Cinryze 500unit powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

C1-esterase inhibitor

Available from:

Shire Pharmaceuticals Ltd

INN (International Name):

C1-esterase inhibitor

Dosage:

500unit

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040300; GTIN: 5060147020267

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CINRYZE 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
C1 inhibitor (human)
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 START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaftlet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Cinryze is and what it is used for
2.
What you need to know before you take Cinryze
3.
How to take Cinryze
4.
Possible side effects
5.
How to store Cinryze
6.
Contents of the pack and other information
1.
WHAT CINRYZE IS AND WHAT IT IS USED FOR
Cinryze contains the human protein called “C1 inhibitor” as the
active substance.
C1 inhibitor is a naturally occurring protein that is normally present
in the blood. If you have a low
amount of C1 inhibitor in your blood or your C1 inhibitor is not
working properly, this can lead to
swelling attacks (called angioedema). Symptoms may include stomach
pains and swelling of the:

hands and feet

face, eyelids, lips or tongue

voice-box (larynx), which may make breathing difficult

genitals
In adults and children, Cinryze can raise the amount of C1 inhibitor
in the blood and either prevent
(prior to undergoing medical or dental procedures) these swelling
attacks from occurring or stop
swelling attacks once they have begun.
In adults, adolescents and children (aged 6 years and above), Cinryze
can raise the amount of C1
inhibitor in the blood and routinely prevent swelling attacks from
occur

Summary of Product characteristics

OBJECT 1
CINRYZE 500 IU POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION
Summary of Product Characteristics Updated 29-Sep-2017 | Shire
Pharmaceuticals Limited
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
Cinryze 500 IU powder and solvent for solution for injection
2. Qualitative and quantitative composition
Each single-use powder vial contains 500 International Units (IU) of
C1 inhibitor (human) produced from
the plasma of human donors.
After reconstitution, one vial contains 500 IU of C1 inhibitor (human)
per 5 ml corresponding to a
concentration of 100 IU/ml. One IU is equivalent to the amount of C1
inhibitor present in 1 ml of normal
human plasma.
The total protein content of the reconstituted solution is 15 ± 5
mg/ml.
Excipient with known effect:
Each vial of Cinryze contains approximately 11.5 mg of sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for solution for injection.
White powder.
The solvent is a clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Treatment and pre-procedure prevention of angioedema attacks in
adults, adolescents and children (2
years old and above) with hereditary angioedema (HAE).
Routine prevention of angioedema attacks in adults, adolescents and
children (6 years old and above)
with severe and recurrent attacks of hereditary angioedema (HAE), who
are intolerant to or insufficiently
protected by oral prevention treatments, or patients who are
inadequately managed with repeated acute
treatment.
4.2 Posology and method of administration
Cinryze therapy should be initiated under supervision of a physician
experienced in the care of patients
with hereditary angioedema (HAE).
Posology
_Adults_
Treatment of angioedema attacks
• 1000 IU of Cinryze at the first sign of t