COMBINEB ( Nebuliser Solution Unit Dose Vial Ipratropium Bromide 0.5 mg and Salbutamol 2.5 mg )

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Toimeaine:

SALBUTAMOL SULPHATE; IPRATROPIUM BROMIDE MONOHYDRATE

Saadav alates:

AIN MEDICARE SDN. BHD.

INN (Rahvusvaheline Nimetus):

SALBUTAMOL SULPHATE; IPRATROPIUM BROMIDE MONOHYDRATE

Ühikuid pakis:

2.5ml mL

Valmistatud:

AIN MEDICARE SDN. BHD.

Toote omadused

USER INFORMATION
NEBULISER SOLUTION
COMBINEB
NEBULISER SOLUTION UNIT DOSE VIAL
IPRATROPIUM BROMIDE 0.5MG AND SALBUTAMOL 2.5MG
COMPOSITION:
Each 2.5 mL
COMBINEB
contains:
Ipratropium bromide 0.5 mg corresponding to Ipratropium bromide
monohydrate 0.525 mg and salbutamol 2.5 mg
corresponding to salbutamol sulphate 3.0 mg.
CHARACTERISTIC:
COMBINEB
is a clear and colourless nebuliser solution.
PHARMACODYNAMICS:
Ipratropium bromide has anticholinergic (parasympatholytic)
properties. In preclinical studies, it appears to inhibit
vagally mediated reflexes by antagonising the action of
acetylcholine, the transmitter agent released from the vagus
nerve.
The bronchodilation following inhalation of ipratropium bromide is
primarily local and site specific to the lung
and not systemic in nature.
Salbutamol is a beta2-adrenergic agent which acts on airway smooth
muscle resulting in relaxation. Salbutamol
relaxes all smooth muscle from the trachea to the terminal bronchioles
and protects against bronchoconstrictor
challenges.
COMBINEB
provide the simultaneous delivery of ipratropium bromide and
salbutamol sulphate allowing effects on
both muscarinic and beta2-adrenergic receptors in the lung leading to
increased bronchodilation over that provided by
each agent singly.
PHARMACOKINETICS:
Ipratropium bromide is not readily absorbed into the systemic
circulation either from the surface of the lung or from
the gastrointestinal tract as assessed by blood level and renal
excretion studies. The elimination halflife
of drug and metabolites is about 3 to 4 hours after inhalation or
intravenous administration. Ipratropium bromide does
not cross the blood-brain barrier.
Salbutamol is rapidly and completely absorbed following oral
administration either by the inhaled or the gastric route.
Peak plasma salbutamol concentrations are seen within three hours of
administration and the drug is excreted
unchanged in the urine after 24 hours. The elimination half-life is 4
hours. Salbutamol will cross the blood brain barrier
reaching concentrati