Gleptosil 200 mg/ml Solution for Injection

国: イギリス

言語: 英語

ソース: VMD (Veterinary Medicines Directorate)

有効成分:

Iron

から入手可能:

Ceva Animal Health Ltd

ATCコード:

QBO3AC

INN（国際名）:

Iron

医薬品形態:

Solution for injection

処方タイプ:

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

治療群:

Pigs

治療領域:

Mineral antianaemia

認証ステータス:

Authorized

承認日:

1995-08-30

製品の特徴

Revised: October 2022
AN: 01664/2022
Page 1 of 4
SUMMARY OF PRODUCTS CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Gleptosil 200mg/ml solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Iron
(as gleptoferron complex).
EXCIPIENTS:
Phenol
For the full list of excipients see
Section 6.1
200 mg/ml
498 mg/ml)
5 mg/ml
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
Neonatal pigs:
For the prevention and treatment of iron deficiency anaemia.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Normal aseptic injection techniques should be practised.
ii)
Special precautions for the person administering the veterinary
medicinal product to animals
Revised: October 2022
AN: 01664/2022
Page 2 of 4
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
The sachet should not be opened until the product is required
for use.
Avoid the introduction of contamination during use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
There are normally no undesirable side effects associated with the use
of
the product. Its use does not result in permanent staining of the
injected
muscle tissue.
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.
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 injectio