Arrow - Salbutamol

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Salbutamol 0.12%{relative} (as salbutamol sulphate)

제공처:

Actavis New Zealand Limited

INN (국제 이름):

Salbutamol 0.12% w/v (as salbutamol sulphate)

복용량:

2.5 mg/2.5mL

약제 형태:

Solution for inhalation

구성:

Active: Salbutamol 0.12%{relative} (as salbutamol sulphate) Excipient: Sodium chloride Sulfuric acid Water for injection

패키지 단위:

Ampoule, plastic, 2.5 mL LDPE with twist off seal, packaged in strips of 10 with Al foil overwrap, 20 dose units

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Sicor (Societa Italiana Corticosteroidi) Srl

제품 요약:

Package - Contents - Shelf Life: Ampoule, plastic, 2.5 mL LDPE with twist off seal, packaged in strips of 10 with Al foil overwrap - 20 dose units - 2 years unopened stored at or below 25°C protect from light 3 months opened stored at or below 25°C protect from light - Ampoule, plastic, 2.5 mL LDPE with twist off seal, packaged in strips of 10 with Al foil overwrap - 30 dose units - 2 years unopened stored at or below 25°C protect from light 3 months opened stored at or below 25°C protect from light

승인 날짜:

2006-05-17

제품 특성 요약

ARROW – SALBUTAMOL 
DESCRIPTION 
Salbutamol (as salbutamol sulfate).  The chemical name for salbutamol sulfate 1-(4-
hydroxy-3-hydroxymethylphenyl)-2-(t-butylamino)-ethanol sulfate. Its structural 
formula is: 

2 
(C
13
H
21
NO
3
)
2
,H
2
SO
4
 Molecular weight:  576.7 

CAS No.: 51022-70-9 
Salbutamol sulfate is a white or almost white odourless powder. It is soluble in 4 
parts of water, slightly soluble in 95% alcohol, in chloroform and solvent ether. 
Approximately 1.2mg of salbutamol sulfate is equivalent to 1 mg of salbutamol. 
PRESENTATION 
The inhalation is presented in ampoules containing a sterile, clear aqueous isotonic, 
preservative-free nebuliser solution for single use.  Each ampoule of Arrow - 
Salbutamol ampoules 2.5 mg/2.5 mL contains salbutamol sulfate equivalent to 2.5 
mg of salbutamol.  Each ampoule of Arrow - Salbutamol 5 mg/2.5 mL contains 
salbutamol sulfate equivalent to 5mg of salbutamol.  Each ampoule also contains the 
inactive ingredients sodium chloride and sulfuric acid in 2.5 mL. 
CLINICAL PARTICULARS 
_ACTIONS _
Salbutamol is a short-acting, relatively selective beta
2
-adrenoceptor agonist. 
Administration by inhalation results in direct stimulation of beta
2
-adrenoceptors in 
bronchial smooth muscle and hence bronchodilation.  This is thought to be due to 
stimulation of adenyl cyclase by salbutamol, resulting in increased levels of cyclic 
AMP within cells.  These are thought to inhibit the entry of calcium ions into the cells, 
thus inhibiting smooth muscle contraction.  High levels of cyclic AMP in mast cells 
may also inhibit the release of histamine and slow reacting substance-A (SRS-A).  
After administration of salbutamol, stimulation of both beta
1
- and beta
2
-adrenoceptors 
o