ADRENALINE
(EPINEPHRINE)
Q. Can it be stored in a fridge?
A. The storage temperature of hameln pharmaceuticals ltd adrenaline
(epinephrine) injection is stated as ‘do not store above 25ºC’.
We have no data on storage in a refrigerator. The formula contains sodium
metabisulphite as a preservative which may precipitate out at low storage
temperatures therefore we would recommend checking it for clarity of
solution before use.
Q. Is it licensed for use in children?
A. hameln pharmaceuticals ltd adrenaline (epinephrine) injection is
licensed for treatment of acute allergy & anaphylactic shock in
adults & children.
Q. Is there any stability information if it is stored
above 25ºC?
A. We have no information on stability of hameln pharmaceuticals ltd
adrenaline (epinephrine) injection outside the recommended temperature
range.
Q. Is it stable when added to a ‘balanced
salt solution’?
A. We have no information on stability in a ‘balanced salt solution’.
hameln pharmaceuticals ltd adrenaline (epinephrine) injection is not
licensed for ophthalmic use.
Q. What is the preferred site of injection?
A. hameln pharmaceuticals ltd adrenaline (epinephrine) injection SmPC
states that it should not be injected into extremities & not into
the buttocks because of the risk of tissue necrosis.
Q. Can it be diluted for emergency use instead of
using a syringe?
A. The use for cardiac resuscitation has been removed from hameln pharmaceuticals
ltd adrenaline (epinephrine) injection marketing authorization because
of the risk of not diluting it properly. Current medical practice advises
that the correct strength preparation is administered.
AMINOPHYLLINE
Q. What is the maximum concentration for continuous
infusion?
A. hameln pharmaceuticals ltd aminophylline injection is stable in large
volume solutions over a wide pH range if the concentration does not
exceed 40mg/ml.
Q. If diluted into infusion fluid does it need to
be protected from light?
A. We have no information to suggest that hameln pharmaceuticals ltd
aminophylline injection needs to be protected from light if diluted
into an infusion fluid.
Q. What is the pH?
A. The pH of hameln pharmaceuticals ltd aminophylline injection is 8.8
– 10
Q. What is the minimum volume it can be diluted
in?
A. Hameln pharmaceuticals ltd aminophylline injection does not need
to be diluted. It can be given by slow IV injection at a rate not exceeding
25mg per minute.
Q. What are the excipients?
A. The excipients of hameln pharmaceuticals ltd aminophylline injection
are Ethylenediamine (to ensure stability) & WFI.
ATROPINE
Q. Can it be stored in a fridge?
A. The storage temperature of hameln pharmaceuticals ltd atropine injection
is stated as ‘do not store above 25ºC’. We have no
data on storage in a refrigerator.
CALCIUM GLUCONATE
Q. Can it be given orally?
A. hameln pharmaceuticals ltd calcium gluconate injection is not licensed
for oral use. However there is no clear reason why it cannot be given
orally. The formula is calcium gluconate, calcium d saccharate (to help
dissolve a supersaturated solution) & WFI.
Q. What is the aluminium content?
A. The specification for hameln pharmaceuticals ltd calcium gluconate
injection does not require testing for aluminium ions. Therefore it
is not normally carried out. In 1998 three batches were assayed for
aluminium content. Aluminium content was between 3.58-4.70ppm. Three
batches of raw material were also assayed & aluminium content was
less than 0.46ppm
Q. What is the specific gravity?
A. We only measure specific gravity at in-process control of bulk solutions,
not on the finished product. The average specific gravity of a sample
of 14 batches of hameln pharmaceuticals ltd calcium gluconate injection
was 1,047 g/cm³.
Q. What is the conversion of mmol to mg?
A. Hameln pharmaceuticals ltd calcium gluconate injection 10% contains
8.9mg calcium or 220micromol calcium in 1ml
Q. What is the pH?
A. The pH of hameln pharmaceuticals ltd calcium gluconate injection
is 6-7
Q. What is the osmolality
A. We do not routinely test solutions for osmolality. Two retained samples
of hameln pharmaceuticals ltd calcium gluconate injection were analysed
in 2002. Results were 278 & 282 mOsmol/kg. The average result was
280 mOsmol/kg
Q. Can it be given by IM injection?
A. hameln pharmaceuticals ltd calcium gluconate injection is licensed
for administration by IV injection only. At the last license renewal
the IM route of administration was removed because of the risk of tissue
necrosis.
Q. Calcium gluconate has been accidentally frozen
is it still safe to use?
A. We do not have any stability data on hameln pharmaceuticals ltd calcium
gluconate after it has been frozen and we therefore recommend that the
product should not be used after it has been frozen but destroyed in
the correct manner.
ERGOMETRINE
Q. How long is it stable at room temperature?
A. We have no information on stability if hameln pharmaceuticals ltd
ergometrine injection is stored outside its normal storage range of
below 10ºC. Degradation is indicated by a yellow discolouration.
