BIOLOGICAL THERAPIES THIAMINE HYDROCHLORIDE 100 mg in 1 mL injection vial

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

thiamine hydrochloride, Quantity: 100 mg/mL

Sẵn có từ:

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

INN (Tên quốc tế):

Thiamine hydrochloride

Dạng dược phẩm:

Injection

Thành phần:

Excipient Ingredients: disodium edetate; benzyl alcohol; water for injections

Tuyến hành chính:

Intramuscular, Intravenous

Các đơn vị trong gói:

Pack of 1 vial, Pack of 10 vials, Pack of 5 vials, Pack of 6 vials

Loại thuốc theo toa:

Not scheduled. Not considered by committee

Chỉ dẫn điều trị:

Thiamine Hydrochloride Injection is used for the prevention and treatment of vitamin B1 deficiency.

Tóm tắt sản phẩm:

Visual Identification: A clear and colourless solution contained in an amber glass vial, sealed with a grey chlorobutyl rubber stopper and aluminium seal with red polypropylene flip-off insert; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 12 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2014-09-25

Tờ rơi thông tin

Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL Injection
1
BIOLOGICAL THERAPIES
THIAMINE HYDROCHLORIDE 100 MG IN 1 ML INJECTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN THIS MEDICINE?
This medicine contains the active ingredient thiamine hydrochloride.
It is used for the prevention and treatment of vitamin B1
deficiency. For more information, see Section 1. Why am I being given
this medicine? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN THIS MEDICINE?
Do not use if you have ever had an allergic reaction to this medicine
or any of the ingredients listed at the end of the CMI.
This medicine must not be given to a child under 2 years.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given this medicine? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Thiamine Hydrochloride 100 mg in 1
mL Injection and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS THIS MEDICINE GIVEN TO ME?
This medicine is given as an injection into a vein or a muscle. This
medicine must only be given by a doctor or nurse. The usual
dose is 5 mg to 100 mg under normal circumstances or much higher
amounts in critically ill patients.
More instructions can be found in Section 4. How is this medicine
given to me? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN THIS MEDICINE?
THINGS YOU
MUST DO
•
Remind or tell any doctor, surgeon, anaesthetist, dentist or
pharmacist you visit that you are being
treated with Thiamine Hydrochloride Injection.
•
Tell your doctor if you feel that giving this medicine is not helping
your condition.
•
Keep all of your doctor’s appointments

Đặc tính sản phẩm

AUSTRALIAN PRODUCT INFORMATION
BIOLOGICAL THERAPIES THIAMINE HYDROCHLORIDE
100 MG IN 1 ML INJECTION
_Biological Therapies _
_Page 1 of 7 _
_Version ID: pi119s2110 _ AUST R: 218622
1. NAME OF THE MEDICINE
Thiamine hydrochloride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL Injection contains 100 mg of thiamine hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
Injection for Intravenous or Intramuscular use.
The injection is a clear and colourless solution.
The pH of the solution is 2.5 to 3.5.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Thiamine Hydrochloride 100 mg in 1 mL Injection is used for the
prevention and treatment of vitamin B
1
deficiency.
4.2 DOSE AND METHOD OF ADMINISTRATION
Use in one patient on one occasion only and discard any residue.
Thiamine Hydrochloride 100 mg in 1 mL Injection is administered by IM
injection or slow IV injection over a period
of at least 10 minutes.
Due to the potential for serious anaphylactic reactions, parenteral
administration of thiamine is only indicated
when oral administration of thiamine is not acceptable or possible.
Facilities for treating anaphylaxis should be
available when administering Thiamine Injection.
If the thiamine hydrochloride solution is cloudy or contains visually
detectable particles, please contact the Quality
Assurance Manager at Biological Therapies.
Thiamine Deficiency
Simple thiamine deficiency is rare and as a result multiple vitamin
deficiencies should be suspected either in
those patients exhibiting signs consistent with thiamine deficiency,
or those considered to be at risk of developing
thiamine deficiency. Consideration should be given to administering
other water soluble vitamins in conjunction
with thiamine.
In critically ill thiamine deficient adults and in patients with
malabsorption syndromes, the usual IM or IV dosage
of thiamine hydrochloride is 5 to 100 mg three times daily. In
patients with beriberi, the dose should then be
reduced according to response and fo