Marion powder for solution for injection/infusion

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

ceftriaxone (ceftriaxone sodium)

Disponibil de la:

Anfarm Hellas S.A.

Codul ATC:

J01DD04

INN (nume internaţional):

ceftriaxone (ceftriaxone sodium)

Dozare:

1000mg

Forma farmaceutică:

powder for solution for injection/infusion

Unități în pachet:

glass vial

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2022-04-12

Prospect

PACKAGE LEAFLET – INFORMATION FOR THE PATIENT
MARION POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G
MARION POWDER AND SOLVENT FOR SOLUTION FOR I.M. INJECTION 1G
CEFTRIAXONE (AS CEFTRIAXONE SODIUM)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Marion is and what it is used for
2.
What you need to know before you are given MARION
3.
How MARION is given
4.
Possible side effects
5.
How to store MARION
6. Contents of the pack and other information
1.
WHAT MARION IS AND WHAT IT IS USED FOR
MARION
is an antibiotic given to adults and children (including newborn
babies). It
works by killing bacteria that cause infections. MARION contains a
medicine called
ceftriaxone. It belongs to a group of medicines called cephalosporins.
MARION
is used to treat infections of
•
the brain (meningitis).
•
the lungs.
•
the middle ear.
•
the abdomen and abdominal wall (peritonitis).
•
the urinary tract and kidneys.
•
bones and joints.
•
the skin or soft tissues.
•
the blood.
•
the heart.
It can be given:
•
to treat specific sexually transmitted infections (gonorrhoea and
syphilis).
•
to treat patients with low white blood cell counts (neutropenia) who
have fever
due to bacterial infection.
•
to treat infections of the chest in adults with chronic bronchitis.
•
to treat Lyme disease (caused by tick bites) in adults and children
including
newborn babies from 15 days of age.
•
to prevent infections during surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MARION
YOU MUST NOT

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT

MARION
_ _
Powder and Solvent for solution for I.M. injection 1g

MARION
_ _
Powder for solution for injection or infusion 1g
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

MARION
_ _
Powder and Solvent for solution for I.M. injection 1g:
Each vial contains ceftriaxone sodium equivalent to ceftriaxone 1g.
Each ampoule of
solvent contains lidocaine hydrochloride 35mg, water for injection qs
3.5ml

MARION Powder for solution for injection or infusion 1g:
Each vial contains ceftriaxone sodium equivalent to ceftriaxone 1g
3. PHARMACEUTICAL FORM
Powder and solvent for solution for I.M. injection
Powder for solution for injection or infusion
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ceftriaxone is indicated for the treatment of the following infections
in adults and children
including term neonates (from birth):
•
Bacterial Meningitis
•
Community acquired pneumonia
•
Hospital acquired pneumonia
•
Acute otitis media
•
Intra-abdominal infections
•
Complicated urinary tract infections (including pyelonephritis)
•
Infections of bones and joints
•
Complicated skin and soft tissue infections
•
Gonorrhoea
•
Syphilis
•
Bacterial endocarditis
Marion may be used:
For treatment of acute exacerbations of chronic obstructive pulmonary
disease in adults
For treatment of disseminated Lyme borreliosis (early (stage II) and
late (stage III)) in adults and
children including neonates from 15 days of age
For pre-operative prophylaxis of surgical site infections
In the management of neutropenic patients with fever that is suspected
to be due to a bacterial
infection
In the treatment of patients with bacteraemia that occurs in
association with, or is suspected to be
associated with, any of the infections listed above
Marion should be co-administered with other antibacterial agents
whenever the possible range of
causative bacteria would not fall within its spectrum (see section
4.4).
Consideration should be given to official guidel