PHARMACOR EVEROLIMUS everolimus 0.75 mg tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

everolimus, Quantity: 0.75 mg

Disponibil de la:

Pharmacor Pty Ltd

Forma farmaceutică:

Tablet, uncoated

Compoziție:

Excipient Ingredients: lactose monohydrate; lactose; crospovidone; butylated hydroxytoluene; magnesium stearate; acetone; ethanol absolute; hypromellose

Calea de administrare:

Oral

Unități în pachet:

120's, 60's

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Everolimus is indicated for the prophylaxis of organ rejection in adult patients at mild to moderate immunological risk receiving an allogeneic renal or cardiac transplant and in adult patients receiving an allogeneic hepatic transplant (see section 4.4 Special warnings and precautions for use).

Rezumat produs:

Visual Identification: White to off white, round shaped tablets debossed with "EVR" on one side and "75" on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Registered

Data de autorizare:

2021-04-21

Prospect

Pharmacor everolimus
1
PHARMACOR EVEROLIMUS
EVEROLIMUS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
1.
WHY AM I USING EVEROLIMUS?
Pharmacor everolimus contains the active ingredient everolimus.
Everolimus is used to used to treat adult patients who have had
kidney, heart
or liver transplants.
For more information, see Section 1. Why am I using everolimus? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE EVEROLIMUS?
Do not use if you have ever had an allergic reaction to everolimus 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
everolimus? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with everolimus 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 EVEROLIMUS?
KIDNEY AND HEART TRANSPLANTATIONS:
•
The usual starting dose is 0.75 mg PHARMACOR EVEROLIMUS twice daily,
taken in the morning and in the evening together with
cyclosporine.
•
The first dose of PHARMACOR EVEROLIMUS will be given as soon as
possible after transplantation.
LIVER TRANSPLANTATION:
•
The general recommended daily dose is 1 mg PHARMACOR EVEROLIMUS twice
daily, taken in the morning and in the evening,
together with tacrolimus.
•
The first dose of PHARMACOR EVEROLIMUS will be given approximately
four weeks after transplantation.
More instructions can be found in Section 4. How do I use everolimus?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING EVEROLIMUS?
THINGS
YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
everolimus.
•
Keep all of your doctor's appointments so that your progress can be
checked.
•
Make sure you use a highly effective contraceptive to prevent
pregnancy during treatment with PHARMACOR
EVEROLIMUS. If you become pregnant wh

Caracteristicilor produsului

Pharmacor everolimus Ver 03 Page 1
AUSTRALIAN
PRODUCT
INFORMATION
–
PHARMACOR
EVEROLIMUS
(EVEROLIMUS) TABLETS
1.
NAME OF THE MEDICINE
Everolimus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Everolimus is a white to faintly yellow powder practically insoluble
in water but soluble in
organic solvents such as ethanol and methanol.
PHARMACOR EVEROLIMUS 0.25 MG:
Each uncoated tablet contains 0.25 mg Everolimus.
PHARMACOR EVEROLIMUS 0.5 MG:
Each uncoated tablet contains 0.5 mg Everolimus.
PHARMACOR EVEROLIMUS 0.75 MG:
Each uncoated tablet contains 0.75 mg Everolimus.
PHARMACOR EVEROLIMUS 1 MG:
Each uncoated tablet contains 1 mg Everolimus.
Excipient with known effect: contain lactose
For the full list of excipients, see section 6.1 List of excipients
.
3.
PHARMACEUTICAL FORM
Uncoated tablet.
PHARMACOR EVEROLIMUS 0.25 MG:
White to off white, round shaped tablets debossed
with "EVR" on one side and "25" on other side.
PHARMACOR EVEROLIMUS 0.5 MG:
White to off white, round shaped tablets debossed
with "EVR" on one side and "50" on other side.
PHARMACOR EVEROLIMUS 0.75 MG:
White to off white, round shaped tablets debossed
with "EVR" on one side and "75" on other side.
PHARMACOR EVEROLIMUS 1 MG:
White to off white, round shaped tablets debossed with
"EVR" on one side and "100" on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHARMACOR EVEROLIMUS is indicated for the prophylaxis of organ
rejection in adult
patients at mild to moderate immunological risk receiving an
allogeneic renal or cardiac
transplant
and
in
adult
patients
receiving
an
allogeneic
hepatic
transplant
Pharmacor everolimus Ver 03 Page 2
(see section 4.4 Special warnings and precautions for use).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Treatment with PHARMACOR EVEROLIMUS should only be initiated and
maintained by
physicians who are experienced in immunosuppressive therapy following
organ transplantation.
Everolimus should be used in combination with cyclosporin
microemulsion and corticosteroids
with cyclosporin exposure reduced over tim