Botox 200unit powder for solution for injection vials

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Botulinum toxin type A

थमां उपलब्ध:

AbbVie Ltd

ए.टी.सी कोड:

M03AX01

INN (इंटरनेशनल नाम):

Botulinum toxin type A

डोज़:

200unit

फार्मास्यूटिकल फॉर्म:

Powder for solution for injection

प्रशासन का मार्ग:

Intradermal; Intramuscular

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Caution - AMP level prescribing advised

उत्पाद समीक्षा:

BNF: 04090300; GTIN: 5016007202854

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BOTOX,
50 Allergan Units, Powder for Solution for Injection
BOTOX,
100 Allergan Units, Powder for Solution for Injection
BOTOX,
200 Allergan Units, Powder for Solution for Injection
Botulinum toxin type A
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What BOTOX is and what it is used for
2.
What you need to know before you use BOTOX
3.
How to use BOTOX
4.
Possible side effects
5.
How to store BOTOX
6.
Contents of the pack and other information
1.
WHAT BOTOX IS AND WHAT IT IS USED FOR
BOTOX is a muscle relaxant used to treat a number of conditions within
the body. It
contains the active substance Botulinum toxin type A and is injected
into either the
muscles, the bladder wall or deep into the skin. It works by partially
blocking the
nerve impulses to any muscles that have been injected and reduces
excessive
contractions of these muscles. In the case of chronic migraine, it is
thought that
BOTOX blocks pain signals, which indirectly block the development of a
migraine.
When injected into the skin, BOTOX works on sweat glands to reduce the
amount of
sweat produced.
When injected into the bladder wall, BOTOX works on the bladder muscle
to prevent
leakage of urine (urinary incontinence) due to uncontrolled
contractions of the bladder
muscle.
1.
BOTOX can be injected directly into the muscles, and can be used to
control the
following conditions:
2
•
In
CHILDREN
aged two years or older with cerebral palsy, who can walk, BOTOX
is used to control
FOOT DE

उत्पाद विशेषताएं

OBJECT 1
BOTOX 200 UNITS
Summary of Product Characteristics Updated 08-Mar-2018 | Allergan Ltd
1. Name of the medicinal product
BOTOX
200 Allergan Units
Powder for solution for injection
2. Qualitative and quantitative composition
Botulinum toxin* type A, 200 Allergan Units/vial.
* from _Clostridium botulinum_
Botulinum toxin units are not interchangeable from one product to
another.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection.
BOTOX product appears as a thin white deposit that may be difficult to
see on the base of the vial.
4. Clinical particulars
4.1 Therapeutic indications
BOTOX is indicated for:
NEUROLOGIC DISORDERS:
• treatment OF FOCAL SPASTICITY, including:
dynamic equinus foot deformity due to spasticity in ambulant
PAEDIATRIC CEREBRAL PALSY
patients, two years of age or older
wrist and hand disability due to UPPER LIMB SPASTICITY associated with
stroke in adults
ankle disability due to LOWER LIMB SPASTICITY associated with stroke
in adults
• symptomatic relief of BLEPHAROSPASM, HEMIFACIAL SPASM and
IDIOPATHIC CERVICAL DYSTONIA (spasmodic
torticollis)
• prophylaxis of headaches in adults with CHRONIC MIGRAINE
(headaches on at least 15 days per month of
which at least 8 days are with migraine)
BLADDER DISORDERS:
• management of BLADDER DYSFUNCTIONS in adult patients who are not
adequately managed with
anticholinergics
OVERACTIVE BLADDER with symptoms of urinary incontinence, urgency and
frequency
NEUROGENIC DETRUSOR OVERACTIVITY with urinary incontinence due to
subcervical spinal cord
injury (traumatic or non-traumatic), or multiple sclerosis
SKIN AND SKIN APPENDAGE DISORDER:
• management of severe HYPERHIDROSIS OF THE AXILLAE, which does not
respond to topical treatment with
antiperspirants or antihidrotics
• temporary improvement in the appearance of the following facial
lines, when the severity of these lines
has an important psychological impact in adult patients:
moderate to severe vertical lines between the eyebrows seen at max