Pfizer Limited
Walton Oaks, Dorking Road, Walton on the Hill,
Tadworth, Surrey KT20 7NS, UK
Telephone: +44 (0)1304 616161
Worldwide Biopharmaceutical Businesses
Dear Healthcare Professional,
You are invited to attend a meeting entitled “A local COPD update including an introduction
to the new, once daily LAMA/LABA combination Ultibro® Breezhaler®▼
(glycopyrronium bromide / indacaterol maleate)” organised and funded by Pfizer on
Thursday 15th October 2015 in a private meeting room at The Cromwell Hotel, High St,
Stevenage, SG1 3AZ
The key speakers at the meeting will be Dr Mehul Patel, Respiratory Consultant at Lister
Hospital, Stevenage and Mr Darush Attar-Zadeh, Pharmacist and National Public Health
Trainer.
Details of how to register for the meeting are included on the following page.
I hope that you will be able to attend what should be an informative and interesting meeting.
Yours sincerely,
Ravi Nahar
Respiratory Network Sales Specialist
This meeting is organised by Pfizer on behalf of the Novartis - Pfizer Alliance
Page 1 of 4
UK/MTGGIPR/15-0248
August 2015
REG08-WI-GBR09-RF11b 1.0
Registered in England: No 526209
Registered Office: Ramsgate Road
Sandwich, Kent CT13 9NJ, UK
ULTIBRO® BREEZHALER® ▼ PRESCRIBING
INFORMATION
85 micrograms/43 micrograms inhalation powder,
hard capsules (indacaterol/glycopyrronium)
Refer to Ultibro® Breezhaler® Summary of Product
Characteristics (SmPC) before prescribing.
Indications: Ultibro Breezhaler is indicated as a maintenance
bronchodilator treatment to relieve symptoms in adult patients
with chronic obstructive pulmonary disease (COPD).
Presentation: Hard capsules for inhalation containing 110
micrograms indacaterol and 50 micrograms glycopyrronium,
with the delivered dose equivalent to 85 micrograms of
indacaterol and 43 micrograms of glycopyrronium. Dose and
administration: The recommended dose is the inhalation of the
content of one capsule once a day using the Ultibro Breezhaler
inhaler. Ultibro Breezhaler should be administered at the same
time of day each day. No dose adjustment is required for
elderly patients or patients with mild to moderate renal
impairment or patients with mild to moderate hepatic
impairment. There is no relevant use of Ultibro Breezhaler in
patients under 18 years. Ultibro Breezhaler capsules are for
inhalation use only and must not be swallowed.
Contraindications: Hypersensitivity to the active substance,
lactose monohydrate or magnesium stearate. Precautions:
Ultibro Breezhaler should not be used for the treatment of
asthma. Ultibro Breezhaler is not indicated for the treatment of
acute episodes of bronchospasm, i.e. as a rescue therapy. In
clinical studies with Ultibro Breezhaler, paradoxical
bronchospasm was not observed. However, paradoxical
bronchospasm has been observed with other inhalation
therapy and can be life-threatening. If this occurs, Ultibro
Breezhaler should be discontinued immediately. Immediate
hypersensitivity reactions have been reported after
administration of Ultibro Breezhaler components. If signs
suggesting allergic reactions occur, in particular, angioedema,
urticaria or skin rash, Ultibro Breezhaler should be discontinued
immediately and alternative therapy instituted. Ultibro
Breezhaler should be used with caution in patients with
narrow-angle glaucoma or urinary retention. Patients should be
informed about the signs and symptoms of acute narrow-angle
glaucoma and should be informed to stop using Ultibro
Breezhaler and contact their doctor immediately should this
event occur. In patients with severe renal impairment, including
those with end-stage renal disease requiring dialysis, Ultibro
Breezhaler should be used only if the expected benefit
outweighs the potential risk and these patients should be
monitored closely for potential adverse reactions. Ultibro
Breezhaler should be used with caution in patients with a
history of cardiovascular disorders such as coronary artery
disease, acute myocardial infarction, cardiac arrhythmias and
hypertension. Beta2-adrenergic agonists may produce a
clinically significant cardiovascular effect in some patients; if
such effects occur, treatment may need to be discontinued.
