Lumaren

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RANITIDINE

Available from:

Elpen Pharmaceutical Co. Inc. 95 Marathonos Ave., 190 09 Pikermi, Attica, Greece

ATC code:

A02BA02

INN (International Name):

RANITIDINE 50 mg

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

RANITIDINE 50 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Withdrawn

Authorization date:

2007-01-10

Patient Information leaflet

 
1
LUMAREN 
® 

              ΕΓΚΎΚΛΙΟΣ ΕΟΦ 
           (RANITIDINE)   
             44891/6-12-2000

         (ΚΩΔΙΚΌΣ ΦΟΧ 5504000Β) 

1. PRODUCT CHARACTERISTICS 

1.1 NAME: LUMAREN
®

Injection 50mg/2ml amp 

1.2 COMPOSITION        
ACTIVE INGREDIENT
: Ranitidine hydrochloride._ _
. 
INJECTION: Sodium chloride, potassium dihydrogen phosphate,
disodium hydrogen phosphate 
dihydrate, water for injections. 

1.3 PHARMACEUTICAL FORM    
Ampoules with solution for injection. 

1.4 STRENGTH 
INJECTION: Each ampoule (2 ml) contains
ranitidine hydrocloride equivalent to 50mg ranitidine. 

1.5 DESCRIPTION – PACKAGE 
INJECTION:  Colourless to light yellow solution for injection in
2ml ampoules. It is marketed in 
packs of 5 ampoules.  

1.6 PHARMACOTHERAPEUTIC CLASS 
Antiulcerant / Histamine H
2
-receptor antagonist. 

1.7 LICENCE HOLDER 
Greece: ELPEN Pharmaceutical Co., Inc. 
95 Marathonos Ave., Pikermi, Attica 19009. 
Cyprus: C.Tsisios & Co Ltd, P.O.Box 56495,  Limassol 

1.8 MANUFACTURER 
ELPEN Pharmaceutical Co., Inc. 
95 Marathonos Ave., Pikermi, Attica 19009. 

2. INFORMATION ON THE MEDICINE THAT YOUR DOCTOR PRESCRIBED FOR
YOU 

2.1 GENERAL INFORMATION 
LUMAREN
®
(Ranitidine) is a highly effective histamine H
2
-receptor antagonist, with very rapid 
action. It inhibits both basal and stimulated gastric secretion,
reducing the volume and the acid 
and pepsin concentration of the secretion. 

2.2 INDICATIONS 
• Duodenal ulcer, gastric and anastomotic ulcer  
• Gastric hypersecretory conditions (Zollinger-Ellison syndrome,
short bowel syndrome, systemic 
mastocytosis etc)  

2

• Oesophagitis due to gastro-oesophageal reflux, prevention of
gastric bleeding in severely ill 
patients, metabolic alkalosis in patients with prolonged gastric
aspiration  
• Prevention of pulmonary aspiration of gast

Summary of Product characteristics

Page 1 of 4 
SUMMARY OF  PRODUCT CHARACTERISTICS 

1.  NAME OF THE MEDICINAL PRODCUT 
 LUMAREN
®

Injection 50mg/2ml amp 

2   QUALITATIVE AND QUANTITATIVE PRODUCT   
ACTIVE INGREDIENT
: Ranitidine hydrochloride. 
SOLUTION FOR  INJECTION: Each ampoule (2 ml) contains
ranitidine hydrochloride equivalent to 50mg 
ranitidine 
_ _

3.  PHARMACEUTICAL FORM 
SOLUTION FOR  INJECTION 50MG/2ML AMP 

4. CLINICAL PARTICULARITIES 

4.1 THERAPEUTICS  INDICATIONS 
 LUMAREN
®
 is indicated for: 
• Duodenal ulcer, gastric and anastomotic ulcer  
• Gastric hypersecretory conditions (Zollinger-Ellison syndrome,
short bowel syndrome, systemic 
mastocytosis etc)  
• Oesophagitis due to gastro-oesophageal reflux, prevention of
gastric bleeding in severely ill 
patients, metabolic alkalosis in
patients with prolonged gastric aspiration  
• Prevention of pulmonary aspiration of gastric content during
general anaesthesia and obstetrics  
• Prevention of duodenal ulcer related to NSAIDs
therapy, in particular: 
1. In asymptomatic patients with recently diagnosed ulcer
irrespective of age, and especially in 
those over 70 years  
2. In women over 70 years of age without a history of ulcer, due
to 5 times higher relative risk of 
developing gastric ulcer, in comparison to men of the same age

3.  In patients with a history of ulcer
in whom long-term administration of NSAIDs is  
necessary  

4.2  POSOLOGY AND  METHOD OF ADMINISTRATION 
_ INJECTION_ 
ADULTS: When oral use is not possible, Lumaren
®
 may be administered parenterally.  
Lumaren
®
 injection may be administered by intramuscular or
slow intravenous injection, or by 
intravenous infusion.   
INTRAMUSCULAR INJECTION: The dosage is 50mg every 6-8 hours. 
SLOW INTRAVENOUS INJECTION (over more than 2 minutes):
The dosage is 50mg, diluted to 20ml. The 
injection may be repeated eve