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Syntometrine injection

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Pharmacy Only: Prescription

Updated on 16 February 2021

File name

Syntometrine PIL IE 008.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change of manufacturer address of Syntometrine from:

Panpharma GmbH, Arzneimittelwerk, Bunsenstrasse 4, D-22946 Trittau, Germany

to:

Panpharma GmbH, Bunsenstraβe 4, 22946 Trittau, Germany

Date of revision updated.

Updated on 16 February 2021

File name

Syntometrine PIL IE 008.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Deletions crossed through in red and additions underlined in green.

Change of manufacturer address of Syntometrine from:

Panpharma GmbH, Arzneimittelwerk, Bunsenstrasse 4, D-22946 Trittau, Germany

to:

Panpharma GmbH, Bunsenstraβe 4, 22946 Trittau, Germany

Date of revision updated.

Updated on 11 June 2020

File name

Syntometrine PIL IE 007.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Manufactured by:

Rotexmedica Panpharma GmbH, Arzneimittelwerk, Bunsenstrasse 4, 22946 Trittau, Germany

Updated on 27 March 2019

File name

Syntometrine PIL IE 006.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 25 March 2019

File name

Syntometrine PIL IE 006.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 22 March 2019

File name

Syntometrine PIL IE 006.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 22 March 2019

File name

Syntometrine SPC IE 006.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 27 November 2018

File name

Syntometrine PIL IE 005.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 27 November 2018

File name

Syntometrine SPC IE 005.pdf

Reasons for updating

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

4.4       Special warnings and precautions for use

Anaphylaxis in women with latex allergy

There have been reports of anaphylaxis following administration of oxytocin in women with a known latex allergy. Due to the existing structural homology between oxytocin and latex, latex allergy/intolerance may be an important predisposing risk factor for anaphylaxis following oxytocin administration.

