Hydrocortistab 25mg/1ml suspension for injection ampoules

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Hydrocortisone acetate

זמין מ:

Advanz Pharma

קוד ATC:

H02AB09

INN (שם בינלאומי):

Hydrocortisone acetate

כמות:

25mg/1ml

טופס פרצבטיות:

Suspension for injection

מסלול נתינה (של תרופות):

Intraarticular; Periarticular

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 10010202; GTIN: 5060064170694

מאפייני מוצר

OBJECT 1
HYDROCORTISTAB INJECTION 25 MG/ML
Summary of Product Characteristics Updated 07-Aug-2017 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Hydrocortistab Injection
Hydrocortisone Acetate 25mg/ml Suspension for Injection
2. Qualitative and quantitative composition
Hydrocortisone Acetate Ph Eur 2.5% w/v (25 mg/ml).
3. Pharmaceutical form
Suspension for injection.
4. Clinical particulars
4.1 Therapeutic indications
This medicine is indicated for the local treatment, by intra-articular
or periarticular injection, of arthritic
conditions such as rheumatoid arthritis and osteoarthritis when few
joints are involved. It is also suitable
for the symptomatic treatment, by local injection, of certain
non-articular inflammatory conditions such as
inflamed tendon sheaths and bursae.
This medicine is not suitable for the production of systemic effects.
4.2 Posology and method of administration
For intra-articular or periarticular injection. This medicine may also
be injected into non-articular tissues
(e.g. tendon sheaths/bursae).
Adults: 5-50 mg, depending on the size of the joint.
Children: 5-30 mg daily in divided doses.
Elderly: Steroids should be used cautiously in the elderly, since
adverse effects are enhanced in old age.
No more than three joints should be treated in one day. The injection
may be repeated at intervals of
about three weeks.
4.3 Contraindications
This medicine is contra-indicated in patients with known
hypersensitivity to any of the ingredients. It is
also contraindicated in patients with systemic infections (unless
specific anti-infective therapy is
employed) and in patients vaccinated with live vaccines.
Intra-articular and periarticular injections of this medicine is
contra-indicated when the joint or
surrounding tissues are infected. The presence of infection also
precludes injection into tendon sheaths
and bursae. This medicine must not be injected directly into tendons,
nor should it be injected into spinal
or other non-diarthrodial joints.
4.4 Special warnings and