Dysport

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Clostridium botulinum type A toxin haemagglutinin complex 500 U

Tilgjengelig fra:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Clostridium botulinum type A toxin haemagglutinin complex 500 U

Dosering :

500 U

Legemiddelform:

Powder for injection

Sammensetning:

Active: Clostridium botulinum type A toxin haemagglutinin complex 500 U Excipient: Albumin Lactose monohydrate

Enheter i pakken:

Vial, glass, 2 x 500U, 1000 U

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Ipsen Biopharm Limited

Indikasjoner:

Dysport is also indicated for the symptomatic treatment of axillary hyperhidrosis (excessive sweating)

Produkt oppsummering:

Package - Contents - Shelf Life: Vial, glass, 500U - 2 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Autorisasjon dato:

1991-03-04

Informasjon til brukeren

DYSPORT
®
1
DYSPORT
®
_(Clostridium botulinum type A toxin-haemagglutinin complex) _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dysport. It does not
contain all of 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 Dysport
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 WITH THE MEDICINE.
You may need to read it again.
WHAT IS DYSPORT
Dysport is a muscle relaxant
produced by Clostridium botulinum
bacteria. It acts on the junctions
between the nerves and muscles,
preventing the release of one of the
chemical messengers called
acetylcholine from the nerve endings
that would normally cause the
muscle to contract. If the messenger
is prevented from being released this
results in a weakened muscle and
helps to reduce some of the abnormal
muscle contractions.
WHAT DYSPORT IS USED
FOR
Dysport is used for the treatment of
•
upper limb spasticity in adults.
Upper limb spasticity is an
increased stiffness in the arm
and/or hand muscles that
develops in many patients after a
stroke, for example, and can lead
to restricted use of the arm or
hand.
•
lower limb spasticity in adults.
Lower limb spasticity is an
increased stiffness in the leg
and/or foot muscles that develops
in many patients after a stroke,
for example, and can lead to
restricted use of the leg or foot.
•
spasmodic torticollis in adults.
Spasmodic torticollis is where
there is a turning movement of
the neck leading to an unusual
head and shoulder position
•
upper and lower limb spasticity in
children (2 years of age and
older) which may be due to
cerebral palsy. Cerebral palsy
spasticity is a disorder in which
some muscles become stiff and
movement is difficult
•
blepharospasm or hemifacial
spasm in adults. Blepharospasm
is a condition affecti

Preparatomtale

NEW ZEALAND DATASHEET
1 PRODUCT NAME
DYSPORT
®
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clostridium botulinum type A toxin-haemagglutinin complex
3 PHARMACEUTICAL FORM
DYSPORT Powder for Injection contains 300 or 500 IPSEN units per vial
of _Clostridium botulinum_
type A toxin-haemagglutinin complex, 125 microgram human serum albumin
and 2.5 mg lactose
in a sterile, lyophilised form without a preservative.
ONE IPSEN UNIT is not equivalent to ONE UNIT of another botulinum
toxin preparation. From
now on in this Product Information the term Ipsen unit will simply be
replaced by the term unit.
_Clostridium botulinum_ type A toxin-haemagglutinin complex has a
molecular weight of about
900,000D and is a complex of proteins.
DYSPORT is a white lyophilised powder for reconstitution contained in
Type 1 glass vials 3 mL
of capacity, with 13 mm bromobutyl freeze-drying closures oversealed
by 13 mm aluminium
overseals with centre hole, crimped over.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
DYSPORT is indicated for the treatment of focal spasticity of:
•
Upper limbs in adults
•
Lower limbs in adults
•
Upper limbs in children aged 2 years and older
•
Lower limbs in children aged 2 years and older.
DYSPORT
is indicated in adults for the treatment of:
•
Spasmodic torticollis
•
Blepharospasm
•
Hemifacial spasm
•
Moderate to severe glabellar lines
and / or lateral canthal lines (crow’s feet)
DYSPORT is also indicated for the symptomatic treatment of axillary
hyperhidrosis (excessive
sweating).
2
4.2 Dosage and method of administration
The units of DYSPORT are specific to the preparation and are not
interchangeable with other
preparations of botulinum toxin.
DYSPORT should only be administered by appropriately trained
physicians.
The exposed central portion of the rubber stopper should be cleaned
with alcohol and allowed to
dry immediately prior to piercing the septum. Sterile needles of a
suitable gauge should be used
for drawing up and administering the product.
Reconstitution with preservative-free