PALLADONE 10 MGML

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

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Fachinformation Fachinformation (SPC)
17-08-2016

Wirkstoff:

HYDROMORPHONE HYDROCHLORIDE

Verfügbar ab:

RAFA LABORATORIES LTD

ATC-Code:

N02AA03

Darreichungsform:

SOLUTION FOR INJECTION

Zusammensetzung:

HYDROMORPHONE HYDROCHLORIDE 20 MG / 2 ML

Verabreichungsweg:

I.M, I.V, S.C

Verschreibungstyp:

Required

Hergestellt von:

RAFA LABORATORIES LTD, JERUSALEM

Therapiegruppe:

HYDROMORPHONE

Therapiebereich:

HYDROMORPHONE

Anwendungsgebiete:

Relief of moderate to severe pain such as that due to surgery or cancer.

Berechtigungsdatum:

2012-04-30

Fachinformation

                                1
Doctor Leaflet
HIGHLY CONCENTRATED
PALLADONE INJECTION 10 MG/ML
(Preservative Free)
Solution for injection
IM, SC, IV
Narcotic prescription required
COMPOSITION
Each 2 ml ampoule contains: Hydromorphone HCl 20 mg (10mg/ml).
Palladone Injection also contains citric acid 2 mg/ml and tri-sodium
citrate dihydrate 2.28 mg/ml
Palladone Injection contains no preservatives.
The solution is clear and colorless.
ACTION
Hydromorphone is a semisynthetic opioid agonist analgesic that acts
primarily at the mu opiate
receptor. Opiate receptors in the central nervous system mediate
analgesic activity. Opioid
agonists occupy the same receptors as endogenous opioid peptides
(enkephalins or endorphins),
and both may alter the central release of neurotransmitters from
afferent nerves sensitive to
noxious stimuli. Opioid antagonists block the opiate receptor, inhibit
the pharmacological
activity of the agonist and will precipitate withdrawal in dependent
patients.
Hydromorphone has similar pharmacological and pharmacokinetic
properties to morphine to
which it is chemically related. Hydromorphone is recognized by the
World Health Organization
as an alternative opioid to morphine for severe pain. This is
important since one of the
cornerstones of severe pain management is opioid rotation. Opioid
rotation consists of
switching a patient from one opioid to another in order to achieve
adequate analgesia with few
side effects. In particular, hydromorphone may have a better side
effect profile than morphine
in some individuals, producing less severe constipation and vomiting.
In the post-operative
setting as well, hydromorphone is a suitable alternative to morphine,
especially in patients with
a history of an unsatisfactory response to morphine e.g. excessive
vomiting.
There are several administration techniques for parenteral delivery of
hydromorphone,
including a single or double injection (e.g. post-operative), multiple
intermittent bolus injections
(e.g. in the cancer patient), or continuous infusion with or without
bolus as-needed in
                                
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