Water for injections 10ml ampoules

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Download 환자 정보 전단 (PIL)
08-06-2018
Download 제품 특성 요약 (SPC)
08-06-2018

유효 성분:

Water for injection

제공처:

hameln pharma Ltd

INN (국제 이름):

Water for injection

복용량:

1ml/1ml

약제 형태:

Solution for injection

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 09020201; GTIN: 5016386004308

환자 정보 전단

                                PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
WATER FOR INJECTIONS BP
1. What Water for Injections BP is and what
it is used for
Water for Injections BP contains water that has
been very carefully cleaned and purified so there
are no chemicals, bacteria or moulds in it. It is
used to:
• dissolve
and
dilute
other
medicines
so
that
they can be given into your blood stream as an
intravenous injection (into the vein).
2. What you need to know before you are
given Water for Injections BP
DO NOT USE WATER FOR INJECTIONS BP:
• if you are allergic to Water for Injections BP.
OTHER MEDICINES AND WATER FOR INJECTIONS
BP:
Tell
your
doctor
or
nurse
if
you
are
taking,
have
recently
taken
or
might
take
any
other
medicines, including medicines obtained without
a prescription.
Important information about your medicine
►
Your doctor or nurse will give you the injection
►
If this injection causes you any problems talk to your doctor, nurse
or pharmacist
►
Please tell your doctor or pharmacist, if you have any other medical
conditions or have an allergy to
any of the ingredients of this medicine
►
Please tell your doctor or pharmacist, if you are taking any other
medicines
•
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Water for Injections BP is and what it is used for
2. What you need to know before you are given Water for Injections BP
3. How to use Water for Injections BP
4. Possible side effects
5. How to store Water for Injections BP
6. Contents of the pack and other information
PREGNANC
                                
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제품 특성 요약

                                OBJECT 1
WATER FOR INJECTIONS BP
Summary of Product Characteristics Updated 02-Feb-2017 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Water for Injections BP.
2. Qualitative and quantitative composition
Each ml contains 100% Water for Injections Ph. Eur.
3. Pharmaceutical form
Sterile injection.
4. Clinical particulars
4.1 Therapeutic indications
Water for Injections BP is used as a dissolvent and diluent for
injectable medicines.
4.2 Posology and method of administration
Water for Injections BP is administered by Intravenous Injection.
Dosage for Adults (including the
elderly) and Children:- as required, by intravenous injection.
4.3 Contraindications
None known.
4.4 Special warnings and precautions for use
None known.
4.5 Interaction with other medicinal products and other forms of
interaction
None known.
4.6 Fertility, pregnancy and lactation
None known.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are
asked to report any suspected adverse reactions via the Yellow Card
Scheme at:
www.mhra.gov.uk/yellowcard.
4.9 Overdose
None known.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Water for Injections BP is used as a dissolvent and diluent for
injectable medicines.
5.2 Pharmacokinetic properties
Not Applicable.
5.3 Preclinical safety data
No further information other than that which is included in the
Summary of Product Characteristics.
6. Pharmaceutical particulars
6.1 List of excipients
None.
6.2 Incompatibilities
None known.
6.3 Shelf life
60 months for ampoules.
60 months for vials 1ml to 30ml.
48 months for vials 20ml
36 months for vials 50ml to 200ml.
6.4 Special precautions for storage
Do not store above 25° C.
6.5 Nature and contents of container
Ampoules
Type I clear glass ampoul
                                
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