Methadone 1mg/ml oral solution sugar free

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Methadone hydrochloride

Dostupno od:

Rosemont Pharmaceuticals Ltd

ATC koda:

N07BC02

INN (International ime):

Methadone hydrochloride

Doziranje:

1mg/1ml

Farmaceutski oblik:

Oral solution

Administracija rute:

Oral

Razred:

Schedule 2 (CD)

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 04100300; GTIN: 5016119132599 5016119156090 5016119156793 5016119156298 5016119156991

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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
Various
Various
N/A
P0832
P0791
N/A
1 of 2
Methadone Hydrochloride Sugar Free 1mg/1ml
Oral Solution (Plastic)
24/04/17
-
DH
-
1
-
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
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 adrenal and sexual
hormones.
You may notice that some of the side effects become less severe with
time as you get used to the methadone.
When taken for a long period of time, it is possible that you may
become

Svojstava lijeka

OBJECT 1
METHADONE HYDROCHLORIDE SUGAR FREE 1MG/1ML
ORAL SOLUTION (GLASS PACKS)
Summary of Product Characteristics Updated 08-Nov-2017 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution
Metharose Sugar Free Green 1mg/1ml Oral Solution
2. Qualitative and quantitative composition
Methadone Hydrochloride Ph.Eur 1mg/1ml
3. Pharmaceutical form
Green 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.
Use during labour is not recommended, the prolonged duration of action
increases the risk of neonatal
depression.
Methadone is not suitable for children.
Known hypersensitivity to the hydroxybenzoates or methadone.
Raised intracran