Questran Lite

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

קנה את זה

עלון מידע עלון מידע (PIL)
14-10-2013
מאפייני מוצר מאפייני מוצר (SPC)
29-01-2020

מרכיב פעיל:

Colestyramine 0.851 g/g (4g anhd cholestyramine resin / 4.7g Questran Lite powder);  

זמין מ:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (שם בינלאומי):

Colestyramine 0.851 g/g (4g anhd cholestyramine resin / 4.7g questran light powder)

כמות:

4.7 g

טופס פרצבטיות:

Powder for oral suspension

הרכב:

Active: Colestyramine 0.851 g/g (4g anhd cholestyramine resin / 4.7g Questran Lite powder)   Excipient: Aspartame Citric acid Colloidal silicon dioxide Orange flavour 059107 AGEP0551 Propylene glycol alginate Xanthan gum

יחידות באריזה:

Sachet, 50 x 4.7g sachets, 60 dose units

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

sanofi-aventis SpA

סממני תרפויטית:

Reduction of serum cholesterol levels and prevention of coronary heart disease. QUESTRAN is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins). QUESTRAN LITE may be useful to lower elevated cholesterol that occurs in patients with combined hypercholesterolemia and hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern.

leaflet_short:

Package - Contents - Shelf Life: Sachet, 4.7g sachets - 50 dose units - 36 months from date of manufacture stored at or below 30°C

תאריך אישור:

1991-10-24

עלון מידע

                                 
 
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION _ _
QUESTRAN® LITE
 
_cholestyramine resin _
_ _
_ _
WHAT IS IN THIS LEAFLET 
_ _
This leaflet answers some common 
questions about QUESTRAN LITE. 
It does not contain all the available 
information. It does not take the 
place of talking to your doctor or 
pharmacist. 
 
All medicines have risks and 
benefits. Your doctor has weighed 
the risks of you taking QUESTRAN 
LITE against the benefits they 
expect it will have for you. 
 
IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 
 
KEEP THIS LEAFLET.  
You may need to read it again. 
_ _
_ _
WHAT QUESTRAN LITE 
IS USED FOR 
_ _
QUESTRAN LITE is used to reduce 
high levels of cholesterol in the 
blood & the prevention of coronary 
heart disease. The relief of pruritis 
(itching) associated with the flow of 
bile being partially blocked. The 
relief of diarrhoea caused by 
surgery or disease of the small 
bowel.  
  
QUESTRAN LITE contains 
cholestyramine (KOL-es-TIE-
rameen) which belong to a group of 
medicines called resins. It reduces 
the level of cholesterol in the blood 
by combining with bile in the small 
intestine to form an insoluble 
complex, which is then excreted in 
faeces.  
 
The reduction of blood cholesterol 
levels help to prevent blockages in 
the blood vessels to the heart 
which reduces the likelihood of 
angina (chest pain with heart 
disease) & heart attacks  
 
QUESTRAN LITE may be used 
alone or in combination with other 
medicines. Your doctor will inform 
you if this is necessary. 
 
Your doctor may have prescribed 
QUESTRAN LITE for another 
reason. Ask your doctor if you have 
any questions about why 
QUESTRAN LITE was prescribed 
for you. 
 
There is no evidence that 
QUESTRAN LITE is addictive. 
 
This medicine is only available with 
a doctor’s prescription. 
 
The safety & effectiveness of using 
QUESTRAN LITE i
                                
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מאפייני מוצר

                                NEW ZEALAND DATA SHEET
1.
QUESTRAN LITE
Cholestyramine resin for Oral Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aspartame Formulation.
QUESTRAN LITE is a sugar free formulation containing 4g of
cholestyramine per 4.7g of QUESTRAN LITE powder.
Cholestyramine is the chloride salt of a basic anion exchange resin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of serum cholesterol levels and prevention of coronary heart
disease. QUESTRAN is indicated as adjunctive therapy to diet for the
reduction of elevated serum cholesterol in patients with primary
hypercholesterolemia (elevated low density lipoproteins). QUESTRAN
LITE may be useful to lower elevated cholesterol that occurs in
patients
with combined hypercholesterolemia and hypertriglyceridemia, but it is
not
indicated where hypertriglyceridemia is the abnormality of most
concern.
Relief of pruritus associated with partial biliary obstruction.
Patients with
primary biliary cirrhosis may exhibit elevated serum cholesterol as
part of
their disease. When cholestyramine is used to treat the pruritus of
partial
biliary obstruction, it may lower serum cholesterol levels, produce no
change, or cause rapid escape from a temporary lowering to
pretreatment
levels or rebound.
Relief of diarrhoea following ileal resection or ileal disease
(cholerrhoeic
enteropathy).
4.2 DOSAGE AND METHOD OF ADMINISTRATION_ _
ADULTS:
Usual maintenance therapy: 12 to 16g of cholestyramine resin
equivalent
to 14.1 to 18.8g QUESTRAN LITE per day (without regard to meals), is
usually effective.
CHILDREN:
Dosage in infants and children has not been established. Begin therapy
with small doses. Subsequent adjustment should be made according to
clinical response or laboratory results and the benefit/risk ratio.
USE IN CHOLESTEROL LOWERING:
Define the type of hyperlipoproteinaemia. A trial of diet, weight
reduction,
etc., should be undertaken before therapy with QUESTRAN LITE
                                
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