Heparin Leo 5000 iu/ ml 5000 iu/ml

国家: 约旦

语言: 英文

来源: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

下载 资料单张 (PIL)
07-12-2022

有效成分:

Heparin Sodium 5000 iu/ml

可用日期:

الشركة العربية للمستحضرات الطبية والزراعية - Arab Company for Medical & Agricultural Products

ATC代码:

B01AB01

INN(国际名称):

Heparin Sodium 5000 iu/ml

剂量:

5000 iu/ml

每包单位数:

50 Vial X 5ml

厂商:

ليو فارما برودكتس (الدانمارك)

资料单张

                                To be used together with CRT017 195 x 96,5 x 50 mm
or CRT018 118 x 46 x 65 mm
To be folded to 115 x 57 mm
Creation Date:
Revision Date:
Sign:
Sign:
Scale:
OMA
30/07/2012
Ref. No.:
Size:
Material:
Type:
100%
INS040-00
230 x 450 mm
45 g white
Insert, 2 + 4 columns
PACKAGING COMPONENT SPECIFICATION
LEO Pharma
Internal Market Access
Industriparken 55
2750 Ballerup
Denmark
Heparin 10 x 10 ml and 50 x 5 ml
Denmark
Scale Get-up
Matrial No
Sent by e-mail
Subject
Date
Colour
Sign.
Date
Sign.
Preparation
Place of production
Strength
Packsize
Comments:
▲
100%
E+S+A
056845
EBD
OMA
Black
Heparin LEO
Page 1 of 2 Pointsize: 6 pt
09/10/17
16/10/17
INS 230 x 450 mm
HEPARIN LEO
1.
NAME OF THE MEDICINAL PRODUCT
Heparin
Heparin sodium
Carefully read this insert before administering this
product. It contains information about your treatment.
If you have any doubt or you are not sure about
something, please ask your physician or Pharmacist.
Keep this insert as you might need to read it again.
Verify this product fully corresponds to the one
prescribed by your physician.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparin sodium 1,000 IU/ml
Pack sizes: 5 ml x 5 and 5 ml x 50.
Excipients, which the clinician should be aware of:
Benzyl alcohol, methyl- and propylparahydroxybenzoate
Heparin sodium 5,000 IU/ml
Pack sizes: 5 ml x 5 and 5 ml x 50.
Excipients, which the clinician should be aware of:
Benzyl alcohol, methyl- and propylparahydroxybenzoate
All excipients are listed under section 6.1
Not all pack sizes and strengths may be marketed
Sale under prescription
3.
PHARMACEUTICAL FORM
Solution for injection
Vials with clear, colourless or yellow liquid, free of
turbidity and visible particles.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Heparin is indicated for prophylaxis and treatment of
venous thrombosis and pulmonary embolism; in the
treatment of myocardial infarction and arterial embolism;
for prevention of clotting in arterial and heart surgery
and for prevention of cerebral thrombosis. Heparin may
also be used as an anti
                                
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