Tramal 100

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Tramadol hydrochloride 50 mg/mL

Tilgængelig fra:

Seqirus (NZ) Ltd

INN (International Name):

Tramadol hydrochloride 50 mg/mL

Dosering:

100 mg/2mL

Lægemiddelform:

Solution for injection

Sammensætning:

Active: Tramadol hydrochloride 50 mg/mL Excipient: Sodium acetate trihydrate Water for injection

Enheder i pakken:

Ampoule, glass, 2mL, 5 dose units

Klasse:

Prescription

Recept type:

Class C2 Controlled Drug

Fremstillet af:

Proto Chemicals AG

Terapeutiske indikationer:

Relief of moderate to severe pain.

Produkt oversigt:

Package - Contents - Shelf Life: Ampoule, glass, 2mL - 5 dose units - 60 months from date of manufacture stored at or below 30°C - Ampoule, glass, 2mL - 10 dose units - 60 months from date of manufacture stored at or below 30°C

Autorisation dato:

1996-06-17

Indlægsseddel

NEW ZEALAND CONSUMER MEDICINE INFORMATION
TRAMAL
®
TRAMADOL HYDROCHLORIDE IMMEDIATE RELEASE CAPSULES (50 MG) AND SOLUTION
FOR INJECTION
(50 MG/ML, 100 MG/2ML)
WARNING
LIMITATIONS OF USE
TRAMAL
®
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 AND HARMFUL USE
TRAMAL
®
poses risks of abuse, misuse and addiction which can lead to overdose
and death.
Your doctor will monitor you regularly during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
TRAMAL
®
can cause life-threatening or fatal breathing problems (slow, shallow,
unusual or no
breathing), even when used as recommended. These problems can occur at
any time during
use, but the risk is higher when first starting TRAMAL
®
and after a dose increase, if you are
older, or have an existing problem with your lungs. Your doctor will
monitor you and change the
dose as appropriate.
USE OF OTHER MEDICINES WHILE USING TRAMAL
®
USING TRAMAL
®
WITH OTHER MEDICINES THAT CAN MAKE YOU FEEL DROWSY SUCH AS SLEEPING
TABLETS (E.G. BENZODIAZEPINES), OTHER PAIN RELIEVERS, ANTIHISTAMINES,
ANTIDEPRESSANTS,
ANTIPSYCHOTICS, GABAPENTINOIDS (E.G. GABAPENTIN AND PREGABALIN),
CANNABIS AND ALCOHOL
MAY RESULT IN SEVERE DROWSINESS, DECREASED AWARENESS, BREATHING
PROBLEMS, COMA AND
DEATH. Your doctor will minimise the dose and duration of use; and
monitor you for signs and
symptoms of breathing difficulties and sedation. You must not drink
alcohol while using
TRAMAL
®
.
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about TRAMAL
®
. It does not contain all the
available information. It does not replace talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking TRAMAL
®
against the benefits this medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
KEEP THIS LEAFLET. You may need to read it again.
WHAT TRAMAL
®
IS USED FOR

Produktets egenskaber

1
NEW ZEALAND DATA SHEET
TRAMAL
®
CAPSULES
TRAMAL
®
SOLUTION FOR INJECTION
TRAMAL
®
SR TABLETS
1.
PRODUCT NAME
Tramal
®
(tramadol hydrochloride) immediate release capsules 50 mg
Tramal
®
(tramadol hydrochloride) solution for injection 50 mg/mL, 100 mg/2mL
Tramal
®
SR tablets (tramadol hydrochloride) sustained release tablets) 50 mg,
100 mg, 150
mg, 200 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRAMAL
®
50 MG CAPSULES ARE YELLOW-YELLOW CAPSULES CONTAINING: 50 mg tramadol
hydrochloride.
TRAMAL
®
50 MG AND 100 MG INJECTIONS CONTAIN: tramadol hydrochloride 50 mg/mL.
TRAMAL
®
SR SUSTAINED RELEASE TABLETS CONTAIN: tramadol hydrochloride in the
following
dose strengths: 50, 100, 150 and 200 mg.
For full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
Tramal
®
capsules, Tramal
®
solution for injection, and Tramal
®
SR tablets contain tramadol
hydrochloride which is ( +) -
_cis_-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)-cyclohexanol
hydrochloride. Tramadol hydrochloride is an odourless, white to
off-white crystalline powder
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, Tramal
®
should only be used in
patients for 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
Tramal
®
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 Tramal
®
.
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 (