CHEMISTS' OWN MACROGOL JUNIOR WITH ELECTROLYTES powder for oral solution sachet

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
26-11-2017

Aktivna sestavina:

macrogol 3350, Quantity: 6562.5 mg; sodium bicarbonate, Quantity: 89.25 mg; potassium chloride, Quantity: 23.3 mg; sodium chloride, Quantity: 175.35 mg

Dostopno od:

Arrotex Pharmaceuticals Pty Ltd

INN (mednarodno ime):

macrogol 3350,potassium chloride,sodium bicarbonate,sodium chloride

Farmacevtska oblika:

Powder, oral

Sestava:

Excipient Ingredients: acesulfame potassium

Pot uporabe:

Oral

Enote v paketu:

2,8,30

Tip zastaranja:

Not scheduled. Not considered by committee

Terapevtske indikacije:

For effective relief from constipation and treatment of chronic constipation in adults and children aged 2 years and older. For resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum, or the rectum and colon, confirmed by physical examination of abdomen and rectum, in adults and children 2 years and older. For prevention of recurrence of faecal impaction in children aged 2 years and older. Use in children 2 years and older should be limited to 12 weeks except under medical supervision.

Povzetek izdelek:

Visual Identification: A white to almost white fine powder in single-dose sachets.; Container Type: Sachet; Container Material: Al laminated with LDPE/paper; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Licence status A

Datum dovoljenje:

2014-02-27