Patients with unstable ischaemic heart disease, left ventricular
failure, history of myocardial infarction, arrhythmia (excluding
chronic stable atrial fibrillation), a history of long QT syndrome
or whose QTc was prolonged were excluded from the clinical
trials, and as there is no experience in these patient groups,
Ultibro Breezhaler should be used with caution. Upon initiation
of treatment plasma glucose should be monitored more closely
in diabetic patients. Use with caution in patients with
convulsive disorders or thyrotoxicosis. Patients with rare
hereditary problems of galactose intolerance, the Lapp lactose
deficiency or glucose-galactose malabsorption should not take
this medicine.
Drug interactions: Concomitant administration of orally inhaled
indacaterol and glycopyrronium, under steady-state conditions
of both components, did not affect the pharmacokinetics of
either component. No specific interaction studies were
conducted for Ultibro Breezhaler. Information on the potential
for interactions is based on the potential for each individual
component. The concomitant use of Ultibro Breezhaler with
beta-adrenergic blockers, anticholinergics or sympathomimetic
agents is not recommended. Caution is required with the
concomitant use of hypokalaemic treatment. Pregnancy and
lactation: There are no data from the use of Ultibro Breezhaler
in pregnant women. Indacaterol may inhibit labour due to a
relaxant effect on uterine smooth muscle and therefore Ultibro
Breezhaler should only be used during pregnancy if the
expected benefit to the patient justifies the potential risk to the
foetus. The use of Ultibro Breezhaler by breast-feeding women
should only be considered if the expected benefit to the
woman is greater than any possible risk to the infant. Effects on
ability to drive and use machines: This medicinal product has
no or negligible influence on the ability to drive and use
machines. However, the occurrence of dizziness may influence
the ability to drive and use machines. Undesirable effects: Very
common (≥1/10): upper respiratory tract infection. Common
(≥1/100 to <1/10): nasopharyngitis, urinary tract infection,
sinusitis, rhinitis, dizziness, headache, cough (usually of mild
intensity), oropharyngeal pain (including throat irritation),
dyspepsia, dental caries, gastroenteritis, musculoskeletal pain,
pyrexia and chest pain. Uncommon (≥1/1000 to <1/100:
Hypersensitivity, angioedema, diabetes mellitus and
hyperglycaemia, insomnia, paraesthesia, glaucoma, ischaemic
heart disease, atrial fibrillation, tachycardia, palpitations,
paradoxical bronchospasm, epistaxis, dry mouth, pruritus/rash,
muscle spasm, myalgia, pain in extremity, bladder obstruction
and urinary retention, peripheral oedema, fatigue. Ultibro
Breezhaler showed similar adverse reactions to the individual
components; indacaterol and glycopyrronium, and as such, the
type and severity of adverse reactions associated with each of
these components may be expected in the combination.
Quantities and basic NHS price (excl. VAT): Ultibro Breezhaler
with 30 day supply of 85 micrograms/43 micrograms capsules:
£32.50. Ultibro Breezhaler with 12 day supply of 85
micrograms/43 micrograms capsules: £13.00. Marketing
authorisation number: EU/1/13/862/002, 003 Legal category:
POM. Date of last revision of prescribing information:
September 2015. UB05
Full prescribing information is available from Novartis
Pharmaceuticals UK Ltd, Frimley Business Park, Frimley,
Camberley, Surrey GU16 7SR. Telephone: 01276 698370. Email: medinfo.uk@novartis.com
Adverse events should be reported. Reporting
forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse
events should also be reported to Novartis 01276
698370
INVITATION TO
“A local COPD update including an introduction to the new, once daily LAMA/LABA
combination Ultibro® Breezhaler® ▼ (glycopyrronium bromide/indacaterol maleate)”
On
Thursday 15th October 2015 at 18.30
To be held at
The Cromwell Hotel, High St, Stevenage, SG1 3AZ
Agenda
18.30
Arrival, Registration and Hot Buffet
19.00
“A local COPD update including an introduction to the new, once daily
LAMA/LABA combination Ultibro® Breezhaler® ▼ (glycopyrronium
bromide/indacaterol maleate)”
Dr Mehul Patel, Respiratory Consultant, Lister Hospital, Stevenage.
