Octim 150micrograms/dose nasal spray

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Desmopressin acetate

Предлага се от:

Ferring Pharmaceuticals Ltd

АТС код:

H01BA02

INN (Международно Name):

Desmopressin acetate

дозиране:

150microgram/1dose

Лекарствена форма:

Spray

Начин на приложение:

Nasal

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 06050200; GTIN: 05015919487939

Листовка

OCTIM
®
NASAL SPRAY
Desmopressin acetate
PATIENT INFORMATION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE.
• Keep this leaflet, you may need to read it again
• If you have further questions, please ask your doctor or
pharmacist
• This medicine has been prescribed for you personally and
you should not pass it on to others. It may harm them even
if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
IMPORTANT THINGS THAT YOU NEED TO KNOW:
• Octim Nasal Spray is used
- during surgery or following trauma in patients with
mild to moderate haemophilia (blood condition) or
von Willebrand’s disease (blood clotting condition)
- to test for fibrinolytic response
• You should avoid drinking large amounts of fluid while you
are being treated with Octim Nasal Spray.
• If you experience unusually bad or prolonged headache,
confusion, unexplained weight gain, ankle swelling, nausea
or vomiting stop using Octim Nasal Spray.
In this leaflet:
1. What Octim Nasal Spray is and what it is used for
2. Before you use Octim Nasal Spray
3. How to use Octim Nasal Spray
4. Possible side effects
5. Storing Octim Nasal Spray
6. Further information
1. WHAT OCTIM NASAL SPRAY IS AND WHAT IT IS USED FOR
Octim Nasal Spray is a solution for nasal use only. It contains
Desmopressin acetate, an antidiuretic (reduces urine production).
It is used:
• during surgery or following trauma in patients with mild to
moderate haemophilia (blood condition) or von Willebrand’s
disease (blood clotting condition) to increase blood clotting
factors _(Note: Octim Nasal Spray is not suitable for every _
_ patient or for the treatment of all types of haemophilia or _
_ von Willebrand’s disease)._
• to test for fibrinolytic response (a test to measure the
capacity of the body to dissolve blood clots once they
have formed)
2. BEFORE YOU USE OCTIM NASAL SPRAY
DO NOT USE OCTIM NASAL SPRAY IF

Данни за продукта

OBJECT 1
OCTIM NASAL SPRAY
Summary of Product Characteristics Updated 25-Jul-2012 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
OCTIM
®
Nasal Spray
2. Qualitative and quantitative composition
Desmopressin acetate 150 micrograms per actuation
For excipients, see 6.1
3. Pharmaceutical form
Nasal Spray, Solution
Clear, colourless solution
4. Clinical particulars
4.1 Therapeutic indications
OCTIM Nasal Spray is indicated as follows:
1) To increase Factor VIIIC and Factor VIII:Ag (vWf) in patients with
mild to moderate haemophilia or
von Willebrand's disease undergoing surgery, following trauma or with
other bleeding episodes such as
menorrhagia and epistaxis.
2) To test for fibrinolytic response.
4.2 Posology and method of administration
MILD TO MODERATE HAEMOPHILIA AND VON WILLEBRAND'S DISEASE:
Adults (including the elderly) should take 300 micrograms (one spray
into each nostril) half an hour
before surgery or at bleeding.
Under direct medical supervision, further doses may be administered at
12 hourly intervals so long as
cover is required. As some patients have shown a diminishing response
to successive doses, Factor VIII
levels should continue to be monitored.
Unless specifically directed by the doctor, when OCTIM Nasal Spray is
self-administered by the patient,
there should be an interval of at least three days between doses.
Increase of Factor VIII levels are dependent on basal levels and are
normally between 2 and 5 times the
pre-treatment levels. If results from a previous administration of
desmopressin are not available then
blood should be taken pre-dose and 60 minutes post-dose for assay of
Factor VIII levels in order to
monitor response.
FIBRINOLYTIC RESPONSE TESTING:
Adults (including the elderly) should take 300 micrograms (one spray
in each nostril). A sample of
venous blood should be taken 60 minutes later.
In patients with a normal response, the sample should show
fibrinolytic activity of euglobulin clot
precipitate on fibrin plates of at least 240mm
2
.
4.3 Contraindications
OCTIM