CERTICAN everolimus 0.25mg dispersible tablet blister pack

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

everolimus, Quantity: 0.25 mg

Fáanlegur frá:

Novartis Pharmaceuticals Australia Pty Ltd

Lyfjaform:

Tablet, dispersible

Samsetning:

Excipient Ingredients: butylated hydroxytoluene; lactose monohydrate; hypromellose; magnesium stearate; crospovidone; lactose; silicon dioxide

Stjórnsýsluleið:

Oral

Einingar í pakka:

50 Tablets, 60 Tablets, 100 Tablets, 120 Tablets

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

Certican 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 Precautions).

Vörulýsing:

Visual Identification: White to yellowish, marbled, round, flat tablets with bevelled edge. Diameter 9mm. Engraved with "JO" on one side and "NVR" on the other.; Container Type: Blister Pack; Container Material: Other plastic laminate/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Leyfisstaða:

Licence status A

Leyfisdagur:

2005-03-17

Vara einkenni

Page 1 of 31
AUSTRALIAN PRODUCT INFORMATION - CERTICAN
®
(EVEROLIMUS)
1
NAME OF THE MEDICINE
Australian Approved Name: everolimus
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CERTICAN TABLETS
0.25mg; 0.50 mg; 0.75 mg; 1.0 mg everolimus.
CERTICAN DISPERSIBLE TABLETS
0.10mg; 0.25mg everolimus.
Everolimus is a white to faintly yellow powder practically insoluble
in water but soluble in
organic solvents such as ethanol and methanol.
3
PHARMACEUTICAL FORM
CERTICAN TABLETS
(white to yellowish, marbled, round, flat with bevelled edge)
0.25mg (engraved with “C” on one side and “NVR” on the other):
60’s; 0.50 mg (engraved with
“CH” on one side and “NVR” on the other): 60’s; 0.75 mg
(engraved with “CL” on one side and
“NVR” on the other): 60’s; 1.0 mg (engraved with “CU” on one
side and “NVR” on the other):
50’s, 60’s, 100’s, 120’s.
CERTICAN DISPERSIBLE TABLETS
(white to yellowish, marbled, round, flat with bevelled edge) 0.10mg
(engraved with “I” on one side and “NVR” on the other): 0.25mg
(engraved with “JO” on one side
and “NVR” on the other): 50’s, 60’s, 100’s, 120’s
List of excipients with known effect: lactose, galactose, milk, sugars
For the full list of excipients, see Section 6.1 List of excipients
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Certican 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 Precautions).
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment
with
Certican
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 time post-transplantation (see
_Therapeutic Drug Monitoring_
).
_ _
KIDNEY AND HEART TRANSPLANTATION
An initial dose regimen of