TRAMADOL PANPHARMA 100 MG 2ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TRAMADOL HYDROCHLORIDE

Available from:

PHARMALOGIC LTD

ATC code:

N02AX02

Pharmaceutical form:

SOLUTION FOR INJECTION / INFUSION

Composition:

TRAMADOL HYDROCHLORIDE 100 MG / 2 ML

Administration route:

S.C, I.V, I.M

Prescription type:

Required

Manufactured by:

PANPHARMA GMBH, GERMANY

Therapeutic group:

TRAMADOL

Therapeutic area:

TRAMADOL

Therapeutic indications:

Moderate severe to severe pain .

Authorization date:

2018-01-31

Summary of Product characteristics

TRAMADOL 100 MG ROTEXMEDICA
SOLUTION FOR INJECTION.
COMPOSITION
Tramadol 100 mg Rotexmedica solution for injection: 1 ampoule of 2 ml
contains 100 mg tramadol hydrochloride
Other ingredients: Sodium acetate and water for injections.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Moderate to severe pain.
PHARMACOTHERAPEUTIC GROUP -
Centrally acting opioid analgesic. Tramadol: N02AX02
DOSAGE AND METHOD OF ADMINISTRATION
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
Rotexmedica
solution for injection should be adjusted depending on the severity of
the pain
and the individual clinical response of the patient.
_ADULTS:_ A single dose of 50 mg or 100 mg 4-6 hourly (1 or 2 ml of
Tramadol
Rotexmedica solution for injection) is usually required.
Intravenous injection must be given slowly over 2-3 minutes.
For severe (postoperative) pain, administer an initial bolus of 100 mg
during
the 60 minutes following the initial bolus, further doses of 50 mg may
be
given every 10 to 20 minutes, up to a total dose of 250 mg including
the
initial bolus.
Subsequent doses should be 50 or 100 mg administered every 4-6 hours.
If the administration of Tramadol Rotexmedica solution for injection
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 Rotexmedica solution for injection is injected into the veins
(usually
into blood vessels under the surface of the arms), muscle (usually the
buttocks)
or under the skin.
Administration into the veins is slow, with 1 ml Tramadol Rotexmedica
solution
for injection (equivalent to 50 mg tramadol hydrochloride)/minute.
Alternatively Tramadol Rotexmedica solution for injection may be
diluted with
a suitable infusion solution (0.9% physiological saline or 5% glu