HYDROMORPHONE-HAMELN hydromorphone hydrochloride 2 mg/1 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydromorphone hydrochloride, Quantity: 2 mg

Available from:

Hameln Pharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; citric acid monohydrate; sodium citrate dihydrate; sodium hydroxide; hydrochloric acid; sodium chloride

Administration route:

Intramuscular, Intravenous, Subcutaneous

Units in package:

10 ampoules, 5 ampoules

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Hydromorphone-hameln and Hydromorphone-hameln-HP injections are indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Product summary:

Visual Identification: Clear, colourless solution free of visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-10-07

Patient Information leaflet

HYDROMORPHONE-HAMELN/HYDROMORPHONE-HAMELN-HP v1.0 210621
1
HYDROMORPHONE-HAMELN/HYDROMORPHONE-
HAMELN-HP INJECTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or
pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING HYDROMORPHONE-HAMELN/HYDROMORPHONE-HAMELN-HP ?
HYDROMORPHONE-HAMELN/HYDROMORPHONE-HAMELN-HP contains the active
ingredient hydromorphone hydrochloride.
HYDROMORPHONE-HAMELN/HYDROMORPHONE-HAMELN-HP is used for the
short-term relief of severe pain for which other
treatment options have failed or otherwise unsuitable to provide
sufficient management of pain.
For more information, see Section 1. Why am I using
HYDROMORPHONE-HAMELN/HYDROMORPHONE-HAMELN-HP
? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE HYDROMORPHONE-HAMELN/HYDROMORPHONE-
HAMELN-HP ?
Do not use if you have ever had an allergic reaction to hydromorphone
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see
Section 2. What should I know before I use
HYDROMORPHONE-HAMELN/HYDROMORPHONE-
HAMELN-HP ? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with
HYDROMORPHONE-HAMELN/HYDROMORPHONE-HAMELN-HP and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE HYDROMORPHONE-HAMELN/HYDROMORPHONE-HAMELN-HP?
•
Your doctor will tell you exactly how much to take.
•
Follow the instructions given to you by your doctor or pharmacist
exactly.
•
HYDROMORPHONE-HAMELN/HYDROMORPHONE-HAMELN-HP Injection must only be
administered by injection.
More instructions can be found in Section 4. How do I use
HYDROMORPHONE-HAMELN/HYDROMORPHONE-HAMELN-HP
? in
the ful

Summary of Product characteristics

AUSTRALIAN
PRODUCT
INFORMATION
–
HYDROMORPHONE-HAMELN
AND
HYDROMORPHONE-HAMELN-HP
(HYDROMORPHONE
HYDROCHLORIDE)
INJECTION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids,
Hydromorphone-hameln/Hydromorphone-
hameln-HP injections should only be used in patients for whom other
treatment options, including
non-opioid analgesics, are ineffective, not tolerated or otherwise
inadequate to provide appropriate
management of pain (see Section 4.4 Special warnings and precautions
for use).
_HAZARDOUS AND HARMFUL USE _
Hydromorphone-hameln/Hydromorphone-hameln-HP injections pose risks of
hazardous and harmful
use which can lead to overdose and death. Assess the patient’s risk
of hazardous and harmful use
before prescribing and monitor the patient regularly during treatment
(see Section 4.4. Special
warnings and precautions for use).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of Hydromorphone-
hameln/Hydromorphone-hameln-HP
injections. Be aware of situations which increase the risk of
respiratory depression, modify dosing in patients at risk and monitor
patients closely, especially on
initiation or following a dose increase (see Section 4.4 Special
warnings and precautions for use).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, _
_INCLUDING ALCOHOL _
Concomitant
use
of
opioids
with
benzodiazepines,
gabapentinoids,
antihistamines,
tricyclic
antidepressants,
antipsychotics,
cannabis
or
other
central
nervous
system
(CNS)
depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death. Limit
dosages and durations to the minimum required; and monitor patients
for signs and symptoms of
respiratory
depression
and
sedation.
Caution
patients
not
to
drink
alcohol
while
taking
Hydromorphone-hameln/Hydromorphone-hameln-HP injections.
1
NAME OF THE MEDICINE
Hydromorphone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydromor