BERINERT

Israel - English - Ministry of Health

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Active ingredient:
C - 1 ESTERASE INHIBITOR HUMAN
Available from:
GENMEDIX , ISRAEL
ATC code:
B06AC01
Pharmaceutical form:
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
Composition:
C - 1 ESTERASE INHIBITOR HUMAN 500 IU/VIAL
Administration route:
I.V
Prescription type:
Required
Manufactured by:
CSL BEHRING GmbH, GERMANY
Therapeutic group:
C1- INHIBITOR,PLASMA DERIVED
Therapeutic area:
C1- INHIBITOR,PLASMA DERIVED
Therapeutic indications:
Hereditary angioedema type I and II (HAE).Treatment and pre-procedure (prior to oral, dental, and upper respiratory tract procedures) prevention of acute episodes
Authorization number:
145 06 33056 00
Authorization date:
2015-12-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

01-03-2020

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’

REGULATIONS (PREPARATIONS) - 1986

This medicine can be sold with a physician's prescription only

Berinert is usually injected into a vein (intravenously) by the physician or nurse. You or

your carer might also administer Berinert as an injection but only after receiving

adequate training. If your physician decides that you are suitable for home-treatment,

detailed instructions will be given to you. You will be required to keep a diary in order to

document each treatment received at home and to bring it to each of your visits to the

physician. Regular review of your or your carer’s injection technique will be performed to

ensure continued appropriate handling.

Berinert

®

Powder and Solvent for Solution for Injection / Infusion

500 IU

The active ingredient and its quantity:

The vial with the powder contains:

C1 - Esterase Inhibitor Human 500 IU

For list of excipients, please see section 6.

Read this entire leaflet carefully before you use this medicine. This leaflet contains concise

information about the medicine. If you have any further questions, ask your physician or

pharmacist.

This medicine has been prescribed for the treatment of your illness. Do not pass it on to others.

It may harm them, even if you think that their illness is the same as yours.

1. What is the medicine used for?

Hereditary angioedema type I and II (HAE)

Treatment and pre-procedure (prior to oral, dental, and upper respiratory tract procedures)

prevention of acute episodes.

Hereditary Angioedema is a congenital, non-allergic disease of the vascular system.

Hereditary Angioedema is caused by deficiency, absence or defective synthesis of C1-

esterase inhibitor which is an important protein.

The illness is characterized by the following symptoms:

- swelling of the hands and feet that occurs suddenly

- facial swelling with tension sensation that occurs suddenly

- eyelid swelling, lip swelling, possibly laryngeal (voice box) swelling with breathing

difficulties

- tongue swelling

- colic pain in abdominal region.

Generally, all parts of the body can be affected.

Therapeutic group:

C1 enzyme inhibitor, medicines used in Hereditary Angioedema

2. Before using the medicine

X

Do not use the medicine if:

You are hypersensitive (allergic) to the active ingredient (Human C1 - Esterase Inhibitor) or to

any of the other ingredients this medicine contains (listed in section 6).

!

Special warnings regarding the use of this medicine

Before taking Berinert tell your physician:

If you have experienced allergic reactions to Berinert in the past. Antihistamines and

corticosteroids should be prophylactically taken if advised by your physician.

If allergic or anaphylactic-type reactions occur (a serious allergic reaction that causes

severe breathing difficulty or dizziness). The administration of Berinert should then

be stopped immediately (e.g. discontinue injection).

If you suffer from laryngeal swelling (laryngeal oedema). You should be carefully

monitored with emergency treatment in stand-by if required.

Caution should be taken during unlicensed use beyond the approved indications and

dosages (e.g. Capillary Leak Syndrome). See section 4 “Side Effects”.

Your physician will consider carefully the benefit of treatment with Berinert compared with

the risk of these complications.

Virus safety

When medicines are made from human blood or plasma, certain measures are put in

place to prevent infections being passed on to patients. These include:

careful selection of blood and plasma donors to make sure those at risk of carrying

infections are excluded.

testing of each blood and plasma donation for signs of virus/infection.

