Prevymis

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Letermovir 240mg

Prieinama:

Merck Sharp & Dohme (New Zealand) Limited

Vaisto forma:

Concentrate for infusion

Sudėtis:

Active: Letermovir 240mg Excipient: Hydroxypropyl-beta-cyclodextrin Sodium chloride Sodium hydroxide Water for injection

Recepto tipas:

Prescription

Terapinės indikacijos:

Prevymis is indicated for the prophylaxis of cytomegalovirus (CMV) infection or disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

Produkto santrauka:

Package - Contents - Shelf Life: Vial, glass, single dose, 30 mL, Type I, closed with silicone coated chlorobuytl rubber stopper and green flip off lid - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at or below 25°C protect from light 48 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Leidimo data:

2018-09-26

Pakuotės lapelis

PREVYMIS
®
1
.
PREVYMIS®
_Letermovir _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PREVYMIS. 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 PREVYMIS
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 PREVYMIS IS
USED FOR
PREVYMIS is a medicine to help to
keep you from getting sick from
CMV (cytomegalovirus) in adults
who have recently had a bone
marrow transplant. PREVYMIS
works by preventing the body from
making more CMV.
CMV is a virus. It’s a virus that a lot
of people have, but they don’t even
know it. For most people, CMV just
stays in their body and it doesn’t hurt
them. However, if your immune
system is weak after you get a bone
marrow transplant, you may be at
high risk of becoming ill from CMV.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE
PREVYMIS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PREVYMIS IF YOU:

ARE ALLERGIC TO LETERMOVIR OR ANY
OF THE OTHER INGREDIENTS OF
PREVYMIS.

ARE TAKING ANY OF THE FOLLOWING
MEDICINES:

Pimozide (for Tourette’s
syndrome)

Ergot alkaloids (for migraine
headaches)
IF YOU ARE TAKING PREVYMIS WITH
CICLOSPORIN, DO NOT TAKE:

Pitavastatin or simvastatin
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives, swelling of the face,
lips, mouth, throat or other parts of
the body, shortness of breath,
wheezing or trouble breathing.
DO NOT TAKE PREVYMIS IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
DO NOT TAKE PREVYMIS IF THE
EXPIRY DATE PRINTED ON THE PACK HAS
PASSED.
IT IS NOT KNOWN IF PREVYMIS IS
SAFE AND EFFECTIVE FOR PEOPLE UNDE

Prekės savybės

1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
PREVYMIS
®
letermovir 240 mg film coated tablet
PREVYMIS
®
letermovir 480 mg film coated tablet
PREVYMIS
®
letermovir 240 mg/12mL concentrated injection for infusion
PREVYMIS
®
letermovir 480 mg/24mL concentrated injection for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PREVYMIS tablets and concentrated injection for infusion contain
letermovir.
FILM COATED TABLET
Each film-coated tablet contains 240 mg or 480 mg of letermovir.
Excipients with known effect
Each 240 mg film-coated tablet contains 3.96 mg of lactose (as
monohydrate) and 1.90 mg (or
0.08 mmol) of sodium.
Each 480 mg film-coated tablet contains 6.38 mg of lactose (as
monohydrate) and 3.80 mg (or
0.17 mmol) of sodium.
For the full list of excipients, see section 6.1.
CONCENTRATED INJECTION FOR INFUSION
Each single-dose vial contains 240 mg (12 mL per vial) or 480 mg (24
mL per vial) of letermovir.
Each mL contains 20 mg of letermovir.
Excipient with known effect
Each 240 mg vial contains 22.91 mg (or 1.00 mmol) sodium.
Each 480 mg vial contains 45.82 mg (or 1.99 mmol) sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
FILM COATED TABLET
PREVYMIS 240 mg tablet is a yellow oval tablet. Each tablet is
debossed with “591” on one side and MSD
logo on the other side.
PREVYMIS 480 mg tablet is a pink oval, bi-convex tablet. Each tablet
is debossed with “595” on one side
and MSD logo on the other side.
CONCENTRATED INJECTION FOR INFUSION
PREVYMIS 240 mg/12 mL (20 mg/mL) concentrated injection for infusion
is supplied as a clear solution
and may contain a few small translucent or white particles in a
single-dose vial.
PREVYMIS 480 mg/24 mL (20 mg/mL) concentrated injection for infusion
is supplied as a clear solution
and may contain a few small translucent or white particles in a
single-dose vial.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
2
PREVYMIS is indicated for the prophylaxis of cytomegalovirus (CMV)
infection or disease in adult CMV-
seropositive recipients