Tramadol 100mg/2ml solution for injection ampoules

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Tramadol hydrochloride

Доступна с:

hameln pharma Ltd

код АТС:

N02AX02

ИНН (Международная Имя):

Tramadol hydrochloride

дозировка:

50mg/1ml

Фармацевтическая форма:

Solution for injection

Администрация маршрут:

Intramuscular; Intravenous

класс:

Schedule 3 (CD No Register Exempt Safe Custody)

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 04070200; GTIN: 5016386008511

тонкая брошюра

PATIENT INFORMATION LEAFLET
TRAMADOL HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION OR INFUSION
tramadol hydrochloride
HAMELN
1. What Tramadol hydrochloride 50 mg/ml
Solution for Injection or Infusion is and
what it is used for
Tramadol
-
the
active
substance
in
Tramadol
hydrochloride 50 mg/ml Solution for Injection or
Infusion - is a
PAINKILLER
belonging to the class
of opioids that acts on the central nervous system.
It relieves pain by acting on specific nerve cells of
the spinal cord and brain.
Tramadol
hydrochloride
50
mg/ml
Solution
for
Injection or Infusion is used for the treatment of
moderate to severe pain.
2.
What
you
need
to
know
before
you
use Tramadol hydrochloride 50 mg/ml
Solution for Injection or Infusion
DO NOT USE TRAMADOL HYDROCHLORIDE 50
MG/ML SOLUTION FOR INJECTION OR INFUSION:
• if you are
ALLERGIC
to tramadol hydrochloride
or any of the other ingredients of this medicine
(listed in section 6)
• if you are also taking
MAO INHIBITORS
(certain
medicines used for treatment of
DEPRESSION
)
or have taken them in
THE LAST 14 DAYS
before
treatment with Tramadol hydrochloride 50 mg/
ml Solution for Injection or Infusion (see “Other
medicines and Tramadol hydrochloride 50 mg/ml
Solution for Injection or Infusion”)
• if you are an
EPILEPTIC
and your fits are not
adequately controlled by treatment
• if you have
DRUNK
enough
ALCOHOL
to make you
feel woozy or drunk
• if you have taken more than the prescribed
dose of your
SLEEPING TABLETS
or other pain
killers, which can slow down your breathing and
reactions. (See section “Other medicines and
Tramadol hydrochloride 50 mg/ml Solution for
Injection or Infusion” for details)
You should not take this product for the treatment
of withdrawal symptoms caused by opiates
(morphine- like medicines).
WARNINGS AND PRECAUTIONS:
TALK
TO
YOUR
DOCTOR
OR
NURSE
BEFORE
USING TRAMADOL HYDROCHLORIDE 50 MG/ML
SOLUTION FOR INJECTION OR INFUSION:
• if you have a head injury, breathing difficulties or
severe liver or kidney problems.
• if you think that yo

Характеристики продукта

OBJECT 1
TRAMADOL HYDROCHLORIDE 50 MG/ML SOLUTION FOR
INJECTION OR INFUSION
Summary of Product Characteristics Updated 01-Jun-2017 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Tramadol hydrochloride 50 mg/ml solution for injection or infusion
2. Qualitative and quantitative composition
Tramadol hydrochloride 50 mg/ml of injection solution (50 ml per 1 ml
ampoule, 100 mg per 2 ml
ampoule)
Excipient with known effect: 1 ml of solution for injection or
infusion contains 0.7 mg sodium.
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Clear, colourless sterile solution for injection or infusion.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of moderate to severe pain.
4.2 Posology and method of administration
The dose should be adjusted to the intensity of the pain and the
sensitivity of the individual patient. The
lowest effective dose for analgesia should generally be selected. The
total daily dose of 400 mg tramadol
hydrochloride should not be exceeded, except in special clinical
circumstances.
Unless otherwise prescribed, Tramadol hydrochloride 50 mg/ml solution
for injection or infusion should
be administered as follows:
ADULTS AND ADOLESCENTS ABOVE THE AGE OF 12 YEARS:
The usual dose is 50 or 100mg 4-6 hourly by the intravenous or
intramuscular route. Dosage should be
adjusted according to pain severity and response.
Intravenous injections must be given slowly over 2-3 minutes.
For post-operative pain administer an initial bolus of 100mg. During
the 60 minutes following the initial
bolus, further doses of 50mg may be given every 10-20 minutes, up to a
total dose of 250mg including the
initial bolus. Subsequent doses should be 50mg or 100mg 4-6 hourly up
to a total daily dose of 400mg.
_Children _
Tramadol hydrochloride 50 mg/ml solution for injection or infusion is
not suitable for children below the
age of 12 years.
_Geriatric patients _
A dose adjustment is not usually necessary in elderly patients (up to
75 years) without clinically manifest
hepatic or