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NutropinAq 10mg/2mL

Last Updated on eMC 08-Jul-2013 View document  | Ipsen Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 08-Jul-2013 and displayed until Current

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 25-Apr-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0In Section 2 Qualitative and Quantitative composition:$0$0The following information has been added:$0$0One ml contains 5 mg ofsomatropin*$0$0In Section 4.1 Therapeutic indications:$0$0The indications have been split into subheadings(i.e. paediatric population and adult population).$0The following information in bold has been added:$0$0Long-term treatment of girls from 2 years old with growthfailure associated with Turner syndrome.$0$0Please note: The licensed age has not changed, butis now more explicit.$0$0The following information has been removed fromsection 4.4 (Special warnings and precautions for use), and has been added withinthis section:$0$0In adults with growth hormonedeficiency the diagnosis should be established depending on the etiology:$0$0Adult-onset: The patient musthave growth hormone deficiency as a result of hypothalamic or pituitary disease, and atleast one other hormone deficiency diagnosed (except for prolactin). Test for growthhormone deficiency should not be performed until adequate replacement therapy for otherhormone deficiencies have been instituted.$0$0Childhood-onset: Patients whohave had growth hormone deficiency as a child should be retested to confirm growthhormone deficiency in adulthood before replacement therapy with NutropinAq is started.$0$0In Section 4.2 Posology and method of administration:$0$0The following information has been added:$0$0Precaution to be taken beforemanipulating or administering the product$0$0NutropinAq is supplied as amulti-dose solution. After removal from the refrigerator, if the solution is cloudy, the contentmust not be injected. Gently swirl. Do not shake vigorously as it could denature theprotein. NutropinAq is intended for use only with the NutropinAq Pen.$0$0In Section 4.4 Special warnings and precautions for use:$0$0Information was removed from this section and wasmoved to section 4.1. The warnings and precautions are now listed undersubheadings.$0$0The following was added to this section:$0$0Excipients$0$0This medicinal productcontains less than 1 mmol sodium (23 mg) per cartridge, i.e. essentially ‘sodium- free’.$0$0In Section 4.5 Interaction with other medicinal products and other formsof interaction:$0$0The following information has been added:$0$0In patients with diabetesmellitus requiring drug therapy, the dose of insulin and/or oral hypoglycemic medicinal productmay require adjustment when somatropin therapy is initiated (see section 4.4).$0$0In Section 4.6 Fertility, pregnancy and lactation:$0$0The information within this section has now been capturedunder subheadings. The following now reads (new information bolded):$0$0Pregnancy$0$0There are no or limited data from the use of somatropin in pregnantwomen. Thus, the risk for humans isunknown. Animal studies are insufficient with respect to reproductive toxicity(see section 5.3).$0$0Somatropin is not recommended during pregnancy and should bediscontinued if pregnancy occurs. Duringpregnancy, maternal somatropin will largely be replaced by placental growth hormone.$0$0Breast-feeding$0$0It is unknown whether somatropin/metabolitesare excreted in human milk. Noanimal data are available. Caution should be exercised while breast-feeding during treatment with NutropinAq.$0$0Fertility$0$0The effect of NutropinAq has not been assessed in conventional animalfertility studies (see section 5.3) or clinical studies.$0$0In Section 4.7 Effects on ability to drive and use machines:$0$0The following information has been removed:$0$0No studies on the effects ofNutropinAq on the ability to drive and use machines have been performed.$0$0In Section 4.8 Undesirable effects:$0$0The following information in bold has been added:$0$0Summary of the safety profile$0$0The adverse reactions reportedin both adults and children receiving Nutropin, NutropinAq, Nutropin Depot or Protropin (somatrem)are listed in the table below, based on experience from clinical trials all approved indications (642 patients)and post-marketing sources which included a surveillancesurvey (National Cooperative Growth Study [NCGS] in 35,344patients). Approximately 2.5 % of patients from the NCGS have experienced drugrelated adverse reactions.$0$0Additional information regarding the most frequentand serious reported reactions is mentioned within newly added text, and reference toadverse reactions reported within clinical trials and in the post marketingsurveillance survey are also discussed.$0$0The System Organ Classes (SOCs) within thetabulated summary of adverse reactions have been re-ordered.$0$0The following adverse reaction was added to theRespiratory thoracic and mediastinal disorders SOC:$0$0Uncommon: Adenoidalhypertrophy$0$0An amendment was made to the following adversereaction within the Musculoskeletal and connective tissue disorders SOC:$0$0Epiphysiolysis was amended toSlipped capital femoral epiphysis$0$0The following sections were added:$0$0- Description of selected adverse reactions (i.e.neoplasms, intracranial hypertension, hypothyroidism, glycaemic control,injection site reactions and slipped capital femoral epiphysis).$0$0- Reporting of suspected adverse reactions$0$0In Section 4.9 Overdose:$0$0The following was added:$0$0Management$0$0Treatment is symptomatic andsupportive. There is no antidote for somatropin overdose. It is recommended to monitorthyroid function following an overdose.$0$0In Section 5.1 Pharmacodynamic properties:$0$0The following in bold has been added:$0$0Pharmacotherapeutic group: Pituitary and hypothalamic hormones andanaloguesSomatropin and analogues, ATCCode: H01 AC 01$0$0Mechanism of action$0$0Somatropin stimulates growthrate and increases adult height in children who lack endogenous growth hormone and in children who have growth failure dueto Turner Syndrome or CRI.$0$0The following section has been added:$0$0Clinical efficacy and safety$0$0In Section 5.2 Pharmacokinetic properties:$0$0The section titled “Characteristics in patients” hasbeen amended to “Special population”, and was updated to include sub headings. Newinformation is provided within the following sub headings:$0$0- Paediatric population$0$0- Older people$0$0- Race$0$0- Gender$0$0In Section 5.3 Preclinical data:$0$0This section has been expanded.$0$0In Section 6.6 Special precautions for disposal:$0$0The following has been added:$0$0Any unused medicinal product or waste materialshould be disposed of in accordance with local requirements.$0

