TRAMADOL MEDOCHEMIE 100 MG2 ML

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

TRAMADOL HYDROCHLORIDE

Disponible desde:

DEVRIES & CO. LTD

Código ATC:

N02AX02

formulario farmacéutico:

SOLUTION FOR INJECTION / INFUSION

Composición:

TRAMADOL HYDROCHLORIDE 50 MG / 1 ML

Vía de administración:

S.C, I.M, I.V

tipo de receta:

Required

Fabricado por:

MEDOCHEMIE LTD, CYPRUS

Área terapéutica:

TRAMADOL

indicaciones terapéuticas:

Moderate to severe pain

Fecha de autorización:

2019-06-17

Ficha técnica

TRAMADOL MEDOCHEMIE 100 MG/2 ML
1. NAME OF THE MEDICINAL PRODUCT
Tramadol Medochemie 100 mg/2 ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tramadol Medochemie 100 mg/2 ml ampoule contains 100 mg tramadol
hydrochloride in 2 ml aqueous solution.
Excipient with known effect: This medicine contains less than 1 mmol
sodium (23 mg) per 2 ml, that is to say essentially
‘sodium-free’.
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection or infusion.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moderate to severe pain
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held
with patients to put in place a strategy for ending
treatment with tramadol in order to minimise the risk of addiction and
drug withdrawal syndrome (see section 4.4).
The injection is for parenteral administration either intramuscularly,
by slow intravenous injection or, when diluted in
solution, by infusion or patient-controlled analgesia. As with all
analgesic drugs the dosing of Tramadol Medochemie
100 mg/2 ml should be adjusted depending on the severity of the pain
and the individual clinical response of the
patient.
_ _
_Adults:_
A single dose of 50 or 100 mg 4-6 hourly (1 or 2 ml of Tramadol
Medochemie 100 mg/2 ml) is usually required.
Intravenous injections must be given slowly over 2-3 minutes.
In severe (post-operative) pain, an initial bolus of 100 mg is
administered 10-20 minutes up to a total dose of 250 mg
including the initial bolus.
Subsequent doses should be 50 or 100 mg administered 4-6 hourly.
If the administration of Tramadol Medochemie 100 mg/2 ml has been
forgotten, the pain may return. The dose should
not be doubled. Administration should be continued as before.
A total daily dose of 400 mg should not be exceeded except in special
clinical circumstances.
Tramadol Medochemie 100 mg/2 ml is injected into the veins (usually
into a blood vessel under the surface of the
arm), muscles (usually the buttocks) or under the sk