Manufacturers of these products also include steps in the processing of the blood or plasma

that can inactivate or remove viruses. Despite these measures, when medicines prepared

from human blood or plasma are administered, the possibility of passing on infection cannot

be totally excluded. This also applies to any unknown or emerging viruses or other types of

infections.

The measures taken are considered effective for viruses such as human immunodeficiency

virus (HIV), hepatitis B virus, hepatitis C virus, hepatitis A virus and parvovirus B19.

Your physician may recommend that you consider vaccination against hepatitis A and B if

you regularly receive human plasma-derived products.

It is strongly recommended to record the following details every time that Berinert is given:

the date of administration, batch number and the injected volume.

Tell your physician or pharmacist

if you are taking or have recently taken any

other medicines, including non-prescription drugs and nutrition supplements.

Berinert should not be mixed with other medicines or diluents in the syringe.

Pregnancy and Breastfeeding

Berinert will be used during pregnancy and breast-feeding only if it is clearly needed.

If you are pregnant, think you may be pregnant, planning to become pregnant or breast-feeding,

consult your physician or pharmacist before taking this medicine.

Driving and use of machinery

No studies on the effects on the ability to drive and use machines have been performed.

Important information about some of the ingredients of this medicine

Berinert contains up to 486 mg of sodium (approximately 21 mmol) per 100 ml solution.

Please take this into account if you are on a low sodium diet.

3.

How to use this medicine

Always use according to your physician's instructions. Check with your physician or

pharmacist if you are not sure. Treatment should be initiated and supervised only by a

physician who is experienced in the treatment of C1-esterase inhibitor deficiency.

The dosage and administration will be determined by the physician only.

Do not exceed the recommended dose.

Reconstitution and Method of Administration

Berinert is usually injected into a vein (intravenously) by the physician or nurse. You or your

carer might also administer Berinert as an injection but only after receiving adequate training. If

your physician decides that you are suitable for home-treatment, detailed instructions will be

given to you. You will be required to keep a diary in order to document each treatment received

at home and to bring it to each of your visits to the physician. Regular review of your or your

carer’s injection technique will be performed to ensure continued appropriate handling.

General Instructions

The powder must be dissolved and withdrawn from the vial under aseptic conditions. Use the

syringe provided with the product.

The prepared solution should be colorless and clear. After filtering or withdrawal (see below)

and prior to administration, the solution should be checked by eye for small particles or

discoloration.

Do not use the solution if it is visibly cloudy or if it contains particles.

Any unused product or waste material should be disposed of as instructed by your physician

or nurse.

Reconstitution

Without opening the vials, warm the Berinert powder and the solvent to room temperature. This

can be done either by leaving the vials at room temperature for about an hour or by holding the

vials in your hands for a few minutes. Do not expose the vials to direct heat. The vials must not

be heated above body temperature (37°C).

Carefully remove the protective caps from the solvent vial and the product vial. Clean the

exposed rubber stoppers of both vials with one alcohol swab each and allow them to dry. The

solvent can now be transferred to the powder using the administration set (Mix2Vial) attached.

Please follow the instructions given below.

1. Open the Mix2Vial package by peeling off

the lid. Do not remove the Mix2Vial from the

blister package!

2. Place the solvent vial on an even, clean

surface and hold the vial tightly. Take the

Mix2Vial together with the blister package

and push the spike of the blue adapter end

straight down through the solvent vial

stopper.

3. Carefully remove the blister package from

the Mix2Vial set by holding at the rim and

pulling vertically upwards. Make sure that

you only pull away the blister package and

not the Mix2Vial set.

4. Place the product vial on an even and firm

surface. Invert the solvent vial with the

Mix2Vial set attached and push the spike of

the transparent adapter end straight down

through the product vial stopper. The solvent

will automatically flow into the product vial.

5. With one hand grasp the product-side of

the Mix2Vial set and with the other hand

grasp the solvent-side and carefully, counter

clockwise, unscrew the set into two pieces.

