PRAMIN INJECTION

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

METOCLOPRAMIDE HYDROCHLORIDE

متاح من:

RAFA LABORATORIES LTD

ATC رمز:

A03FA01

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

METOCLOPRAMIDE HYDROCHLORIDE 5 MG/ML

طريقة التعاطي:

I.M, I.V

نوع الوصفة الطبية :

Required

المصنعة من قبل:

RAFA LABORATORIES LTD, JERUSALEM

المجموعة العلاجية:

METOCLOPRAMIDE

المجال العلاجي:

METOCLOPRAMIDE

الخصائص العلاجية:

Metoclopramide is an antiemetic and stimulates GI motility. Adult population: Pramin is indicated in adults for: - Prevention of postoperative nausea and vomiting (PONV) - Prevention of delayed nausea and vomiting caused by chemotherapy (delayed CINV) - Prevention of nausea and vomiting caused by radiation therapy -Symptomatic treatment of nausea and vomiting, including nausea and vomiting caused by migraine attack. In migraine attacks, metoclopramide can be used concomitantly with oral analgesics to improve their absorption. - Diabetic gastroparesis - To faciliate diagnostic procedures (ie, to faciliate small bowel intubation and as an aid in radiological examinations) (injection only). Pediatric population. Pramin is indicated in children aged 1 to 18 years for: - Second line-therapy: Treatment of established postoperative nausea and vomiting (PONV) - Second-line therapy: Prevention of delayed nausea and vomiting caused by chemotherapy (delayed CINV) - To facilitate diagnostic procedures (ie, to faciliate small bowel intubation and as an aid in radiological examinations) (injection only)

تاريخ الترخيص:

2020-10-31

نشرة المعلومات

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
PRAMIN TABLETS
ACTIVE INGREDIENT:
Each tablet contains: Metoclopramide hydrochloride 10 mg
For the list of the additional ingredients, see section 6. See also
'Important information about some
of the medicine's ingredients' in section 2.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions,
please refer to your doctor or pharmacist.
This medicine has been prescribed to treat your condition. Do not pass
it on to others. It may harm
them, even if you think their medical condition is similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended to prevent nausea and vomiting and to
stimulate motility of the digestive
system. The medicine is given in specific conditions, as determined by
the doctor.
THERAPEUTIC GROUP: dopamine receptor antagonists 2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
additional ingredients the
medicine contains (for the list of the additional ingredients, see
section 6).
•
You suffer from conditions in which stimulating the digestive system
may cause harm, such as:
bleeding in the digestive system, obstruction or perforation in the
digestive system (e.g., in the
intestine or stomach).
•
You suffer or it is suspected that you suffer from pheochromocytoma (a
rare tumor of the
adrenal gland).
•
You suffer or have suffered in the past from involuntary repetitive
muscle spasms (tardive
dyskinesia), after taking certain medicines (such as neuroleptic
medicines or medicines
containing metoclopramide).
•
You suffer from Parkinson's disease or epilepsy.
•
You are taking levodopa, or other dopaminergic medicine. See also
section 'Drug interactions'.
•
You had gastrointestinal surgery in the last 3-4 days.
•
You suffer or have suffered in the pas

خصائص المنتج

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pramin® Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains: Metcolopramide hydrochloride 10 mg/2 ml.
Excipient with known effects: Sodium.
Each ampoul contains about 6 mg sodium per 2 ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for IV or IM injection.
Clear, colorless solution in clear glass ampoules.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Metoclopramide is an antiemetic and stimulates GI motility.
Adult population
Pramin® Injection is indicated in adults for:
-
Prevention of postoperative nausea and vomiting (PONV)
-
Prevention of delayed nausea and vomiting caused by chemotherapy
(delayed
CINV)
-
Prevention of nausea and vomiting caused by radiation therapy
-
Symptomatic treatment of nausea and vomiting, including nausea and
vomiting
caused by migraine attack. In migraine attacks, metoclopramide can be
used
concomitantly with oral analgesics to improve their absorption.
-
Diabetic gastroparesis
- To faciliate diagnostic procedures (i.e., to faciliate small bowel
intubation and as
an aid in radiological examinations)
Pediatric population
Pramin® Injection is indicated in children aged 1 to 18 years for:
-
Second line-therapy: Treatment of established postoperative nausea and
vomiting (PONV)
-
Second-line therapy: Prevention of delayed nausea and vomiting caused
by
chemotherapy (delayed CINV)
-
To facilitate diagnostic procedures (i.e., to faciliate small bowel
intubation and as
an aid in radiological examinations)
2
4.2
Posology and method of administration
Posology
Adult patients
For all adult indications except diabetic gastroparesis and
facilitation of diagnostic procedures
(see below):
- The recommended dose is 10 mg, 1 to 3 times a day.
- The maximum recommended daily dose is 30 mg or 0.5 mg/kg bodyweight
whichever is lower.
- The maximum recommended treatment period is usually 5 days.
Pediatric patients
For all pediatric indications except facilitation of