RAPILYSIN reteplase 10U powder for injection vial water for injections diluent syringe composite pk

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Reteplase

Disponible depuis:

Teva Pharma Australia Pty Ltd

Statut de autorisation:

Registered

Notice patient

RAPILYSIN
pronounced RAP-EE-LIE-SIN
_contains the active ingredient _
_reteplase_
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RAPILYSIN
injection.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking RAPILYSIN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT RAPILYSIN IS
USED FOR
RAPILYSIN contains the active
ingredient reteplase.
RAPILYSIN is used to treat acute
myocardial infarctions (also called
“heart attacks”). This condition
occurs when the blood flow to part
of the heart is blocked.
This blockage causes that part of
the heart muscle (called the
myocardium) to start to die.
RAPILYSIN works by dissolving
the blood clot that is blocking your
heart blood vessel. It is best given
within six hours of the start of any
heart symptoms.
If a myocardial infarction is not
treated quickly, then it may lead to
minor to severe heart damage and
sometimes, death.
There are many different types of
medicines used to treat myocardial
infarctions.
RAPILYSIN belongs to a group of
medicines called thrombolytics.
RAPILYSIN is related to a normal
substance found in the blood.
RAPILYSIN only acts for a short
period of time to dissolve clots.
Your doctor, however, may have
prescribed RAPILYSIN for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY RAPILYSIN
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
RAPILYSIN
_WHEN YOU MUST NOT _
_HAVE_
_RAPILYSIN_
DO NOT USE RAPILYSIN IF:
1. YOU HAVE HAD AN ALLERGIC
REACTION TO RAPILYSIN OR
ANY INGREDIENTS LISTED AT THE
END OF THIS LEAFLET
2. YOU HAVE HAD PROLONGED HEART
MASSAGE (ALSO CALLED CPR) IN
THE LAST 10 DAYS
3. YOU HAVE A TENDENCY

Résumé des caractéristiques du produit

RAPILYSIN
®
PRODUCT INFORMATION -
1 (10)
RAPILYSIN
®
Reteplase: Recombinant Plasminogen Activator (rbe)
DESCRIPTION
RAPILYSIN

is a sterile, purified, stable recombinant plasminogen activator
(rbe), (reteplase),
concentrate produced from genetically engineered E Coli cells
containing a cloned human gene for part of
the plasminogen activator protein structure.
RAPILYSIN

is a highly purified single chain protein with a molecular weight of
39 kD. Reteplase is
obtained by genetic engineering technology, and is a variant of
plasminogen activator comprising only the
kringle 2 and protease domains. RAPILYSIN is a lyophilised powder for
reconstitution prior to injection.
RAPILYSIN

is reconstituted with sterile Water for injections.
Potency is expressed in units (U) using a reference standard which is
specific for reteplase, and is not
comparable for units used for other thrombolytic agents. 10 units of
reteplase correspond to 17.4 mg of
reteplase protein mass.
_ _
COMPOSITION
Each single use vial of lyophilisate powder for injection contains the
active ingredient reteplase
(plasminogen activator) 10U (rDNA) nominal activity. Each vial also
contains the excipients potassium
phosphate dibasic, phosphoric acid, tranexamic acid, sucrose and
polysorbate 80.
Each single use pre-filled syringe with solvent for reconstitution
contains sterile Water for injections
10mL.
RAPILYSIN contains no preservatives.
PHARMACOLOGY
PHARMACODYNAMICS
Reteplase is recombinant plasminogen activator which catalyses the
cleavage of endogenous plasminogen
to generate plasmin. Plasmin in turn degrades fibrinogen and fibrin,
which is a component of the matrix
of the thrombi, thereby exerting its thrombolytic effect.
Reteplase (10 + 10 U) dose dependently reduces plasma fibrinogen
levels by about 75 to 90%. The
fibrinogen level normalises within 2 days. As with other plasminogen
activators a rebound phenomenon
then occurs during which fibrinogen levels reach a maximum within 9
days and remain elevated for up to
18 days.
RAPILYSIN
®
PRODUC