Spiriva

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Tiotropium bromide monohydrate 22.5ug equivalent 18 µg tiotropium

MAH:

Boehringer Ingelheim (NZ) Limited

INN:

Tiotropium bromide monohydrate 22.5 µg (equivalent 18 µg tiotropium)

dosage:

18 mcg

pharmaceutical_form:

Powder filled inhalation capsule

composition:

Active: Tiotropium bromide monohydrate 22.5ug equivalent 18 µg tiotropium Excipient: Gelatin Lactose monohydrate

units_in_package:

Blister pack, (Wannenblister)10 capsules + HandiHaler, 10 dose units

class:

Prescription

prescription_type:

Prescription

manufactured_by:

Boehringer Ingelheim Pharma GmbH & Co KG

therapeutic_indication:

SPIRIVA is indicated for the long term once daily maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA reduces the frequency of exacerbations and improves exercise tolerance and health-related quality of life.

leaflet_short:

Package - Contents - Shelf Life: Blister pack, (Wannenblister)10 capsules + HandiHaler - 10 dose units - 24 months from date of manufacture stored at or below 25°C 9 days opened stored at or below 25°C - Blister pack, (Al form)10 capsules + HandiHaler - 10 dose units - 18 months from date of manufacture stored at or below 25°C 9 days opened stored at or below 25°C - Blister pack, (Wannenblister)30 capsules - 30 dose units - 24 months from date of manufacture stored at or below 25°C 9 days opened stored at or below 25°C - Blister pack, (Al form) 30 capsules - 30 dose units - 18 months from date of manufacture stored at or below 25°C 9 days opened stored at or below 25°C - Unknown, Handihaler Device for separate sale - 1 pieces -  

authorization_date:

2000-12-14

PIL

SPIRIVA NZ CMI v04
1
SPIRIVA
®
_POWDER FOR INHALATION _
_Tiotropium bromide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Spiriva capsules.
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 taking Spiriva
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor or from
www.medsafe.govt.nz/Consumers/
cmi/CMIForm.asp and may contain
important information about the
medicine and its use of which you
should be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SPIRIVA IS USED
FOR
Spiriva is used to make breathing
easier for people with chronic
obstructive pulmonary disease
(COPD).
This helps to improve your condition
and to prevent exacerbations
(periodic worsening of symptoms)
from occurring.
Spiriva improves breathing by
relaxing the air passages that carry
air to and from the lungs. It begins to
act within 30 minutes after use and
the effect should last a full day.
Spiriva contains the active ingredient
tiotropium bromide. It belongs to a
group of medicines called
anticholinergics.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU TAKE
SPIRIVA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SPIRIVA IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
tiotropium bromide
•
any of the ingredients listed at the
end of this leaflet
•
any medicine containing atropine
•
any other anticholinergic
medicines.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swe

SPC

SPIRIVA NZ DS V02
1
NEW ZEALAND DATASHEET
1. PRODUCT NAME
SPIRIVA
18 microgram powder filled inhalation capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 22.5 microgram of tiotropium bromide monohydrate
equivalent to 18
microgram of tiotropium.
Excipients with known effect:
Each capsule contains 5.5 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Inhalation powder, hard capsules.
Light green hard capsules, containing a white or yellowish white
powder, with product code
(TI 01) and company logo printed on the capsule.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SPIRIVA is indicated for the long term once daily maintenance
treatment of bronchospasm and
dyspnoea associated with chronic obstructive pulmonary disease (COPD),
including chronic
bronchitis and emphysema. SPIRIVA reduces the frequency of
exacerbations and improves
exercise tolerance and health-related quality of life.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose
The recommended dosage of SPIRIVA is inhalation of the contents of one
capsule once daily
with the HandiHaler device at the same time of day (see Instructions
for use).
Special populations
Elderly patients can use SPIRIVA at the recommended dose.
Renally impaired patients can use SPIRIVA at the recommended dose.
However, as with all
predominantly renally excreted drugs, SPIRIVA use should be monitored
closely in patients
with moderate to severe renal impairment.
Hepatically impaired patients can use SPIRIVA at the recommended dose.
_Paediatric population_
There is no experience with SPIRIVA in infants and children and
therefore should not be used
in this age group.
Method of administration
SPIRIVA capsules must not be swallowed.
Instructions for use
The HandiHaler is an inhalation device especially designed for
inhalation from SPIRIVA
capsules. You must not use it to take any other medication.
SPIRIVA NZ DS V02
2
Handling Instructions
Remember to carefully follow your doctor’s instructions for using
SPIRIVA.
AFTER