Ceftriaxone sodium powder for solution for injection

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

ceftriaxone (ceftriaxone sodium)

Dostopno od:

Harbin Pharmaceutical Group Co.

Koda artikla:

J01DD04

INN (mednarodno ime):

ceftriaxone (ceftriaxone sodium)

Odmerek:

1000mg

Farmacevtska oblika:

powder for solution for injection

Enote v paketu:

(10) glass vial

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2018-04-11

Lastnosti izdelka

哈药集团制药总厂
HARBIN PHARMACEUTICAL GROUP CO., LTD General Pharm. Factory
CEFTRIAXONE SODIUM FOR INJECTION 1.0 G
Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of
interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
LEGAL STATUS
哈药集团制药总厂
HARBIN PHARMACEUTICAL GROUP CO., LTD General Pharm. Factory
CEFTRIAXONE SODIUM FOR INJECTION 1.0 G
1. NAME OF THE MEDICINAL PRODUCT
Ceftriaxone sodium for injection 1g vials.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1g vial contains 1g ceftriaxone as 1.19g hydrated disodium
ceftriaxone.
3. PHARMACEUTICAL FORM
Powder for solution for injection
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Ceftriaxone is indicated for the treatment of the following infections
when
known or likely to be due to one or more susceptible micro-organisms
(see
section 5.1) and when parenteral therapy is required:
Pneumonia.
septicaemia.
Meningitis.
Bone, skin and soft tissue infections.
Infections in neutropenic patients.
Gonorrhoea.
Peri-operative prophylaxis of infections associated with surgery.
Treatment may be started before the results of susceptibility tests
are known.
Consideration should be given to off