Gleptoferron

Main information

  • Trade name:
  • Gleptoferron Labiana 200 mg/ ml Solution for Injection
  • INN (International Name):
  • Iron
  • Pharmaceutical form:
  • Solution for injection
  • Prescription type:
  • POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Gleptoferron Labiana 200 mg/ml Solution for Injection
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Pigs
  • Therapeutic area:
  • Mineral antianaemia

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 32112/4001
  • Authorization date:
  • 24-10-2017
  • Last update:
  • 19-01-2018

Summary of Product characteristics: dosage, interactions, side effects

Revised: February 2018

AN: 01770/2017

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Gleptoferron Labiana 200 mg/ml Solution for Injection

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active Sustance:

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.

A dark brown, slightly viscous, sterile, colloidal, aqueous solution

4.

CLINICAL PARTICULARS

4.1.

Target species

Neonatal pigs.

4.2.

Indications for use, specifying the target species

For the prevention and treatment of iron deficiency anaemia.

4.3.

Contraindications

Do not use in case of:

Hypersensitivity to gleptoferron complex or any of the excipients.

In animals with hepatic and/or renal disease.

Do not administer to piglets suspected to suffer from deficiency of vitamin E

and/or selenium.

Do not use in clinically diseased animals, especially not in case of diarrhoea.

4.4.

Special warnings for each target species

The sachet in the low-density polyethylene collapsible bottles with a nominal

capacity of 100 ml and 200 ml should not be opened until the product is required

for use.

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Revised: February 2018

AN: 01770/2017

4.5.

Special precautions for use

Special precautions for use in animals

Normal aseptic injection techniques should be practised.

Avoid the introduction of contamination during use.

It is advisable to stretch the skin at the injection site to minimize leakage after

withdrawal of the needle.

Special precautions to be taken by the person administering the veterinary

medicinal product to animals

People

with

known

hypersensitivity

iron

dextran,

those

with

haemochromatosis should avoid contact with the product.

Care should be taken to avoid accidental self-injection, as well as contact with the

eyes and mouth.

In case of accidental injection, seek medical advice immediately and show the

package leaflet or label to the physician.

Wash hands after use.

4.6.

Adverse reactions (frequency and seriousness)

There are normally no undesirable side effects associated with the use of the

product. Sometimes a slight staining of muscle tissue may occur at the

administration site. Occasional deaths have occurred in piglets following the

administration of parenteral

iron preparations.

These deaths have been

associated with maternal dietary deficiency of vitamin E and/or selenium.

Very rarely piglet deaths have been reported which have been attributed to an

increased susceptibility to infection due to temporary blocking of the

reticuloendothelial system.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reaction(s)

during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals )

- rare (more than 1 but less than 10 animals in 10,000 animals).

4.7.

Use during pregnancy, lactation or lay

Not applicable.

4.8.

Interaction with other medicinal products and other forms of

interaction

There are no known interactions between the product and other medicaments.

There are no known other forms of interaction. Do not mix with other products

prior to administration.

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Revised: February 2018

AN: 01770/2017

4.9.

Amount to be administered and administration route

Use only automatic syringe equipment. Swab the septum before use. The product

is administered as a single 1 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 should be administered as follows:

For the prevention of iron deficiency anaemia: not later than the third day of life.

For the treatment of iron deficiency anaemia: at the onset of clinical anaemia

normally within the first three weeks of life.

4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary

Over dosage with the product is unlikely to result in signs of intoxication.

4.11. Withdrawal period

Meat and offal: zero days.

5.

PHARMACOLOGICAL PROPERTIES

ATCVet Code: QBO3AC91

Pharmacotherapeutic group: Antianaemic preparations, Iron preparations, Iron

trivalent, parenteral preparations

5.1.

Pharmacodynamic properties

Injectable iron-carbohydrate complexes are established haematinic agents in

veterinary medicine. Following intramuscular injection, the complex is absorbed

and metabolised to release the iron for utilisation and/or storage in accordance

with the nutritional status of the animal. In iron deficient states, the iron is utilised

for the synthesis of haemoglobin and other iron-containing molecules. Excess

iron is stored principally in the liver.

5.2.

Pharmacokinetic particulars

Absorption of the product has been shown to be rapid. Over 95% of the

administered iron (1mL/200 mg iron administered at three days of age) was

absorbed by 24 hours after injection.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients

Phenol

Sodium chloride

Water for injections

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Revised: February 2018

AN: 01770/2017

6.2.

Major Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not

be mixed with other veterinary medicinal products

6.3.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life after opening the immediate packaging: 28 days

6.4.

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5.

Nature and composition of immediate packaging

Low-density polyethylene collapsible bottles (LDPE) with a nominal capacity

of 100 ml and 200 ml closed with a chlorobutyl rubber closure and an

aluminium ring seal. Each bottle is sealed in a sachet. The sachet is a

polyester/polyethylene laminate. Do not open the sachet until ready to use

the veterinary medicinal product.

High-density polyethylene collapsible bottles (HDPE) with a nominal

capacity of 100 ml and 200 ml closed with a chlorobutyl rubber closure and

an aluminium ring seal.

Carton box with 1, 10, 20 or 40 vials of 100 ml or 1, 10 or 20 vials of 200 ml.

Not all pack sizes may be marketed

6.6

Special precautions for the disposal of unused veterinary medicinal

product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such

veterinary medicinal products should be disposed of in accordance with local

requirements.

7.

MARKETING AUTHORISATION HOLDER

Labiana Life Sciences S.A.

c/Venus 26

Can Parellada Industrial

08228 Terrassa

Barcelona

Spain

8.

MARKETING AUTHORISATION NUMBER

Vm 32112/4001

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AN: 01770/2017

9.

DATE OF FIRST AUTHORISATION

24 October 2017

10.

DATE OF REVISION OF THE TEXT

February 2018

Approved 20 February 2018

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