Hydromorphone Hydrochloride 20 mg/ml Solution for Injection / Concentrate for Solution for Infusion

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

HYDROMORPHONE HYDROCHLORIDE

Pieejams no:

Martindale Pharmaceuticals Ltd

ATĶ kods:

N02AA; N02AA03

SNN (starptautisko nepatentēto nosaukumu):

HYDROMORPHONE HYDROCHLORIDE

Deva:

20 milligram(s)/millilitre

Zāļu forma:

Solution for Injection and Concentrate for Infusion

Receptes veids:

Product subject to prescription which may not be renewed (A)

Ārstniecības joma:

Natural opium alkaloids; hydromorphone

Autorizācija statuss:

Marketed

Autorizācija datums:

2005-10-28

Lietošanas instrukcija

00000
IN THIS LEAFLET:
1. What Hydromorphone Injection is and what it is used for.
2. Before you are given Hydromorphone Injection
3. How Hydromorphone Injection is given
4. Possible side effects
5. Storing Hydromorphone Injection
6. Further Information
1. WHAT HYDROMORPHONE INJECTION IS AND WHAT IT
IS USED FOR.
Hydromorphone hydrochloride, the active ingredient in
Hydromorphone Injection, is a powerful pain killer.
Hydromorphone Injection is used to treat long lasting severe
pain.
2. BEFORE YOU ARE GIVEN HYDROMORPHONE
INJECTION.
YOU SHOULD NOT BE GIVEN HYDROMORPHONE INJECTION IF:
• you are allergic (hypersensitive) to hydromorphone
hydrochloride or to any of the other ingredients in this
medicine, listed in section 6 of this leaflet
• you are suffering from severe, undiagnosed headaches and
have been sick, or if you have suffered a head injury (raised
intracranial pressure)
• you suffer from alcoholism
• you suffer from any breathing difficulties or problems with
your lungs such as chronic obstructive pulmonary disease,
cor pulmonale (a heart condition caused by lung disease),
emphysema (enlarged and damaged lungs) or asthma
• you suffer from phaeochromocytoma, a condition where your
adrenal glands secrete too much hormone. The symptoms of
this condition include headaches, sweating and feeling your
heart beat (palpitations)
• you are taking or have recently (in the last two weeks) taken
any medicines used to treat depression known as Monoamine
Oxidase Inhibitors (MAOI’s) (see ‘Taking other medicines’).
TAKE SPECIAL CARE WITH HYDROMORPHONE INJECTION. TELL YOUR DOCTOR BEFORE HAVING THIS MEDICINE IF:
• you suffer from liver or kidney problems
• you have reduced lung function
• you suffer from problems with your prostate
• you suffer from an underactive thyroid
• you suffer from low blood pressure
• you suffer from problems related to your adrenal gland (the
organ responsible for stress levels), including Addison’s disease
(an illness caused by a lack of the hormone cortisol, which
co

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydromorphone Hydrochloride 20 mg/ml Solution for Injection /
Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml ampoule contains 20mg Hydromorphone Hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
Concentrate for solution for infusion
A clear colourless solution for injection in Type I glass ampoules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of severe pain associated with palliative care.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In those patients with severe chronic pain associated with cancer,
dosage should be individualised based on the response
and tolerance of the patient, higher than usual dosages of
hydromorphone are often required.
Usual dose:
Intramuscular administration [Adult dose and adolescents (>12 years)]
Dosage by intramuscular injection is 1-2mg every 3 – 6 hours.
Elderly: The initial dose should be reduced in the elderly.
4.3 CONTRAINDICATIONS
Known hypersensitivity to hydromorphone. The presence of increased
intracranial pressure or head injury, acute
alcoholism and respiratory depression (chronic obstructive airways
disease, cor pulmonale, emphysema, status
asthmaticus). Avoid injection in phaeochromocytoma. Current use of
monoamine oxidase inhibitor (MAOI) drugs or
within 2 weeks of discontinuing their use.
AGE
BOLUS
INFUSION
Adults and adolescents (>12 years)
subcutaneous (s.c.) use
1-2 mg s.c. every 3-4 hours
0.15-0.45 mg/h 0.004
mg/kg bodyweight/h
intravenous (i.v.) use
1-1.5 mg i.v. every 3-4 hours
to be injected slowly over at
least 2-3 minutes
0.15-0.45 mg/h 0.004 mg/kg
bodyweight/h
PCA (s.c. and i.v.)
0.2 mg bolus, stop interval 5-10 min.
Children (<12 years)
Not recommended
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