Fragmin 100,000units/4ml solution for injection vials

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Dalteparin sodium

Sẵn có từ:

Pfizer Ltd

Mã ATC:

B01AB04

INN (Tên quốc tế):

Dalteparin sodium

Liều dùng:

25000unit/1ml

Dạng dược phẩm:

Solution for injection

Tuyến hành chính:

Subcutaneous

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 02080100; GTIN: 5012882008215

Tờ rơi thông tin

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
FRAGMIN® 100,000 IU/4 ml Multidose Vial
dalteparin sodium
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, pharmacist or
nurse.
•
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Fragmin is and what it is used for
2. What you need to know before you are given Fragmin
3. How Fragmin is given to you
4. Possible side effects
5. How to store Fragmin
6. Contents of the pack and other information
1. WHAT FRAGMIN IS AND WHAT IT IS USED FOR
Fragmin contains the active ingredient dalteparin sodium. It is
available in one strength:
100,000 IU (International Units)/4 ml Solution for injection.
Fragmin belongs to a group of medicines called low molecular weight
heparins or
antithrombotics, which help prevent the formation of blood clots by
thinning the blood.
• Fragmin is used to treat blood clots (venous thromboembolism).
• Venous thromboembolism is a condition where blood clots develop in
the legs (deep vein
thrombosis) or the lungs (pulmonary embolism), e.g. after surgery or
prolonged bed-rest.
Ask your doctor if you are unsure why you have been given Fragmin.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FRAGMIN
YOU SHOULD NOT BE GIVEN FRAGMIN:
• if you are allergic (hypersensitive) to the active ingredient
dalteparin sodium or a similar
product or any of the other ingredients of this medicine (listed in
section 6).
• if you have an active stomach or ulcer of the duodenum (small
intestine).
• if you have suffered from a brain haemorrhage (bleeding in your
brain).
• if you suffer from any condition which may cause you to bleed more
easily (e.g. haemophilia,
liver failure). Ask your doctor if you are unsure.
• if you have a condition calle

Đặc tính sản phẩm

OBJECT 1
FRAGMIN 100,000 IU / 4ML MULTIDOSE VIAL
Summary of Product Characteristics Updated 19-May-2016 | Pfizer
Limited
1. Name of the medicinal product
Fragmin 100,000 IU / 4ml Multidose Vial
2. Qualitative and quantitative composition
Active ingredient
Dalteparin sodium (INN)
Quality according to Ph. Eur.
Potency is described in International anti-Factor Xa units (IU) of the
1st International Standard for Low
Molecular Weight Heparin.
Content of active ingredient
Fragmin 100,000 IU/4 ml: Multidose vial containing dalteparin sodium
corresponding to 25,000 IU (anti-
Factor Xa)/ml.
3. Pharmaceutical form
Solution for injection for subcutaneous administration.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of venous thromboembolism (VTE) presenting clinically as
deep vein thrombosis (DVT),
pulmonary embolism (PE) or both.
4.2 Posology and method of administration
Recommended dosage for adults
Treatment of venous thromboembolism (VTE).
Fragmin can be administered subcutaneously either as a single daily
injection or as twice daily injections.
(a) Once daily administration
200 IU/kg body weight is administered s.c once daily. Monitoring of
the anticoagulant effect is not
necessary. The single daily dose should not exceed 18,000 IU.
(b) Twice daily administration
A dose of 100 IU/kg body weight administered s.c twice daily can be
used for patients with increased risk
of bleeding. Monitoring of the treatment is generally not necessary
but can be performed with a functional
anti-Factor Xa assay. Maximum plasma levels are obtained 3-4 hours
after s.c injection, when samples
should be taken. Recommended plasma levels are between 0.5-1.0 IU
(anti-Factor Xa)/ml.
Simultaneous anticoagulation with oral vitamin K antagonists can be
started immediately. Treatment with
Fragmin is continued until the prothrombin complex levels (factor II,
VII, IX and X) have decreased to a
therapeutic level. At least five days of combined treatment is
normally required.
PAEDIATRIC POPULATION
The safety and efficacy of dalteparin so