Discard the solvent vial with the blue Mix2Vial

adapter attached.

6. Gently swirl the product vial with the

transparent adapter attached until the

substance is fully dissolved. Do not shake.

7. Draw air into an empty, sterile syringe. Use

the syringe provided with the product. While

the product vial is upright, connect the

syringe to the Mix2Vial’s Luer Lock fitting by

screwing clockwise. Inject air into the product

vial.

Withdrawal and application

8. While keeping the syringe plunger

pressed, turn the system upside down and

draw the solution into the syringe by pulling

the plunger back slowly.

9. Now that the solution has been transferred

into the syringe, firmly hold on to the barrel of

the syringe (keeping the syringe plunger

facing down) and disconnect the transparent

Mix2Vial adapter from the syringe by

unscrewing counter clockwise.

Administration

Berinert is to be administered by slow intravenous injection or infusion (4 ml/minute).

If you have accidentally taken a higher dosage

If you have taken an overdose or if a child has accidentally swallowed the medicine, proceed

immediately to a physician or a hospital emergency room and bring the package of the medicine

with you.

Continue with the treatment as recommended by your physician.

Even if there is an improvement in your health, do not stop taking this medicine without

consulting your physician.

Do not take medicines in the dark! Check the label and the dose each time you take your

medicine. Wear glasses if you need them.

If you have any further questions regarding the use of this medicine, consult your physician or

pharmacist.

4. Side Effects

Like all medicines, Berinert may cause side effects in some users, although not everybody gets

them. Do not be alarmed while reading the list of side effects, you may not suffer from any of

them.

Undesired reactions with Berinert are rare.

Rare side effects: (effects that appear in up to 1 in 1,000 users)

There is a risk of increased formation of blood clots in treatment attempts for prophylaxis

or therapy of Capillary Leak Syndrome (outflow of fluid from the small blood vessels into

the tissue) e. g. during or after surgery under extra-corporal circulation. See section

2 "Special warnings regarding the use of this medicine".

Increase in body temperature as well as burning and stinging where the injection was

given.

Hypersensitive or allergic reactions (such as irregular heartbeat, fast heartbeat, fall or

rise in blood pressure, reddening of the skin, rash, breathing difficulty, headache,

dizziness, nausea).

Very rare side effects: (effects that appear in up to 1 in 10,000 users)

hypersensitive reactions might progress as far as shock.

Refer to your physician immediately if any of the side effects appears or if you experience

side effects not mentioned in this leaflet.

Reporting of side effects

Side effects can be reported to the Ministry of Health by clicking on the link "Reporting Side

Effects Of Drug Treatment" that appears on the homepage of the Ministry of Health's website

(www.health.gov.il) which links to an online form for reporting side effects, or by the following

link:

https://sideeffects.health.gov.il

In addition, you can report by emailing the Registration Holder’s Patient Safety Unit at:

drugsafety@neopharmgroup.com

5. How to Store the Medicine

Avoid poisoning! This medicine and all other medicines must be stored in a safe place

out of the reach and sight of children and/or infants to avoid poisoning. Do not induce

vomiting unless explicitly instructed to do so by your physician.

Do not use the medicine after the expiry date (exp. date) stated on the package. The

expiry date refers to the last day of that month.

Do not store at temperature above 30°C.

Do not freeze.

Store the product vial in the outer packaging to protect from light.

This medicine does not contain a preservative and therefore the prepared solution

should preferably be used immediately.

If the prepared solution is not administered immediately, it must be stored only in the vial

at a temperature below +30°C and used within 8 hours.

Medicines should not be disposed of via household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the

environment.

6. Additional Information

In addition to the active ingredient, this medicine also contains:

Powder vial: Glycine, Sodium chloride, Sodium citrate

Solvent vial: Water for injections

What the medicine looks like and content of the package

Berinert is presented as a white powder and is supplied with water for

injections as solvent.

