
ANTIHEMOPHILIC FACTOR (HUMAN),
METHOD M, MONOCLONAL PURIFIED
FACTOR VIII (HUMAN) 220 - 2000 IU/ vial
Powder for solution for injection,
for intravenous use.
THERAPEUTIC INDICATIONS
HEMOFIL
M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified,
is indicated in
hemophilia A (classical hemophilia)
for the prevention and control of hemorrhagic episodes.
DESCRIPTION
HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal
Purified [HEMOFIL
M], is a sterile, nonpyrogenic, dried preparation of antihemophilic
factor (Factor VIII, Factor VIII:C,
AHF) in concentrated form with a specific activity range of 2 to 22
AHF International Units/mg of total
protein. HEMOFIL M contains a maximum of 12.5 mg/mL Albumin, and per
AHF International Unit,
0.07 mg polyethylene glycol (3350), 0.39 mg histidine as stabilizing
agents, not more than 0.1 mg
glycine, 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl
phosphate) and 50 ng detergent
(octoxynol 9). In the absence of the added Albumin (Human), the
specific activity is approximately
2,000 AHF International Units/mg of protein
_[see Clinical Pharmacology]._
HEMOFIL M is prepared by the Method M process from pooled human plasma
by immunoaffinity
chromatography utilizing a murine monoclonal antibody to Factor
VIII:C, followed by an ion exchange
chromatography step for further purification. Source material may be
provided by other US licensed
manufacturers. HEMOFIL M also includes an organic solvent (tri-n-butyl
phosphate) and detergent
(octoxynol 9) virus inactivation step designed to reduce the risk of
transmission of hepatitis and other
viral
diseases.
The
process
further
includes
a
nanofiltration
step
between
immunoaffinity
chromatography and ion-exchange chromatography as an additional viral
clearance step to further
improve the viral safety margin of the final product.
Use of an organic solvent (tri-n-butyl phosphate; TNB