Trikafta 50/25/37.5

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Elexacaftor 50mg;  ; Ivacaftor 37.5mg;  ;  ; Tezacaftor 25mg;  ;  ; Ivacaftor 75mg

Fáanlegur frá:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Lyfjaform:

Film coated tablet

Samsetning:

Active: Elexacaftor 50mg   Ivacaftor 37.5mg     Tezacaftor 25mg     Excipient: Croscarmellose sodium Hypromellose Hypromellose acetate succinate Magnesium stearate Microcrystalline cellulose Opadry orange 20A130039 Sodium laurilsulfate Active: Ivacaftor 75mg Excipient: Carnauba wax Colloidal silicon dioxide Croscarmellose sodium Hypromellose acetate succinate Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opacode black S-1-17823 Opadry blue 85F105098 Sodium laurilsulfate

Gerð lyfseðils:

Prescription

Ábendingar:

Trikafta is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Vörulýsing:

Package - Contents - Shelf Life: Blister pack, PCTFE (Aclar)/PVC/Al, 7 x IVA tablets per strip, 4 strips per pack - 28 tablets -   - Blister pack, PCTFE (Aclar)/PVC/Al, 14 x ELX/TEZ/IVA tablets per strip, 4 strips per pack - 56 tablets -   - Combination pack, 28-day calendar pack, PCTFE (Aclar)/PVC/Al co-pack 4 x 21 tablets (14 x ELX/TEZ/IVA and 7 x IVA) - 84 tablets - 36 months from date of manufacture stored at or below 30°C

Leyfisdagur:

2021-06-04

Upplýsingar fylgiseðill

211209 Trikafta® CMI
1
TRIKAFTA®
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.

This medicine is new or being used differently. Please report side
effects. See the full CMI for further details. Read before
using this medicine.
1.
WHY AM I USING TRIKAFTA?
Trikafta contains the active ingredients elexacaftor, tezacaftor and
ivacaftor. Trikafta is used for the chronic treatment of cystic
fibrosis in patients aged 6 years and older with at least one
_F508del_ mutation in the cystic fibrosis transmembrane conductance
regulator (CFTR) gene.
For more information, see Section 1. Why am I using Trikafta? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TRIKAFTA?
Do not use if you have ever had an allergic reaction to Trikafta or
any of the ingredients listed at the end of the CMI.
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.
For more information, see Section 2. What should I know before I use
Trikafta? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Trikafta and affect how it works.
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 TRIKAFTA?
Your doctor will tell you how much Trikafta you need to take each day.
This may depend on your condition and whether or not
you are taking other medicines. Trikafta is for oral use.
More instructions can be found in Section 4. How do I use Trikafta? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TRIKAFTA?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
Trikafta.
•
Use Trikafta exactly as your doctor has prescribed.
•
Take Trikafta with fat-containing food and avoid food or drinks
containing grapefruit.
•
Tell your doctor if you are pregnant or become pregnant while using
Trikafta.
THI

Vara einkenni

1
20231012 Trikafta Data Sheet
NEW ZEALAND DATA SHEET – TRIKAFTA
®
(ELEXACAFTOR/TEZACAFTOR/IVACAFTOR, IVACAFTOR)
FILM-COATED TABLETS
1
TRIKAFTA FILM-COATED TABLETS
Trikafta (elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg and
ivacaftor 150 mg) film-
coated tablets
Trikafta (elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg and
ivacaftor 75 mg) film-
coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ELEXACAFTOR 100 MG/TEZACAFTOR 50 MG/IVACAFTOR 75 MG AND IVACAFTOR 150
MG_
MORNING DOSE
Each film-coated tablet contains 100 mg of elexacaftor, 50 mg of
tezacaftor and 75 mg of
ivacaftor as a fixed dose combination tablet.
EVENING DOSE
Each film-coated tablet contains 150 mg of ivacaftor.
_ELEXACAFTOR 50 MG/TEZACAFTOR 25 MG/IVACAFTOR 37.5 MG AND IVACAFTOR 75
MG_
MORNING DOSE
Each film-coated tablet contains 50 mg of elexacaftor, 25 mg of
tezacaftor and 37.5 mg of
ivacaftor as a fixed dose combination tablet.
EVENING DOSE
Each film-coated tablet contains 75 mg of ivacaftor.
Excipients with known effect:
lactose monohydrate
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
COMPOSITE PACK
_TRIKAFTA 100 MG/50 MG/75 MG AND 150 MG FILM-COATED TABLETS _
_ _
MORNING DOSE: _elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg _
Orange, capsule-shaped tablet debossed with “T100” on one side and
plain on the other (7.9 mm
x 15.5 mm).
EVENING DOSE: _Ivacaftor 150 mg film-coated tablet _
Light blue, capsule-shaped tablet printed with “V 150” in black
ink on one side and plain on the
other (16.5 mm x 8.4 mm).
_ _
2
20231012 Trikafta Data Sheet
_TRIKAFTA 50 MG/25 MG/37.5 MG AND 75 MG FILM-COATED TABLETS _
MORNING DOSE:_ elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg _
Light orange, capsule-shaped tablet debossed with “T50” on one
side and plain on the other (6.4
mm x 12.2 mm).
EVENING DOSE: _Ivacaftor 75 mg film-coated tablet_
Light blue, capsule-shaped tablet printed with “V 75” in black ink
on one side and plain on the
other (12.7 mm x 6.8 mm).
4
CLINIC