WELIREG 40 MG FILM-COATED TABLETS

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

BELZUTIFAN

Beschikbaar vanaf:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC-code:

L01XX74

farmaceutische vorm:

FILM COATED TABLETS

Samenstelling:

BELZUTIFAN 40 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

MERCK SHARP & DOHME LLC, USA

Therapeutisch gebied:

BELZUTIFAN

therapeutische indicaties:

For the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for VHL associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable or undesirable.

Autorisatie datum:

2023-07-17

Bijsluiter

Welireg
®
40 mg film-coated
tablets (Belzutifan)
PATIENT ALERT CARD
IMPORTANT SAFETY INFORMATION
PLEASE KEEP THIS CARD WITH YOU AT ALL TIMES
•
This patient alert card contains important safety information that you
need to be aware of before, during, and after
treatment with WELIREG (belzutifan).
•
Show this card to any health care professional involved in your care.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in the package
leaflet.
Side effects can be reported to the Ministry of Health by using the
link: https://sideeffects.health.gov.il
Side effects can also be reported directly to MSD company on Tel:
09-9533333.
By reporting side effects, you can help provide more information on
the safety of this medicine.
Welireg can cause low oxygen levels in your body that can be severe
and may require you to stop treatment, receive oxygen
therapy, or be hospitalized. This is called ‘hypoxia’.
Your healthcare provider will monitor your oxygen levels before you
start and during treatment with Welireg
.
CONTACT YOUR DOCTOR IMMEDIATELY IF YOU EXPERIENCE ANY OF THE
FOLLOWING:
•
Difficulty breathing or shortness of breath
•
Increased heart rate
•
Rapid breathing
•
Feeling anxious or restless
•
Bluish discoloration of the skin and around your mouth
•
You are unable to complete sentences when at rest due to
breathlessness
•
Unusual tiredness
•
Confusion
IMPORTANT SAFETY INFORMATION FOR PATIENTS
IF THESE SIGNS OR SYMPTOMS BECOME SEVERE OR ARE RAPIDLY WORSENING,
THEN GO TO YOUR
NEAREST EMERGENCY ROOM OR CALL 101 IMMEDIATELY TO SEEK MEDICAL ADVICE.
IMPORTANT SAFETY INFORMATION
PLEASE KEEP THIS CARD WITH YOU AT ALL TIMES
•
This patient alert card contains important safety information that you
need
to be aware of before, during, and after treatment with WELIREG
(belzutifan).
•
Show this card to any health care professional involved in your care.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This i