Sympagesic 500 mg/ml + 4 mg/ml Solution for Injection for Horses, Cattle, Pigs and Dogs

国: イギリス

言語: 英語

ソース: VMD (Veterinary Medicines Directorate)

有効成分:

Hyoscine Butylbromide, Metamizole sodium monohydrate

から入手可能:

Dechra Regulatory BV

ATCコード:

QA03DB04

INN（国際名）:

Hyoscine Butylbromide, Metamizole sodium monohydrate

医薬品形態:

Solution for injection

処方タイプ:

POM-V - Prescription Only Medicine – Veterinarian

治療群:

Cattle, Dogs, Horses, Pigs

治療領域:

Neurological Agent muscle relaxant

認証ステータス:

Authorized

承認日:

2019-05-21

製品の特徴

Unlimited Renewal: August 2023
AN: 01489/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sympagesic 500 mg/ml + 4 mg/ml solution for injection for horses,
cattle, pigs and
dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Metamizole sodium monohydrate
500.0 mg
(equivalent to 443 mg metamizole)
Hyoscine butylbromide
4.0 mg
(equivalent to 2.76 mg hyoscine)
EXCIPIENTS:
Phenol
5.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, yellowish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses, cattle, pigs, dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Horses, cattle, pigs, dogs: treatment of smooth muscle spasms and pain
associated
with underlying disorders of the gastro-intestinal tract, urogenital
system and bile
excretory organs.
Horses only: Spasmodic colics.
Cattle, pigs, dogs: Supportive therapy for acute diarrhoea and
gastroenteritis.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances or to
any of the
excipients.
Unlimited Renewal: August 2023
AN: 01489/2023
Page 2 of 6
Do not use in cases of:
- gastro-intestinal ulceration
- chronic gastro-intestinal disorders
- mechanic obstruction in the gastro-intestinal system
- paralytic ileus
- disorders of the haematopoietic system
- coagulopathies
- renal insufficiency
- tachyarrhythmia
- glaucoma
- prostate adenoma.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Due to the risk of anaphylactic shock, metamizole-containing solutions
should be
administered slowly when given intravenously.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
In a very small number of people, metamizole can cause reversible, but
potentially
serious agranulocytosis and other reactions such as skin allergy. Take
care to avoid
self-injection.
In case of accidental self-inje