ADVAGRAF XL tacrolimus 0.5 mg prolonged-release capsule blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

tacrolimus, Quantity: 0.5 mg

제공처:

Astellas Pharma Australia Pty Ltd

INN (국제 이름):

Tacrolimus

약제 형태:

Capsule, modified release

구성:

Excipient Ingredients: iron oxide yellow; hypromellose; iron oxide red; titanium dioxide; lactose monohydrate; ethylcellulose; magnesium stearate; sodium lauryl sulfate; Gelatin; hyprolose; butan-1-ol; purified water; industrial methylated spirit; simethicone; lecithin; ethanol; Shellac; strong ammonia solution; sulfuric acid

관리 경로:

Oral

패키지 단위:

50, 30

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

ADVAGRAF XL is indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

제품 요약:

Visual Identification: Oblong, light yellow and orange capsule imprinted with '0.5mg' & '*647'; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

승인 상태:

Licence status A

승인 날짜:

2016-05-23

환자 정보 전단

PROGRAF
®
; ADVAGRAF
® XL
PROGRAF® and Advagraf® XL
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.
1.
WHY AM I USING PROGRAF OR ADVAGRAF XL?
PROGRAF or ADVAGRAF XL contains the active ingredient tacrolimus.
PROGRAF or ADVAGRAF XL is used so that your new liver, kidney, lung or
heart will not be attacked or rejected by your body.
For more information, see Section 1. Why am I using PROGRAF or
ADVAGRAF XL? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PROGRAF OR ADVAGRAF XL?
Do not use if you have ever had an allergic reaction to PROGRAF or
ADVAGRAF XL, macrolide antibiotics, or any of the ingredients
listed at the end of the CMI. ADVAGRAF XL and PROGRAF are not
interchangeable.
For more information, see Section 2. What should I know before I use
PROGRAF or ADVAGRAF XL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PROGRAF or ADVAGRAF XL and affect
how it works.
Tell your doctor or pharmacist if you are taking any other medicines,
including any medicines, vitamins or supplements that you buy
without a prescription from your pharmacy, supermarket or health food
shop
See Section 3. What if I am taking other medicines? in the full CMI
for information.
4.
HOW DO I USE PROGRAF OR ADVAGRAF XL?
•
PROGRAF capsules should be taken in two doses (e.g. morning and
evening) each day.
•
ADVAGRAF XL should be taken once a day in the morning.
•
PROGRAF or ADVAGRAF XL capsules should be taken at least 1 hour before
or 2 to 3 hours after a meal preferably with water
and not with grapefruit juice.
•
More instructions can be found in Section 4. How do I use PROGRAF or
ADVAGRAF XL? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PROGRAF OR ADVAGRAF XL?
THINGS YOU
SHOULD DO
•
Tell your doctor if you become pregnant while taking PROGRAF or
ADVAGRAF XL.
•
PROGRAF or ADVAGRAF XL suppresses your immune system by lowering your
body's immune defence

제품 특성 요약

1
AUSTRALIAN PRODUCT INFORMATION
PROGRAF
® (TACROLIMUS) CAPSULES AND CONCENTRATED INJECTION
ADVAGRAF
® XL (TACROLIMUS) PROLONGED-RELEASE CAPSULES
1
NAME OF THE MEDICINE
Tacrolimus
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROGRAF CAPSULES
Each 0.5 mg capsule contains 0.5 mg tacrolimus
Each 1 mg capsule contains 1 mg tacrolimus
Each 5 mg capsule contains 5 mg tacrolimus
Excipients with known effect: sugars as lactose and soya bean
products.
For the full list of excipients, see Section 6.1 List of excipients.
ADVAGRAF XL PROLONGED-RELEASE CAPSULES
Each 0.5 mg prolonged-release capsule contains 0.5 mg tacrolimus
Each 1 mg prolonged-release capsule contains 1 mg tacrolimus
Each 3 mg prolonged-release capsule contains 3 mg tacrolimus
Each 5 mg prolonged-release capsule contains 5 mg tacrolimus
Excipients with known effect: sugars as lactose and soya bean
products.
For the full list of excipients, see Section 6.1 List of excipients.
PROGRAF CONCENTRATED INJECTION
Each 1 mL of Concentrated Injection contains 5 mg tacrolimus.
Contains: Contains alcohol as 95% v/v ethanol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
PROGRAF CAPSULES
Capsule
Supplied as:
PROGRAF capsules 0.5 mg: light yellow hard gelatine capsules with
‘0.5 mg’ and ‘[f]607’ printed in red.
PROGRAF capsules 1 mg: white, hard gelatine capsules with _'_1 mg_'_
and _'_[f]617_'_ printed in red.
PROGRAF capsules 5 mg: greyish-red, hard gelatine capsules with _'_5
mg_'_ and _'_[f]657_'_ printed in white.
2
ADVAGRAF XL PROLONGED-RELEASE CAPSULES
Prolonged release capsule
Supplied as:
ADVAGRAF XL 0.5 mg prolonged-release capsules: oblong capsules with a
light yellow cap imprinted
with “0.5 mg” and an orange body imprinted with “
647”.
ADVAGRAF XL 1 mg prolonged-release capsules: oblong capsules with a
white cap imprinted with
“1 mg” and an orange body imprinted with “
677”.
ADVAGRAF XL 3 mg prolonged-release capsules: oblong capsules with an
orange cap imprinted with
“3 mg” and an orange