PERGOVERIS SOLUTION FOR INJECTION IN PRE-FILLED PEN (300 IU + 150 IU)0.48 mL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Follitropin alfa (r-hFSH); Lutropin alfa (r-LH)

Available from:

MERCK PTE. LTD.

ATC code:

G03GA30

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Follitropin alfa (r-hFSH) 300 IU/0.48ml; Lutropin alfa (r-LH) 150 IU/0.48ml

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Merck Serono S.p.A

Authorization status:

ACTIVE

Authorization date:

2019-06-11

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each multidose pre-filled pen contains 300 IU (equivalent to 22
micrograms) of follitropin alfa*
(r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa*
(r-hLH) in 0.48 mL solution.
*recombinant human follitropin alfa and recombinant human lutropin
alfa are produced in Chinese
hamster ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless to slightly yellow solution.
The pH of the solution is 6.5 – 7.5, its osmolality is 250 – 400
mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pergoveris is indicated for the stimulation of follicular development
in adult women with severe LH
and FSH deficiency (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Pergoveris should be initiated under the supervision of
a physician experienced in the
treatment of fertility disorders.
Posology
In LH and FSH deficient women, the objective of Pergoveris therapy is
to promote follicular
development followed by final maturation after the administration of
human chorionic gonadotropin
(hCG). Pergoveris should be given as a course of daily injections. If
the patient is amenorrhoeic and
has low endogenous oestrogen secretion, treatment can commence at any
time.
Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in
pre-filled pen
Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in
pre-filled pen
Each multidose pre-filled pen contains 450 IU (equivalent to 33
micrograms) of follitropin alfa*
(r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa*
(r-hLH) in 0.72 mL solution.
Each multidose pre-filled pen contains 900 IU (equivalent to 66
micrograms) of follitropin alfa*
(r-hFSH) and 450 IU (equivalent to 18 micrograms) of lutropin alfa*
(r-hLH) in 1.44 mL solution.
A treatment regimen comme