VERQUVO 5 MG

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

VERICIGUAT

Tillgänglig från:

BAYER ISRAEL LTD, ISRAEL

ATC-kod:

C01DX22

Läkemedelsform:

FILM COATED TABLETS

Sammansättning:

VERICIGUAT 5 MG

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

BAYER AG., GERMANY

Terapiområde:

VERICIGUAT

Terapeutiska indikationer:

Verquvo is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

Tillstånd datum:

2022-02-09

Bipacksedel

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s
prescription only
VERQUVO
® 2.5 MG FILM-COATED
TABLETS
VERQUVO
® 5 MG FILM-COATED TABLETS
VERQUVO
® 10 MG FILM-COATED
TABLETS
ACTIVE INGREDIENT
Each tablet contains:
vericiguat 2.5 mg
vericiguat 5 mg
vericiguat 10 mg
Inactive
ingredients
and
allergens:
See
section 2 under ‘Important information about
some
of
this
medicine’s
ingredients’
and
section 6 ‘Additional information’.
READ
THE
ENTIRE
LEAFLET
CAREFULLY
BEFORE
YOU START 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 to treat
your illness. 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?
Verquvo is intended to reduce the risk of
cardiovascular death and heart failure (HF)
hospitalization following a hospitalization
for
heart failure or need for outpatient intravenous
diuretics, in adults with symptomatic chronic
heart failure and ejection fraction (EF, amount
of blood pumped with each heartbeat) less
than 45%.
THERAPEUTIC
GROUP:
vasodilators
for
heart
disease, soluble guanylate cyclase stimulator.
Heart failure is a condition in which your heart
is weak and cannot pump enough blood to
your body. Some common symptoms of heart
failure are shortness of breath, tiredness, or
swelling caused by a build-up of fluid.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active
ingredient vericiguat or to any of the
other ingredients of this medicine (see
section 6 ‘Additional information’)
•
you are taking any medicines that contain
another
SOLUBLE
GUANYLATE
CYCLASE
STIMULATOR, such as riociguat used to
treat high blood pressure in the lungs
If any of the above applies to you, TALK TO YOUR
DOCTOR FIRST and do not take this m

Produktens egenskaper

1
RESTRICTED
1.
NAME OF THE MEDICINAL PRODUCT
Verquvo 2.5 mg film-coated tablets
Verquvo 5 mg film-coated tablets
Verquvo 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Verquvo 2.5 mg film-coated tablets
Each film-coated tablet contains 2.5 mg vericiguat.
_Excipient with known effect _
Each film-coated tablet contains 58.14 mg lactose (as monohydrate),
see section 4.4.
Verquvo 5 mg film-coated tablets
Each film-coated tablet contains 5 mg vericiguat.
_Excipient with known effect _
Each film-coated tablet contains 55.59 mg lactose (as monohydrate),
see section 4.4.
Verquvo 10 mg film-coated tablets
Each film-coated tablet contains 10 mg vericiguat.
_Excipient with known effect _
Each film-coated tablet contains 111.15 mg lactose (as monohydrate),
see section 4.4.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Verquvo 2.5 mg film-coated tablets
Round, biconvex, white film-coated tablet with a diameter of 7 mm,
marked with “2.5” on one side
and “VC” on the other side.
Verquvo 5 mg film-coated tablets
Round, biconvex, brown-red film-coated tablet with a diameter of 7 mm,
marked with “5” on one side
and “VC” on the other side.
Verquvo 10 mg film-coated tablets
Round, biconvex, yellow-orange film-coated tablet with a diameter of 9
mm, marked with “10” on one
side and “VC” on the other side.
2
RESTRICTED
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Verquvo is indicated to reduce the risk of cardiovascular death and
heart failure (HF) hospitalization
following a hospitalization for heart failure or need for outpatient
IV diuretics, in adults with
symptomatic chronic HF and ejection fraction less than 45%. (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Vericiguat is administered in conjunction with other heart failure
therapies.
Before starting vericiguat, care should be taken to optimise volume
status and diuretic therapy to
stabilise patients after the decompensation event, particularly in
p