Previron 200 mg/ml Solution for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Iron

Available from:

Laboratorios Hipra SA

ATC code:

QB03AC

INN (International Name):

Iron

Pharmaceutical form:

Solution for injection

Prescription type:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Pigs

Therapeutic area:

Mineral antianaemia

Authorization status:

Authorized

Authorization date:

2016-11-09

Summary of Product characteristics

Revised: November 2021
AN: 02259/2020 & 02260/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Previron 200 mg/ml solution for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Iron (III)
………............................................................
200.0 mg
(as gleptoferron……………………
532.6 mg)
EXCIPIENTS:
Phenol
...............................................................................
5.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Dark brown, slightly viscous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (piglets)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention of iron deficiency anaemia in piglets.
4.3
CONTRAINDICATIONS
Do not use in piglets suspected to suffer from deficiency of vitamin E
and/or
selenium.
Do not use in cases of hypersensitivity to the active substance.
Do not use in clinically diseased animals, especially not in case of
diarrhoea.
Do not administer intravenously.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: November 2021
AN: 02259/2020 & 02260/2020
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
It is advisable to stretch the skin at the injection site to minimise
leakage after
withdrawal of the needle. Normal aseptic injection techniques should
be practised.
Avoid the introduction of contamination during use.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
People with known hypersensitivity to the active substance
(gleptoferron) or with
hemochromatosis should avoid contact with the veterinary medicinal
product.
Take care to avoid accidental self-injection and contact with mucous
membranes._ _
In case of accidental self-injection, seek medical advice immediately
and show the
package leaflet or the label to the physician.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY