欣得泰凍晶注射劑0.25毫克

Kraj: Tajwan

Język: chiński

Źródło: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Składnik aktywny:

CETRORELIX ACETATE

Dostępny od:

台灣默克股份有限公司 台北市內湖區堤頂大道2段89號6樓 (23526610)

Kod ATC:

H01CC02

Forma farmaceutyczna:

凍晶注射劑

Skład:

CETRORELIX ACETATE (9200042810) (0.26-0.27mg)MG

Sztuk w opakowaniu:

小瓶裝;;附等支數1公撮注射針筒裝溶劑

Klasa:

製　劑

Typ recepty:

限由醫師使用

Wyprodukowano przez:

Abbott Biologicals B.V. VEERWEG 12, 8121 AA OLST, THE NETHERLANDS NL

Dziedzina terapeutyczna:

cetrorelix

Wskazania:

預防接受卵巢強效刺激排卵治療的患者，早發性的排出不成熟的卵。

Podsumowanie produktu:

有效日期: 2026/08/01; 英文品名: CETROTIDE 0.25MG

Data autoryzacji:

2001-08-01

Ulotka dla pacjenta

Based on EU SmPC verion 03/10/2019 and CCDSv4 (Cetrotide)
CETROTIDE 0.25 MG
powder and solvent for solution for injection
1. NAME OF THE MEDICINAL PRODUCT
CETROTIDE 0.25 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 0.25 mg cetrorelix (as acetate).
After reconstitution with the solvent provided, each ml of the
solution contains 0.25 mg cetrorelix.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Appearance of the powder: white lyophilisate
Appearance of the solvent: clear and colourless solution
The pH of the reconstituted solution is 4.0 – 6.0
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of premature ovulation in patients undergoing a controlled
ovarian stimulation, followed by oocyte pick-up
and assisted reproductive techniques.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cetrotide should only be prescribed by a specialist experienced in
this field.
Posology
The first administration of Cetrotide should be performed under the
supervision of a physician and under conditions
where treatment of possible allergic/pseudo-allergic reactions
(including life-threatening anaphylaxis) is immediately
available. The following injections may be self-administered as long
as the patient is made aware of the signs and
symptoms that may indicate hypersensitivity, the consequences of such
a reaction and the need for immediate medical
intervention.
The contents of 1 vial (0.25 mg cetrorelix) are to be administered
once daily, at 24 h intervals, either in the morning or in
the evening. Following the first administration, it is advised that
the patient be kept under medical supervision for
30 minutes to ensure there is no allergic/pseudo-allergic reaction to
the injection.
_ _
_Elderly _
There is no relevant use of Cetrotide in the geriatric population.
_ _
_Paediatric population _
There is no relevant use of Cetrotide in the paediatric population.
Method of administration
Cetroti