Noradrenaline (base) 8mg/8ml concentrate for solution for infusion ampoules

Country: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Noradrenaline acid tartrate

থেকে পাওয়া:

base) 8mg/8ml concentrate for solution for infusion ampoules (Aguettant Ltd

এটিসি কোড:

C01CA03

INN (International Name):

Noradrenaline acid tartrate

ডোজ:

1mg/1ml

ফার্মাসিউটিকাল ফর্ম:

Solution for infusion

প্রশাসন রুট:

Intravenous

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 02070200; GTIN: 5060238380010

তথ্য লিফলেট

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NORADRENALINE 1MG/ML
Recto/Verso
102563
NOIR
1
07/10/14
420 x 297 mm
148,5 x 36 mm
Laboratoire AGUETTANT sas
PRODUIT : Noradrenaline (Norepinephrine) 1 mg/ml,
concentrate for solution for infusion
NOM DE FICHIER ET N° DE VERSION : Notice-Noradrenaline
1mgml-GB-Adresse-DEF.indd
ARTICLE DE CONDITIONNEMENT : Notice Page 4
Fabrication Aguettant
PAYS : Royaume-Uni - Changement d’adresse de la filiale
POLICE : Times New Roman
TAILLE POLICE : Texte : 10 pts
Sous-titres : 11 pts
Titre : 15 pts
CODE ARTICLE : 102563 09/14
DIMENSIONS : A plat 210x297mm - Plié 148,5x36mm
ECHELLE D’IMPRESSION : 100% sur A3
DATE DE CRÉATION : 6 décembre 2013
DATE DE LA VERSION : 18 septembre 2014
Noir  Caractères
Gris  Découpe
Combinations requiring precautions for use
+ NON-SELECTIVE MAO INHIBITORS:
increase in the pressor action of the
sympathomimetic which is usually moderate. Should only be used under
close medical supervision.
+ SELECTIVE MAO-A INHIBITORS:
by extrapolation from non-selective MAO
inhibitors, risk of increase in the pressor action. Should only be
used under
close medical supervision.
+ LINEZOLID:
by extrapolation from non-selective MAO inhibitors: risk of
increase in the pressor action. Should only be used under close
medical
supervision.
Caution is required when using Noradrenaline with alpha and beta
blockers as
severe hypertension may result.
Caution is required when using Noradrenaline with the following drugs
as they
may cause increased cardiac effects : Thyroid hormones, Cardiac
glycosides,
Anti-arrhythmics.
Ergot alkaloids or oxytocin may enhance the vasopressor and
vasoconstrictive
effects.
4.6 FERTILITY, PREGNANCY AND LACTATION
Pregnancy
Noradrenaline may impair placental perfusion and induce fetal
bradycardia.
It may also exert a contractile effect on the pregnant uterus and lead
to fetal
asphyxia in late pregnancy.
These possible risks to the fetus should therefore

পণ্য বৈশিষ্ট্য

OBJECT 1
NORADRENALINE (NOREPINEPHRINE) 1
MG / ML CONCENTRATE FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 11-Jun-2018 | Aguettant Ltd
1. Name of the medicinal product
NORADRENALINE (NOREPINEPHRINE) 1 mg / ml Concentrate for solution for
infusion
2. Qualitative and quantitative composition
Each ml of concentrate for solution for infusion contains 2 mg
Noradrenaline tartrate, equivalent to 1 mg
Noradrenaline base
Each 4ml ampoule contains 8mg Noradrenaline tartrate equivalent to 4mg
Noradrenaline base.
Each 8ml ampoule contains 16mg Noradrenaline tartrate equivalent to
8mg Noradrenaline base.
This medicinal product contains sodium.
Each ml of concentrate for solution for infusion contains 3.3 mg
equivalent to 0.14 mmol of sodium
Each 4ml ampoule contains 13.2 mg equivalent to 0.57 mmol of sodium
Each 8ml ampoule contains 26.4 mg equivalent to 1.14 mmol of sodium
To be taken into consideration by patients on a controlled sodium
diet.
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion
Clear, colourless liquid
pH = 3.0 to 4.0
4. Clinical particulars
4.1 Therapeutic indications
Noradrenaline is indicated for the emergency restoration of blood
pressure in cases of acute hypotension.
4.2 Posology and method of administration
Posology
_Adults: _
Initial rate of infusion:
The initial rate of infusion should be between 10 ml/hour and 20
ml/hour (0.16 ml/min to 0.33 ml/min).
This is equivalent to 0.8 mg/hr to 1.6 mg/hr noradrenaline tartrate
(or 0.4 mg/hr to 0.8 mg/hr
noradrenaline base).
Titration of dose:
Once an infusion of noradrenaline has been established the dose should
be titrated according to the
pressor effect observed. There is great individual variation in the
dose required to attain and maintain
normotension. The aim should be to establish a low normal systolic
blood pressure (100-120 mm Hg) or
to achieve an adequate mean arterial blood pressure (greater than 65
to 80 mm Hg – depending on the
patient's condition).
Noradrenaline ta