Glypressin 1 mg/ 8.5 ml solution for injection

  • Name:

    Glypressin 1 mg/ 8.5 ml 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: 24/2/2016
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Ferring Ireland Limited

Ferring Ireland Limited

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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 24 February 2016 PIL

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 9: new text, "Date of last renewal: 25th September 2014"

Section 10: revision of text updated to February 2016

Updated on 24 February 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 February 2016 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • 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

Section 9: new text, "Date of last renewal: 25th September 2014"

Section 10: revision of text updated to February 2016

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 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 28 April 2014 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

1.         TRADE NAME OF THE MEDICINAL PRODUCT

 

Glypressin  1 mg/ 8.5 ml solution for injection


2.         Qualitative And Quantitative Composition
 

8.5 ml of injection solution contains 1 mg1mg Terlipressin Acetate (0.12 mg/ml) and 1.33 mmol of sodium.

                   

For a full list of excipients see section 6.1.


3.         Pharmaceutical Form


Solution for injection.

Clear, colourless aqueous fluid.


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 (iInternational 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 (2 x 8.5 ml) 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 (8.5 ml) 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:


An i.v. injection 3 to 4 mg (3x8.5ml to 4x8.5ml) terlipressin acetate 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 medicamentsmedicinal products and other forms of interaction


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 reflexofenic inhibition of the cardiac activity via the vagus nerve due to 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 any 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

Torsades de pointe

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

 

 

Pregnancy, puerperium and perinatal conditions

 

 

 

Uterine constriction

Decreased uterine blood flowUterine ischemia

 

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 mg2mg terlipressin acetate/4 hours) should not be exceeded as the risk of severe circulatory adverse effects is dose-dependent.

 

Elevated blood pressure in patients with recognised hypertension can be controlled with 150 mcg clonidine i.v.  Bradycardia requiring treatment 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

 

Terlipressin initially has an effect of its own, but is converted by enzymatic cleavage to lysine vasopressin. Doses of 1 and 2 mg terlipressin acetate effectively reduce the portal venous pressure and produce marked vasoconstriction. The lowering of portal pressure and azygos blood flow is dependent on dose. The effect of the low dose is reduced after 3 hours, while haemodynamic data show that 2 mg terlipressin acetate is more effective than 1 mg terlipressin acetate as the higher dose produces a dependable effect throughout the period of treatment (4 hours)

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 (T1/2a)) is about 8-10 minutes.

The half-life of elimination (T1/2b)) 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         


Sodium chloride

Acetic acid

Sodium acetate

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


2 years            


6.4       Special precautions for storage


Store in a refrigerator (2-8°C). Keep the ampoules in the outer carton in order to protect from light.


6.5      Nature and contents of container


Each carton contains five clear hydrolytic class 1 glass ampoules, 10ml nominal volume. 

The ampoule has a coloured dot indicating the cut area. It contains 8.5ml of solution for injection.  


6.6       Instructions for use / handling

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


Each ampoule is 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 1009/4/2


9.         Date Of First Authorisation / Renewal Of Authorisation

            25th September 2009



10.       DATE OR REVISION OF THE TEXT

September 2009April 2014           

Updated on 28 April 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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.         TRADE NAME OF THE MEDICINAL PRODUCT

 

Glypressin  1 mg/ 8.5 ml solution for injection


2.         Qualitative And Quantitative Composition
 

8.5 ml of injection solution contains 1 mg1mg Terlipressin Acetate (0.12 mg/ml) and 1.33 mmol of sodium.

                   

For a full list of excipients see section 6.1.


3.         Pharmaceutical Form


Solution for injection.

Clear, colourless aqueous fluid.


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 (iInternational 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 (2 x 8.5 ml) 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 (8.5 ml) 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:


An i.v. injection 3 to 4 mg (3x8.5ml to 4x8.5ml) terlipressin acetate 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 medicamentsmedicinal products and other forms of interaction


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 reflexofenic inhibition of the cardiac activity via the vagus nerve due to 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 any 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

Torsades de pointe

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

 

 

Pregnancy, puerperium and perinatal conditions

 

 

 

Uterine constriction

Decreased uterine blood flowUterine ischemia

 

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 mg2mg terlipressin acetate/4 hours) should not be exceeded as the risk of severe circulatory adverse effects is dose-dependent.

 

Elevated blood pressure in patients with recognised hypertension can be controlled with 150 mcg clonidine i.v.  Bradycardia requiring treatment 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

 

Terlipressin initially has an effect of its own, but is converted by enzymatic cleavage to lysine vasopressin. Doses of 1 and 2 mg terlipressin acetate effectively reduce the portal venous pressure and produce marked vasoconstriction. The lowering of portal pressure and azygos blood flow is dependent on dose. The effect of the low dose is reduced after 3 hours, while haemodynamic data show that 2 mg terlipressin acetate is more effective than 1 mg terlipressin acetate as the higher dose produces a dependable effect throughout the period of treatment (4 hours)

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 (T1/2a)) is about 8-10 minutes.

The half-life of elimination (T1/2b)) 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         


Sodium chloride

Acetic acid

Sodium acetate

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


2 years            


6.4       Special precautions for storage


Store in a refrigerator (2-8°C). Keep the ampoules in the outer carton in order to protect from light.


6.5      Nature and contents of container


Each carton contains five clear hydrolytic class 1 glass ampoules, 10ml nominal volume. 

The ampoule has a coloured dot indicating the cut area. It contains 8.5ml of solution for injection.  


6.6       Instructions for use / handling

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


Each ampoule is 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 1009/4/2


9.         Date Of First Authorisation / Renewal Of Authorisation

            25th September 2009



10.       DATE OR REVISION OF THE TEXT

September 2009April 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 5.1 - Pharmacodynamic properties

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 5.1 - Pharmacodynamic properties

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 13 January 2011 PIL

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided

Updated on 13 January 2011 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided