Robinul

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Glycopyrronium bromide 0.2 mg/mL; Glycopyrronium bromide 0.2 mg/mL

Mevcut itibaren:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Adı):

Glycopyrronium bromide 0.2 mg/mL

Doz:

0.2 mg/mL

Farmasötik formu:

Solution for injection

Kompozisyon:

Active: Glycopyrronium bromide 0.2 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection Active: Glycopyrronium bromide 0.2 mg/mL Excipient: Benzyl alcohol Hydrochloric acid Water for injection

Paketteki üniteler:

Ampoule, glass, 1mL, 5 dose units

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

Anonima Materie Sintetiche & Affini SpA (AMSA)

Terapötik endikasyonlar:

ROBINUL is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions, and to block cardiac vagal inhibitory reflexes during induction of anaesthesia and intubation when indicated. ROBINUL Injectable may be used intraoperatively to counteract drug-induced or vagal traction reflexes with the associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g. bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarising muscle relaxants.

Ürün özeti:

Package - Contents - Shelf Life: Ampoule, glass, 1mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, Type I with grey rubber stopper 1 mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C

Yetkilendirme tarihi:

1978-06-08

Bilgilendirme broşürü

Robinul NZ CMI.doc 
Based on Robinul-Inj-PI-28Oct02A 
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION 
ROBINUL
® 
INJECTABLE 
_Glycopyrrolate Injection _

WHAT IS IN THIS LEAFLET 

This leaflet answers some 
common questions about 
ROBINUL Injection.  It does not 
contain all of the available 
information. 

It does not take the place of talking 
to your doctor or pharmacist. 

All medicines have risks and 
benefits.  Your doctor has weighed 
the risks of you taking ROBINUL 
Injection against the benefits they 
expect it will have for you. 
_ _
IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 

KEEP THIS LEAFLET WITH THE 
MEDICINE. 
You may need to read it again. 

WHAT ROBINUL 
INJECTION IS USED FOR 

ROBINUL is used before surgery 
to decrease the volume of 
secretions from your mouth, lungs 
and stomach.  
It can also be used either before or 
during surgery to maintain your 
heart’s normal beating rhythm. 
ROBINUL is also used to counter 
the effects of some other 
medicines, which can slow your 
heartbeat or produce excessive 
secretions when used during 
surgery 

Your doctor, however, may have 
prescribed ROBINUL Injection for 
another purpose.  Ask your doctor 
if you have any questions about 
why ROBINUL Injection has been 
prescribed for you. 

ROBINUL works in the nervous 
system by blocking an enzyme, 
which is responsible for 
producing saliva in your mouth 
and secretions in your stomach 
and lungs. This enzyme also 
slows down the heart rate. 
When this enzyme is blocked 
secretions dry up and the heart 
rate increases.  

ROBINUL Injection is not habit 
forming. 

This medicine is available only 
with a doctor’s prescription. 

BEFORE YOU ARE GIVEN 
ROBINUL INJECTION 
_ _
_WHEN YOU MUST NOT BE _
_GIVEN IT _

DO NOT HAVE ROBINUL 
INJECTION IF: 

1. 
YOU ARE ALLERGIC TO 
ROBINUL OR ANY OF THE 
INGREDIENTS LIST

Ürün özellikleri

NEW ZEALAND DATA SHEET
New Zealand Data Sheet _ February 2019
Page 1 of 9
1 PRODUCT NAME
ROBINUL®
_(GLYCOPYRRONIUM BROMIDE (GLYCOPYRROLATE) INJECTION)_
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL ampoule contains Glycopyrronium bromide (glycopyrrolate)
0.2 mg, Water
for Injections q.s., Sodium Chloride 9 mg and Sodium
hydroxide/Hydrochloric acid (for pH
adjustment)
Glycopyrronium bromide (glycopyrrolate) is a white, odourless,
crystalline powder with a bitter
taste. It is a quaternary ammonium compound. Glycopyrronium bromide
(glycopyrrolate) is
chemically designated as 3- (alpha-cyclopentylmandeloyloxy)-1,
1-dimethylpyrrolidinium
bromide and has a molecular weight of 398.34. It is soluble in water
and alcohol and practically
insoluble in chloroform and ether.
ROBINUL is a clear, colourless sterile solution with a pH of 2.5 -
4.0.
The chemical name(s) for Glycopyrronium bromide (glycopyrrolate) is :
Pyrrolidinium, 3-
[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl- bromide.
3-Hydroxy-1,1-dimethylpyrrolidinium bromide α-cyclopentylmandelate
Molecular formula: C
19
H
28
BrN0
3
Molecular Mass: 398.33 CAS:
_[596-51-0]_
_ _
_._
3 PHARMACEUTICAL FORM
Injection
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In _Anaesthesia: _ ROBINUL is indicated for use as a preoperative
antimuscarinic to reduce
salivary, tracheobronchial and pharyngeal secretions; to reduce the
volume and free acidity of
gastric secretions, and to block cardiac vagal inhibitory reflexes
during induction of anaesthesia
and intubation when indicated. ROBINUL Injectable may be used
intraoperatively to counteract
drug-induced or vagal traction reflexes with the associated
arrhythmias. Glycopyrronium
bromide (glycopyrrolate) protects against the peripheral muscarinic
effects (e.g. brady
cardia
and excessive secretions) of cholinergic agents such as neostigmine
and pyridostigmine given
to reverse the neuromuscular blockade due to non-depolarising muscle
relaxants.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet _ February 2019
Page 2 of 9
In