Relistor Solution For Injection 12mg0.6mL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Methylnaltrexone Bromide

Available from:

LINK HEALTHCARE SINGAPORE PTE LTD

ATC code:

A06AH01

Dosage:

12mg/0.6mL

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Methylnaltrexone Bromide 12mg/0.6mL

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

DSM Pharmaceuticals, Inc

Authorization status:

ACTIVE

Authorization date:

2010-04-07

Patient Information leaflet

 
1.  NAME OF THE MEDICINAL PRODUCT 

Relistor 12 mg /0.6 ml solution for injection  

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each vial of 0.6 ml contains 12 mg methylnaltrexone bromide. 
One ml of solution contains 20 mg methylnaltrexone bromide. 

For a full list of excipients, see section 6.1. 

3.  PHARMACEUTICAL FORM 

Solution for injection. 
Sterile, clear solution, colourless to pale-yellow, essentially free from visible 
particulates. 

4.  CLINICAL PARTICULARS 

4.1  THERAPEUTIC INDICATIONS 

Treatment of opioid-induced constipation in advanced
illness patients who are 
receiving palliative care when response to
usual laxative therapy has not been 
sufficient. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

For adults only. 

RELISTOR should be added to
induce prompt bowel movements when response to 
usual laxative therapy has been insufficient. 

The recommended dose of methylnaltrexone bromide is 8 mg (0.4
ml RELISTOR) 
(for patients weighing 38-61 kg) or 12 mg
(0.6 ml RELISTOR) (for patients weighing 
62-114 kg). 

The usual administration
schedule is one single dose every other day. Doses may also 
be given with longer intervals, as per clinical need. 

Patients may receive two consecutive doses 24 hours apart,
only when there has been 
no response (bowel movement) to the dose on the preceding day. 

Patients whose weight falls outside of the ranges should
be dosed at 0.15 mg/kg. The 
injection volume for these patients should be calculated: 

Dose (ml) = patient weight (kg) x 0.0075 

Renal patients 
No dose adjustment is required
in patients with mild or moderate impairment. In 
patients with severe renal impairment
(creatinine clearance less than 30 ml/min), 
reduce the dose

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Relistor 12 mg /0.6 ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 0.6 ml contains 12 mg methylnaltrexone bromide.
One ml of solution contains 20 mg methylnaltrexone bromide.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Sterile, clear solution, colourless to pale-yellow, essentially free
from visible
particulates.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of opioid-induced constipation in advanced illness patients
who are
receiving palliative care when response to usual laxative therapy has
not been
sufficient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For adults only.
RELISTOR should be added to induce prompt bowel movements when
response to
usual laxative therapy has been insufficient.
The recommended dose of methylnaltrexone bromide is 8 mg (0.4 ml
RELISTOR)
(for patients weighing 38-61 kg) or 12 mg (0.6 ml RELISTOR) (for
patients weighing
62-114 kg).
The usual administration schedule is one single dose every other day.
Doses may also
be given with longer intervals, as per clinical need.
Patients may receive two consecutive doses 24 hours apart, only when
there has been
no response (bowel movement) to the dose on the preceding day.
Patients whose weight falls outside of the ranges should be dosed at
0.15 mg/kg. The
injection volume for these patients should be calculated:
Dose (ml) = patient weight (kg) x 0.0075
Renal patients
No dose adjustment is required in patients with mild or moderate
impairment. In
patients with severe renal impairment (creatinine clearance less than
30 ml/min),
reduce the dose of methylnaltrexone bromide by one half. There are no
data available
from patients with end-stage renal impairment on dialysis, and
RELISTOR is not
recommended in these patients (see section 4.4).
Hepatic impairment
No dose adjustment is necessary in patients with mild to moderate
hepatic impairment
(see section 5.2).
There are no data available from patients with severe hepat