Marion powder and solvent for solution for i/m injection

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

ceftriaxone (ceftriaxone sodium)

Dostupno od:

Anfarm Hellas S.A.

ATC koda:

J01DD04

INN (International ime):

ceftriaxone (ceftriaxone sodium)

Doziranje:

1000mg

Farmaceutski oblik:

powder and solvent for solution for i/m injection

Jedinice u paketu:

(1) glass vial and solvent in ampoule 3.5ml

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2016-10-17

Uputa o lijeku

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)
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START HAVING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If any of the side effects become serious or troublesome, or if you
notice any side
effects not listed in this leaflet, please tell your doctor or nurse.
IN THIS LEAFLET:
1. What MARION is and what it is used for
2. Before you are given MARION
3. How MARION is given
4. Possible side effects
5. How to store MARION
6. Further 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. BEFORE YOU ARE GIVEN MARION
YOU MUST NOT BE GIVEN MARION IF:

You are allergic (hypersensitive) to ceftriaxone (the only ingredient
in MARION).

You are allergic to antibiotics called ‘cephalosporins’. These
include cefalexin,
cefaclor and cefuroxime.

You have had a SUDDEN OR SEVERE allergic react

Svojstava lijeka

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
Ceftriaxone 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.
Treatment may be started before the results of susceptibility tests
are known.
Ceftriaxone should be co-administered with other antibacterial agents
whenever the
possible range of causative bacteria would not