Glypressin 1 mg Powder and Solvent for Solution for Injection

  • Name:

    Glypressin 1 mg Powder and Solvent for Solution for Injection

  • Company:
    info
  • Active Ingredients:

    Terlipressin acetate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Summary of Product Characteristics last updated on medicines.ie: 12/7/2019

Click on this link to Download PDF directly

Ferring Ireland Limited

Ferring Ireland Limited

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1 - 0 of 35 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 12 July 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 6 June 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2 - update of information on the ampoule and vial.

Updated on 25 May 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 May 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to include new HPRA contact information

Updated on 25 May 2015 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

Update to include new HPRA contact information

Updated on 28 April 2014 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

1.         NAME OF THE MEDICINAL PRODUCT

Glypressin 1 mg Powder and Solvent for Solution for Injection

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ampoule contains terlipressin acetate 1 mg.

 

Excipient: Each 5 ml vial of solvent contains 17.7 mg sodium.

 

For full list of excipients, see section 6.1.

3.         PHARMACEUTICAL FORM


Powder and solvent for solution for injection.

 

White, sterile powder. 

Clear, colourless solvent.

4.         CLINICAL PARTICULARS

4.1       Therapeutic Indications

For use in the short term management of bleeding oesophageal varices.

 

“Emergency treatment of type 1 hepatorenal syndrome, as defined by IAC (internationalInternational Ascites Club) criteria”.


4.2       Posology and method of administration


1) Short term management of bleeding oesophageal varices

Adults:
Initially an i.v. injection of 2 mg terlipressin acetate is given every 4 hours. The treatment should be maintained until bleeding has been controlled for 24 hours, but up to a maximum of 48 hours. After the initial dose, the dose can be adjusted to 1 mg terlipressin acetate i.v. every 4 hours in patients with body weight < 50 kg or if adverse effects occur.


2) In type 1 hepatorenal syndrome

3 to 4 mg every 24 hours as 3 or 4 administrations

In the absence of any reduction of the serum creatinine after 3 days of treatment, cessation of Glypressin treatment is advised.

 

In other cases, Glypressin treatment is to be pursued until the obtaining either of a serum creatinine less than 130 µmol/litre or of a drop of at least 30% in the serum creatinine with respect to the value measured at the time of diagnosis of hepatorenal syndrome.

 

The standard average duration of treatment is 10 days


4.3       Contraindications

Hypersensitivity to terlipressin or any other excipient of the product.

Contraindicated in pregnancy.


4.4       Special warnings and precautions for use

Blood pressure, heart rate and fluid balance should be monitored during treatment.

 

Caution should be exercised in treating patients with hypertension, recognised heart disease, renal dysfunction, cerebral or peripheral vascular disease, asthma or respiratory failure.

 

To avoid local necrosis at the injection site, the injection must be administered intravenously.

 

In patients with septic shock with a low cardiac output terlipressin should not be used.

 

Prior to use of terlipressin for hepatorenal syndrome, it must be ascertained that the patient has an acute functional renal failure and this functional renal failure does not respond to a suitable plasma expansion therapy.

 

Children and the elderly: Particular caution should be exercised in the treatment of children and elderly patients, as experience is limited in these groups.

There is no data available regarding dosage recommendation in these special patient categories.

4.5              Interaction with other medicinal products and other forms of interactionsinteraction

The hypotensive effect of non-selective beta-blockers on the portal vein is increased with terlipressin. Concomitant treatment with medicinal products with a known bradycardiac effect (e.g. propofol, sufentanil) may lower the heart rate and cardiac output.  These effects are due to reflexogenic inhibition of the cardiac activity via the vagus nerve due to the elevated blood pressure. 


4.6       PregnancyFertility, pregnancy and lactation

Treatment with GLYPRESSIN during pregnancy is contraindicated (see sections 4.3 and 5.3).  GLYPRESSIN has been shown to cause uterine contractions and increased intrauterine pressure in early pregnancy and may decrease the uterine blood flow.  GLYPRESSIN may have harmful effects on pregnancy and foetus. 

 

Spontaneous abortion and malformation of the foetus have been shown in rabbits after treatment with GLYPRESSIN.

 

Information on transfer of GLYPRESSIN to breast milk is insufficient.  GLYPRESSIN should not be used in breast feeding women.

