Novistig 0.5 mg/ml + 2.5 mg/ml solution for injection

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Glycopyrronium bromide; Neostigmine Metilsulfate

Διαθέσιμο από:

Sintetica Ireland Limited

Φαρμακολογική κατηγορία (ATC):

A03AB02

INN (Διεθνής Όνομα):

Glycopyrronium bromide; Neostigmine Metilsulfate

Δοσολογία:

0.5 mg/ml + 2.5 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Θεραπευτική περιοχή:

glycopyrronium bromide

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2021-01-29

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVISTIG 0.5 MG/ML + 2.5 MG/ML SOLUTION FOR INJECTION
GLYCOPYRRONIUM BROMIDE/NEOSTIGMINE METILSULFATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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.
-
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 Novistig is and what it is used for
2.
What you need to know before you are given Novistig
3.
How to use Novistig
4.
Possible side effects
5.
How to store Novistig
6.
Contents of the pack and other information
1.
WHAT NOVISTIG IS AND WHAT IT IS USED FOR
Novistig contains two active ingredients:
-
Neostigmine metilsulfate which belongs to a group of medicines called
cholinesterase inhibitors. It has
the effect of reversing the action of certain muscle-relaxing drugs
-
Glycopyrronium bromide which belongs to a group of medicines called
anticholinergic drugs. Its
purpose is to block some of the unwanted effects that may occur with
neostigmine metilsulfate such as
slowing the heart rate or excess production of saliva.
Glycopyrronium bromide and neostigmine metilsulfate Injection is used
at the end of an operation to reverse
the effects of some of the drugs used during surgery such as
anaesthetics and muscle relaxants.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NOVISTIG
DO NOT USE NOVISTIG:
-
if you are allergic to glycopyrronium bromide or neostigmine
metilsulfate or any of the other ingredients
of this medicine (listed in section 6)
-
if you have a blockage in your stomach, intestine or urinary passages
such as bladder or kidneys
-
if you are also receiving suxamethonium, a muscle relaxant usually
given during operations.
Make sure your doctor knows if you suffer from any of the above.
WARNINGS AND PRECAUTIONS
Talk to your doctor before you are g

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
29 January 2021
CRN0095ZX
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Novistig 0.5 mg/ml + 2.5 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution for injection contains 0.5 mg of glycopyrronium
bromide and 2.5 mg neostigmine metilsulfate.
Excipients with known effect:
1 ml of solution contains 3 mg (0.13 mmol) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution, practically free of visible particles.
Osmolality: 240-340 mOSm/Kg
pH: 3.4-3.8
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reversal of residual non-depolarising (competitive) neuromuscular
block.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage:
_Adults and elderly patients: _
1 – 2 ml intravenously over a period of 10 to 30 seconds (equivalent
to neostigmine metilsulfate 2.5
mg with Glycopyrronium Bromide 0.5 mg to neostigmine metilsulfate 5 mg
with glycopyrronium bromide 1 mg). Alternatively
0.02 ml/kg intravenously over a period of 10 to 30 seconds may be
used, (equivalent to neostigmine metilsulfate 0.05 mg/kg
with glycopyrronium bromide 0.01 mg/kg).
These doses may be repeated if adequate reversal of neuromuscular
blockade is not achieved. Total doses in excess of 2 ml are
not recommended as this dose of neostigmine may produce depolarising
neuromuscular block.
_Paediatric population:_ 0.02 ml/kg intravenously over a period of 10
to 30 seconds (equivalent to neostigmine
metilsulfate 0.05 mg/kg with glycopyrronium bromide 0.01 mg/kg).
Alternatively, dilute to 10 ml with water for injections and
administer 1 ml per 5 kg bodyweight.
Method of administration: For intravenous injection.
4.3 CONTRAINDICATIONS
-Hypersensitivity to the two active substances or to any of the
excipients listed in section 6.1
-Novistig 0.5 mg/ml + 2.5 mg/ml solution for injection should not be
given to patients with mechanical obstruction of the
gastrointestinal or urin