SOMAVERT pegvisomant {rbe} 20mg powder for injection vial with diluent

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

Pegvisomant, Quantity: 20 mg

Beszerezhető a:

Pfizer Australia Pty Ltd

INN (nemzetközi neve):

Pegvisomant

Gyógyszerészeti forma:

Injection, solution

Összetétel:

Excipient Ingredients: water for injections

Az alkalmazás módja:

Subcutaneous

db csomag:

1 vial of active and 1 vial of diluent, 30 vials of active and 30 vials of diluent

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

The treatment of acromegaly in patients who have had inadequate response to surgery and/or radiation and/or other medical therapies or for whom these therapies are not appropriate. The treatment goal is to normalise IGF-1 levels.

Termék összefoglaló:

Visual Identification: Clear, colourless solution.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2005-12-09

Termékjellemzők

Version: pfpsomvv10821
Supercedes: pfpsomvv10321
Page: 1 of 16
AUSTRALIAN
PRODUCT
INFORMATION
-
SOMAVERT
® (PEGVISOMANT (RBE)) POWDER FOR
INJECTION WITH DILUENT
1. NAME OF THE MEDICINE
Pegvisomant (rbe)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SOMAVERT is available in single-dose sterile vials containing 10, 15,
or 20 mg of
pegvisomant protein (approximately 10, 15, and 20 U activity,
respectively).
Vials
containing
10,
15,
and
20 mg
of
pegvisomant
protein
correspond
to
approximately 21, 32, and 43 mg pegvisomant, respectively.
EXCIPIENT(S) WITH KNOWN EFFECT
•
Mannitol
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Powder for injection.
SOMAVERT is a sterile, white to slightly off-white lyophilised powder
intended for
subcutaneous injection after reconstitution with 1 mL of sterile Water
for Injections
included in the pack.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment of acromegaly in patients who have had inadequate
response to surgery
and/or radiation and/or other medical therapies or for whom these
therapies are not
appropriate. The treatment goal is to normalise IGF-I levels.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of acromegaly.
It should be considered whether to continue treatment with
somatostatin analogues as
the use in combination with SOMAVERT has not been studied.
For the different dosage regimens the following strengths are
available: SOMAVERT
10 mg, SOMAVERT 15 mg and SOMAVERT 20 mg.
Version: pfpsomvv10821
Supercedes: pfpsomvv10321
Page: 2 of 16
Prior to the start of pegvisomant, patients should have an assessment
of baseline levels
of liver tests [serum alanine aminotransferase (ALT), aspartate
aminotransferase
(AST),
serum
total
bilirubin
(TBIL),
and
alkaline
phosphatase
(ALP)].
For
recommendations regarding initiation of pegvisomant based on baseline
liver tests and
recommendations for monitoring of liver tests while on pegvisomant,
r