IPRAX-MOL Respules 2.5mg + 0.500

Страна: Танзанія

мова: англійська

Джерело: Tanzania Medicinces & Medical Devices Authority

Активний інгредієнт:

Salbutamol , ipratropium bromide

Доступна з:

AXA Parenterals Limited, INDIA

Код атс:

ADRENERGICS, INHALANTS

ІПН (Міжнародна Ім'я):

Salbutamol and ipratropium bromide

Дозування:

2.5mg + 0.500

Фармацевтична форма:

Respules

Виробник:

AXA PARENTERALS LIMITED, INDIA

Огляд продуктів:

Physical description: Clear colourless solution, free from extraneous particles; Local technical representative: SkillMix Consulting Group (9256)

Статус Авторизація:

Registered/Compliant

Дата Авторизація:

2022-09-21

Характеристики продукта

5.
PRODUCT INFORMATION
5.1.
PRESCRIBING INFORMATION (SUMMARY OF PRODUCT CHARACTERISTICS)
“Prescription only medicine”
1.
NAME OF THE MEDICINAL PRODUCT: IPRAX-MOL (Salbutamol and Ipratropium Bromide Nebulizer Solution
(Sterile) 2.5 mg & 500 mcg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A)
QUALITATIVE COMPOSITION
PRODUCT NAME: IPRAX-MOL
GENERIC NAME: Salbutamol and Ipratropium Bromide Nebulizer Solution
Sterile 2.5 mg & 500mcg
LABEL CLAIM: Each 2.5 mL contains:
Salbutamol Sulphate BP
Eq. to Salbutamol……………….…2.5 mg
Ipratropium Bromide BP…........….500 mcg
In Isotonic Solution..………………..q.s AVERAGE FILL VOLUME : 2.5 mL
3.
PHARMACEUTICAL FORM
Nebulizer Solution (Respules) DESCRIPTION: Clear colourless solution, free from extraneous
particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The
management
of
bronchospasm
in
patients
suffering
from
chronic
obstructive
pulmonary
disease
who
require
regular
treatment
with
both
ipratropium and salbutamol.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
SALBUTAMOL AND IPRATROPIUM BROMIDE NEBULIZER SOLUTION is intended for
inhalation only and may be administered from a suitable nebuliser or
an
intermittent positive pressure ventilator. The single dose units must
not be
taken orally or administered parenterally.
Treatment should be initiated and administered under medical
supervision,
e.g. in the hospital setting. Home based treatment can be recommended
in
exceptional cases (severe symptoms or experienced patients requiring
higher
doses) when a low dose rapid acting beta-agonist bronchodilator has
been
insufficient in providing relief after consultation with an
experienced physician.
The treatment with the nebuliser solution in UDVs should always be
started
with the lowest recommended dose (1 UDV). In very severe cases two
unit
dose vials may be required for symptom relief. Administration should
be
stopped when sufficient symptom relief is achieved.
The recommended dose is:
_Adults (including elderly patients and children over 12 years): _