XYNTHA 1000 IU

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

MOROCTOCOG ALFA

MAH:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC_code:

B02BD02

pharmaceutical_form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

composition:

MOROCTOCOG ALFA 1000 IU/VIAL

administration_route:

I.V

prescription_type:

Required

manufactured_by:

PFIZER INC, USA

therapeutic_group:

COAGULATION FACTOR VIII

therapeutic_area:

COAGULATION FACTOR VIII

therapeutic_indication:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)

authorization_date:

2022-12-31

PIL

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
XYNTHA
® 250 IU
XYNTHA
® 500 IU
XYNTHA
® 1000 IU
XYNTHA
® 2000 IU
LYOPHILIZED POWDER AND DILUENT FOR SOLUTION FOR INTRAVENOUS (IV)
INJECTION
EACH VIAL CONTAINS:
MOROCTOCOG ALFA 250IU, 500IU, 1000IU, 2000IU
For a list of inactive ingredients and allergens, see section 6,
‘Further
information.’
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information about this medicine. If you have
any
further questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if it seems to you that their medical condition
is
similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Treatment and prophylaxis of bleeding in patients with hemophilia A
)congenital factor VIII deficiency(.
THERAPEUTIC GROUP: coagulation factor.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE if you have had immediate, life-threatening
sensitivity reaction, including anaphylaxis, to the active ingredient
or
to any of the other ingredients in this medicine, which are listed in
section 6, including sensitivity to protein derived from hamster.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
CONTACT YOUR DOCTOR IMMEDIATELY IF BLEEDING IS NOT CONTROLLED AFTER
INJECTING THE MEDICINAL PRODUCT.
BEFORE TREATMENT WITH XYNTHA
®
, TELL YOUR DOCTOR IF:

you have any allergies, including an allergy to hamsters.

you are pregnant or are planning to become pregnant.

you are breastfeeding or are planning to breastfeed.
CHILDREN AND ADOLESCENTS
XYNTHA
®
may be used in children and adolescents of all ages.
TESTS AND FOLLOW-UP
Your body may produce antibodies to the medicinal product, that may
reduce the efficacy of the medicinal product. The attending doctor may
ask you to take periodic blood tests to monitor these antibodies in
your
blood.
DRUG INTERACTIONS
IF YOU ARE TAKING OR

SPC

Xyntha LPD WC 09 Aug 2022
1
2021-0072524
FULL PRESCRIBING INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
XYNTHA
® 250 IU
XYNTHA
® 500 IU
XYNTHA
® 1000 IU
XYNTHA
® 2000 IU
QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS
Intravenous
Infusion
Available as 250, 500,
1000, or 2000 IU in
single-use vials.
Polysorbate 80 (0.4 mg/vial or
prefilled dual-chamber
syringe
), Sucrose (12 mg/vial or
prefilled dual-
chamber syringe
), L-Histidine (6 mg/vial or
prefilled
dual-chamber syringe
), Calcium Chloride Dihydrate
(1 mg/vial or
prefilled dual-chamber syringe
), Sodium
Chloride (72 mg/vial or
prefilled dual-chamber
syringe
) [after reconstitution with diluent].
Xyntha is prepared by a modified process that eliminates any exogenous
human- or animal-derived
protein in the cell culture process, purification, or final
formulation. The purification process uses a
series of chromatography steps, one of which is based on affinity
chromatography using a synthetic
peptide affinity ligand. The process also includes a solvent-detergent
viral inactivation step and a
virus-retaining nanofiltration step.
The labelled potency of Xyntha is based on the European Pharmacopoeial
chromogenic substrate
assay, in which the Pfizer In-House Recombinant Factor VIII Potency
Reference Standard has
been calibrated to the WHO 7
th
International Standard using the one-stage clotting assay. This
method of potency assignment is intended to harmonize Xyntha with
clinical monitoring using a
one-stage
clotting assay.
2.
INDICATIONS AND CLINICAL USE
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor VIII
deficiency)
GERIATRICS (≥ 65 YEARS OF AGE):
Clinical studies of Xyntha did not include sufficient numbers of
subjects aged 65 and over to
determine whether they respond differently from younger subjects.
Other reported clinical
Xyntha LPD WC 09 Aug 2022
2
2021-0072524
experience has not identified diffe