19.45
Question and Answer Session
20.00
Coffee
20.10
“Making Every Contact Count”
Mr Darush Attar-Zadeh, Pharmacist and National Trainer in Smoking Cessation.
21.00
Questions and Answers Session
21.15
Summary and Close
This meeting is organised & funded by Pfizer Ltd on behalf of the Novartis - Pfizer Alliance. Please note that,
under the law and the ABPI Code of Practice, Pfizer may only provide hospitality and/or promote its medicines
to members of the healthcare professions and appropriate administrative staff. Therefore, no unqualified person
(e.g. non-medical spouses, partners) may be invited to or attend Pfizer meetings.
……………………………………………………………………………
REPLY*
Please reply to confirm your attendance at this meeting;
By email: ravinder.nahar@pfizer.com
Alternatively, you can respond by telephone to: Ravi Nahar - 07880256994
(Please include the meeting date and any special dietary requirements in your response).
To contact Pfizer for any other purpose, including adverse event reports or medical
information requests, please call 01304 616161
*By providing your personal information, you agree that the information will be held on a database (located within or outside the EU)
controlled by Pfizer Limited and used for the purpose of meeting registration and contacting you about similar events in the future. Only
Pfizer, organisations working with Pfizer in the administration of your information, and Pfizer and Novartis group companies will have
access to your information. Pfizer will always employ appropriate technical security measures to protect your personal information and to
ensure that it is not accessed by unauthorised persons. You will at any time have the right to access your information, you can request that
your information on the Pfizer database is amended, or you can unsubscribe from any programme at any time by emailing us at:
DataProtectionUK@Pfizer.com.
UK/MTGGIPR/15-0248
August 2015
REG08-WI-GBR09-RF11b 1.0
Page 3 of 4
ULTIBRO® BREEZHALER® ▼ PRESCRIBING
INFORMATION
85 micrograms/43 micrograms inhalation powder,
hard capsules (indacaterol/glycopyrronium)
Refer to Ultibro® Breezhaler® Summary of Product
Characteristics (SmPC) before prescribing.
Indications: Ultibro Breezhaler is indicated as a maintenance
bronchodilator treatment to relieve symptoms in adult patients
with chronic obstructive pulmonary disease (COPD). Presentation:
Hard capsules for inhalation containing 110 micrograms
indacaterol and 50 micrograms glycopyrronium, with the
delivered dose equivalent to 85 micrograms of indacaterol and 43
micrograms of glycopyrronium. Dose and administration: The
recommended dose is the inhalation of the content of one
capsule once a day using the Ultibro Breezhaler inhaler. Ultibro
Breezhaler should be administered at the same time of day each
day. No dose adjustment is required for elderly patients or
patients with mild to moderate renal impairment or patients with
mild to moderate hepatic impairment. There is no relevant use of
Ultibro Breezhaler in patients under 18 years. Ultibro Breezhaler
capsules are for inhalation use only and must not be swallowed.
Contraindications: Hypersensitivity to the active substance,
lactose monohydrate or magnesium stearate. Precautions: Ultibro
Breezhaler should not be used for the treatment of asthma.
Ultibro Breezhaler is not indicated for the treatment of acute
episodes of bronchospasm, i.e. as a rescue therapy. In clinical
studies with Ultibro Breezhaler, paradoxical bronchospasm was
not observed. However, paradoxical bronchospasm has been
observed with other inhalation therapy and can be lifethreatening. If this occurs, Ultibro Breezhaler should be
discontinued immediately. Immediate hypersensitivity reactions
have been reported after administration of Ultibro Breezhaler
components. If signs suggesting allergic reactions occur, in
particular, angioedema, urticaria or skin rash, Ultibro Breezhaler
should be discontinued immediately and alternative therapy
instituted. Ultibro Breezhaler should be used with caution in
patients with narrow-angle glaucoma or urinary retention.