Lactation

It is not known whether GLYPRESSIN is excreted in human breast milk. The excretion of GLYPRESSIN in milk has not been studied in animals. A risk to the suckling child cannot be excluded. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with GLYPRESSIN should be made taking into account the benefit of breast-feeding to the child and the benefit of GLYPRESSIN therapy to the woman.


4.7       Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8       Undesirable effects

The most commonly reported undesired effects in clinical trials (frequency 1-10%) are paleness, increased blood pressure, abdominal pain, nausea, diarrhoea, and headache. 


MedDRA System Organ Class

COMMON

UNCOMMON

RARE

Not known

Disorder

(10-1%)

(1-0.1%)

(0.1-0.01%)

(cannot be estimated from the available data

Metabolism and nutrition disorders

 

Hyponatraemia if fluid not monitored

 

 

Nervous system disorders

Headache

 

 

 

Cardiac disorders

Bradycardia

Atrial Fibrillation

 

Torsade de pointes

 

 

Ventricular Extracystoles

 

 Cardiac failure

 

 

Tachycardia

 

 

 

 

Chest pain

 

 

 

 

Myocardial Infarction

 

 

 

 

Fluid overload with pulmonary oedema

Torsade de pointes

Cardiac failure

 

 

 

Vascular disorders

Peripheral vasoconstriction

Intestinal ischaemia

 

 

 

Peripheral ischemia

Peripheral cyanosis

 

 

 

Facial pallor

Hot flushes

 

 

 

Hypertension

 

 

 

Respiratory, thoracic and mediastinal disorders

 

Respiratory distress

Dyspnoea

 

 

 

Respiratory failure

 

 

Gastrointestinal disorders

Transient abdominal cramps

Transient nausea

 

 

 

Transient diarrhoea

Transient vomiting

 

 

Skin and subcutaneous tissue disorders

 

 Skin necrosis

 

 Skin necrosis

Pregnancy, puerperium and perinatal conditions

 

Uterine hypertonus

Uterine ischemia

 

Uterine constriction

Decreased uterine blood flow

General disorders and administration site disorders

 

Injection site necrosis

 

 


Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie


4.9       Overdose

The recommended dose (2 mg/4 hours) should not be exceeded as the risk of severe circulatory adverse effects is dose-dependent.

 

Elevated blood pressure in patients with hypertension can be controlled with clonidine 150 µg iv.  Severe bradycardia should be treated with atropine.


5.         PHARMACOLOGICAL PROPERTIES

5.1       Pharmacodynamic properties

Pharmacotherapeutic group: Posterior pituitary lobe hormones (vasopressin and analogues)

ATC code: H01B A04

 

Glypressin may be regarded as a circulating depot of lysine vasopressin.  Following i.v. injection, three glycyl moieties are enzymatically cleaved from the N terminal to release lysine vasopressin.

The slowly released vasopressin reduces blood flow in the splanchnic circulation in a prolonged manner, thereby helping to control bleeding from ruptured oesophageal varices.


5.2       Pharmacokinetic properties

Glypressin is administered by bolus i.v. injection.  It shows a biphasic plasma level curve which indicates that a two compartment model can be applied.  The half life of Distribution (T 1/2α) is about 8-10 minutes.  The half-life of elimination (T ½ β) is about 50-70 minutes.

 

Lysine vasopressin reaches maximum plasma levels about 1-2 hours following i.v. administration and has a duration of activity of 4-6 hours.


5.3       Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.


6.         PHARMACEUTICAL PARTICULARS

6.1       List of excipients

Powder for solution for injection (vial):)

Mannitol

Hydrochloric acid (for pH-adjustment)


Solvent (ampoule):)

Sodium chloride

Hydrochloric acid (for pH-adjustment).

Water for injections


6.2       Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


6.3       Shelf life

Unopened:3 years.


6.4       Special precautions for storage

Do not store above 25°C.  Store in the original package in order to protect from light.

The reconstituted solution must be used immediately after reconstitution.

 

6.5       Nature and contents of container

Type I glass vial with bromobutyl rubber stopper and type I glass ampoule.

 

The vial contains terlipressin acetate 1 mg.  The ampoule has a coloured dot indicating the cut area and contains 5 ml of clear, colourless solvent.

