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Emgality Summary of Product Characteristics (SmPC)
Emgality® (galcanezumab) Pen: Information on Needle
The pre-filled pen comes with a 27 gauge (thin wall) x 12.7 mm permanently built in needle.
General
information
The
needle is built into the cartridge that is inside the pen and cannot
be changed or taken off. The needle or needle attachment must not be
touched.1
The
needle included in the pack is only suitable for subcutaneous
injection.2
Dripping
from the Needle
A
drop of medicine may be seen when the base cap is removed. It is okay
to see a drop of liquid on the tip of the needle.3
This will not affect the dose. 1
Pre-Filled
Pen Function: Needle Retraction
When
the medicine is completely delivered, the needle begins to travel
upward (retract). The patient may feel the needle travel upwards in
the pen. The second loud click is heard right before the needle stops
retracting. The whole process of the needle retraction occurs very
quickly.1
If
the needle does not retract after the injection the needle must
not be touched and the base cap must not be replaced. The pen must be
stored in a safe place to avoid an accidental needlestick injury.
Patients can contact their doctor, pharmacist or nurse for
instructions on how to return the pen.3
The
instructions for using the pen included with the Package Leaflet,
must be followed carefully. The pre-filled pen is for total use
only.2
After
training, patients may self-inject galcanezumab if a healthcare
professional determines that it is appropriate. 2
References
1.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2.
Emgality [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
3.
Emgality [instructions for use]. Eli Lilly Nederland B.V., The
Netherlands.
▼ This
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.
Date of Last Review:February 15, 2019
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