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MANNITOL SUSPENSION VEHICLE FOR DE-CAPEPTYL SR INJECTION

Active substance(s): LANREOTIDE ACETATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Mannitol Solution 0.8 % for Injection.
Other licensed names
Mannitol Suspension Vehicle for De-Capeptyl SR Injection.
Note (for use only with the De-Capeptyl SR product range).

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
No active ingredient.

3

PHARMACEUTICAL FORM
A clear, colourless, sterile liquid.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Not applicable.

4.2

Posology and method of administration
None stated.

4.3

Contraindications

None stated.

4.4

Special warnings and precautions for use
None stated.

4.5

Interaction with other medicinal products and other forms of interaction
None stated.

4.6

Pregnancy and lactation
None stated.

4.7

Effects on ability to drive and use machines
None stated.

4.8

Undesirable effects
None stated.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9

Overdose
None stated.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
None stated.

5.2

Pharmacokinetic properties
None stated.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Mannitol,
Water for injections

6.2

Incompatibilities
None stated.

6.3

Shelf life
3 years.
After reconstitution, chemical and physical in use stability has been
demonstrated for 24 hours at 25°C. 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 2 to 8°C.

6.4

Special precautions for storage
None

6.5

Nature and contents of container
-A 2 ml type 1glass ampoule containing a clear, colourless, sterile liquid.
-A 3 ml type 1 glass ampoule containing a clear, colourless, sterile liquid.

6.6

Special precautions for disposal
For use in combination with other products to be injected in accordance with
instructions accompanying those products.

7

MARKETING AUTHORISATION HOLDER
Ipsen Limited
190 Bath Road
Slough
SL1 3XE
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 34926/0008

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13 November 2001

10

DATE OF REVISION OF THE TEXT
23/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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