Risperidone 1mg/ml oral solution sugar free

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Risperidone

Inapatikana kutoka:

Rosemont Pharmaceuticals Ltd

ATC kanuni:

N05AX08

INN (Jina la Kimataifa):

Risperidone

Kipimo:

1mg/1ml

Dawa fomu:

Oral solution

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 04020100; GTIN: 5016119325298

Taarifa za kipeperushi

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JOB INFORMATION
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JOB SPECIFICATION
MAIN BODY TEXT
Univers Roman
UNIVERS BOLD
1mg/ml
BLACK
CUTTER
UKL472
376
300 x 400mm
N/A
150 x 37mm
1
8pt
Yes
100ml
N/A
N/A
J2A98RBJ1
P0794
N/A
1 of 2
Risperidone 1mg/ml Oral Solution
15/12/17
-
DH
-
2
-
APPROVALS
THIRD PARTY APPROVAL REQUIRED
Name:
Name:
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AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
YES
NO
N/A
TICK APPLICABLE BOX
TICK APPLICABLE BOX
RARE (AFFECTS 1 TO 10 USERS IN 10,000):
n
infection
n
inappropriate secretion of a hormone that controls urine volume
n
sugar in the urine, low blood sugar, high blood triglycerides (a fat)
n
lack of emotion, inability to reach orgasm
n
neuroleptic malignant syndrome (confusion, reduced or loss of
consciousness, high fever, and severe muscle
stiffness)
n
blood vessel problems in the brain
n
coma due to uncontrolled diabetes
n
shaking of the head
n
glaucoma (increased pressure within the eyeball), problems with
movement of your eyes, eye rolling, eyelid
margin crusting
n
eye problems during cataract surgery. During cataract
surgery, a condition called intraoperative floppy iris
syndrome (IFIS) can happen if you take or have taken
Risperidone. If you need to have cataract surgery, be sure to
tell your eye doctor if you take or have taken this medicine
n
dangerously low numbers of a certain type of white blood
cell needed to fight infection in your blood
n
severe allergic reaction characterised by fever, swollen mouth, face,
lip or tongue, shortness of breath, itching,
skin rash and sometimes drop in blood pressure
n
dangerously excessive intake of water
n
irregular heart beat
n
blood clot in the legs, blood clot in the lungs
n
tro

Tabia za bidhaa

OBJECT 1
RISPERIDONE 1MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 16-Jan-2018 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Risperidone 1mg/ml Oral Solution
2. Qualitative and quantitative composition
Each ml of oral solution contains 1mg Risperidone
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution
A clear colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Risperidone is indicated for the treatment of schizophrenia.
Risperidone is indicated for the treatment of moderate to severe manic
episodes associated with bipolar
disorders.
Risperidone is indicated for the short-term treatment (up to 6 weeks)
of persistent aggression in patients
with moderate to severe Alzheimer's dementia unresponsive to
non-pharmacological approaches and
when there is a risk of harm to self or others.
Risperidone is indicated for the short-term symptomatic treatment (up
to 6 weeks) of persistent
aggression in conduct disorder in children from the age of 5 years and
adolescents with subaverage
intellectual functioning or mental retardation diagnosed according to
DSM-IV criteria, in whom the
severity of aggressive or other disruptive behaviours require
pharmacologic treatment. Pharmacological
treatment should be an integral part of a more comprehensive treatment
programme, including
psychosocial and educational intervention. It is recommended that
risperidone be prescribed by a
specialist in child neurology and child and adolescent psychiatry or
physicians well familiar with the
treatment of conduct disorder of children and adolescents.
4.2 Posology and method of administration
Risperidone should be diluted with water or orange juice. When diluted
in this way, the product should be
used immediately. This liquid should not be mixed with coffee and tea
(see section 6 Pharmaceutical
Particulars).
Schizophrenia
_Adults_
Risperidone may be given once daily or twice daily.
Patients should start with 2 mg/day risperidone. The dosage may be
increased