Innohep 20,000units/2ml solution for injection vials

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Tinzaparin sodium

Inapatikana kutoka:

LEO Pharma

ATC kanuni:

B01AB10

INN (Jina la Kimataifa):

Tinzaparin sodium

Kipimo:

10000unit/1ml

Dawa fomu:

Solution for injection

Njia ya uendeshaji:

Subcutaneous; Intravenous

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 02080100; GTIN: 5702191004533

Taarifa za kipeperushi

120 mm
320 mm
189 mm
20 mm
(centred)
PACKAGE LEAFLET: INFORMATION FOR THE USER
TINZAPARIN 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.
•
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
•
In this leaflet innohep 10,000 IU/ml will be called innohep.
WHAT IS IN THIS LEAFLET
1. What innohep
®
is and what it is used for
2. What you need to know before you use innohep
®
3. How to use innohep
®
4. Possible side effects
5. How to store innohep
®
6. Contents of the pack and other information
1. WHAT INNOHEP
®
IS AND WHAT IT IS USED FOR
innohep is a type of heparin – a low molecular
weight heparin – and belongs to a group of
medicines called anticoagulants; these medicines
affect how your blood clots.
innohep prevents clotting, allowing normal blood
flow through the arteries and veins.
innohep is used to:
•
Prevent blood clots in adults before and after an
operation.
•
Prevent blood clots in adults who have an
increased risk of blood clots e.g. due to an acute
illness with limited mobility.
•
Prevent blood clots being formed in haemodialysis
equipment in patients undergoing haemodialysis
or haemofiltration. In haemodialysis, wastes and
fluids from the blood are removed by a dialysis
machine and a dialysis filter, which acts as a kind
of artificial kidney.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
INNOHEP
®
DO NOT USE INNOHEP
•
If you are allergic (hypersensitive) to tinzaparin or
any of the other ingredients of this medicine; you
can find a list of ingredients in section 6 of this
leaflet.
•
If you have ever had a reaction to heparin t

Tabia za bidhaa

OBJECT 1
INNOHEP 10,000 IU/ML
Summary of Product Characteristics Updated 30-Mar-2017 | Leo
Laboratories Limited
1. Name of the medicinal product
innohep 10,000 IU/ml
2. Qualitative and quantitative composition
Tinzaparin sodium 10,000 anti-Factor Xa IU/ml
Excipients with known effect:
Benzyl alcohol (10 mg/ml) and sodium (in total < 23 mg/dose).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Vials of 2 ml filled with a colourless to straw coloured liquid, free
from turbidity and from matter that
deposits on standing.
4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis of venous thromboembolism in adult patients undergoing
surgery, particularly orthopaedic,
general or oncological surgery.
Prophylaxis of venous thromboembolism in non-surgical adult patients
immobilised due to acute medical
illness including: acute heart failure, acute respiratory failure,
severe infections, active cancer, as well as
exacerbation of rheumatic diseases.
Prevention of clotting in extracorporeal circuits during haemodialysis
and haemofiltration in adults.
4.2 Posology and method of administration
Posology
Prophylaxis of thromboembolic events in adults:
Administration is by subcutaneous injection.
_Surgical patients at moderate risk of thromboembolic events:_
3,500 anti-Xa IU given SC 2 hours before surgery and then once daily
for as long as the patient is
considered to be at risk of VTE.
_Surgical patients at high risk of thromboembolic events e.g.
undergoing orthopaedic or cancer surgery:_
4,500 anti-Xa IU given SC 12 hours before surgery and then once daily
for as long as the patient is
considered to be at risk of VTE.
_Non-surgical patients immobilised due to acute medical illness:_
3,500 anti-Xa IU given SC once daily in patients at moderate risk of
VTE, or 4,500 anti-Xa IU given SC
once daily in patients at high risk of VTE. Administration should
continue for as long as the patient is
considered to be at risk of VTE.
Neuraxial anaesthesia
Caution is advised when perform