Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Chemi S.p.A., Via dei Lavoratori, 54, Cinisello Balsamo (MI), 20092 Italy
Ghemaxan 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringes.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless to pale yellow solution. |
Each pre-filled syringe contains enoxaparin sodium 2,000 IU anti-Xa activity (equivalent to 20 mg) in 0.2 mL water for injections.
For the full list of excipients, see section 6.1.
Enoxaparin sodium is a biological substance obtained by alkaline depolymerisation of heparin benzyl ester derived from porcine intestinal mucosa.
| Active Ingredient | Description | |
|---|---|---|
| Enoxaparin |
Enoxaparin is a LMWH with a mean molecular weight of approximately 4,500 daltons, in which the antithrombotic and anticoagulant activities of standard heparin have been dissociated. The drug substance is the sodium salt and has a high anti-Xa activity. |
| List of Excipients |
|---|
|
Water for injections |
Solution for injection in a 0.5 mL or 1 mL Type I glass pre-filled syringe with staked needle and needle guard (synthetic polyisoprene rubber) closed with elastomeric plunger stopper (chlorobutyl rubber) and plunger rod. The solution for injection is available in two different presentations:
1. The syringe is equipped with a needle guard
Ghemaxan 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringes: packs of 2, 6 or 10 pre-filled syringes and multipacks containing 12 (2 packs of 6), 20 (2 packs of 10), 24 (4 packs of 6), 30 (3 packs of 10), 50 (5 packs of 10) and 90 (9 packs of 10) pre-filled syringes.
2. The syringe is not equipped with a needle guard
Ghemaxan 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringes: packs of 2 and 10 pre-filled syringes.
Not all pack sizes may be marketed.
Chemi S.p.A., Via dei Lavoratori, 54, Cinisello Balsamo (MI), 20092
Italy
PA22937/001/001
Date of first authorisation: 19th June 2020
| Drug | Countries | |
|---|---|---|
| GHEMAXAN | Austria, Brazil, Finland, Ireland |
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