PREVYMIS letermovir 240 mg film-coated tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

letermovir, Quantity: 240 mg

Saatavilla:

Merck Sharp & Dohme (Australia) Pty Ltd

Lääkemuoto:

Tablet, film coated

Koostumus:

Excipient Ingredients: Carnauba Wax; croscarmellose sodium; magnesium stearate; silicon dioxide; microcrystalline cellulose; povidone; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide yellow

Antoreitti:

Oral

Kpl paketissa:

28 tablets

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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).

Tuoteyhteenveto:

Visual Identification: Yellow oval tablet debossed with "591" on one side and MSD logo on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2018-06-22

Pakkausseloste

PREVYMIS
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
Please report side effects. See the full CMI for further details.
1.
WHY AM I USING PREVYMIS?
PREVYMIS contains the active ingredient letermovir. PREVYMIS is used
to help 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. For more information, see Section 1. Why am I using
PREVYMIS? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PREVYMIS?
Do not use if you have ever had an allergic reaction to letermovir or
any of the ingredients listed at the end of the CMI. Do not use
PREVYMIS if you are taking pimozide or ergot alkaloids. Do not use
pitavastatin or simvastatin if you are taking PREVYMIS with
ciclosporin. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN
TO BECOME PREGNANT OR ARE BREASTFEEDING OR PLAN TO BREASTFEED. For
more information, see Section 2. What should I know
before I use PREVYMIS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PREVYMIS and affect how it works.
PREVYMIS may affect the way other medicines work. A list
of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE PREVYMIS?
IF YOU TAKE THE TABLETS:
•
Take 1 tablet once a day.
•
Swallow the tablet whole. Do not break, crush, or chew the tablet.
Take it with or without food.
•
Take PREVYMIS at about the same time each day.
•
Your doctor will tell you when to take your tablets.
IF YOU RECEIVE PREVYMIS THROUGH AN IV (INTRAVENOUSLY):
•
You will receive PREVYMIS once a day and it will take about 1 hour.
More instructions can be found in Section 4. How do I use PREVYMIS? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PREVYMIS?
THINGS YOU
SHOULD DO
•
T

Valmisteyhteenveto

1 This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at https://www.tga.gov.au/reporting-problems
AUSTRALIAN PRODUCT INFORMATION - PREVYMIS
® (LETERMOVIR)
1
NAME OF THE MEDICINE
letermovir
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, LIST OF EXCIPIENTS.
CONCENTRATED INJECTION FOR INFUSION
Each single-dose vial contains 240 mg (12 mL per vial) or 480 mg (24
mL per vial) 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, LIST OF EXCIPIENTS.
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.
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4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PREVYMIS is indicated for the prophylaxis of