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

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

HYDROMORPHONE HYDROCHLORIDE

Dostępny od:

Ethypharm

Kod ATC:

N02AA; N02AA03

INN (International Nazwa):

HYDROMORPHONE HYDROCHLORIDE

Dawkowanie:

20 milligram(s)/millilitre

Forma farmaceutyczna:

Solution for injection/infusion

Dziedzina terapeutyczna:

Natural opium alkaloids; hydromorphone

Status autoryzacji:

Marketed

Data autoryzacji:

2005-10-28

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROMORPHONE HYDROCHLORIDE 20MG/ML SOLUTION FOR INJECTION/CONCENTRATE
FOR
SOLUTION FOR INFUSION
HYDROMORPHONE HYDROCHLORIDE 50MG/ML SOLUTION FOR INJECTION/CONCENTRATE
FOR
SOLUTION FOR INFUSION
Hydromorphone Hydrochloride (referred to as Hydromorphone Injection in
this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN HYDROMORPHONE
INJECTION BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hydromorphone Injection is and what it is used for
2.
What you need to know before you are given Hydromorphone Injection
3.
How Hydromorphone Injection is given
4.
Possible side effects
5.
How to store Hydromorphone Injection
6.
Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
HYDROMORPHONE INJECTION
YOU SHOULD NOT BE GIVEN
HYDROMORPHONE INJECTION IF:
• you are allergic to hydromorphone hydrochloride or to any of the
other ingredients in this medicine, (listed
in section 6)
• have severe pain in your abdomen;
• have a condition where the small bowel does not work
properly(paralytic ileus);
• you suffer from any breathing difficulties or problems with your
lungs such as severe chronic obstructive
pulmonary disease, cor pulmonale (a heart condition caused by lung
disease),
• 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’).
WARNINGS AND PRECAUTIONS
Talk to

Charakterystyka produktu

Health Products Regulatory Authority
03 March 2020
CRN009CR4
Page 1 of 8
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
For the relief of severe pain in cancer.
Hydromorphone Hydrochloride 20 mg/ml Solution for Injection /
Concentrate for Solution for Infusion is indicated in adults
and adolescents aged >12 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosing of Hydromorphone Hydrochloride 20 mg/ml Solution for
Injection / Concentrate for Solution for Infusion has to be
adjusted to the patients' severity of pain and to their individual
response. The dose should be titrated until optimum analgesic
effect is achieved
While the dose to be administered should be sufficient to achieve
appropriate analgesia, the aim should also be to keep the
dose as small as possible in the individual case.
Hydromorphone Hydrochloride 20 mg/ml Solution for Injection /
Concentrate for Solution for Infusion should not be
administered longer than absolutely necessary. If long-term treatment
is required careful and regular monitoring should
control whether and to what degree further treatment is necessary.
When a patient no longer requires therapy with
hydromorphone, it may be advisable to taper the daily dose gradually
to prevent withdrawal symptoms.
Hydromorphone Hydrochloride 20 mg/ml Solution for Injection /
Concentrate for Solution for Infusion is not suitable for initial
opioid therapy. Higher strengths may only be used as individual doses
in patients who have no longer sufficiently responded
to lower doses of hydromorphone preparations or comparably st