Metoclopramide Actavis 10

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Metoclopramide hydrochloride 10mg

Dostupné s:

Teva Pharma (New Zealand) Limited

INN (Mezinárodní Name):

Metoclopramide hydrochloride 10 mg

Dávkování:

10 mg

Léková forma:

Film coated tablet

Složení:

Active: Metoclopramide hydrochloride 10mg Excipient: Colloidal silicon dioxide Hypromellose Macrogol 6000 Maize starch Microcrystalline cellulose Pregelatinised maize starch Purified talc Stearic acid Titanium dioxide

Druh předpisu:

Prescription

Výrobce:

Ipca Laboratories Limited

Terapeutické indikace:

ADULTS (20 years and over) Digestive Disorders Metoclopramide restores normal co-ordination and tone to the upper digestive tract and relieves symptoms of gastroduodenal dysfunction including: · Dyspepsia · Heartburn · Flatulence · Sickness · Regurgitation of bile · Pain These symptoms may be associated with such conditions as: · Peptic ulcer · Duodenitis · Reflux oesophagitis · Gastritis · Hiatus hernia · Cholelithiasis and post-cholecystectomy dyspepsia Nausea and Vomiting Metoclopramide is indicated in the treatment of nausea and vomiting associated with: · Gastrointestinal disorders · Cyclical vomiting · Intolerance to cytotoxic medicines · Congestive heart failure · Deep x-ray or cobalt therapy · Post anaesthetic vomiting Migraine Metoclopramide relieves symptoms of nausea and vomiting, and overcomes gastric stasis associated with attacks of migraine. This improvement in gastric emptying assists the absorption of concurrently administered oral antimigraine therapy (e.g. paracetamol) which may otherwise be impaired in such patients Post-Operative Conditions · Post-operative gastric hypotonia · Post-vagotomy syndrome Metoclopramide promotes normal gastric emptying and restores motility in vagotomised patients, and where postoperative symptoms suggest gastroduodenal dysfunction Diagnostic Procedures · Radiology · Duodenal intubation Metoclopramide speeds up the passage of a barium meal by decreasing gastric emptying time, co-ordinating peristalsis and dilating the duodenal bulb Metoclopramide also facilitates duodenal intubation procedures YOUNG ADULTS AND CHILDREN The use of Metoclopramide in patients under 20 years should be restricted to the following and used only as second line therapy: · Severe intractable vomiting of known cause · Vomiting associated with radiotherapy and intolerance to cytotoxic medicines · As an aid to gastrointestinal intubation · As part of the premedication before surgical procedures

Přehled produktů:

Package - Contents - Shelf Life: Blister pack, PVC/Alu in an outer carton - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/Alu in an outer carton - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Datum autorizace:

2013-08-15

Charakteristika produktu

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Metoclopramide Actavis 5, film coated tablets, 5 mg
Metoclopramide Actavis 10, film coated tablets, 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg or 10 mg of metoclopramide hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Metoclopramide Actavis 5: White to off-white, circular, biconvex film
coated tablets plain on both
sides.
Metoclopramide Actavis 10: White to off-white, circular, biconvex film
coated tablets with breakline
on both sides. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults (20 years and over)_
DIGESTIVE DISORDERS
Metoclopramide Actavis restores normal co-ordination and tone to the
upper digestive tract and
relieves symptoms of gastroduodenal dysfunction including:
•
Dyspepsia
•
Heartburn
•
Flatulence
•
Sickness
•
Regurgitation of bile
•
Pain.
These symptoms may be associated with such conditions as:
•
Peptic ulcer
•
Duodenitis
•
Reflux oesophagitis
•
Gastritis
•
Hiatus hernia
•
Cholelithiasis and post-cholecystectomy dyspepsia.
NAUSEA AND VOMITING
Metoclopramide Actavis is indicated in the treatment of nausea and
vomiting associated with:
•
Gastrointestinal disorders
•
Cyclical vomiting
•
Intolerance to cytotoxic medicines
•
Congestive heart failure
•
Deep x-ray or cobalt therapy
•
Post-anaesthetic vomiting.
Version 1.0
2
MIGRAINE
Metoclopramide Actavis relieves symptoms of nausea and vomiting, and
overcomes gastric stasis
associated with attacks of migraine. This improvement in gastric
emptying assists the absorption of
concurrently administered oral antimigraine therapy (e.g. paracetamol)
which may otherwise be
impaired in such patients.
POST-OPERATIVE CONDITIONS
•
Post-operative gastric hypotonia
•
Post-vagotomy syndrome.
Metoclopramide Actavis promotes normal gastric emptying and restores
motility in vagotomised
patients, and where postoperative symptoms suggest gastroduodenal
dysf