 

Pack size:  5 sets of 1 vial + 1 ampoule.


6.6       Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Reconstitute Glypressin with the solvent provided immediately prior to use.  For single use only. Discard any unused solution.


7.     MARKETING AUTHORISATION HOLDER

Ferring Ireland Ltd

United Drug House

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

 

8.     MARKETING AUTHORISATION NUMBER

PA 1009/4/1


9.     DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

Date of first authorisation:      9th April 1987

 

Date of last renewal:               9th April 2007


10.    DATE OF REVISION OF THE TEXT

August 2009

March 2014



Updated on 28 April 2014 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

1.         NAME OF THE MEDICINAL PRODUCT

Glypressin 1 mg Powder and Solvent for Solution for Injection

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ampoule contains terlipressin acetate 1 mg.

 

Excipient: Each 5 ml vial of solvent contains 17.7 mg sodium.

 

For full list of excipients, see section 6.1.

3.         PHARMACEUTICAL FORM


Powder and solvent for solution for injection.

 

White, sterile powder. 

Clear, colourless solvent.

4.         CLINICAL PARTICULARS

4.1       Therapeutic Indications

For use in the short term management of bleeding oesophageal varices.

 

“Emergency treatment of type 1 hepatorenal syndrome, as defined by IAC (internationalInternational Ascites Club) criteria”.


4.2       Posology and method of administration


1) Short term management of bleeding oesophageal varices

Adults:
Initially an i.v. injection of 2 mg terlipressin acetate is given every 4 hours. The treatment should be maintained until bleeding has been controlled for 24 hours, but up to a maximum of 48 hours. After the initial dose, the dose can be adjusted to 1 mg terlipressin acetate i.v. every 4 hours in patients with body weight < 50 kg or if adverse effects occur.


2) In type 1 hepatorenal syndrome

3 to 4 mg every 24 hours as 3 or 4 administrations

In the absence of any reduction of the serum creatinine after 3 days of treatment, cessation of Glypressin treatment is advised.

 

In other cases, Glypressin treatment is to be pursued until the obtaining either of a serum creatinine less than 130 µmol/litre or of a drop of at least 30% in the serum creatinine with respect to the value measured at the time of diagnosis of hepatorenal syndrome.

 

The standard average duration of treatment is 10 days


4.3       Contraindications

Hypersensitivity to terlipressin or any other excipient of the product.

Contraindicated in pregnancy.


4.4       Special warnings and precautions for use

Blood pressure, heart rate and fluid balance should be monitored during treatment.

 

Caution should be exercised in treating patients with hypertension, recognised heart disease, renal dysfunction, cerebral or peripheral vascular disease, asthma or respiratory failure.

 

To avoid local necrosis at the injection site, the injection must be administered intravenously.

 

In patients with septic shock with a low cardiac output terlipressin should not be used.

 

Prior to use of terlipressin for hepatorenal syndrome, it must be ascertained that the patient has an acute functional renal failure and this functional renal failure does not respond to a suitable plasma expansion therapy.

 

Children and the elderly: Particular caution should be exercised in the treatment of children and elderly patients, as experience is limited in these groups.

There is no data available regarding dosage recommendation in these special patient categories.

4.5              Interaction with other medicinal products and other forms of interactionsinteraction

The hypotensive effect of non-selective beta-blockers on the portal vein is increased with terlipressin. Concomitant treatment with medicinal products with a known bradycardiac effect (e.g. propofol, sufentanil) may lower the heart rate and cardiac output.  These effects are due to reflexogenic inhibition of the cardiac activity via the vagus nerve due to the elevated blood pressure. 


4.6       PregnancyFertility, pregnancy and lactation

Treatment with GLYPRESSIN during pregnancy is contraindicated (see sections 4.3 and 5.3).  GLYPRESSIN has been shown to cause uterine contractions and increased intrauterine pressure in early pregnancy and may decrease the uterine blood flow.  GLYPRESSIN may have harmful effects on pregnancy and foetus. 

 

Spontaneous abortion and malformation of the foetus have been shown in rabbits after treatment with GLYPRESSIN.

 

Information on transfer of GLYPRESSIN to breast milk is insufficient.  GLYPRESSIN should not be used in breast feeding women.