Updated on 20 July 2018

File name

Syntometrine SPC IE 004.pdf

Reasons for updating

  • File format updated to PDF

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

Free text change information supplied by the pharmaceutical company

File format update to PDF

Updated on 19 January 2017

Reasons for updating

  • New SPC for new product

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

Updated on 19 January 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

$04.      CLINICAL PARTICULARS$0$04.1       Therapeutic indications$0$0Syntometrineis indicated in the active management of the third stage of labour(as a means to promote separation of the placenta and to reduce blood loss)or, routinely, following the birth of the placenta, to prevent or treatpostpartum haemorrhage in those patients who have not recently received apressor agent.$0$0$0$04.2       Posology and method of administration$0$0Posology$0$0Syntometrineshould be used under medical supervision only Syntometrine shouldonly be administered by a healthcare professional.$0$0$0$0GeneralTarget Population Adults$0$0Active management of third stage of labour: Intramuscularinjection of 1 ml to be administered to the mother following delivery of thebaby's anterior shoulder or immediately after delivery of the baby.  Expulsion of the placenta -usually separatedby the first strong uterine contraction following the injection of Syntometrine- should be manually assisted by applyinggentle fundal pressure.controlled cordtraction.$0$0Prevention and treatment of postpartum haemorrhage:  Intramuscular injection of 1 mlto be administered to the mother following expulsion of the placenta, or whenbleeding occurs.$0$0 $0$0Special populations$0$0Renal impairment /Hepatic impairment $0$0Nostudies have been performed in patients with renal or hepatic impairment.However considering the metabolic pathway of ergometrine and oxytocine,use is contraindicated in severe hepatic and renal impairment and caution isrequired in mild or moderate hepatic and renal impairment (see sections 4.3Contraindications, 4.4 Warnings and precautionsSpecialwarnings and precautions for use and 11 Clinicalpharmacology5.2 Pharmacokinetic properties).$0$0 $0$0Paediatric patients $0$0No studies have been performed in paediatric patients.Syntometrine is not indicated for use in children.$0$0$0$0$0Methodof administration$0$0Intramuscularinjection is the recommended route$0$0Intravenous administration of Syntometrine (0.5 to 1 mlby slow injection) is possible, but should be limited to use only incases of severe haemorrhage due to uterine atony.$0$0 $0$04.3       Contraindications$0$0·Hypersensitivity to the active substances or to anyof the excipients listed in section 6.1.$0$0·Hypersensitivity to the active ingredients.$0$0 $0$04.4       Special warnings and precautions for use$0$0Whenthe intravenous route is employed, care should be exercised in patients ofdoubtful cardiac status.$0$0Inbreech presentation and other abnormal presentations Syntometrine should not begiven before delivery of the child is completed, and in multiple births notbefore the last child has been delivered (seesection 4.6 Fertility, pregnancy and breast-feeding).$0$0Activemanagement of the third stage of labour requires expert obstetric supervision.$0$0Ergometrinederivatives are excreted in breast milk but in unknown amounts. It can alsosuppress lactation, so repeated use should be avoided (see section 4.6 Fertility,pregnancy and lactation).Syntometrine hasthe potential to cause serious adverse drug reactions in breastfednewborns/infants. Postpartum women receiving Syntometrine should avoidbreastfeeding at least 12 hours after the administration. Milk secreted duringthis period should be expressed and discarded (see section 4.6 Fertility,pregnancy and breast-feeding).$0$0Cautionshould be exercised in the presence of mild or moderate hypertension, sepsis,  malnutrition, cardiac disorder,hepatic or renal impairment.  Raynaud'sdisease or previous administration of a pressor agent.$0$0Severeforms of the conditions arecontraindications (see sections 4.3 Contraindications and 5.1Pharmacodynamic properties). $0$0Ergometrinecan cause vasoconstriction and should therefore be used with caution inpatients with Raynauds Phenomenon. Treatment should be stopped if signs ofvasoconstriction develops.$0$0Cautionshould be exercised in the presence of malnutrition or following previous administrationof a pressor agent.$0$0 $0$0Syntometrinemay rarely give rise to widespreadvasoconstriction and rarely acute pulmonary oedema.$0$0Ergotalkaloids are substrates of CYP3A4.Theconcomitant use of Syntometrinewith strong CYP3A4 inhibitors such as macrolide antibiotics (e.g.troleandomycin, erythromycin, clarithromycin), HIV protease or reversetranscriptase inhibitors (e.g. ritonavir, indinavir, nelfinavir, delavirdine),or azole antifungals (e.g. ketoconazole, itraconazole, voriconazole) should beavoided, since this can result in an elevated exposure to methylergometrine andergot toxicity (vasospasm and ischemia of the extremities and other tissues).Caution should be exercised when Syntometrine is used concurrently with othervasoconstrictors or other ergot alkaloids. Concurrent use of vasoconstrictorsand Syntometrine after delivery during anesthesia may lead to severe postpartumhypertension. Methylergometrine may enhancethe vasoconstrictor/vasopressor effects of other drugs such as triptans (5HT1B/1Dreceptor agonists), sympathomimetics (including those in localanesthetics), beta-blockers or other ergot alkaloids (see section 4.5Interaction with other medicinal products and other forms of interaction).$0$0 $0$04.5       Interaction with other medicinal productsand other forms of interaction$0$0Interactions related toergometrine administration$0$0 $0$04.6       Fertility, pregnancy and lactation$0$0Breast-feeding$0$0Ergometrine derivatives are excreted in breast milkbut in unknown amounts. There is no specific data available for elimination ofergometrine partitioned in breast-milk. Ergometrine can inhibit prolactinsecretion and in turn can suppress lactation, so its repeated use should beavoided.$0$0Ergometrine issecreted into milk and the inhibitory effect of ergometrine on prolactin cancause a reduction in milk secretion. Syntometrine has the potential to causeserious adverse drug reactions in breastfed newborns/infants. Postpartum womenreceiving Syntometrine should avoid breastfeeding at least 12 hours after theadministration. Milk secreted during this period should be discarded.Breast-feeding should be discontinued in case where repeated postpartumadministration of Syntometrine is necessary. Drugs used to suppress lactation(e.g bromocriptine) can be taken 12 h after the Syntometrine injection.$0$0 $0$04.8       Undesirable effects$0$0$0$0$0$0System OrganClass$0$0$0$0Adverse drugreaction$0$0$0$0$0$0Immune system disorders$0$0$0$0Anaphylactic/ anaphylactoidreactions associated with dyspnoea, hypotension, collapse or shock$0$0$0$0$0$0Nervous system disorders$0$0$0$0Cerebrovascular accident: headache, dizziness$0$0$0$0$0$0Cardiac disorders$0$0$0$0myocardial infarction, coronary arteriospasm (seesection 4.4 Special warnings and precautions for use) bradycardia, cardiacarrhythmias, chest pain$0$0$0$0$0$0Vascular disorders$0$0$0$0hypertension$0$0$0$0$0$0Gastrointestinal disorders$0$0$0$0vomiting, nausea, abdominal pain$0$0$0$0$0$0Skin and subcutaneous tissue disorders$0$0$0$0rash, angioedema$0$0$0$0$0$0$0$0Immune systemdisorders: anaphylactoidreactions associated with dyspnoea, hypotension, collapse or shock$0$0Nervous systemdisorders: cerebrovascular accident: headache,dizziness$0$0Cardiacdisorders: myocardial infarction, coronary arteriospasm (see section 4.4Warnings and precautions for use) bradycardia,cardiac arrhythmias, chest pain $0$0Vasculardisorders: hypertension$0$0Gastrointestinaldisorders: vomiting, nausea,abdominal pain$0$0Skinand subcutaneous tissue disorders: rash$0$0$0$0Additionalinformation on the individual components$0$0$0$0Thefollowing ADRsreported with oxytocin may also occur with Syntometrine, even if not observedduring post marketing period.$0$0$0$0$0$0$0$0System organclass$0$0$0$0Adverse drugreaction$0$0$0$0$0$0$0$0Immune systemdisorders$0$0$0$0Anaphylacticreactions$0$0$0$0$0$0Skin andsubcutaneous tissue disorders$0$0$0$0Angioedema $0$0$0$0$0$04.9       Overdose$0$0Nocase of maternal intoxication with Syntometrine has been reported.  If such a case were to occurInthe event of maternal intoxication the most likely symptoms wouldbe those of ergometrine intoxication: nausea, vomiting, hypertension orhypotension, vasospastic reactions, respiratory depression, convulsions,coma.  Treatment wouldhave to be symptomatic.$0$0Incases of oral ingestion, although the benefit of gastric decontamination isuncertain, activated charcoal may be given to patients who present within 1hour of ingesting a toxic dose (more than 125 micrograms/kg in adults) or anyamount in a child or in adults with peripheral vascular disease, ischaemicheart disease, severe infection, or hepatic or renal impairment. Alternatively,gastric lavage may be considered in adults within 1 hour of ingesting apotentially life-threatening overdose.$0$0Inboth acute and chronic poisoning by all routes, attempts must be made tomaintain an adequate circulation to the affected parts of the body in order toprevent the onset of gangrene. In severe arterial vasospasm vasodilators suchas sodium nitroprusside by intravenous infusion have been given; heparin anddextran 40 have also been advocated to minimise the risk of thrombosis.Analgesics may be required for severe ischaemic pain.$0$0Accidentaladministration to the newborn infant has been reported (both published andunpublished) and has proved fatal.  Inthese accidental neonatal overdosage cases,symptoms such as respiratory depression, convulsions, cyanosis,oliguria, hypertonia and heart arrhythmia have been reported.  Treatment has been symptomatic in most cases,respiratory and cardiovascular support has been required.$0

