Imposil 10% w/v Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Iron

Available from:

Alstoe Ltd (Alstoe Animal Health)

ATC code:

amended)

INN (International Name):

Iron

Authorization status:

Expired

Summary of Product characteristics

Revised: February 2010
(ATCVet code amended)
SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Imposil 10% w/v solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Iron
(as macromolecular complex of iron
hydroxide and dextran glucoheptonic acid
EXCIPIENTS
Phenol .
For a full list of excipients see Section 6.1
10.0 %w/v
28.4%w/v)
0.50%w/v
3.
PHARMACEUTICAL FORM
Solution for injection
Dark brown slightly viscous solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Neonatal pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
NEONATAL PIGS:
For the prevention and treatment of iron deficiency anaemia.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings are necessary.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Revised: February 2010
(ATCVet code amended)
Revised: February 2010
(ATCVet code amended)
Normal aseptic injection techniques should be practised. Do not mix
with other products prior to injection.
ii.
Special precautions for the person administering the veterinary
medicinal product to animals
Care should be taken to avoid accidental self injection. In the event
of
accidental self injection seek medical advice. Wash hands after use.
iii.
Other precautions
none
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Piglets born to sows that are deficient in Vitamin E/selenium are
prone to
suffer adverse reactions, including death, following administration of
any form
of iron injection. Such occurrences are rare. There is no known
antidote.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Not applicable
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.9
AMOUNT(S) TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Swab the septum before use. Use a dry sterile needle and syringe.
Imposil is
administered as a single 2 mL (200 mg iron) dose by deep intramuscular
injection into the hind limb midway between the stifle joint and the
base of the
tail. Injections