Acupan

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

nefopam (nefopam hydrochloride)

可用日期:

Biocodex

INN（国际名称）:

nefopam (nefopam hydrochloride)

剂量:

10mg/ml

药物剂型:

solution for injection

处方类型:

Prescription

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ACUPAN
® 20 MG, SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nefopam (hydrochloride)
.................................................................
20.00 mg
For one ampoule of 2 ml.
Excipient with known effect: none
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in ampoule.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Acupan
is
indicated
in
adults
for
the
symptomatic
treatment
of
acute
painful
conditions, especially post-operative pains.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
As for any antipain treatment, the dosage must be adapted to pain
intensity and
patient response.
_POSOLOGY _

IM route: Acupan should be administered by deep intramuscular route.
The usual
recommended dose is 20 mg per injection. If necessary, it can be
repeated every 6
hours without exceeding the total dose of 120 mg/day.

IV route: Acupan should be administered by slow intravenous infusion
in more
than 15 minutes, the patient laying down in order to avoid some side
effects such as
nausea, dizziness, sweat. The usual recommended unique dose is 20 mg
per
injection. If necessary, it can be repeated every 4 hours, without
exceeding 120
mg/day.
Paediatric population: the safety and efficacy of Acupan in children
below 15 years of
age have not been established.
_METHOD OF ADMINISTRATION _
Acupan can be administered in the usual solutions for perfusion
(isotonic solution of
sodium chloride or glucose solution). It is recommended to avoid
mixing Acupan and
other injectable drugs in the same syringe.
4.3.
CONTRAINDICATIONS

Hypersensitivity to the active ingredient or to any of the excipients
listed in section
6.1.

Children below 15 years of age in of the absence of clinical studies.

Convulsions or previous history of convulsions.

Risk of urinary retention linked to uretroprostatic disorders.

Risk of acute angle glaucoma.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_SP