RELISTOR methylnaltrexone bromide 12 mg/0.6 mL solution for injection vial

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

methylnaltrexone bromide, Quantity: 12 mg

Հասանելի է:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (Միջազգային անվանումը):

Methylnaltrexone bromide

Դեղագործական ձեւ:

Injection, solution

Կազմը:

Excipient Ingredients: hydrochloric acid; sodium hydroxide; sodium calcium edetate; glycine hydrochloride; water for injections; sodium chloride

Կառավարման երթուղին:

Subcutaneous

Միավորները փաթեթում:

1 vial

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

RELISTOR is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care when response to laxative therapy has not been sufficient.

Ապրանքի ամփոփագիր:

Visual Identification: clear and colourless to pale yellow aqueous solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2008-11-17

Տեղեկատվական թերթիկ

RELISTOR®
1
RELISTOR®
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.
1.
WHY AM I USING RELISTOR?
RELISTOR contains the active ingredient methylnaltrexone bromide.
RELISTOR is used to relieve constipation caused by strong
pain relievers called opiates (for example, morphine, codeine).
For more information, see Section 1. Why am I using RELISTOR? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RELISTOR?
Do not use if you have ever had an allergic reaction to RELISTOR 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
RELISTOR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with RELISTOR 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 RELISTOR?
•
RELISTOR is given by subcutaneous injection in the upper arm, abdomen
or thigh as a single dose, on alternate days.
•
RELISTOR is for single use in one patient only.
More instructions can be found in Section 4. How do I use RELISTOR? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RELISTOR?
THINGS YOU
SHOULD DO
•
Be near a toilet. A bowel movement may occur quickly, within 30mins
after being given RELISTOR.
•
Remind any doctor, dentist or pharmacist you visit that you are using
RELISTOR.
•
Tell your doctor if you experience severe or persistent diarrhoea
whilst using RELISTOR.
THINGS YOU
SHOULD NOT DO
•
Do not use RELISTOR if you know or suspect there is a blockage of the
intestines (mechanical bowel
obstruction).
DRIVING OR USING
MACHINES
•
Be careful driving or operating dangerous machinery until you know how
it affects you, as RELISTOR
may cause dizziness.
LOOKING AFTER
YOUR

Ապրանքի հատկությունները

Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION -
RELISTOR
®
(METHYLNALTREXONE BROMIDE)
1
NAME OF THE MEDICINE
Methylnaltrexone bromide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-use vial of RELISTOR injection contains 12 mg of
methylnaltrexone bromide in 0.6 mL
of water for injections, with a concentration of 20 mg/mL of
methylnaltrexone bromide.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
RELISTOR is a sterile, clear and colourless to pale yellow aqueous
solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
RELISTOR is indicated for the treatment of opioid-induced constipation
in patients with advanced
illness who are receiving palliative care when response to laxative
therapy has not been sufficient.
4.2
DOSE
AND
METHOD
OF
ADMINSTRATION
USUAL DOSAGE
FOR SUBCUTANEOUS INJECTION ONLY
Contains no antimicrobial agent. RELISTOR is for single use in one
patient only. Discard any
residue.
RELISTOR should be injected in the upper arm, abdomen or thigh. It is
recommended to move to a
different site each time an injection is given. Avoid repeated
injections at the exact same spot
previously used. Do not inject into areas where the skin is tender,
bruised, red or hard. Avoid areas
with scars or stretch marks.
RELISTOR is administered as a single dose on alternate days. Doses may
also be given with
longer intervals, as needed. If there has been no bowel movement
within 24 hours of the last dose,
an additional dose may be given. In clinical trials, RELISTOR was
administered concomitantly with
a laxative regimen.
RELISTOR can be injected without regard to food. The recommended dose
of RELISTOR is
detailed in table 1. below.
Table 1.
PATIENT WEIGHT (KG)
INJECTION VOLUME
DOSE
38 to less than 62
0.4 mL
8 mg
62 to 114
0.6 mL
12 mg
Less than 38 or more than
114
Patient weight (kg) x 0.0075; rounded to
nearest 0.1 mL
0.15 mg/kg
Page 2 of 10
DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT
In patients with severe renal impairment (creatinine clearance less