Adequan 250 mg/ml Solution for Injection

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Polysulphated Glycosaminoglycan

Tersedia dari:

Daiichi Sankyo Altkirch SARL

Kode ATC:

QM01AX12

INN (Nama Internasional):

Polysulphated Glycosaminoglycan

Bentuk farmasi:

Solution for injection

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Horses

Area terapi:

Anti Inflammatory

Status otorisasi:

Authorized

Tanggal Otorisasi:

1996-01-05

Karakteristik produk

Revised: January 2015
AN: 01275/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Adequan 250 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE(S):
MG
Polysulphated Glycosaminoglycan (PSGAG)
250
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, pale yellow aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horse
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of lameness in horses due to traumatic or degenerative
aseptic joint disease.
4.3
CONTRAINDICATIONS
Do not use in animals with infected or actively inflamed joints or
with
severe degradation of joint cartilage.
Do not use in animals with known sensitivity to the active ingredient.
Do not use in cases of advanced renal or hepatic disease.
Do not use in pregnant animals.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
In the presence of an active joint inflammation, therapy with a
suitable anti-inflammatory agent should be given prior to intra-
articular treatment with Adequan. The anti-inflammatory
Revised: January 2015
AN: 01275/2014
Page 2 of 5
treatment should be discontinued as soon as possible since
steroidal and non-steroidal agents may contribute to the
degeneration of cartilage.
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Care should be taken to avoid accidental self-injection.
In the case of accidental eye or skin contact, wash the affected
area thoroughly with copious amounts of water. If irritation
persists, seek medical attention.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
After intra-articular injection, reactions in the joint, including
joint
oedema, may occur after the first injection and occasionally after
further injections.
Should an acute inflammation occur, postpone further injections.
If signs or symptoms of hy