TRAMADOL SANDOZ tramadol hydrochloride 100 mg/2 mL injection ampoule

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

tramadol hydrochloride, Quantity: 50 mg/mL

Доступно од:

Sandoz Pty Ltd

INN (Међународно име):

Tramadol hydrochloride

Фармацеутски облик:

Injection, solution

Састав:

Excipient Ingredients: sodium acetate; water for injections

Пут администрације:

Intramuscular, Intravenous

Јединице у пакету:

5 ampoules

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Tramadol Sandoz injections are indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Резиме производа:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Licence status A

Датум одобрења:

2005-11-29

Информативни летак

TRAMADOL SANDOZ
1
TRAMADOL SANDOZ
®
_tramadol hydrochloride injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Tramadol Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TRAMADOL
SANDOZ IS USED
FOR
This medicine is used to relieve
severe pain.
It contains the active ingredient
tramadol hydrochloride.
Tramadol hydrochloride belongs to a
group of medicines called opioid
analgesics (pain relievers).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
Tramadol Sandoz is for use in adults
and children over 12 years of age. It
should not be used in children under
the age of 12 years or following the
removal of tonsils and/or adenoids in
people under 18.
BEFORE YOU USE
TRAMADOL SANDOZ
_WHEN YOU MUST NOT USE IT _
DO NOT USE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
tramadol hydrochloride, the
active ingredient, or to any of the
other ingredients listed at the end
of this leaflet under Product
Description
•
any other similar medicines
known as opioid analgesics, e.g.
morphine, codeine.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
throat or other parts of the body
•
skin rash, itching or hives on the
skin
WARNING
LIMITATIONS OF USE
Tramadol Sandoz should only be used when your doctor decides that
other treatment options are not able to effectively
manage your pain or you cannot tolerate them.
HAZARDOUS

Карактеристике производа

220208-Tramadol Sandoz injection-pi
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
TRAMADOL SANDOZ
® (TRAMADOL HYDROCHLORIDE)
INJECTION
1
NAME OF THE MEDICINE
Tramadol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of Tramadol Sandoz injection contains 50 mg of tramadol
hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tramadol Sandoz 50 mg/1 mL injection - Clear colourless liquid free
from visible particles.
Tramadol Sandoz 100 mg/2 mL injection - Clear colourless liquid free
from visible particles.
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, Tramadol
Sandoz injection should
only be used in patients whom other treatment options, including
non-opioid analgesics, are
ineffective, not tolerated or otherwise inadequate to provide
appropriate management of pain
(see Section 4.4 Special warnings and precautions for use).
HAZARDOUS AND HARMFUL USE
Tramadol Sandoz injection poses risks of hazardous and harmful use
which can lead to
overdose and death. Assess the patient’s risk of hazardous and
harmful use before prescribing
and monitor the patient regularly during treatment (see Section 4.4
Special warnings and
precautions for use).
LIFE THREATENING RESPIRATORY DEPRESSION
Serious, life-threatening or fatal respiratory depression may occur
with the use of Tramadol
Sandoz injection. Be aware of situations which increase the risk of
respiratory depression,
modify dosing in patients at risk and monitor patients closely,
especially on initiation or
following a dose increase (see Section 4.4 Special warnings and
precautions for use).
CONCOMITANT
USE
OF
BENZODIAZEPINES
AND
OTHER
CENTRAL
NERVOUS
SYSTEM
(CNS)
DEPRESSANTS, INCLUDING ALCOHOL
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma and death.
Lim