Hydromorphone hydrochloride 20 mg/ml solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hydromorphone hydrochloride

Available from:

AS Kalceks

ATC code:

N02AA03

INN (International Name):

Hydromorphone hydrochloride

Pharmaceutical form:

Solution for injection/infusion

Therapeutic area:

hydromorphone

Authorization status:

Marketed

Authorization date:

2022-04-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROMORPHONE HYDROCHLORIDE 20 MG/ML SOLUTION FOR INJECTION/INFUSION
HYDROMORPHONE HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION/INFUSION
hydromorphone hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
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 nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hydromorphone hydrochloride is and what it is used for
2.
What you need to know before you use Hydromorphone hydrochloride
3.
How to use Hydromorphone hydrochloride
4.
Possible side effects
5.
How to store Hydromorphone hydrochloride
6.
Contents of the pack and other information
1.
WHAT HYDROMORPHONE HYDROCHLORIDE
IS AND WHAT IT IS USED FOR
This medicine contains the active substance hydromorphone
hydrochloride, which is a potent
analgesic (strong “painkiller”) of the opioid group.
You have been prescribed Hydromorphone hydrochloride for the treatment
of severe pain.
The medicine is intended for use in adults and adolescents over 12
years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROMORPHONE HYDROCHLORIDE_ _
DO NOT USE HYDROMORPHONE HYDROCHLORIDE IF YOU:
-
are allergic to hydromorphone or any of the other ingredients of this
medicine (listed in
section 6);
-
have breathing problems (respiratory depression);
-
suffer from a severe lung disease associated with obstruction of the
airways (severe
chronic obstructive pulmonary disease or severe COPD);
-
have heart problem after long-term lung disease (cor pulmonale);
-
have severe pain in your abdomen;
-
have a condition where the small bowel does not work properly
(paralytic ileus);
-
are taking a t

Summary of Product characteristics

Health Products Regulatory Authority
09 December 2022
CRN00D7PJ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydromorphone hydrochloride 20 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 20 mg hydromorphone hydrochloride
(corresponding to 17.73 mg hydromorphone).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
SOLUTION FOR INJECTION/INFUSION (INJECTION/INFUSION).
CLEAR COLOURLESS OR YELLOWISH SOLUTION, FREE FROM VISIBLE PARTICLES.
PH OF SOLUTION IS 3.5-4.5.
Osmolality of solution is approximately 280mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of severe pain in adults and adolescents over 12
years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosing of Hydromorphone hydrochloride 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 a sufficiently high dose should generally be administered, the
smallest dose to achieve analgesia should be aimed at in
the individual case.
Hydromorphone hydrochloride 20 mg is not suitable for initial opioid
therapy. These higher dosage forms may only be used as
individual doses in patients who have no longer sufficiently responded
to lower doses of hydromorphone preparations (2 mg)
or comparably strong analgesics within the scope of chronic pain
therapy. The reservoir of a pain pump can also be filled with
individual doses of 10 mg, 20 mg or 50 mg as the dose control is
secured by the pump calibration.
Hydromorphone 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.
AGE
BOLUS
INFUSION
Adults and adolescents (> 12 y