Pabal 100micrograms/1ml solution for injection ampoules

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Carbetocin

متاح من:

Ferring Pharmaceuticals Ltd

ATC رمز:

H01BB03

INN (الاسم الدولي):

Carbetocin

جرعة:

100microgram/1ml

الشكل الصيدلاني:

Solution for injection

طريقة التعاطي:

Intravenous

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 07010100; GTIN: 5015919825182

نشرة المعلومات

Final folding :
33mm
35mm
Min : 6mm
Min : 6mm
Our item number with the font OCR B medium 6pts
FRONT
FRONT
REAR
REAR
Fiber direction
Code:
E-MS-3063.03
Referred to
E-MS-3000
MATERIAL SPECIFICATION FOR:
LEAFLET FLAT 150 X 500MM,
FOLDED 150 X 35MM
Ferring International Center
VERSION NO.
EFFECTIVE DATE
REASON FOR THE CHANGE
01
New document
MATERIAL
OP Polar Bright
ADDITIONAL INFORMATION:
NA
GRAMMAGE
45 ±2 g/m
2
FOLDED SIZE
150 x 35 mm
AUTHOR Packaging Support
Date
REVIEWER Packaging Support
Date
SUPPLIER APPROVAL
APPROVAL Maintenance
Date
RELEASED BY DCC
Date
17-Sep-2013
Folding updated and pharmacode length changed
02
150 mm
5 mm
3 mm
3 mm
500 mm
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No text
area
= Folding
line
2mm
8mm
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8mm
2mm
03
24-Oct-2014
Maximum length of
pharmacode : 19mm
Pharmacode is centered
at 86.5mm from the top
Final folding added with pharmacode position (QR#90286)
Max size of pharmacode updated (from 20mm to 19mm)
200905XXXX
100 mcg/ml
Solution for injection
Carbetocin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN AN INJECTION
OF PABAL BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, midwife or nurse.
•
If you get any side effects, tell your doctor, midwife or nurse. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pabal is and what it is used for
2.
What you need to know before you are treated with Pabal
3.
How Pabal is given to you
4.
Possible side effects
5.
How Pabal is stored
6.
Contents of the pack and other information
1
WHAT PABAL IS AND WHAT IT IS USED FOR
Pabal is used to treat women who have just had a baby by caesarean
section.
In some women, after a caesarean, the womb (uterus) doesn’t contract
(shrink)
quickly enough. This makes it more likely that they’ll bleed more
than normal. Pabal
makes the womb contract and so reduces the risk of bleeding.
The active ingredient in

خصائص المنتج

OBJECT 1
PABAL 100 MICROGRAMS IN 1ML SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 30-May-2018 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
PABAL 100 micrograms/ml solution for injection
2. Qualitative and quantitative composition
Carbetocin 100 micrograms/ml.
Oxytocic activity: approximately 50 IU of oxytocin/vial
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
A clear colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
PABAL is indicated for the prevention of uterine atony following
delivery of the infant by Caesarean
section under epidural or spinal anaesthesia
4.2 Posology and method of administration
Posology:
Withdraw 1 ml of PABAL containing 100 micrograms carbetocin and
administer only by intravenous
injection, under adequate medical supervision in a hospital.
_Paediatric population_
No data available
Method of administration
PABAL must be administered slowly, over 1 minute only after delivery
of the infant by Caesarean
section. It should be given as soon as possible after delivery,
preferably before removal of the placenta.
PABAL is intended for single use only. No further doses of carbetocin
should be administered.
4.3 Contraindications
• During pregnancy and labour before delivery of the infant.
• Carbetocin must not be used for the induction of labour.
• Hypersensitivity to carbetocin, oxytocin or to any of the
excipients listed in section 6.1.
• Hepatic or renal disease.
• Cases of pre-eclampsia and eclampsia.
• Serious cardiovascular disorders.
• Epilepsy
4.4 Special warnings and precautions for use
Carbetocin is intended for use only at well-equipped specialist
obstetrics units with experienced and
qualified staff available at all times.
The use of carbetocin at any stage before delivery of the infant is
not appropriate because its uterotonic
activity persists for several hours after a single bolus injection.
This is in marked contrast to the rapid
reduction of effect observed aft