The made up Berinert 500 solution should be colourless and clear

Presentation

Box with 500 IU contains:

1 vial with powder (500 IU)

1 vial with 10 ml water for injections

1 filter transfer device 20/20 (Mix2Vial)

Administration set (inner box):

1 disposable 10 ml syringe

1 venipuncture set

2 alcohol swabs

1 plaster

Registration Holder and address:

Genmedix, 12 Beit HaRishonim St., Emek–Hefer 3877701.

Manufacturer and address:

CSL Behring GmbH

Emil-von-Behring-Strasse 76

35041 Marburg

Germany.

Drug registration number at the national medicines registry of the Ministry of

Health:

145 06 33056

This leaflet was checked and approved by the Ministry of Health in 04/2016.

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Berinert

®

500 IU

Powder and solvent for solution for injection / infusion.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance: human C1-esterase inhibitor

Berinert contains 500 IU per injection vial.

The potency of C1-esterase inhibitor is expressed in International Units (IU), which are

related to the current WHO Standard for C1-esterase inhibitor products.

Berinert 500 contains 50 IU/ml C1-esterase inhibitor after reconstitution with 10 ml water

for injections.

The total protein content of the reconstituted 500 IU solution is 6.5 mg/ml.

Excipients with known effect:

Sodium up to 486 mg (approximately 21 mmol) per 100 ml solution.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Powder and solvent for solution for injection / infusion.

White Powder.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Hereditary angioedema type I and II (HAE)

Treatment and pre-procedure (prior to oral, dental, and upper respiratory tract procedures)

prevention of acute episodes.

4.2

Posology and method of administration

Treatment should be initiated under the supervision of a physician experienced in the

treatment of C1-esterase inhibitor deficiency.

Posology

Adults

Treatment of acute angioedema attacks:

20 IU per kilogram body weight (20 IU/kg b.w.)

Pre-procedure prevention of angioedema attacks:

1000 IU less than 6 hours prior to oral, dental, and upper respiratory tract procedures.

Paediatric Population

Treatment of acute angioedema attacks:

20 IU per kilogram body weight (20 IU/kg b.w.).

Pre-procedure prevention of angioedema attacks:

15 to 30 IU per kilogram body weight (15-30 IU/kg b.w.) less than 6 hours prior to oral,

dental, and upper respiratory tract

procedures. Dose should be selected taking into account

clinical circumstances (e.g. type of procedure and disease severity).

Method of administration

Berinert is to be reconstituted according to section 6.6. The reconstituted solution should be

colourless and clear. The solution is to be administered by slow i.v. injection or infusion (4

ml/minute).

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4

Special warnings and precautions for use

In patients with known tendency towards allergies, antihistamines and corticosteroids

should be administered prophylactically.

If allergic or anaphylactic-type reactions occur, the administration of Berinert has to be

stopped immediately (e.g. discontinue injection/infusion) and an appropriate treatment has

to be initiated. Therapeutic measures depend on the kind and severity of the undesirable

effect. The current medical standards for shock treatment are to be observed.

Patients with laryngeal oedema require particularly careful monitoring with emergency

treatment in stand-by.

Unlicensed use or treatment of Capillary Leak Syndrome (CLS) with Berinert (see also

section “4.8 Undesirable effects”) is not advised.

Berinert contains up to 486 mg sodium (approximately 21 mmol) per 100 ml solution. To be

taken into consideration by patients on a controlled sodium diet.

Home-treatment and self-administration

There are limited data on the use of this medicinal product in home- or self-administration,

which is defined as patient-self administration or an administration by a relative or another

caregiver (i.e. visiting nurse) in a home setting. Patients should only be considered for self-

administration if they have been trained by a healthcare professional and have demonstrated

their proficiency by a series of uneventful and witnessed successful injections. Potential

risks associated with home-treatment are related to the administration itself as well as the

handling of adverse drug reactions, particularly hypersensitivity. The decision on the use of

home-treatment for an individual patient should be made by the treating physician, who

should ensure that appropriate training is provided and the use reviewed at intervals.

