DILAUDID-HP hydromorphone hydrochloride 50mg/1mL injection ampoule

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

hydromorphone hydrochloride, Quantity: 50 mg/mL

Հասանելի է:

Mundipharma Pty Ltd

INN (Միջազգային անվանումը):

hydromorphone hydrochloride

Դեղագործական ձեւ:

Injection, concentrated

Կազմը:

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

Կառավարման երթուղին:

Subcutaneous, Intramuscular, Intravenous

Միավորները փաթեթում:

5 x 1mL ampoules

Ռեկվիզորի տեսակը:

(S8) Controlled Drug

Թերապեւտիկ ցուցումներ:

DILAUDID-HP injection is 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.

Ապրանքի ամփոփագիր:

Visual Identification: Clear, colourless to pale yellow solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Լիազորման կարգավիճակը:

Licence status A

Հաստատման ամսաթիվը:

2016-09-09

Տեղեկատվական թերթիկ

DILAUDID
® / DILAUDID
®
-HP INJECTION
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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 DILAUDID / DILAUDID-HP?
DILAUDID / DILAUDID-HP contains the active ingredient hydromorphone
hydrochloride. DILAUDID / DILAUDID-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 DILAUDID /
DILAUDID-HP? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DILAUDID / DILAUDID-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
DILAUDID / DILAUDID-HP? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DILAUDID / DILAUDID-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 DILAUDID / DILAUDID-HP?
•
Your doctor will tell you exactly how much to take.
•
Follow the instructions given to you by your doctor or pharmacist
exactly.
•
You must only take DILAUDID / DILAUDID-HP Injection by mouth.
More instructions can be found in Section 4. How do I use DILAUDID /
DILAUDID-HP? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DILAUDID / DILAUDID-HP?
THINGS YOU
SHOULD DO
•
REMIND ANY DOCTOR, DENTIST OR PHARMACIST YOU VISIT THAT YOU ARE USING
DILAUDID / DILAUDID-HP
•
TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING ANY OTH

Ապրանքի հատկությունները

DILAUDID
®
/DILAUDID
®
-HP INJECTION
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION – DILAUDID
®
/ DILAUDID
®
-HP
(HYDROMORPHONE HYDROCHLORIDE) INJECTION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids,
DILAUDID/DILAUDID-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 _
DILAUDID/DILAUDID-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
DILAUDID/DILAUDID-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 DILAUDID/DILAUDID-HP injections.
1
NAME OF THE MEDICINE
Hydromorphone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DILAUDID 2 mg injection contains 2 mg hydromorphone hydrochloride in 1
mL