Lactation

It is not known whether GLYPRESSIN is excreted in human breast milk. The excretion of GLYPRESSIN in milk has not been studied in animals. A risk to the suckling child cannot be excluded. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with GLYPRESSIN should be made taking into account the benefit of breast-feeding to the child and the benefit of GLYPRESSIN therapy to the woman.


4.7       Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8       Undesirable effects

The most commonly reported undesired effects in clinical trials (frequency 1-10%) are paleness, increased blood pressure, abdominal pain, nausea, diarrhoea, and headache. 


MedDRA System Organ Class

COMMON

UNCOMMON

RARE

Not known

Disorder

(10-1%)

(1-0.1%)

(0.1-0.01%)

(cannot be estimated from the available data

Metabolism and nutrition disorders

 

Hyponatraemia if fluid not monitored

 

 

Nervous system disorders

Headache

 

 

 

Cardiac disorders

Bradycardia

Atrial Fibrillation

 

Torsade de pointes

 

 

Ventricular Extracystoles

 

 Cardiac failure

 

 

Tachycardia

 

 

 

 

Chest pain

 

 

 

 

Myocardial Infarction

 

 

 

 

Fluid overload with pulmonary oedema

Torsade de pointes

Cardiac failure

 

 

 

Vascular disorders

Peripheral vasoconstriction

Intestinal ischaemia

 

 

 

Peripheral ischemia

Peripheral cyanosis

 

 

 

Facial pallor

Hot flushes

 

 

 

Hypertension

 

 

 

Respiratory, thoracic and mediastinal disorders

 

Respiratory distress

Dyspnoea

 

 

 

Respiratory failure

 

 

Gastrointestinal disorders

Transient abdominal cramps

Transient nausea

 

 

 

Transient diarrhoea

Transient vomiting

 

 

Skin and subcutaneous tissue disorders

 

 Skin necrosis

 

 Skin necrosis

Pregnancy, puerperium and perinatal conditions

 

Uterine hypertonus

Uterine ischemia

 

Uterine constriction

Decreased uterine blood flow

General disorders and administration site disorders

 

Injection site necrosis

 

 


Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie


4.9       Overdose

The recommended dose (2 mg/4 hours) should not be exceeded as the risk of severe circulatory adverse effects is dose-dependent.

 

Elevated blood pressure in patients with hypertension can be controlled with clonidine 150 µg iv.  Severe bradycardia should be treated with atropine.


5.         PHARMACOLOGICAL PROPERTIES

5.1       Pharmacodynamic properties

Pharmacotherapeutic group: Posterior pituitary lobe hormones (vasopressin and analogues)

ATC code: H01B A04

 

Glypressin may be regarded as a circulating depot of lysine vasopressin.  Following i.v. injection, three glycyl moieties are enzymatically cleaved from the N terminal to release lysine vasopressin.

The slowly released vasopressin reduces blood flow in the splanchnic circulation in a prolonged manner, thereby helping to control bleeding from ruptured oesophageal varices.


5.2       Pharmacokinetic properties

Glypressin is administered by bolus i.v. injection.  It shows a biphasic plasma level curve which indicates that a two compartment model can be applied.  The half life of Distribution (T 1/2α) is about 8-10 minutes.  The half-life of elimination (T ½ β) is about 50-70 minutes.

 

Lysine vasopressin reaches maximum plasma levels about 1-2 hours following i.v. administration and has a duration of activity of 4-6 hours.


5.3       Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.


6.         PHARMACEUTICAL PARTICULARS

6.1       List of excipients

Powder for solution for injection (vial):)

Mannitol

Hydrochloric acid (for pH-adjustment)


Solvent (ampoule):)

Sodium chloride

Hydrochloric acid (for pH-adjustment).

Water for injections


6.2       Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


6.3       Shelf life

Unopened:3 years.


6.4       Special precautions for storage

Do not store above 25°C.  Store in the original package in order to protect from light.

The reconstituted solution must be used immediately after reconstitution.

 

6.5       Nature and contents of container

Type I glass vial with bromobutyl rubber stopper and type I glass ampoule.

 

The vial contains terlipressin acetate 1 mg.  The ampoule has a coloured dot indicating the cut area and contains 5 ml of clear, colourless solvent.

 

Pack size:  5 sets of 1 vial + 1 ampoule.


