Mestinon

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Pyridostigmine bromide 60mg equivalent to a 2% overage is added during manfuacuture;  

Dostupno od:

iNova Pharmaceuticals (New Zealand) Limited

INN (International ime):

Pyridostigmine bromide 60 mg (= a 2% overage is added during manfuacuture)

Doziranje:

60 mg

Farmaceutski oblik:

Tablet

Sastav:

Active: Pyridostigmine bromide 60mg equivalent to a 2% overage is added during manfuacuture   Excipient: Colloidal silicon dioxide Lactose Stearic acid

Jedinice u paketu:

Bottle, plastic, HDPE bottle, PP child resistant, pulp liner with Al/PET heat seal, 100 tablets

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

DPx Fine Chemicals Austria GmbH & Co KG

Terapijske indikacije:

Myasthenia gravis; paralytic ileus; postoperative urinary retention.

Proizvod sažetak:

Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle, PP child resistant, pulp liner with Al/PET heat seal - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Datum autorizacije:

2000-11-08

Uputa o lijeku

MESTINON
®
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
MESTINON
®
_Pyridostigmine Bromide 60mg Tablets _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using MESTINON.
This leaflet answers some common
questions about MESTINON. 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 MESTINON
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 MESTINON IS
USED FOR
MESTINON is used to treat:
•
myasthenia gravis, a long term
condition that causes the muscles
to weaken and tire easily
especially after repeated use.
•
paralytic ileus, a condition where
your intestine stops contracting
and moving its contents along;
and
•
postoperative urinary retention, a
condition when you are unable to
urinate after having surgery.
MESTINON belongs to a group of
medicines called cholinergic
antimyasthenics. It works by
preventing the breakdown of a
natural chemical substance in your
body called acetylcholine. This
chemical is needed to stimulate
muscle movement.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
MESTINON is only available with a
doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE
MESTINON
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MESTINON IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
pyridostigmine bromide or any
other bromides.
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE MESTINON IF YOU
HAVE A BLOCKAGE IN YOUR INTESTINE
OR URINARY

Svojstava lijeka

NEW ZEALAND DATA SHEET
MESTINON®
MESTINON
Page 1 of 8
1 PRODUCT NAME
MESTINON 60 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg pyridostigmine bromide.
Excipients with known effect:
Lactose
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
MESTINON tablets are practically white, round, flat-faced tablets with
beveled edges. Engraved
“Mestinon 60” on outer perimeter and quadrisect scored on the
other side.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Myasthenia gravis, paralytic ileus, and postoperative urinary
retention.
4.2
Dose and method of administration
MESTINON tablets are for oral administration. MESTINON has a gradual
onset of effect (generally 30-
60 minutes).
Myasthenia Gravis
_Adults_
Doses of 30 to 120 mg by mouth are given at intervals throughout the
day when maximum strength
is needed (for example on rising and before meal times). The usual
duration of action of a dose is
three to four hours in the daytime but a longer effect (six hours) is
often obtained with a dose taken
on retiring for bed.
The total daily dose is usually in the range of 5-20 tablets but some
patients may require doses
higher than these.
_Paediatric Population _
Children under 6 years old should receive an initial dose of half a
tablet (30 mg) of MESTINON.
Children 6-12 years old should receive one tablet (60 mg). Dosage
should be increased gradually, in
increments of 15-30 mg daily, until maximum improvement is obtained.
Total daily requirements are
usually in the range of 30-360 mg by mouth.
_Newborn Infants_
Neostigmine has generally been preferred in the treatment of neonatal
myasthenia. However
MESTINON can be given, particularly if neostigmine proves unsuitable
on account of pronounced
cholinergic effects.
NEW ZEALAND DATA SHEET
MESTINON®
MESTINON
Page 2 of 8
The dosage requirements of MESTINON range from 5-10 mg orally every
four hours, given 30-60
minutes before feeding. Treatment is not usually required beyond eight
weeks of age except in the
rare co