Summary of Product Characteristics
last updated on the eMC:
03/11/2010
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 03/11/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 3 - Pharmaceutical form
-
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 - Pregnancy and Lactation
-
Change to section 4.8 - Undesirable Effects
-
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 6.2 - 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 - Instructions for use, handling and disposal
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 30-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Changes made to various sections of the document:
Words in bold have been added to the text in the updated version
Section 1:
Apomorphine hydrochloride 10mg/ml solution for injection/infusion
Section 2:
Each ml contains 10mg apomorphine hydrochloride
2ml contains 20mg apomorphine hydrochloride
5ml contains 50mg apomorphine hydrochloride
Sodium metabisulphite 1 mg/ml
Sodium 0.3 mg/ml (maximum)
For a full list of excipients, see section 6.1
Section 3:
Solution for injection/infusion
A clear colourless to pale yellow solution.
pH 3 - 4
Section 4.2:
FIRST PARAGRAPH
... continuous subcutaneous infusion by minipump and/or syringe driver.
THIRD PARAGRAPH UNDER "Determination of threshold dose"
...a second dose of 2mg apomorphine HCl (0.2ml) can be given subcutaneously after at least 40 minutes and the parient observed for a for an adequate response for a further 30 minutes. In place of: "is injected subcutaneously and the patient observed for a for an adequate response for a further 30 minutes."
FIRST PARAGRAPH UNDER "Continuous Infusion"
... continuous subcutaneous infusion by minipump and/or syringe-driver as follows:
THIRD PARAGRAPH UNDER "Continuous Infusion"
The above volumes are for undiluted apomorphine hydrochloride 10mg.ml. Volumes must be adjusted to allow for dilution undertaken prior to use.
To be put between the 2nd and 3rd paragraphs on the previous version
Section 4.4:
Since apomorphine, especially at high dose, may have the potential for QT prolongation, caution should be exercised when treating patients at risk for torsades de pointes arrhythmia.
Between 2nd and 3rd paragraphs on previous version.
Apomorphine is associated with local subcutaneous effects. These can sometimes be reduced by the rotation of injection sites or possibly by the use of ultrasound (if available) to areas of nodularity and induration.
Between 3rd and 4th paragraphs on previous version.
CAUTION: Apomorphine should not be spilled on clothing or household surfaces and textiles as spillages may turn green.
At the end of the section, just before "Interaction with other medicinal products and other forms of interactions"
Section 4.5:
It is recommended to avoid the administration of apomorphine with otherd rugs known to prolong the QT interval.
At the beginning of the section "Interaction with other medicinal products and other forms of interactions", before the 1st paragraph on the previous version
Section 4.6:
Re-wording of entire "Pregnancy" section to:
There is no experience of apomorphine usage in pregnant women.
Animal reproduction studies do not indicate any teratrogenic effects, but doses given to rats which are toxic to the mother can lead to failure to breathe in the newborn.
The potential risk for humans is unknown (see section 5.3).
Apomorphine hydrochloride should not be used during pregnancy unless clearly necessary.
A replacement of "However, breast-feeding should be avoided during apomorphine therapy." in the "Lactation" section to:
A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with apomorphine should be made taking into account the benefit of breast-feeding to the child and the benefit of apomorphine to the woman.
Section 4.8:
Descriptions of undesirable effects are removed, leaving just the headings e.g. Very common (> 1/10)
Table has been created to organise the list of undesirable effects and their frequency.
Section 5.2:
The metabolism of apomorphine is by glucurondation and sulphonation to at least ten per cent of the total; other pathways have not been described.
To replace: The metabolism of apomorphine in humans does not show enantiomer interconversion nor methylation into (iso)apocodeine. Approximately ten per cent of the metabolism is by glucuronidation and sulphonation.
The effect of apomorphine on reproduction has been investigated in rats. Apomorphine was not teratogenic in this species, but it was noted that doses which are toxic to the mother can cause loss of maternal care and faliure to breathe in the newborn. No carcinogenity studies have been performed.
To replace: There are no data on fertility and embryo-foetal toxicity. No carcinogenicity studies have been performed.
Section 6.1:
Sodium metabisulphite (E223)
Hydrochloric acid (37%) for pH adjustment
Sodium hydroxide (99%) for pH adjustment
Water for Injections
Section 6.2:
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
To replace: As with all parenteral solutions, incompatibility of addictive medications with the solution must be assessed before addition. In the absence of compatibility studies, this solution must not be mixed with other medicinal products, except sodium chloride 0.9% and Water for Injections.
Section 6.3:
... Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and 25°C when the product is diluted with sodium chloride 0.9% injection or Water for Injections in polypropylene syringes. From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2ºC to 8°C, unless opening and dilution has taken place in controlled and validated aseptic conditions.
To replace: 24 hours
Section 6.4:
Remove the rest of the paragraph from under: "Do not store above 25°C. Keep the ampoules in the outer carton, in order to protect from light."
Section 6.5:
Not all pack sizes may be marketed
To be added under the other paragraphs.
Section 6.6
...compatible with sodium chloride solution 9mg/ml (0.9%) solution...#
Section 10
revision date change
|
|
Updated on 06/07/2009 and displayed until 03/11/2010
|
Reasons for adding or updating:
|
|
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
