SOMAVERT pegvisomant {rbe} 15mg powder for injection vial with diluent

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

Pegvisomant, Quantity: 15 mg

Disponível em:

Pfizer Australia Pty Ltd

DCI (Denominação Comum Internacional):

Pegvisomant

Forma farmacêutica:

Injection, solution

Composição:

Excipient Ingredients: water for injections

Via de administração:

Subcutaneous

Unidades em pacote:

30 vials of active and 30 vials of diluent

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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.

Resumo do produto:

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

Status de autorização:

Registered

Data de autorização:

2005-12-09

Características técnicas

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