6.6       Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Reconstitute Glypressin with the solvent provided immediately prior to use.  For single use only. Discard any unused solution.


7.     MARKETING AUTHORISATION HOLDER

Ferring Ireland Ltd

United Drug House

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

 

8.     MARKETING AUTHORISATION NUMBER

PA 1009/4/1


9.     DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

Date of first authorisation:      9th April 1987

 

Date of last renewal:               9th April 2007


10.    DATE OF REVISION OF THE TEXT

August 2009

March 2014



Updated on 18 March 2011 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

Update SPC following EU PSUR harmonisation scheme

Updated on 18 March 2011 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update SPC following EU PSUR harmonisation scheme

Updated on 18 January 2011 PIL

Reasons for updating

  • Change to product name

Free text change information supplied by the pharmaceutical company

Enter full title of medicinal product onto medicines.ie

Updated on 18 January 2011 SmPC

Reasons for updating

  • Change to product name

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Enter full title of medicinal product onto medicines.ie

Updated on 1 September 2009 PIL

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

Section 6.6:  updated container details

Updated on 1 September 2009 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.6:  updated container details

Updated on 15 October 2007 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number

Free text change information supplied by the pharmaceutical company

section 1 (trade name): Changed to Glypressin 1mg Powder and Solvent for Solution for Injection
section 2 (qualitative and quantitative composition): Added sentence, Excipient: Each 5ml Vial of solvent contains 17.7mg sodium. For full list of excipients, see section 6.1
section 3 (pharmaceutical form): Added sentences, White, sterile powder.  Clear, colourless solvent.
section 4.5 (Interactions with other Medicaments and other forms of Interaction): Spelling error, relexofenic changed to reflexogenic.
section 6.1 (List of Excipients): Hydrochloric acid 1M changed to Hydrochloric acid (for pH-adjustment)
section 6.2 (Incompatibilities): None known replaced with In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products
section 6. 3 (Shelf Life): 36 months (unopened) replaced with Unopened: 3 years
section 6. 4 (Special Precautions for Storage): Added sentence, Keep container in the outer carton
section 6. 5 (Nature and Contents of Container): diluent replaced with solvent
section 6. 6 (Instruction for Use/Handling): diluent replaced with solvent and portion replaced with solution
section 8 (MA number): 9th April 2002 replaced with 9th April 2007 and September 2006 replaced with September 2007

Updated on 15 October 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

section 1 (trade name): Changed to Glypressin 1mg Powder and Solvent for Solution for Injection
section 2 (qualitative and quantitative composition): Added sentence, Excipient: Each 5ml Vial of solvent contains 17.7mg sodium. For full list of excipients, see section 6.1
section 3 (pharmaceutical form): Added sentences, White, sterile powder.  Clear, colourless solvent.
section 4.5 (Interactions with other Medicaments and other forms of Interaction): Spelling error, relexofenic changed to reflexogenic.
section 6.1 (List of Excipients): Hydrochloric acid 1M changed to Hydrochloric acid (for pH-adjustment)
section 6.2 (Incompatibilities): None known replaced with In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products
section 6. 3 (Shelf Life): 36 months (unopened) replaced with Unopened: 3 years
section 6. 4 (Special Precautions for Storage): Added sentence, Keep container in the outer carton
section 6. 5 (Nature and Contents of Container): diluent replaced with solvent
section 6. 6 (Instruction for Use/Handling): diluent replaced with solvent and portion replaced with solution
section 8 (MA number): 9th April 2002 replaced with 9th April 2007 and September 2006 replaced with September 2007

Updated on 8 March 2007 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

Variarion approved to change section 4.4 of SPC

Updated on 8 March 2007 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Variarion approved to change section 4.4 of SPC

Updated on 13 February 2007 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

Change due to variation to add a HRS indication, changing sections 4.1, 4.2, 4.4 of the SPC.

Updated on 13 February 2007 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change due to variation to add a HRS indication, changing sections 4.1, 4.2, 4.4 of the SPC.

Updated on 14 July 2005 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 14 July 2005 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 June 2005 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 June 2005 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Updated on 11 August 2004 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 11 August 2004 PIL

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Updated on 26 April 2004 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Updated on 26 April 2004 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 21 May 2003 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 21 May 2003 PIL

Reasons for updating

  • New SPC for new product