RAPAMUNE sirolimus 0.5mg tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

sirolimus, Quantity: 0.5 mg

Dostupné s:

Pfizer Australia Pty Ltd

INN (Mezinárodní Name):

Sirolimus

Léková forma:

Tablet, sugar coated

Složení:

Excipient Ingredients: dl-alpha-tocopherol; iron oxide yellow; macrogol 8000; Carnauba Wax; iron oxide red; microcrystalline cellulose; purified talc; iron oxide black; povidone; magnesium stearate; macrogol 20000; Shellac; sucrose; calcium sulfate; glyceryl monooleate; titanium dioxide; poloxamer; lactose monohydrate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; sulfuric acid

Podání:

Oral

Jednotky v balení:

100

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Rapamune is indicated for the prophylaxis of organ rejection in patients at mild to moderate immunological risk receiving renal transplants. Therapeutic drug monitoring of sirolimus is required.

Přehled produktů:

Visual Identification: Tan triangular shaped tablet branded "RAPAMUNE 0.5mg" in red ink; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Stav Autorizace:

Registered

Datum autorizace:

2011-02-03

Informace pro uživatele

RAPAMUNE
®
_Sirolimus Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Rapamune. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Rapamune
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT RAPAMUNE IS
USED FOR
Rapamune belongs to a group of
medicines called
immunosuppressants. It helps to
control your body's immune system
after you have received an organ
transplant. It is used to prevent your
body from rejecting the transplanted
kidney.
Rapamune is not recommended for
patients who have received liver or
lung transplants.
Your doctor may have prescribed
Rapamune for another reason. Ask
your doctor if you have any questions
about why Rapamune has been
prescribed for you.
Rapamune is not recommended for
use in children, as there is limited
information available on its effects in
children.
This medicine is available only with
a doctor's prescription.
Rapamune is not habit-forming.
BEFORE YOU TAKE
RAPAMUNE
_WHEN YOU MUST NOT TAKE_
_RAPAMUNE_
DO NOT TAKE RAPAMUNE IF YOU HAVE
AN ALLERGY TO SIROLIMUS OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction
may include wheezing, shortness of
breath, difficulty breathing, or a tight
feeling in your chest, swelling of the
face, lips, tongue or other parts of the
body, rash, itching, hives or flushed
red skin, dizziness or light-
headedness.
IF YOU ARE NOT SURE WHETHER THIS
APPLIES TO YOU, CHECK WITH YOUR
DOCTOR.
DO NOT TAKE RAPAMUNE IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
DO NOT TAKE RAPAMUNE AFTER THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK.
If you take this medicine after the
expiry date has passed, it may not
work as well.
IF YOU ARE NOT

Charakteristika produktu

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Page 1 of 32
AUSTRALIAN
PRODUCT
INFORMATION
-
RAPAMUNE
® (SIROLIMUS)
1.
NAME OF THE MEDICINE
Sirolimus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RAPAMUNE tablets contain 0.5 mg, 1 mg and 2 mg sirolimus.
RAPAMUNE oral solution contains 1 mg/mL sirolimus.
Sirolimus is a white to off-white powder and is insoluble in water,
but freely soluble in benzyl
alcohol, chloroform, acetone and acetonitrile.
EXCIPIENT(S) WITH KNOWN EFFECT:
Rapamune tablets:
•
Sucrose
•
Lactose monohydrate
Rapamune oral solution:
•
Ethanol
For the full list of excipients, see Section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
Rapamune oral solution: Pale yellow to yellow solution.
Rapamune 0.5 mg Tablets: 0.5 mg tan triangular-shaped sugar coated
tablets branded with
“RAPAMUNE 0.5 mg” in red ink.
Rapamune 1 mg Tablets: 1 mg white triangular-shaped coated tablets.
Rapamune 2 mg Tablets: 2 mg yellow triangular-shaped coated tablets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rapamune is indicated for the prophylaxis of organ rejection in
patients at mild to moderate
immunological risk receiving renal transplants. Therapeutic drug
monitoring of sirolimus is
required.
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Supersedes: pfprapaa11121
Page 2 of 32
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Bioavailability has not been determined for tablets after they have
been crushed, chewed, or split
and therefore this cannot be recommended. Patients unable to take the
tablets should be
prescribed the solution and instructed in its use.
Only
physicians
experienced
in
immunosuppressive
therapy
and
management
of
organ
transplant patients should prescribe Rapamune. Patients receiving the
drug should be managed
in facilities equipped and staffed with adequate laboratory and
supportive medical resources.
The physician responsible for maintenance therapy should have complete
information requisite
for the follow-up of the patient.
Therapeutic
drug
monitoring
is
recommended
for
all
patients
receiving
Rapamune
(see