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8-ARGININE-VASOPRESSIN POWDER (SYNTHETIC) BULK MATERIAL

Active substance(s): VASOPRESSIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
8-Arginine Vasopressin (Synthetic)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
8-Arginine Vasopressin (Synthetic)

3.

PHARMACEUTICAL FORM
Bulk material (powder) for importation as a biological raw material.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
Not applicable, bulk material for importation as a biological raw material, (for
manufacture of Pitressin ampoules (PL 12762/0024)

4.2.

Posology and Method of Administration
Not applicable, bulk material for importation as a biological raw material, (for
manufacture of Pitressin ampoules. (PL 12762/0024)

4.3

Contraindications
Not applicable, bulk material for importation as a biological raw material, (for
manufacture of Pitressin ampoules. (PL 12762/0024)

4.4.

Special Warnings and Special Precautions for Use
Not applicable, bulk material for importation as a biological raw material, (for
manufacture of Pitressin ampoules. (PL 12762/0024)

4.5. Interactions with other Medicinal Products and other Forms of
Interaction
Not applicable, bulk material for importation as a biological raw material, (for
manufacture of Pitressin ampoules. (PL 12762/0024)

4.6.

Pregnancy and Lactation
Not applicable, bulk material for importation as a biological raw material, (for
manufacture of Pitressin ampoules. (PL 12762/0024)

4.7.

Effects on Ability to Drive and Use Machines
Not applicable, bulk material for importation as a biological raw material, (for
manufacture of Pitressin ampoules. (PL 12762/0024)

4.8.

Undesirable Effects
Not applicable, bulk material for importation as a biological raw material, (for
manufacture of Pitressin ampoules. (PL 12762/0024)

4.9.

Overdose
Not applicable, bulk material for importation as a biological raw material, (for
manufacture of Pitressin ampoules. (PL 12762/0024)

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Vasopressin is a potent peripheral vasoconstrictor. Vasopressin has a direct
action on the kidney. It also constricts peripheral vessels and causes
contraction of the smooth muscle of the intestine, gall bladder and urinary
bladder.

Due to rapid inactivation by a number of enzymes that cleave the peptide at
several sites, the effects of vasopressin are relatively short lived unless given
by continuous infusions.

5.2.

Pharmacokinetic Properties
Not applicable, bulk material for importation as a biological raw material, (for
manufacture of Pitressin ampoules. (PL 12762/0024)

5.3.

Pre-clinical Safety Data
Not applicable, bulk material for importation as a biological raw material, (for
manufacture of Pitressin ampoules.(PL 12762/0024)

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
None.

6.2.

Incompatibilities
Not applicable, bulk material for importation as a biological raw material, (for
manufacture of Pitressin ampoules. (PL 12762/0024)

6.3.

Shelf Life
12 months.

6.4.

Special Precautions for Storage
Store over a dessicant in a tightly closed glass container.

6.5.

Nature and Contents of Container

Tightly closed flint glass bottle with a screw cap over dessicant of Drierite.

6.6.

Instructions for Use/Handling
None

7

MARKETING AUTHORISATION HOLDER
Mercury Pharmaceuticals Ltd,
Capital House,
85 King William Street,
London EC4N 7BL, UK

8.

MARKETING AUTHORISATION NUMBER(S)
PL 12762/0018

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/03/2010

10

DATE OF REVISION OF THE TEXT
21/03/2014

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