Virus safety

Standard measures to prevent infections resulting from the use of medicinal products

prepared from human blood or plasma include selection of donors, screening of individual

donations and plasma pools for specific markers of infection and the inclusion of effective

manufacturing steps for the inactivation/ removal of viruses. Despite this, when medicinal

products prepared from human blood or plasma are administered, the possibility of

transmitting infective agents cannot be totally excluded. This also applies to unknown or

emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as HIV, HBV, HCV

and for the non-enveloped viruses HAV and parvovirus B19.

Appropriate vaccination (hepatitis A and B) should be generally considered for patients in

regular/repeated receipt of human plasma-derived products.

It is strongly recommended that every time Berinert is administered to a patient, the name

and batch number of the product are recorded in order to maintain a link between the patient

and the batch of the product.

4.5

Interactions with other medicinal products and other forms of interactions

No interaction studies have been performed.

4.6

Fertility, pregnancy and lactation

Pregnancy

There are limited amount of data that indicate no increased risk from the use of Berinert in

pregnant women. Berinert is a physiological component of human plasma. Therefore, no

studies on reproduction and developmental toxicity have been performed in animals and no

adverse effects on fertility, pre- and postnatal development are expected in humans.

Therefore, Berinert should be given to a pregnant woman only if clearly needed.

Breastfeeding

It is unknown whether Berinert is excreted in human milk, but due to its high molecular

weight, the transfer of Berinert into breast milk seems unlikely. However, breastfeeding is

questionable in women suffering from hereditary angioedema. A decision must be made

whether to discontinue breastfeeding or to discontinue the Berinert therapy taking into

account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility

Berinert is a physiological component of human plasma. Therefore, no studies on

reproduction and developmental toxicity have been performed in animals and no adverse

effects on fertility, pre- and postnatal development are expected in humans.

4.7

Effects on ability to drive and use machines

Berinert has no or negligible influence on the ability to drive and use machines.

4.8

Undesirable effects

The following adverse reactions are based on post marketing experience as well as scientific

literature. The following standard categories of frequency are used:

Very common:

1/10

Common:

1/100 to < 1/10

Uncommon:

1/1,000 to < 1/100

Rare:

1/10,000 to < 1/1,000

Very rare:

<

1/10,000 (including reported single cases)

Undesired reactions with Berinert are rare.

Organ class

Very

common

Common

Uncommon

Rare

Very rare

Vascular

disorders

Development

of thrombosis*

General

disorders and

administration

site conditions

Rise in

temperature,

reactions at the

injection site

Immune

system

disorders

Allergic or

anaphylactic-

type reactions

(e.g.

tachycardia,

hyper- or

hypotension,

flushing, hives,

Shock

dyspnoea,

headache,

dizziness,

nausea)

* In treatment attempts with high doses of Berinert for prophylaxis or therapy of Capillary

Leak Syndrome (CLS) before, during or after cardiac surgery under extracorporal

circulation (unlicensed indication and dose), in single cases with fatal outcome.

For safety with respect to transmissible agents, see section 4.4.

Reporting of suspected adverse reactions

Reporting

suspected

adverse

reactions

after

authorisation

medicinal

product

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product.

Any suspected adverse events should be reported to the Ministry of Health according to the

National Regulation by using an online form

https://sideeffects.health.gov.il/

and emailed to the Registration Holder’s Patient Safety Unit at:

drugsafety@neopharmgroup.com

4.9

Overdose

No case of overdose has been reported.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: C1-inhibitor, plasma derived

ATC code: B06AC01

C1-esterase inhibitor is a plasma glycoprotein with a molecular weight of 105 kD and a

carbohydrate moiety of 40 %. Its concentration in human plasma ranges around 240 mg/l.

Besides its occurrence in human plasma, also the placenta, the liver cells, monocytes and

platelets contain C1-esterase inhibitor.

C1-esterase inhibitor belongs to the serine-protease-inhibitor-(serpin)-system of human

plasma as do also other proteins like antithrombin III, alpha-2-antiplasmin, alpha-1-

antitrypsin and others.

