DBL™ Papaverine Hydrochloride

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Papaverine hydrochloride 12 mg/mL

Tersedia dari:

Pfizer New Zealand Limited

INN (Nama Internasional):

Papaverine hydrochloride 12 mg/mL

Dosis:

120 mg/10mL

Bentuk farmasi:

Solution for injection

Komposisi:

Active: Papaverine hydrochloride 12 mg/mL Excipient: Water for injection

Unit dalam paket:

Ampoule, glass, Type I, clear, one point cut, 5 x 10 mL, 50 mL

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

Boehringer Ingelheim Pharma GmbH & Co KG

Ringkasan produk:

Package - Contents - Shelf Life: Ampoule, glass, Type I, clear, one point cut, 5 x 10 mL - 50 mL - 36 months from date of manufacture stored at or below 25°C protect from light

Tanggal Otorisasi:

1984-03-08

Karakteristik produk

Version: pfdpapai10421
Supercedes : pfdpapai10219
Page 1 of 10
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL™ Papaverine Hydrochloride
120 mg/10mL
Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Papaverine Hydrochloride Injection is supplied in ampoules
containing 120 mg of
papaverine hydrochloride BP in water for injection.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
DBL Papaverine Hydrochloride Injection is a sterile, clear, colourless
to pale-yellow solution.
The pH of the injection ranges between 3.0 and 5.0.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL
Papaverine
Hydrochloride
Injection
is
indicated
for
the
treatment
of
erectile
dysfunction.
4.2 DOSE AND METHOD OF ADMINISTRATION
DBL Papaverine Hydrochloride Injection should only be prescribed, and
treatment should be
supervised, by prescribers having expertise in the management of
erectile dysfunction using a
range of treatment modalities.
The use of DBL Papaverine Hydrochloride Injection in combination with
other agents,
including phentolamine and alprostadil is not recommended (see section
4.5).
DBL
Papaverine
Hydrochloride
Injection
should
be
administered
by
intracavernosal
injection.
Before initiation of treatment with DBL Papaverine Hydrochloride
Injection, patients should
be carefully assessed by a specialist practitioner in erectile
dysfunction with appropriate
training in the use of this drug. The dose should be titrated
carefully according to individual
need. The first injection of DBL Papaverine Hydrochloride Injection
must be done by
medically
trained
personnel.
After
proper
training
and
instruction,
DBL
Papaverine
Hydrochloride Injection may be injected at home. If
self-administration is planned, the
Version: pfdpapai10421
Supercedes : pfdpapai10219
Page 2 of 10
specialist should make an assessment of the patient's (or as
appropriate, the partner's) skill
and competence with the procedure. While on self-injection treatment,
it is recommended
that the patient visi