Ceprotin 1000unit powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Protein C

Available from:

Baxalta UK Ltd

ATC code:

B01AD12

INN (International Name):

Protein C

Dosage:

1000unit

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: 02110000

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEPROTIN 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Human Protein C
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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 the side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What CEPROTIN is and what it is used for
2.
What you need to know before you use CEPROTIN
3.
How to use CEPROTIN
4.
Possible side effects
5.
How to store CEPROTIN
6.
Contents of the pack and other information
1.
WHAT CEPROTIN IS AND WHAT IT IS USED FOR
CEPROTIN belongs to a class of medicines called antithrombotics. This
medicine contains Protein C,
a natural protein that is made in the liver and is present in your
blood. Protein C plays a major role in
prevention of excessive clot formation thus, prevent and/or treat
intravascular thrombosis.
CEPROTIN is used in the treatment and prevention of thrombotic and
haemorrhagic skin lesions
(named purpura fulminans) in patients with severe congenital protein C
deficiency. Additionally,
CEPROTIN may be used to treat a rare complication of a blood thinner
medication (anticoagulant
medication named coumarin) which may result in severe skin lesion
(necrosis).
Furthermore CEPROTIN is used to prevent thrombosis in patients with
severe congenital protein C
deficiency if one or more of the following conditions are met:

surgery or invasive therapy is imminent

while initiating coumarin (anticoagulant medication, blood thinner)
therapy

when coumarin therapy alone is not sufficient

when coumarin therapy is not feasible.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CEPROTIN
DO NOT USE C

Summary of Product characteristics

OBJECT 1
CEPROTIN 1000 IU POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 02-Jun-2015 | Shire
Pharmaceuticals Limited
1. Name of the medicinal product
CEPROTIN 1000 IU powder and solvent for solution for injection
2. Qualitative and quantitative composition
Protein C from human plasma purified by mouse monoclonal antibodies.
CEPROTIN 1000 IU* is
prepared as a powder containing nominally 1000 IU human protein C per
container. The product
reconstituted with 10 ml of Sterilised Water for Injections contains
approximately 100 IU/ml human
protein C.
The potency (IU) is determined using a chromogenic substrate method
against the World Health
Organisation (WHO) International standard.
Excipients with known effect:
Sodium chloride: 88 mg/vial
Sodium citrate. 2H
2
O: 44 mg/vial
For the full list of excipients see section 6.1.
* One International Unit (IU) of protein C corresponds to the
amidolytically measured activity of protein
C in 1 ml of normal plasma.
3. Pharmaceutical form
Powder and solvent for solution for injection.
White or cream coloured powder or friable solid. After reconstitution
the solution has a pH of between
6.7 and 7.3 and an osmolality of not lower than 240 mosmol/kg.
4. Clinical particulars
4.1 Therapeutic indications
CEPROTIN is indicated in purpura fulminans and coumarin induced skin
necrosis in patients with severe
congenital protein C deficiency. Furthermore CEPROTIN is indicated for
short-term prophylaxis in
patients with severe congenital protein C deficiency if one or more of
the following conditions are met:
• surgery or invasive therapy is imminent
• while initiating coumarin therapy
• when coumarin therapy alone is not sufficient
• when coumarin therapy is not feasible.
4.2 Posology and method of administration
Treatment with CEPROTIN should be initiated under the supervision of a
physician experienced in
substitution therapy with coagulation factors/inhibitors where
monitoring of protein C activity is feasible.
The dose should be adjusted on