Such a solution should not be used.
Q. Is it derived from blood products?
A. hameln pharmaceuticals ltd ergometrine injection is not derived from
blood products.
Q. Is it derived from animal products?
A. hameln pharmaceuticals ltd ergometrine injection is not derived from
animal products
FUROSEMIDE
Q. Can it be given without dilution?
A. hameln pharmaceuticals ltd furosemide injection can be given without
dilution provided the rate does not exceed 4mg per minute.
Q. What is the smallest volume of infusion fluid
it can be put into for a fluid overloaded patient?
A. The final volume of infusion fluid used for dilution of hameln pharmaceuticals
ltd furosemide injection will depend on the patients fluid balance status.
Where fluid restriction is a problem, it can be given directly IV without
dilution, provided the rate does not exceed 4mg per minute.
Q. What is the number of mmol/ml of sodium in hameln
pharmaceuticals ltd Furosemide?
A. hameln pharmaceuticals ltd furosemide injection contains 0.17 mmol
sodium per ml
Q. What is the number of mg/ml of chloride in hameln
pharmaceuticals ltd Furosemide?
A. hameln pharmaceuticals ltd furosemide injection contains 5.184mg
of chloride per ml
GLUCOSE
Q. Is the glucose anhydrous or monohydrate?
A. The active constituent in hameln pharmaceuticals ltd glucose infusion
is glucose monohydrate.
Q. What is the pH?
A. The pH of hameln pharmaceuticals ltd glucose infusion is 3.5 –
6.5.
Q. Can it be stored in a fridge?
A. The storage temperature of hameln pharmaceuticals ltd glucose infusion
is stated as ‘do not store above 25ºC’. We have no
data on storage in a refrigerator. We would recommend checking the solution
for clarity before use to ensure there is no precipitation.
LIDOCAINE AMPS
Q. Can it be given by IA injection?
A. hameln pharmaceuticals ltd lidocaine ampoules are not licensed for
IA (intra-articular) injection.
Q. Are the ampoules isotonic?
A. Hameln pharmaceuticals ltd lidocaine ampoules are not isotonic.
Q. Are there preservatives in the ampoules?
A. The formula of hameln pharmaceuticals ltd lidocaine ampoules does
not contain any preservatives.
Q. What is the pH?
A. The pH of hameln pharmaceuticals ltd lidocaine ampoules is 4-6.
Q. What are the excipients?
A. The formula of hameln pharmaceuticals ltd lidocaine ampoules contains
the excipients hydrochloric acid &/or sodium hydroxide as pH adjusters.
It also contains water for injections.
Q. Is it indicated for use in podiatry & chiropody?
A. Hameln pharmaceuticals ltd lidocaine ampoules are licensed for indications
not specific groups of procedures. It is indicated generally for local
anaesthesia by surface infiltration, regional, epidural & caudal
routes & for dental anaesthesia.
Q. Is it licensed for use in children?
A. Hameln pharmaceuticals ltd lidocaine ampoules are licensed for use
in children.
Q. Is it licensed for ophthalmic use?
A. hameln pharmaceuticals ltd lidocaine ampoules are not licensed for
ophthalmic use.
METOCLOPRAMIDE
Q. What is the pH?
A. The pH of hameln pharmaceuticals ltd metoclopramide injection is
3 – 4.3
Q. Can it be stored in a fridge?
A. The storage temperature of hameln pharmaceuticals ltd metoclopramide
injection is stated as ‘Store in a cool place’. We have
no data on storage in a refrigerator.
Q. Can it be given as an IV bolus rather than diluted?
A. hameln pharmaceuticals ltd metoclopramide injection should be administered
by slow iv injection (over 2 minutes) or i.m. injection. It does not
require dilution although it may be diluted if required.
MIDAZOLAM
Q. What is the pH?
A. The pH of hameln pharmaceuticals ltd midazolam injection is 2.9 –
3.7
Q. Can it be given by sc injection?
A. hameln pharmaceuticals ltd midazolam injection is not licensed for
sc injection. We are aware that it is used in this way in palliative
care. This use is referenced in the palliative care formulary.
Q. Can it be given by IM injection.
A. Yes. hameln pharmaceuticals ltd midazolam injection is approved for
i.v., i.m. and rectal administration.
Q. Can it be stored in a fridge?
A. We have no data on storage in a refrigerator. Trissel 10th edition
references the fact that midazolam was physically stable when frozen
for 3 days followed by room temperature thawing.
Q. Can it be given orally?
A. hameln pharmaceuticals ltd midazolam injection is not licensed for
oral use. The formula is midazolam hydrochloride, sodium chloride, hydrochloric
acid & WFI. SODIUM CHLORIDE
Q. What is the pH?
A. The pH of hameln pharmaceuticals ltd sodium chloride injection is
5 – 7
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