DBL™ Papaverine Hydrochloride

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Papaverine hydrochloride 12 mg/mL

Disponible depuis:

Pfizer New Zealand Limited

DCI (Dénomination commune internationale):

Papaverine hydrochloride 12 mg/mL

Dosage:

120 mg/10mL

forme pharmaceutique:

Solution for injection

Composition:

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

Unités en paquet:

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

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Boehringer Ingelheim Pharma GmbH & Co KG

Descriptif du produit:

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

Date de l'autorisation:

1984-03-08

Résumé des caractéristiques du produit

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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
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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