TRAMAL INJECTION 100

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TRAMADOL HYDROCHLORIDE

Available from:

TEC-O-PHARM-LIBRA LTD

ATC code:

N02AX02

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

TRAMADOL HYDROCHLORIDE 100 MG / 2 ML

Administration route:

I.V, S.C, I.M

Prescription type:

Required

Manufactured by:

GRUNENTHAL GMBH, GERMANY

Therapeutic group:

TRAMADOL

Therapeutic area:

TRAMADOL

Therapeutic indications:

Moderate to severe pain.

Authorization date:

2022-05-31

Patient Information leaflet

TRAMAL INJECTION 100
1.
NAME OF THE MEDICINAL PRODUCT
TRAMAL INJECTION 100 Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tramal Injection 100 ampoule contains 100mg tramadol
hydrochloride in 2ml colourless aqueous solution.
Excipient with known effect: This medicine contains less than 1 mmol
sodium (23 mg) per 2mL, that is to say essentially
‘sodium-free’.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
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 Tramal Injection 100 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 Tramal
Injection 100) 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 Tramal Injection 100 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.
Tramal Injection 100 is injected into the veins (usually into a blood
vessel under the surface of the arm), muscles (usually the
buttocks) or under the skin. Administration into the veins is slow
with 1 ml Tramal Inj

Summary of Product characteristics

TRAMAL INJECTION 100
1.
NAME OF THE MEDICINAL PRODUCT
TRAMAL INJECTION 100 Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tramal Injection 100 ampoule contains 100mg tramadol
hydrochloride in 2ml colourless aqueous solution.
Excipient with known effect: This medicine contains less than 1 mmol
sodium (23 mg) per 2mL, that is to say essentially
‘sodium-free’.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
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 Tramal Injection 100 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 Tramal
Injection 100) 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 Tramal Injection 100 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.
Tramal Injection 100 is injected into the veins (usually into a blood
vessel under the surface of the arm), muscles (usually the
buttocks) or under the skin. Administration into the veins is slow
with 1 ml Tramal Inj