Under physiological conditions C1-esterase inhibitor blocks the classical pathway of the

complement system by inactivating the enzymatic active components C1s and C1r. The

active enzyme forms a complex with the inhibitor in a stoichiometry of 1 : 1.

Furthermore, C1-esterase inhibitor represents the most important inhibitor of the contact

activation of coagulation by inhibiting factor XIIa and its fragments. In addition, it serves,

besides alpha-2-macroglobulin, as the main inhibitor of plasma kallikrein.

The therapeutic effect of Berinert in hereditary angioedema is induced by the substitution of

the deficient C1-esterase inhibitor activity.

5.2

Pharmacokinetic properties

The product is to be administered intravenously and is immediately available in the plasma

with a plasma concentration corresponding to the administered dose.

The pharmacokinetic properties of Berinert have been investigated in two studies.

A phase I study conducted in 15 healthy, adult subjects provided PK data that was used to

assess the relative bioavailability of Berinert 1500 and Berinert 500. Comparable

bioavailability of the two presentations of Berinert was demonstrated. For C1-INH antigen

concentrations

the C

and AUC

0-last

geometric mean ratios (90% CIs) were 1.02 (0.99, 1.04) and

1.02 (0.99, 1.05) respectively

. Half-life was estimated in a subset of subjects using non-

compartmental PK analyses. The mean half-life of Berinert 1500 and Berinert 500 was 87.7

hours and 91.4 hours, respectively.

Pharmacokinetic properties have been investigated in patients with hereditary angioedema

(34 patients > 18 years, 6 patients < 18 years). These included 15 patients under

prophylactic treatment (with frequent/severe attacks), as well as 25 patients with less

frequent/mild attacks and "on demand" treatment. The data were generated in an attack-free

interval.

The median

in vivo

recovery (IVR) was 86.7 % (range: 54.0 – 254.1 %). The IVR for

children was slightly higher (98.2 %, range: 69.2 – 106.8 %) than for adults (82.5 %, range:

54.0 – 254.1 %). Patients with severe attacks had a higher IVR (101.4 %) compared to

patients with mild attacks (75.8 %, range: 57.2 – 195.9 %).

The median increase in activity was 2.3%/IU/kg b.w. (range: 1.4 – 6.9 %/IU/kg b.w.). No

significant differences were seen between adults and children. Patients with severe attacks

showed a slightly higher increase in activity than patients with mild attacks (2.9, range: 1.4

– 6.9 vs. 2.1, range: 1.5 – 5.1 %/IU/kg b.w.).

The maximum concentration of C1-esterase inhibitor activity in plasma was reached within

0.8 hours after administration of Berinert without significant differences between the patient

groups.

The median half-life was 36.1 hours. It was slightly shorter in children than in adults (32.9

vs. 36.1 hours) and in patients with severe attacks than in patients with mild attacks (30.9

vs. 37.0).

5.3

Preclinical safety data

Berinert contains as active ingredient C1-esterase inhibitor. It is derived from human plasma

and acts like an endogenous constituent of plasma. Single-dose application of Berinert in

rats and mice and repeated-dose application in rats did not show any evidence of toxicity.

Preclinical studies with repeated-dose application to investigate carcinogenicity and

reproductive toxicity have not been conducted because they cannot be reasonably performed

in conventional animal models due to the development of antibodies following the

application of heterologous human proteins.

in vitro

Ouchterlony test and the

in vivo

PCA model in guinea pigs did not show any

evidence of newly arising antigenic determinants in Berinert following pasteurization.

In-vivo thrombogenicity tests in rabbits were performed with doses up to 800 IU/kg of

Berinert. There was no pro-thrombotic risk associated with the i.v. administration of

Berinert up to 800 IU/kg.

