Optivate 1,000unit powder and solvent for solution for infusion vials

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

von Willebrand factor; Factor VIII

থেকে পাওয়া:

Bio Products Laboratory Ltd

এটিসি কোড:

B02BD06

INN (আন্তর্জাতিক নাম):

von Willebrand factor; Factor VIII

ডোজ:

1720unit ; 1000unit

ফার্মাসিউটিকাল ফর্ম:

Powder and solvent for solution for infusion

প্রশাসন রুট:

Intravenous

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Never Valid To Prescribe As A VMP

পণ্য সারাংশ:

BNF: 02110000; GTIN: 5019943000270

তথ্য লিফলেট

MYGPS EUROPE LTD
Tel: [phone] JOB NO. CLIENT: CONTACT: PROJECT NAME: CLIENT ORDER NO. DATE: PROOF NO. OPERATOR: DOC. SIZE:
1040
BPL
Paul Hinde
Optivate Patient Information Leaflet
265764
12/07/2012
2
Hema Joshi
185 x 225mm
PROOF APPROVED
PROOF UNAPPROVED
SIGNED
PANTONE 376C / BLACK
Package Leaflet: Information for the User
OPTIVATE
® 250 IU, 500 IU, 1000 IU
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HUMAN COAGULATION FACTOR VIII
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.
• 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. This includes
any possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1. What Optivate
®
is and what it is used for
2. What you need to know before you use Optivate
®
3. How to use Optivate
®
4. Possible side effects
5. How to store Optivate
®
6. Contents of the pack and other information
1. WHAT OPTIVATE
® IS AND WHAT IT IS USED FOR
Optivate
®
is a high purity factor VIII concentrate from human blood plasma
obtained from screened donors. It is a white
or pale yellow sterile powder, supplied with sterilised water for
injections.
Optivate
®
is given by injection into a vein (intravenously) and is used to
prevent and treat bleeding in patients with
haemophilia A (congenital factor VIII deficiency in the blood). Your
doctor will explain further why this medicine has
been given to you.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPTIVATE
®
DO NOT USE OPTIVATE
®
:
– if you are allergic (hypersensitive) to the human coagulation
factor VIII or any of the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
– If you have a larger or longer bleed than usual and the bleeding
does not stop after an

পণ্য বৈশিষ্ট্য

OBJECT 1
OPTIVATE
Summary of Product Characteristics Updated 26-Nov-2012 | Bio Products
Laboratory Limited
1. Name of the medicinal product
Optivate
®
250 IU, 500 IU, 1000 IU, powder and solvent for solution for injection
Human coagulation factor VIII.
2. Qualitative and quantitative composition
Optivate
®
is presented as a powder and solvent for solution for injection
containing nominally 250 IU,
500 IU or 1000 IU human coagulation factor VIII per vial.
Optivate
®
contains approximately 100 IU/mL human coagulation factor VIII when
reconstituted with 2.5
mL (250 IU), 5 mL (500 IU) or 10 mL (1000 IU) sterilised water for
injections.
The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The specific
activity of Optivate
®
is approximately 43 IU/mg of protein.
Optivate
®
also contains human von Willebrand factor (VWF by ristocetin cofactor
activity) at a
concentration of approximately 430 IU, 860 IU or 1720 IU per vial
respectively for the 250 IU, 500 IU
and 1000 IU presentations.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for solution for injection.
Product vial containing white or pale yellow powder.
Solvent vial containing clear colourless liquid.
4. Clinical particulars
4.1 Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor VIII deficiency).
4.2 Posology and method of administration
Treatment should be initiated under the supervision of a physician
experienced in the treatment of
haemophilia.
Posology
The dosage and duration of the substitution therapy depend on the
severity of the FVIII deficiency, on the
location and extent of the bleeding and the patient's clinical
condition.
_On demand treatment_
The number of units of factor VIII administered is expressed in
International Units (IU), which are related
to the current WHO standard for factor VIII products. Factor VIII
activity in plasma is expressed either as
a percentage (relative to normal human plasma) or in Intern