Giapreza

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Angiotensin II acetate

Available from:

PAION Deutschland GmbH

ATC code:

C09

INN (International Name):

angiotensin II

Therapeutic group:

Agents acting on the renin-angiotensin system

Therapeutic area:

Hypotension; Shock

Therapeutic indications:

Giapreza is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies.

Product summary:

Revision: 3

Authorization status:

Authorised

Authorization date:

2019-08-23

Patient Information leaflet

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GIAPREZA 2.5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
angiotensin II
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What GIAPREZA is and what it is used for
2.
What you need to know before you are given GIAPREZA
3.
How GIAPREZA is used
4.
Possible side effects
5.
How GIAPREZA is stored
6.
Contents of the pack and other information
1.
WHAT GIAPREZA IS AND WHAT IT IS USED FOR
GIAPREZA contains the active substance angiotensin II, a compound
normally produced by the body.
It makes the blood vessels tighten and become narrower, thus
increasing blood pressure.
GIAPREZA is used in an emergency setting to increase blood pressure to
normal levels in adult
patients with seriously low blood pressure who do not respond to
fluids or other medicines that raise
blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GIAPREZA
_ _
YOU MUST NOT BE GIVEN GIAPREZA:
-
if you are allergic to angiotensin II or any of the other ingredients
of this medicine (listed in
section 6).
Your doctor or nurse should be told if any of the above applies to you
before this medicine is used.
WARNINGS AND PRECAUTIONS
GIAPREZA has only been tested in people with septic and distributive
shock. It has not been tested in
other types of shock.
Your doctor or nurse should be told before GIAPREZA is used if you or
someone else in your family
have a history of blood clots, as this medicine has been associated
with the for

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
GIAPREZA 2.5 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains angiotensin II acetate equivalent to
2.5 mg angiotensin II.
One vial of 1 ml concentrate for solution for infusion contains 2.5 mg
of angiotensin II.
One vial of 2 ml concentrate for solution for infusion contains 5 mg
of angiotensin II.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear and colourless solution.
pH: 5.0 to 6.0
Osmolarity: 130 to 170 mOsm/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GIAPREZA is indicated for the treatment of refractory hypotension in
adults with septic or other
distributive shock who remain hypotensive despite adequate volume
restitution and application of
catecholamines and other available vasopressor therapies (see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
GIAPREZA should be prescribed by a physician experienced in the
treatment of shock and is intended
for use in an acute and hospital setting.
Posology
The recommended starting dosage of GIAPREZA is 20 nanograms (ng)/kg
per minute via continuous
intravenous infusion.
GIAPREZA must be diluted in sodium chloride 9 mg/ml (0.9%) solution
for injection prior to use.
One or two millilitres of GIAPREZA must be diluted in sodium chloride
9 mg/ml (0.9%) solution for
injection to achieve a final concentration of 5,000 ng/ml or 10,000
ng/ml (see Table 1).
3
TABLE 1:
PREPARATION OF DILUTED SOLUTION
FLUID
RESTRICTED?
VIAL
STRENGTH
WITHDRAW
AMOUNT
(ML)
INFUSION
BAG SIZE
(ML)
FINAL
CONCENTRATION
(NG/ML)
No
2.5 mg/ml
1
500
5,000
Yes
2.5 mg/ml
1
250
10,000
5 mg/2 ml
2
500
10,