Clexane Forte 150mg/1ml solution for injection pre-filled syringes

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Enoxaparin sodium

제공처:

Sanofi

ATC 코드:

B01AB05

INN (국제 이름):

Enoxaparin sodium

복용량:

150mg/1ml

약제 형태:

Solution for injection

관리 경로:

Subcutaneous

수업:

No Controlled Drug Status

처방전 유형:

Caution - AMP level prescribing advised

제품 요약:

BNF: 02080100; GTIN: 5000283654001

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLEXANE
® FORTE SYRINGES 12,000 IU (120 MG)/0.8 ML SOLUTION FOR INJECTION
CLEXANE
® FORTE SYRINGES 15,000 IU (150 MG)/1 ML SOLUTION FOR INJECTION
enoxaparin 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 or 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Clexane Forte Syringes is and what it is used for
2.
What you need to know before you use Clexane Forte Syringes
3.
How to use Clexane Forte Syringes
4.
Possible side effects
5.
How to store Clexane Forte Syringes
6.
Contents of the pack and other information
1.
WHAT CLEXANE FORTE SYRINGES IS AND WHAT IT IS USED FOR
Clexane Forte Syringes contains the active substance called enoxaparin
sodium that is a low molecular
weight heparin (LMWH).
Clexane Forte Syringes works in two ways.
1)
Stopping existing blood clots from getting any bigger. This helps your
body to break them
down and stops them from causing you harm
2)
Stopping blood clots from forming in your blood.
Clexane Forte Syringes can be used to:
•
Treat blood clots that are in your blood
•
Stop blood clots from forming in your blood in the following
situations:
o
Before and after an operation
o
When you have an acute illness and face period of limited mobility
o
When you have unstable angina (a condition when not enough blood gets
to your
heart)
o
After a heart attack
•
Stop blood clots forming in the tubes of your dialysis machine (used
for people with severe
kidney problems).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CLEXANE FORTE SYRINGES
DO NOT USE CLEXANE FORTE SYRINGES

제품 특성 요약

OBJECT 1
CLEXANE FORTE SYRINGES
Summary of Product Characteristics Updated 09-Jun-2017 | SANOFI
1. Name of the medicinal product
Clexane
®
Forte Syringes 12,000 IU (120 mg)/0.8 ml solution for injection
Clexane
®
Forte Syringes 15,000 IU (150 mg)/1 ml solution for injection
2. Qualitative and quantitative composition
_12,000 IU (120 mg) / 0.8 ml_
Each prefilled syringe contains enoxaparin sodium 12,000 IU anti-Xa
activity (equivalent to 120 mg) in
0.8 ml water for injections.
_15,000 IU (150 mg) /1 ml_
Each prefilled syringe contains enoxaparin sodium 15,000 IU anti-Xa
activity (equivalent to 150 mg) in
1.0 ml water for injections.
For the full list of excipients, see section 6.1.
Enoxaparin sodium is a biological substance obtained by alkaline
depolymerization of heparin benzyl
ester derived from porcine intestinal mucosa.
3. Pharmaceutical form
Solution for injection.
Clear, colourless to pale yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
Clexane Forte Syringes is indicated in adults for:
• Prophylaxis of venous thromboembolic disease in moderate and high
risk surgical patients, in particular
those undergoing orthopaedic or general surgery including cancer
surgery.
• Prophylaxis of venous thromboembolic disease in medical patients
with an acute illness (such as acute
heart failure, respiratory insufficiency, severe infections or
rheumatic diseases) and reduced mobility at
increased risk of venous thromboembolism.
• Treatment of deep vein thrombosis (DVT) and pulmonary embolism
(PE), excluding PE likely to
require thrombolytic therapy or surgery.
• Prevention of thrombus formation in extra corporeal circulation
during haemodialysis.
• Acute coronary syndrome:
- Treatment of unstable angina and Non ST-segment elevation myocardial
infarction (NSTEMI), in
combination with oral acetylsalicylic acid.
- Treatment of acute ST-segment elevation myocardial infarction
(STEMI) including patients to be
managed medically or with subsequent percutaneous coronary
intervention (PCI).
4.2 Posol