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BIOFACTOR STREPTOKINASE 250 000

Active substance(s): STREPTOKINASE

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PATIENT INFORMATION LEAFLET
What you should knowabout

Biofactor Streptokinase
Help your doctor to help you.
Please read this leaflet carefully belore you receive Biofaclor Streptokinase, This
leaflet contains importanl information, It also contains a number of questions
about your medical hislory Ihat will enable your doctor to Ireat you successfully,
Since Biolactor Streplokinase is often used in emergency situations, it may not
always be possible for you to read this leaflet belore treatment. If you have
already been treated wilh this medicine, please read this leaflet now because a
101 of the information will still apply to you,
What is Biofactor Sireptokinase and why are you receiving it?
Biofactor Streptokinase contains a number of ingredients, The aclive
substance is a protein called streptokinase, which dissolves blood
elots, Biofactor Streptokinase is availabie in thrse strengths, containing
100 000. 250 000 or 750 000 International Units of streptokinase.
Your rnedicine also contains human albumin, glycine and mannito!.
You are being treated with Biofactor Streptokinase because you are suffering
from one of the following iIInesses: pulmonary embolism, arterial thrombosis,
deep veln thrombosls or retinal vessel thrombosis, These illnesses are all
caused by a blood dot whieh has been fonned inside one of your blood vessels,
Biofactor Sireptokinase is being given to you to break down the blood dot.
When shoutd you not be lreated with Biofaclor Streplokinase?
Please answer the following questions,
Are you sensitive or allergie to streplokinase?
Have you received anydrug contalning streptokinase over the last 12 months
or sulfered an infection, sueh as rheumatie lever, caused by bacteria which
produce streptokinase (streptococcal bacteria)?
Are you sulfering lrom intemal bleeding?
Have you reeently suffered a stroke?
Have you recently had an operation, in particular on the brain or the spine?
Are you suffering from a cranial tumor?
00 you have any heart of circulatory problems, or are you sulfering from very
high blood pressure that is no longer responding to treatment?
00 you have a elotting disorder?
Are you suffering Irom stomach or intestinal disorders which cause bleeding?
Have you recenUy been given any type of injection?
Have you recently been on a drip or artiflCially respirated?
Have you recently been badly injured?
Have you recenUy given birth of had an abortion?
00 you have any problems in the genijal or urinary tract which cause
bleeding?
00 you have 1iVl!l"i'!P'I .-'~
Are you suffering from tuberculosis or similar lung diseases, or from Severe
bronchitis?
00 you have any problems wlth the panereas (aeute pancreatitis)?
- Are you sulfering trom blood poisoning?
Are you pregnant or breast feeding?
If you answered YES to any of the above questions, you should not be treated
with Biofaelor Streptokinase, Please tell your doctor immediately.
Whal precaullons should be taken before you are Ireated wllh Biofaclor
Streplokinase?
In some cases, it may not be advisable for you 10 be treated with Biofactor
Streptoklnase, but your doctor may decide that treatment is essential. Please
answer the followlng questions.
- Are you suffering from irregular heart beat or do you have problems with the
heart valves?

Are you suffering from 1055 01 vision or eye dlscomfort?

Are you suffering from deep vein thrombosls which is older than 14 days?

Are you suffering trom central retinal artery thrombosis which is older than

6 to 8 hours?

Are you suffering from central retlnal veln thrombosis which is older than

10 days?

If you answered YES to any of the above questions, or if you are unsure, please

tell your doctor immediately, He will Ihen discuss the risks and benefits of

receiving Biofactor Streplokinase.

Is it safe for Biofaclor Sirepiokinase 10 be given 10 pregnanl and

breastfeeding wornen?

If you are pregnant or breastfeeding, please teil your doctor. Biofactor

Streptokinase should not be given to pregnant women unless there is no other,

safer trealment. You should not breastfeed your child while you are belng

treated with Biofactor Streplokinase.

Is I1 safe for Biofaclor Streptokinase 10 be given 10 children?

If Biofactor Streptokinase is to be given to children, a slreptokinase resistance

test should be performed betore treatment. This test will enable the doctor 10

decide whelher it is safe for the child 10 be Irealed with Biofactor Streptokinase

and which dose should be used,

Is II safe to take olher rnedicines while you are belng trealed wilh Biofaclor

Sireptokinase?

If you are belng treated, or have recently been treated, with any other medicine,

please tell your doctor. This is particularly Important If you have been given a

drug thai reduces the clotting activity of the blood. Examples of such drugs

are heparins, coumann derivatives, dipyridamole and dextrans, In these cases,

your doctor will lake steps to neutral;ze the effeets of the other drugs before you

receive Biofactor Streptokinase .




