Regitine

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Phentolamine mesilate 10 mg/mL

Saadav alates:

Novartis New Zealand Ltd

INN (Rahvusvaheline Nimetus):

Phentolamine mesilate 10 mg/mL

Annus:

10 mg/mL

Ravimvorm:

Solution for injection

Koostis:

Active: Phentolamine mesilate 10 mg/mL Excipient: Carbon dioxide Glucose Sodium metabisulfite Water for injection

Ühikuid pakis:

Ampoule, 5x1mL, 5 mL

Klass:

Prescription

Retsepti tüüp:

Prescription

Valmistatud:

Novartis Pharma AG

Näidustused:

Regitine is indicated for: · Therapeutic: Management of hypertensive episodes that may occur in patients with phaeochromocytoma, during preoperative preparation and surgical manipulation. · Diagnostic: Diagnosis of phaeochromocytoma by Regitine® blocking test if other more specific tests are not available. · Preventive: Prevention of dermal necrosis and sloughing after extravasation of noradrenaline

Toote kokkuvõte:

Package - Contents - Shelf Life: Ampoule, 1mL - 5 dose units - 60 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Loa andmise kuupäev:

1977-06-02

Infovoldik

__________________________________________________________________________________________________ 
Regitine
®                                             

          1 
REGITINE
®

10MG/1ML INJECTION 
PHENTOLAMINE MESILATE 
WHAT IS IN THIS LEAFLET  
This leaflet answers some common questions about Regitine
. 

It does not contain all 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 being given Regitine against the benefits they 
expect it will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST. 
KEEP THIS LEAFLET. 
You may need to read it again. 
WHAT REGITINE IS USED FOR 
Regitine is an agent used to lower episodes of high blood pressure in
patients suffering from phaeochromocytoma (a condition 
with excess production of hormones like adrenaline from tumors of
the adrenal gland), when these episodes occur during 
preparation for an operation or during the surgery for this tumour.
It is also used to diagnose this disease if other more specific 
tests are not available.  
Furthermore, Regitine is used to prevent a damage of your skin if
during an intravenous injection of noradrenaline this 
compound has passed accidentally out from your veins into the
surrounding tissue. 
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY REGITINE HAS BEEN
PRESCRIBED FOR YOU. 
Your doctor may have prescribed it for another purpose.  
Regitine is only available with a doctor's prescription. It is
not habit-forming. 
BEFORE YOU ARE GIVEN REGITINE 
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN REGITINE IF YOU HAVE EVER HAD AN ALLERGIC
REACTION TO: 
•  phentolamine, the active ingredient in Regitine 
•  sodium metabisulphite, an

Toote omadused

1 

NEW ZEALAND DATA SHEET 

REGITINE
®
 (
PHENTOLAMINE MESILATE)

10 mg Aqueous solution for injection in 1ml Ampoules 

TRADE NAME 
REGITINE
®
 10 mg aqueous solution for injection in 1 ml ampoules  

DESCRIPTION AND COMPOSITION 
PHARMACEUTICAL FORM(S) 
Aqueous solution for injection in ampoules.  

ACTIVE SUBSTANCE 
1 ml Regitine ampoule contains 10 mg phentolamine mesilate  

ACTIVE MOIETY  
(Phentolamine). 

EXCIPIENTS 
Ampoules: 0.5 mg sodium metabisulphite, 35.0 mg glucose, anhydrous
and water for injection 
up to 1 mL. 
Sodium metabislphite [E223] as antioxidant. 
Information might differ in some countries. 

INDICATIONS_ _
•  Therapeutic: Management of hypertensive episodes that may occur
in patients with 
phaeochromocytoma, during preoperative preparation and
surgical manipulation. 
•  Diagnostic: Diagnosis of phaeochromocytoma by Regitine
®
 blocking test if other more 
specific tests are not available (see Warnings and precautions). 
•  Preventive: Prevention of dermal necrosis and sloughing after
extravasation of 
noradrenaline. 

DOSAGE AND ADMINISTRATION 
DOSAGE  

GENERAL TARGET POPULATION  
•  MANAGEMENT OF HYPERTENSIVE EPISODES IN PATIENTS WITH 
PHAEOCHROMOCYTOMA 
For the management of hypertensive
crises that arise before surgery or during induction of 
anaesthesia, intubation, or surgical removal of tumour, 2-5 mg of
Regitine is injected 
intravenously (i.v) and repeated if necessary, monitoring the
blood pressure response.  
2 

•  DIAGNOSIS OF PHAEOCHROMOCYTOMA - REGITINE BLOCKING TEST 
The test is most reliable in detecting phaeochromocytoma in patients
with sustained 
hypertension and least reliable in those with paroxysmal
hypertension. False-positive tests 
may occur in patients with hypertension without phaeochromocytoma. 
PREPARATION FOR THE TEST: 
Sedatives, analgesics, and all other medications except those that
might be deemed essential 
(such as