ZYDOL 100mg/2ml Mg/Ml Solution for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-11-2015
Summary of Product characteristics
(SPC)
21-10-2016
Active ingredient:
TRAMADOL HYDROCHLORIDE
Available from:
Grünenthal Ltd
ATC code:
N02AX02
INN (International Name):
TRAMADOL HYDROCHLORIDE
Dosage:
100mg/2ml Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Other opioids
Authorization status:
Authorised
Authorization date:
2004-12-22
Patient Information leaflet
ie-pl-solution-for-injection-clean
Jul 2015
Details: Type IAin – change to HPRA from IMB
Page 1
1
_INFORMATION FOR THE HEALTH PROFESSIONAL_
ZYDOL
®
100 MG / 2 ML
SOLUTION FOR INJECTION
TRAMADOL HYDROCHLORIDE
_NAME OF THE MEDICINAL PRODUCT _
ZYDOL 100 mg / 2 ml Solution for Injection
_QUALITATIVE AND QUANTITATIVE COMPOSITION _
Each ZYDOL 100 mg / 2 ml Solution
for injection ampoule contains 100 mg tramadol
hydrochloride in 2 ml solution, i.e. 50
mg tramadol hydrochloride per ml.
Excipient with known effect: 1 ml of solution for injection
contains 0.7 mg sodium.
_ _
_PHARMACEUTICAL FORM _
Solution for injection or infusion
Clear, colourless, aqueous solution.
_ _
_CLINICAL PARTICULARS _
THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
POSOLOGY AND METHOD OF ADMINISTRATION
The dose should be adjusted to the intensity of the pain and
the sensitivity of the individual
patient. The lowest effective
dose for analgesia should generally be selected. The total
daily
dose of 400 mg tramadol hydrochloride should not be exceeded,
except in special clinical
circumstances.
Unless otherwise prescribed, ZYDOL should be administered
as follows:
Adults and adolescents above the age of 12
years
The usual dose is 50 or 100mg 4-6 hourly.
Intravenous injections must be given slowly over 2-3 minutes.
For post-operative pain administer an initial bolus of 100mg.
During the 60 minutes following
the initial bolus, further doses of 50mg may be given
every 10-20 minutes, up to a total dose of
250mg including the initial bolus. Subsequent doses should
be 50mg-100mg 4-6 hourly up to a
total daily dose of 400mg.
Children above the age of 1 year
The
recommended single dose of tramadol is 1-2 mg/kg bod
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ZYDOL 100 mg / 2 ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ZYDOL 100 mg / 2 ml Solution for injection ampoule contains 100 mg tramadol hydrochloride in 2 ml solution,
i.e. 50 mg tramadol hydrochloride per ml.
Excipient with known effect: 1 ml of solution for injection contains 0.7 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear colourless, aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest
effective dose for analgesia should generally be selected. The total daily dose of 400 mg tramadol hydrochloride should
not be exceeded, except in special clinical circumstances.
Unless otherwise prescribed, ZYDOL should be administered as follows:
Adults and adolescents above the age of 12 years
The usual dosage is 50 or 100 mg 4-6 hourly (see section 5.1). Intravenous injections must be given slowly over 2-3
minutes. For post-operative pain, administer an initial bolus of 100 mg. During the 60 minutes following the initial
bolus, further doses of 50mg may be given every 10-20 minutes, up to a total dose of 250mg including the initial bolus.
Subsequent doses should be 50mg-100mg 4-6 hourly up to a total daily dose of 400mg.
Children above the age of 1 year
The recommended single dose of tramadol hydrochloride is 1 mg/kg to 2 mg/kg body weight. The total daily dose of 8
mg tramadol hydrochloride per kg body weight or 400 mg tramadol hydrochloride, whichever is lower, should not be
exceede
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