Local tolerance studies in rabbits demonstrated that Berinert was clinically, locally and

histologically well-tolerated after intravenous, subcutaneous, intra-arterial and intramuscular

application.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Powder:

Glycine

Sodium chloride

Sodium citrate

Solvent:

Water for injections

6.2

Incompatibilities

In the absence of compatibility studies this medicinal product must not be mixed with other

medicinal products and diluents in the syringe/infusion set.

6.3

Shelf life

The expiry date of the product is indicated on the packaging materials.

After reconstitution, the physico-chemical stability of Berinert has been demonstrated

for 48 hours at maximum 30 °C.

From a microbiological point of view and as Berinert contains no preservative, the

reconstituted product should be used immediately.

If it is not administered immediately, storage shall not exceed 8 hours when stored below

C. The reconstituted product should only be stored in the

vial

6.4

Special precautions for storage

Do not store above 30 °C.

Do not freeze.

Keep the vial in the outer carton, in order to protect from light.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5

Nature and contents of container

Immediate containers :

Powder (500 IU) in a vial (Type II glass) with a stopper (bromobutyl rubber), seal

(aluminium) and flip-off cap (plastic).

10 ml of solvent in a vial (Type I glass) with a stopper (chlorobutyl rubber), seal

(aluminium) and flip-off cap (plastic).

Presentation

Box containing:

1 vial with powder

1 solvent vial (10 ml)

1 filter transfer device 20/20 (Mix2Vial)

Administration set (inner box):

1 disposable 10 ml syringe

1 venipuncture set

2 alcohol swabs

1 plaster

Pack size of 1.

6.6

Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with

local requirements.

Method of administration

General instructions

The solution should be colourless and clear.

After filtering/withdrawal (see below) reconstituted product should be inspected visually

for particulate matter and discoloration prior to administration.

Do not use solutions that are cloudy or have deposits.

Reconstitution and withdrawal must be carried out under aseptic conditions. Use the

syringe provided with the product or a silicone-free syringe.

Reconstitution

Bring the solvent to room temperature. Ensure product and solvent vial flip caps are

removed and the stoppers are treated with an antiseptic solution and allowed to dry prior to

opening the Mix2Vial package.

1. Open the Mix2Vial package by peeling off

the lid. Do

not

remove the Mix2Vial from the

blister package!

2. Place the solvent vial on an even, clean

surface and hold the vial tight. Take the

Mix2Vial together with the blister package

and push the spike of the blue adapter end

straight down

through the solvent vial

stopper.

3. Carefully remove the blister package from

the Mix2Vial set by holding at the rim, and

pulling

vertically

upwards. Make sure that

you only pull away the blister package and

not the Mix2Vial set.

4. Place the product vial on an even and firm

surface. Invert the solvent vial with the

Mix2Vial set attached and push the spike of

the transparent adapter end

straight down

through the product vial stopper. The solvent

will automatically flow into the product vial.

5. With one hand grasp the product-side of

the Mix2Vial set and with the other hand

grasp the solvent-side and unscrew the set

carefully counterclockwise into two pieces.

Discard the solvent vial with the blue

Mix2Vial adapter attached.

6. Gently swirl the product vial with the

transparent adapter attached until the

substance is fully dissolved. Do not shake.

7. Draw air into an empty, sterile syringe. Use

the syringe provided with the product or a

silicone-free syringe. While the product vial

is upright, connect the syringe to the

Mix2Vial’s Luer Lock fitting by screwing

clockwise. Inject air into the product vial.

Withdrawal and application

8. While keeping the syringe plunger pressed,

turn the system upside down and draw the

solution into the syringe by pulling the

plunger back slowly.

9. Now that the solution has been transferred

into the syringe, firmly hold on to the barrel

of the syringe (keeping the syringe plunger

facing down) and disconnect the transparent

Mix2Vial adapter from the syringe by

unscrewing counterclockwise.

7.

MANUFACTURER

CSL Behring GmbH

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

8.

LICENSE NUMBER

145 06 33056

9.

REGISTRATION HOLDER

Genmedix, 12 Beit Harishonim St., Emek-Hefer 3877701.

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