Ondansetron-Asteria Inj. 8mg/4ml solution for i/m and i/v injection

দেশ: আর্মেনিয়া

ভাষা: ইংরেজি

সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

সক্রিয় উপাদান:

ondansetron (ondansetron hydrochloride dihydrate)

থেকে পাওয়া:

Hankook Korus Pharm Co.

এটিসি কোড:

A04AA01

INN (আন্তর্জাতিক নাম):

ondansetron (ondansetron hydrochloride dihydrate)

ডোজ:

2mg/ml

ফার্মাসিউটিকাল ফর্ম:

solution for i/m and i/v injection

প্যাকেজ ইউনিট:

(10) ampoules 4ml

প্রেসক্রিপশন টাইপ:

Prescription

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2017-07-10

তথ্য লিফলেট

To be prescribed
Marketing Authorization Holder
BSA
< 0.6m
2
Day 1
5mg/m
2
IV plus
2mg syrup after 12 hours
Days 2-6
2mg syrup
Every 12 hours
≥ 0.6m
2
to ≤1.2m
2
≤ 10 kg
>1.2m
2
5mg/m
2
IV plus
4mg syrup or tablet after 12 hours
5mg/m
2
IV or 8mg IV plus
8mg syrup or tablet after 12 hours
4mg syrup or tablet every 12 hours
8mg syrup or tablet
Every 12 hours
Body Weight
≤ 10kg
Day 1
Up to 3 doses of 0.15mg/kg IV every 4 hours
Days 2-6
2mg syrup Every 12 hours
> 10kg
Up to 3 doses of 0.15mg/kg IV every 4 hours
4mg syrup or tablet every 12 hours
78, Daepungsandan-ro, Daeso-myeon, Eumseong-gun, Chungcheongbuk-do,
Republic of Korea
Woori Venture Tower #201, 70, Seonyu-ro, Yeongdeungpo-ku, Seoul,
Republic of Korea
SOLUTION FOR IM / IV INJECTION
COMPOSITION
Each ampoule contains
Active ingredients :Ondansetron Hydrochloride
…………………………………………………….. 4mg/2mL
Ondansetron Hydrochloride
………………………………………………………………………….
8mg/4mL
Inactive ingredient : Sodium Chloride, Citric Acid Monohydrate, Sodium
Citrate, Water for injection
DESCRIPTION
Colorless, clear solution in transparent ampoule.
INDICATIONS & USAGE
_Adults_
Ondansetron-Asteria Inj. is indicated for the management of nausea and
vomiting induced by cytotoxic chemotherapy and radiotherapy.
Ondansetron-Asteria Inj. is also indicated for the prevention and
treatment of post-operative nausea and vomiting.
_Paediatric Population_
_Injection and oral formulations:_
Ondansetron-Asteria Inj. is indicated for the management of nausea and
vomiting induced by cytotoxic chemotherapy.
No studies have been conducted on the use of orally administered
ondansetron in the prevention or treatment of post-operative nausea
and vomiting; IV injection is recommended for this purpose.
ADMINISTRATION & DOSAGE
Ondansetron is available for oral, parenteral and rectal use to allow
the route of administration and dosing to be flexible.
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AN

পণ্য বৈশিষ্ট্য

Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Ondansetron-Asteria Inj. 8mg/4ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/ampoule
Use
1
Ondansetron hydrochloride
8mg
(as Ondansetron)
Active
ingredient
Excipient(s)
No.
Chemical Name
Quantity/ ampoule
Use
1
Sodium Chloride
20mg
Inactive
ingredient
2
Citric Acid monohydrate
1.0mg
Inactive
ingredient
3
Sodium citrate
0.6mg
Inactive
ingredient
4
Water for injection
q.s
Inactive
ingredient
3. PHARMACEUTICAL FORM
Solution for i/m and i/v injection
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Adults
Ondansetron-Asteria Inj. is indicated for the management of nausea and
vomiting induced by
cytotoxic chemotherapy and radiotherapy.
Ondansetron-Asteria Inj. is also indicated for the prevention and
treatment of post-operative
nausea and vomiting.
Paediatric Population
Injection and oral formulations:
Summary of Product Characteristics
Ondansetron-Asteria Inj. is indicated for the management of nausea and
vomiting induced by
cytotoxic chemotherapy.
No
studies have
been
conducted
on
the use
of
orally
administered
ondansetron
in
the
prevention or treatment of post-operative nausea and vomiting; IV
injection is recommended
for this purpose.
4.2 Posology and method of administration
Ondansetron is available for oral, parenteral and rectal use to allow
the route of administration
and dosing to be flexible
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV
and RINV)
The emetogenic potential of cancer treatment varies according to the
doses and combinations of
chemotherapy and radiotherapy regimens used. The selection of dose
regimen should be
determined by the severity of the emetogenic challenge.
Populations
_CINV AND RINV IN ADULTS _
The recommended intravenous (IV) or intramuscular (IM) dose of
ONDANSETRON-ASTERIA
INJ. is 8 mg administered immediately before treatment.
For highly emetogenic chemotherapy, a maximum initial ondansetron dose
of 16 mg IV infused
over 15 minutes may be used. A sing