Risek 40mg/vial Lyophilized Powder For Intravenous Injection And Infusion

Země: Filipíny

Jazyk: angličtina

Zdroj: FDA (Food And Drug Administration)

Aktivní složka:

Omeprazole (As Sodium)

Dostupné s:

N/A; Importer: Getz Pharma (Phils.), Inc.; Distributor: N/A

INN (Mezinárodní Name):

Omeprazole (As Sodium)

Dávkování:

40mg/vial

Léková forma:

Lyophilized Powder For Intravenous Injection And Infusion

Jednotky v balení:

USP Type II Amber Glass Vial (active) + 10 mL Clear Glass Ampoule (diluent) [Box of 1's], One (1) Box contains: USP Type 1 Amber

Výrobce:

Getz Pharma Pvt. Ltd., Pakistan

Datum autorizace:

2023-05-17

Charakteristika produktu

Manufactured by: Getz Pharma (Pvt.) Ltd., 29-30/27, K.I.A., Karachi -
74900, Pakistan.
Imported by: Getz Pharma (Phils.) Inc., 2/F Tower 1, The Rockwell
Business Center,
Ortigas Ave., Pasig City, Philippines.
AVAILABILITY
Omeprazole (Risek ) IV 40mg lyophilized powder for injection
is available as USP type I amber glass vial + 10mL clear glass
ampoule.
_KEEP OUT OF REACH OF CHILDREN._
CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing
without prescription.
For suspected adverse drug reaction, report to FDA:
www.fda.gov.ph
REGISTRATION NUMBER: DR-XY31530
DATE OF FIRST AUTHORIZATION / RENEWAL OF THE
AUTHORIZATION:
Initial: 7 March, 2006 (Lemery, Mexico)
Initial: 18 November, 2010 (Getz Pharma)
Renewal: 8 April, 2016
DATE OF REVISION OF PACKAGING INSERT: 26 October,
2017.
_Gastrointestinal:_ Diarrhea, constipation, abdominal pain,
nausea/vomiting and flatulence.
UNCOMMON
_Central and peripheral nervous system:_ Dizziness,
paraesthesia, somnolence, insomnia and vertigo.
_Hepatic:_ Increased liver enzymes.
_Skin:_ Rash and/or pruritis, urticaria.
_Other:_ Malaise.
RARE
_Central and peripheral nervous system:_ Reversible mental
confusion, agitation, aggression, depression and hallucinations,
predominantly in severely ill patients.
_Endocrine:_ Gynecomastia.
_Gastrointestinal:_ Dry mouth, stomatitis and gastrointestinal
candidiasis.
_Hematological:_ Leukopenia, thrombocytopenia, agranulocytosis
and pancytopenia.
_Hepatic:_ Encephalopathy in patients with pre-existing severe
liver disease, hepatitis with or without jaundice, hepatic failure,
increased liver enzymes.
_Musculoskeletal:_ Arthritic and myalgic symptoms and muscular
weakness.
_Reproductive system:_ Impotence, breast disorders.
_Skin: _Photosensitivity, bullous eruption erythema multiforme,
Stevens-Johnson syndrome, toxic epidermal necrolysis,
alopecia.
_Others:_ Hypersensitivity reactions e.g., angioedema, fever,
bronchospasm, interstitial nephritis and anaphylactic shock.
Increased sweating, peripheral edema, blurred vision, taste
disturban