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Macugen (pegaptanib) – Labelling - S01LA03

Updated on site: 08-Oct-2017

Medication nameMacugen
ATC CodeS01LA03
Substancepegaptanib
ManufacturerPharmaSwiss Ceska Republika s.r.o

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Macugen 0.3 mg solution for injection pegaptanib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled syringe provides a usable amount to deliver a single dose of 90 microlitres containing pegaptanib sodium, corresponding to 0.3 mg of the free acid form of the oligonucleotide.

3.LIST OF EXCIPIENTS

Sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, sodium hydroxide and hydrochloric acid (for pH adjustment), water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection.

Delivers a single dose of 0.3 mg in 90 microliters

Pack of one pre-filled syringe, a plunger stopper and a pre-attached plunger rod. Needle is not provided.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravitreal use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

CAUTION: Expel excess volume before injecting.

Align the third rib of the plunger stopper with the pre-printed black dosing line.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c

170 00 Praha 7

Czech Republic

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/05/325/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Macugen 0.3 mg injection pegaptanib

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

4.BATCH NUMBER

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Single dose: 0.3 mg/90 µl

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

POUCH containing pre-filled syringe, a plunger stopper and a pre-attached plunger rod

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINSTRATION

Macugen 0.3 mg solution for injection pegaptanib

Intravitreal use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Single dose: 0.3 mg/90 µl

6. OTHER

The pouch must not be opened until the patient has been prepared for injection.

CAUTION: Expel excess volume before injecting

Align the third rib of the plunger stopper with the pre-printed black dosing line.

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