Updated on 20-Mar-2012 and displayed until 08-Jul-2013

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 02-Mar-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.3 Contraindications:$0The following information has been deleted "Growth hormone should not be used in patients with active neoplasm. NutropinAq therapy should be discontinued if evidence of tumour growth develops."$0$0The following information has been added "Somatropin must not be used where there is any evidence of activity of a tumour. Intracranial tumours must be inactive and anti-tumour therapy must be completed prior to starting GH therapy. Treatment should be discontinued if there is evidence of tumour growth."$0$0$0$0$0Section 4.4 Special warnings and precautions for use:$0$0The following information has been added "The maximum recommended dose should not be exceeded (see section 4.2)."$0

Updated on 05-May-2011 and displayed until 20-Mar-2012

Reasons for adding or updating:

  • Change to section 10 date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data

Date of revision of text on the SPC: 14-Apr-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.4 Special warnings and precautions for use: the following additional information added - 

Patients with pre-existing tumours or growth hormone deficiency secondary to an intracranial lesion should be examined routinely for progression or recurrence of the underlying disease process. In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm. Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms.

Somatropin therapy is not indicated in diabetic patients with active proliferative or severe non-proliferative retinopathy.

Leukaemia has been reported in a small number of growth hormone deficient patients treated with growth hormone. A causal relationship to somatropin therapy has not been established.

Pancreatitis in children
Children treated with somatropin have an increased risk of developing pancreatitis compared to adults treated with somatropin. Although rare, pancreatitis should be considered in somatropin-treated children who develop abdominal pain.

In section 4.8 Undesirable effects - further information added and section reformatted into a table with frequencies of adverse events.

In section 5.3 Preclinical safety data - the following information added - Carcinogenecity, mutagenicity and reproduction studies have not been conducted with NutropinAq.

Updated on 28-Feb-2011 and displayed until 05-May-2011

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 24-Jan-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.5 - following text added:
In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked requiring glucocorticoid replacement therapy. In addition, patients treated with glucocorticoid replacement therapy for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses, following initiation of somatropin treatment.

Updated on 08-Apr-2010 and displayed until 28-Feb-2011

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 29-Jul-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to the MAH from Ipsen Ltd to Ipsen Pharma

Updated on 02-Feb-2007 and displayed until 08-Apr-2010

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Oct-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Due to detailed changes to this SPC, please copy and paste the following url into your web browser to view the change details:
 

Updated on 25-Jul-2005 and displayed until 02-Feb-2007

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text
  • Pending awaiting re-submission

Updated on 22-Jun-2005 and displayed until 25-Jul-2005

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Updated on 08-Feb-2005 and displayed until 22-Jun-2005

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use

Updated on 29-Mar-2004 and displayed until 08-Feb-2005

Reasons for adding or updating:

  • New SPC for new product

Company contact details

Ipsen Ltd

Company image
Address

190 Bath Road, Slough, Berkshire, SL1 3XE

Fax

+44 (0)1753 627 778

Medical Information e-mail
Telephone

+44 (0)1753 627 777

Medical Information Direct Line

+44 (0)1753 627 777

Customer Care direct line

+44 (0)1753 627 627

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

somatropin

Legal categories

POM - Prescription Only Medicine

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