How will you be treated with Biolaetor Streptokinase?

Biofactor Streplokinase will be given 10 you by a doetor or nurse. It will be

infused inlo one of your veins.

The dose will be chosen by your doetor 10 sult your individual case. Usually, !wo

dose. are given. The first (called loading) dose is intended to neutralize any

slreptokinase antibodies in your blood and Ihe second (called maintenanee)

dose is intended to dissolve the blood clol.

The loading dose is usually infused lor 30 minutes. Generally, the maintenanee

dose is infused lor 72 hours for the treatment of deep vein thrombosis, for

24 hours for the treatment 01 pulmonary embolism, for 24 to 72 hours for the

treatment 01 arterial thrombosis, and for up to 12 hours lor the treatment 01

central retinal vessel thrombosis.

Belore, during and after treatment with Biolaetor Streptokinase, tests will be

performed to measure the dotting activity of your blood. These tests will enable

the doctor to deeide when treatment should be started and when it can be

stopped after successful breakdown of the dot.

After successful treatment with Biofactor Streptokinase, you will probably be

given an intravenous infusion of heparin to prevent new blood elots from being

formed.

Can you be given too mueh Biofaetor Streptokinase?

Your doctor will ensure that you are given the correct dose 01 Biolaetor

Streptokinase and that it will only be given for as lang as neeessary to aehieve

successful treatment. 1I this medicine is given for too long, bleeding problems

may oecur that will require medical attention.

What side effeets may Biofactor Streptokinase have?

Medicines like Biofactor Streptokinase can cause side effects. Some of Ihe side

effeets will disappear without treatment, but others may need medical attention.

Tell your doetor or nurse immediately il you notice any of the following effects.

• Bleeding
You may notice slight bleeding, especially at sile where the skin has been
punctured by an injeetion needle. Sueh bleeding can be quickly stopped.
Severe bleedlng may occur bu! Is very rare. If necessary, the infusion will be
immediately slopped and appropriate countermeasures laken.
• Early Reaetions
At !he beginning of treatment, you may experience fever, chilis, headaehe,
stomach and intestinal upsets or pain in Ihe muscles and bones. These
effects can easily be trealed by your doetor, and the symptoms disappear
quiekly.
A drop in blood pressura may occur bul this effeet usually disappears if
the infusion rate is slowed. Changes in haart rate (last or slow) haven bean
observed occasionally.
~ Allergie reaelions, SUCh as rashes, flushing or shortlleSS of breath, may
oceur. Sueh symptoms are a form of over sensitivity and are usually caused
by your medicine being infused look quickly. The symptoms usually do not
last long and disappear when the infusion is stopped. If necessary, your
doctor will take the appropriate countermeasures.
Lower baek pain has been reported in some cases during treatment with
streptokinase. Your doetor may decide to give you a painkiller.
Rarely, aeute anaphylactie reactions (a very savere type of allergie response)
have been observed. In such cases, infusion is immediately stopped and
appropriata countenneasures are taken.
• Other Reaelions
The following side effeets have been seen on rare occasions during treatment
with streptokinase.
Allergie responses in the brain and nerve tissues (neuroallergy)
Irritation 01 the eyes
Serum sickness
Fluid in the lungs
Inerease in the levels of some enzymes and bilirubin (a bile pigmenl).
Jaundice may occur as a eonsequence of bilirubin inerease.
Blockage of blood vessels by mobilized blood clots (embolism) that could
eause pain or discomlort in the affected area. Ilthis effeel occurs in the lungs,
streptokinase treatmenl will usually be continued as originally planned in
order 10 dissolve the mobilized blood elots.
Most olthese effeets do not last long and disappear shortly after the inlusion has

stopped. The remaining e!feets can be trealed by other medicines or therapy.

Like all medicines, Biofactor Streptokinase may have unwanted effects that are

very rare. If you notice any undesirable effects not menlioned in this leaflet or

any change in your health while receiving this medicine, or afterward, tell your

doctor or nurse immediately.

Who makes Biofactor Streptokinase

The license holder for Biofaetor Sireptokinase is Biofaetor GmbH, Bad

Harzburg, Germany.

When was !his leaflet prepared?

This leaflet was eompiled in Deeember 1997 and updated in November 2006.

Please remember

This leaflet was written to inform you about Biolaetor Streptokinase. It may not

contain all you wish to know about your medieine. If you have further questions,

or are not sure about something, please ask your doetor.


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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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