Patients should be informed about the signs and symptoms of
acute narrow-angle glaucoma and should be informed to stop
using Ultibro Breezhaler and contact their doctor immediately
should this event occur. In patients with severe renal impairment,
including those with end-stage renal disease requiring dialysis,
Ultibro Breezhaler should be used only if the expected benefit
outweighs the potential risk and these patients should be
monitored closely for potential adverse reactions. Ultibro
Breezhaler should be used with caution in patients with a history
of cardiovascular disorders such as coronary artery disease, acute
myocardial infarction, cardiac arrhythmias and hypertension.
Beta2-adrenergic agonists may produce a clinically significant
cardiovascular effect in some patients; if such effects occur,
treatment may need to be discontinued. Patients with unstable
ischaemic heart disease, left ventricular failure, history of
myocardial infarction, arrhythmia (excluding chronic stable atrial
fibrillation), a history of long QT syndrome or whose QTc was
prolonged were excluded from the clinical trials, and as there is no
experience in these patient groups, Ultibro Breezhaler should be
used with caution. Upon initiation of treatment plasma glucose
should be monitored more closely in diabetic patients. Use with
caution in patients with convulsive disorders or thyrotoxicosis.
Patients with rare hereditary problems of galactose intolerance,
the Lapp lactose deficiency or glucose-galactose malabsorption
should not take this medicine.
Drug interactions: Concomitant administration of orally inhaled
indacaterol and glycopyrronium, under steady-state conditions of
both components, did not affect the pharmacokinetics of either
component. No specific interaction studies were conducted for
Ultibro Breezhaler. Information on the potential for interactions is
based on the potential for each individual component. The
concomitant use of Ultibro Breezhaler with beta-adrenergic
blockers, anticholinergics or sympathomimetic agents is not
recommended. Caution is required with the concomitant use of
hypokalaemic treatment. Pregnancy and lactation: There are no
data from the use of Ultibro Breezhaler in pregnant women.
Indacaterol may inhibit labour due to a relaxant effect on uterine
smooth muscle and therefore Ultibro Breezhaler should only be
used during pregnancy if the expected benefit to the patient
justifies the potential risk to the foetus. The use of Ultibro
Breezhaler by breast-feeding women should only be considered if
the expected benefit to the woman is greater than any possible
risk to the infant. Effects on ability to drive and use machines:
This medicinal product has no or negligible influence on the ability
to drive and use machines. However, the occurrence of dizziness
may influence the ability to drive and use machines. Undesirable
effects: Very common (≥1/10): upper respiratory tract infection.
Common (≥1/100 to <1/10): nasopharyngitis, urinary tract
infection, sinusitis, rhinitis, dizziness, headache, cough (usually of
mild intensity), oropharyngeal pain (including throat irritation),
dyspepsia, dental caries, gastroenteritis, musculoskeletal pain,
pyrexia and chest pain. Uncommon (≥1/1000 to <1/100:
Hypersensitivity, angioedema, diabetes mellitus and
hyperglycaemia, insomnia, paraesthesia, glaucoma, ischaemic
heart disease, atrial fibrillation, tachycardia, palpitations,
paradoxical bronchospasm, epistaxis, dry mouth, pruritus/rash,
muscle spasm, myalgia, pain in extremity, bladder obstruction and
urinary retention, peripheral oedema, fatigue. Ultibro Breezhaler
showed similar adverse reactions to the individual components;
indacaterol and glycopyrronium, and as such, the type and
severity of adverse reactions associated with each of these
components may be expected in the combination. Quantities and
basic NHS price (excl. VAT): Ultibro Breezhaler with 30 day supply
of 85 micrograms/43 micrograms capsules: £32.50. Ultibro
Breezhaler with 12 day supply of 85 micrograms/43 micrograms
capsules: £13.00. Marketing authorisation number:
EU/1/13/862/002, 003 Legal category: POM. Date of last revision
of prescribing information: September 2015. UB05
Full prescribing information is available from Novartis
Pharmaceuticals UK Ltd, Frimley Business Park, Frimley,
Camberley, Surrey GU16 7SR. Telephone: 01276 698370. E-mail:
medinfo.uk@novartis.com
Adverse events should be reported. Reporting
forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events
should also be reported to Novartis 01276 698370