Tramadol Denk 100mg/2ml solution for injection/infusion

Krajina: Arménsko

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktívna zložka:

tramadol (tramadol hydrochloride)

Dostupné z:

Solupharm Pharmazeutische Erzeugnisse GmbH

ATC kód:

N02AX02

INN (Medzinárodný Name):

tramadol (tramadol hydrochloride)

Dávkovanie:

50mg/ml

Forma lieku:

solution for injection/infusion

Počet v balení:

(5) ampoules 2ml

Typ predpisu:

Prescription

Stav Autorizácia:

Registered

Dátum Autorizácia:

2019-07-09

Príbalový leták

SPECIFICATION – DENK PHARMA
product name:
Tramadol Denk 100 mg/2 ml
artwork:
leaflet
language(s):
EN, FR,
material number:
50001582/003
storage
conditions:
25°C
revision of text:
06/2021
open format:
600 x 148 mm
fold:
1 x pre-folded (Einbruchfalz)
folded format:
300 x 148 mm
pharma code:
24009
paper grammar:
40 g/m
2
printing colours:
 PANTONE YELLOW C
 BLACK
revision/date:
1 / 03.05.2022 WHo
2 / 09.05.2022 WHo
_Tramadol Denk 100 mg/2 ml_
Solution for intravenous | intramuscular | subcutaneous
injection or for intravenous infusion
Opioid analgesic
Active substance: tramadol
Package leaflet: Information for the user
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
– Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor
or pharmacist.
– This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
–
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
WHAT TRAMADOL DENK 100 MG/2 ML IS AND WHAT IT
IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TRAMADOL
DENK 100 MG/2 ML
3.
HOW TO USE TRAMADOL DENK 100 MG/2 ML
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TRAMADOL DENK 100 MG/2 ML
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Tramadol Denk 100 mg/2 ml is and
what it is used for
Tramadol – the active substance in Tramadol Denk
100 mg/2 ml – is a centrally acting analgesic (pain­
killer) belonging to the opioid group. It achieves its
pain­relieving effect by acting on specific nerve cells in
the spinal cord and brain.
Tramadol Denk 100 mg/2 ml is used for the treatment
of moderate to severe pain.
2.
What you need to know before you use
Tramadol Denk 100 mg/2 ml
Do not use Tramadol Denk 100 mg/2 ml
•
if you are allergic to tramadol or any of the other ingre­
die

Súhrn charakteristických

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tramadol Denk 100 mg/2 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: tramadol hydrochloride
Each ampoule of 2 ml solution for injection contains 100 mg tramadol
hydrochloride.
Excipient with known effect:
Tramadol Denk 100 mg/2 ml contains less than 1 mmol (23 mg) sodium per
ampoule (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (intramuscular, intravenous, subcutaneous) or
for intravenous infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage should be adjusted to the intensity of pain and the
patient’s individual sensitivity. In
general, the lowest dose sufficient for analgesia should be selected.
Daily doses of 400 mg active substance should not be exceeded, unless
there are special medical
circumstances (e.g. for tumour pain and severe post-operative pain).
Unless otherwise prescribed, this medicine should be dosed as follows:
Adults and adolescents over 12 years of age
Single dose:_ _50-100 mg every 4-6 hours
Maximum daily dose: 400 mg
If no sufficient analgesia occurs within 30-60 minutes following
single-dose administration of
50 mg tramadol hydrochloride, a second single dose of 50 mg can be
given.
If higher requirements are expected for severe pain, the higher single
dose of tramadol
hydrochloride can be administered as the initial dose (100 mg tramadol
hydrochloride).
Depending on the pain, the effect lasts for 4-6 hours. For the
treatment of severe post-operative
pain, even higher doses may be required in the first few hours on an
on-demand basis.
Requirements over 24 hours are generally no higher than with normal
administration.
_ _
_ _
2
Paediatric population
Tramadol Denk 100 mg/2 ml is not suitable for children below 1 year of
age.
Children aged 1-11 years are given 1-2 mg tramadol hydrochloride per
kilogram o