Metharose 1mg/ml oral solution sugar free

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Methadone hydrochloride

Inapatikana kutoka:

Rosemont Pharmaceuticals Ltd

ATC kanuni:

N07BC02

INN (Jina la Kimataifa):

Methadone hydrochloride

Kipimo:

1mg/1ml

Dawa fomu:

Oral solution

Njia ya uendeshaji:

Oral

Darasa:

Schedule 2 (CD)

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 04100300; GTIN: 5016119156991

Taarifa za kipeperushi

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JOB INFORMATION
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JOB SPECIFICATION
MAIN BODY TEXT
Univers Roman
UNIVERS BOLD
1mg/1ml
BLACK
7474
PANTONE
PANTONE
265
CUTTER
BRAILLE
N/A
N/A
210 x 300mm
N/A
30 x 150mm
1
8pt
(Horizontally
condensed to 90%)
No
500ml
500ml
N/A
P0827
P0792
N/A
1 of 2
Metharose® Sugar Free 1mg/1ml Oral Solution
(Methadone Hydrochloride)
31/03/17
-
DH
-
2
-
APPROVALS
THIRD PARTY APPROVAL REQUIRED
Name:
Name:
Signature:
Signature:
Date:
Date:
AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
YES
NO
N/A
TICK APPLICABLE BOX
TICK APPLICABLE BOX
n
blurred vision, small pupils, dry eyes
n
feeling of dizziness
n
changes in your mood, feeling “high” or over excited, feeling
drowsy
n
seeing or hearing things that are not there (hallucinations).
UNCOMMON (AFFECTS LESS THAN 1 IN 100 PEOPLE)
n
feeling dizzy, particularly when standing up. This may be a sign
that you have low blood pressure
n
headache
n
feeling down (dysphoria), agitation, confusion, difficulty
sleeping
n
itching, rashes
n
dry mouth or nose, inflammation of the tongue, facial flushing
n
breast growth and production of breast milk
n
difficulty in passing water (urine), pain in the lower back and
abdomen caused by muscle spasms
n
low body heat (hypothermia)
n
lower sexual urge or desire
n
painful periods or lack of periods.
THE FOLLOWING SIDE EFFECTS HAVE ALSO BEEN REPORTED
n
loss of appetite
n
swollen arms and legs. This may be a sign of your body holding onto
more water than usual
n
reduction in blood platelets, which increase the risk of bleeding or
bruising
n
low potassium and magnesium which will be found by blood tests
n
eye disorders in newborn babies
n
reduction in the body’s normal production of adrena

Tabia za bidhaa

OBJECT 1
METHAROSE SUGAR FREE 1MG/1ML ORAL SOLUTION
Summary of Product Characteristics Updated 08-Nov-2017 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Metharose Sugar Free 1mg/1ml Oral Solution
2. Qualitative and quantitative composition
Methadone Hydrochloride Ph.Eur 1mg/1ml
3. Pharmaceutical form
Brown solution for oral administration
4. Clinical particulars
4.1 Therapeutic indications
For use in the treatment of opioid drug addictions (as a narcotic
abstinence syndrome suppressant).
For use as an analgesic for moderate to severe pain
4.2 Posology and method of administration
Posology
Addiction:
Adults:
Initially 10 - 20mg per day, increasing by 10 - 20mg per day until
there are no signs of
withdrawal or intoxication. The usual dose is 40 - 60mg per day. The
dose is adjusted according
to the degree of dependence with the aim of gradual reduction.
Elderly:
In the case of elderly or ill patients repeated doses should only be
given with extreme caution.
Children:
Not recommended for children.
Pain:
Adults:
Usual single dose, 5 to 10mg orally. Owing to its long plasma half
life, caution with repeated
dosage should be observed in the very ill or elderly. The usual
initial dose should be 5 to 10mg,
6 to 8 hourly, later adjusted to the degree of pain relief obtained.
Elderly:
Use caution with repeated dosage in elderly and ill patients.
Children:
Not suitable
Method of Administration
For oral administration only.
4.3 Contraindications
Respiratory depression, obstructive airways disease. Use during an
asthma attack is not recommended
Concurrent administration with MAO inhibitors or within 2 weeks of
discontinuation of treatment with
them.
Patients dependent on non-opioid drugs
Known hypersensitivity to the hydroxybenzoates.
Use during labour is not recommended, the prolonged duration of action
increases the risk of neonatal
depression.
Methadone is not suitable for children.
Raised intracranial pressure or head injury.
Phaeochromocytoma.
Risk of paralytic ileus (including drug induced gastrointe