Byetta 10micrograms0.04ml solution for injection 2.4ml pre-filled pen

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Exenatide

Available from:

AstraZeneca UK Ltd

ATC code:

A10BJ01

INN (International Name):

Exenatide

Dosage:

250microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010203; GTIN: 5014602101299

Patient Information leaflet

User manual
1
PEN USER MANUAL
BYETTA 10 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN
(EXENATIDE)
Section 1. WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN
READ THIS SECTION COMPLETELY BEFORE YOU BEGIN. THEN, MOVE ON TO
SECTION 2 – GETTING STARTED.
Read these instructions carefully BEFORE using your Byetta
pen. Also read the Byetta Package leaflet
that comes with the Byetta pen carton.
You need to use the pen correctly in order to get the most benefit
from Byetta. Failure to follow these
instructions completely may result in a wrong dose, a broken pen or an
infection.
THESE INSTRUCTIONS DO NOT TAKE THE PLACE OF TALKING WITH YOUR
HEALTHCARE PROFESSIONAL ABOUT
YOUR MEDICAL CONDITION OR YOUR TREATMENT. IF YOU ARE HAVING PROBLEMS
USING YOUR BYETTA PEN,
CONTACT YOUR HEALTHCARE PROFESSIONAL.
IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN

Byetta is injected twice a day, the pen contains enough medicine for
30 days. You do not have
to measure any doses, the pen measures each dose for you.

DO NOT TRANSFER THE MEDICINE IN THE BYETTA PEN TO A SYRINGE.

If any part of your pen appears broken or damaged, do not use the pen.

DO NOT SHARE YOUR PEN OR NEEDLES AS THIS MAY RISK TRANSMISSION OF
INFECTIOUS AGENTS.

This pen is not recommended for use by people who are blind or who
cannot see well enough.
Help will be needed by a person trained to use the pen.

Healthcare professionals or other caregivers should follow local or
institutional policies
regarding needle handling.

FOLLOW THE INSTRUCTIONS FOR HYGIENIC INJECTION TECHNIQUE RECOMMENDED
BY YOUR HEALTHCARE
PROFESSIONAL.

Follow Section 2 only to set up a new pen before first use.

Section 3 of this manual should be used for every injection.
ABOUT INJECTION NEEDLES
Your Byetta pen is suitable for use with Becton, Dickinson and Company
pen injection needles.
DO I USE A NEW NEEDLE FOR EACH INJECTION?

Yes. Do not reuse needles.

Remove the needle immediately after each injection. This will help
prevent leakage of Byetta,
keep out air bubbles

Summary of Product characteristics

OBJECT 1
BYETTA 5 MICROGRAMS SOLUTION FOR INJECTION,
PREFILLED PEN
Summary of Product Characteristics Updated 04-Aug-2017 | AstraZeneca
UK Limited
1. Name of the medicinal product
Byetta 5 micrograms solution for injection in pre-filled pen
Byetta 10 micrograms solution for injection in pre-filled pen
2. Qualitative and quantitative composition
Each dose contains 5 micrograms (mcg) of exenatide in 20 microlitres
(mcl), (0.25 mg exenatide per ml).
Each dose contains 10 micrograms (mcg) of exenatide in 40 microlitres
(mcl), (0.25 mg exenatide per
ml).
Excipient with known effect:
Byetta 5 mcg: Each dose contains 44 mcg metacresol.
Byetta 10 mcg: Each dose contains 88 mcg metacresol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection (injection).
Clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Byetta is indicated for treatment of type 2 diabetes mellitus in
combination with:
- metformin
- sulphonylureas
- thiazolidinediones
- metformin and a sulphonylurea
- metformin and a thiazolidinedione
in adults who have not achieved adequate glycaemic control on
maximally tolerated doses of these oral
therapies.
Byetta is also indicated as adjunctive therapy to basal insulin with
or without metformin and/or
pioglitazone in adults who have not achieved adequate glycaemic
control with these medicinal products.
4.2 Posology and method of administration
Posology
Immediate-release exenatide (Byetta) therapy should be initiated at 5
mcg exenatide per dose
administered twice daily (BID) for at least one month in order to
improve tolerability. The dose of
exenatide can then be increased to 10 mcg BID to further improve
glycaemic control. Doses higher than
10 mcg BID are not recommended.
Immediate-release exenatide is available as either a 5 mcg or a 10 mcg
exenatide per dose pre-filled pen.
Immediate-release exenatide can be administered at any time within the
60-minute period before the
morning and evening meal (or two main meals of the day, approximately
6