Updated on 18 January 2017

File name

PIL_8531_769.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 January 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Correction of spelling/typing errors

Updated on 22 May 2015

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 section 4.8 to include adverse event reporting

Updated on 20 May 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 01 May 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6 - Pharmaceutical particulars

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

Free text change information supplied by the pharmaceutical company

Changes are highlighted in red text below:

2.      QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each 1ml ampoule contains 500 micrograms of Ergometrine Maleate and 5 International Units (equivalent to 8.5 micrograms) of Oxytocin.

 

Excipient with known effect:

Contains 2.76mg/mL (0.120 mmol/mL) of sodium.

 

For a full list of excipients, see section 6.1.

 

4.4       Special warnings and precautions for use

 

Syntometrine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.

 

6.1       List of excipients

Sodium chloride

Maleic acid

Water for injection

Chlorobutanol

Sodium acetate trihydrate

Acetic acid

Updated on 30 April 2014

Reasons for updating

  • Change of manufacturer
  • Change to further information section

Updated on 25 February 2014

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Change of ownership details below:

7.       MARKETING AUTHORISATION HOLDER

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

United Kingdom

 

8.       MARKETING AUTHORISATION NUMBER

PA 943/25/1

Updated on 19 February 2014

Reasons for updating

  • Change to marketing authorisation holder

Updated on 25 February 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions

Updated on 28 August 2012

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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • 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

As the SmPC for this product had not been updated since 1979, there are too many changes made to list them all individually. The entire document was revised to bring it up to date with current information availaible for the product.

Updated on 20 September 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 20 December 2010

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 07 July 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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

In section 1, the name of the medicinal product has been changed to:

Syntometrine 500 micrograms/5IU Solution for Injection

In section 2, the composition of the medicinal product has been changed to:

 

Each 1ml ampoule contains 500 micrograms of Ergometrine Maleate and 5 International Units (equivalent to 8.5 micrograms) of Oxytocin.

Updated on 04 August 2005

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 04 August 2005

Reasons for updating

  • Change to date of revision

Updated on 25 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 August 2003

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 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

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