Albalon Relief

Main information

  • Trade name:
  • Albalon Relief 0.12 % Eye drops, solution
  • Dosage:
  • 0.12 %
  • Pharmaceutical form:
  • Eye drops, solution
  • Units in package:
  • Single use dropper, 0.4 mL
  • Class:
  • General sale
  • Prescription type:
  • General sale
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Boehringer Ingelheim Pharma GmbH & Co KG

Documents

Localization

  • Available in:
  • Albalon Relief 0.12 % Eye drops, solution
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 1369
  • Authorization date:
  • 02-02-1995
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

DATA SHEET

NAME OF MEDICINE

ALBALON RELIEF TM phenylephrine hydrochloride 1.2 mg per mL.

PRESENTATION

Contains: phenylephrinehydrochloride0.12%, polyvinyl alcohol(Liquifilm) 1.4%, disodium

edetate, disodium phosphate monobasic, sodiumphosphate dibasic heptahydrate, sodium

acetate, sodium thiosulphate, sodium hydroxide orhydrochloric acid and purified water.

Phenylephrinehydrochloride is a whiteor almost white crystal orcrystallinepowder that is

freely solublein water and alcohol.

USES: Actions

A soothing, lubricating, decongestant eye drop.It also improvesthe appearance of theeye

through the blanching effect of themild vasoconstrictor, phenylephrine.

PHARMACOKINETICS

Since phenylephrine is absorbed through the mucosa, systemic effects may follow application

to the eyes.

INDICATIONS

ALBALON RELIEF TM is a preservativefree decongestant, vasoconstrictor lubricating eye

drops, for the relief of minor eye irritationscausedby colds, hayfever, dust, smog, contact

lenses, sun, wind, swimming and allergy.

DOSAGE AND ADMINISTRATION

Use one or two drops inthe affectedeye(s). Maybe repeatedin three to four hoursas

needed.

CONTRAINDICATIONS

Hypersensitivityto phenylephrine hydrochlorideor any ofthe other components. Should not

be used in the presenceofnarrow angle glaucomaor other serious eye conditions, orwith

soft contact lenses (seeprecautions).

WARNINGS AND PRECAUTIONS

To avoid contamination, donot touch tip of container to any surface. Do notreuse. Once

opened, discard. Pupils may dilate in some individuals. If you experience eye pain, changes

in vision, continued redness or irritationof theeye, or if the conditionworsens orpersists for

more than 72hours, discontinue useand consult a doctor. Overuse of this product may

produce increased redness of the eye. If solutionchanges colour orbecomescloudy, do not

use.

Patients using other eye productsshould beadvised to seekmedical advice before using

ALBALON RELIEF TM eyedrops. For external use only.

Not for usewhile wearingsoft contact lenses. Patients wearing soft contact lensesshould be

instructed toremove theirlensesprior toinstilling ALBALONRELIEF TM eye drops andwait at

least 15 minutes before reinserting the lenses.

Use in pregnancy: CategoryB2.

The Australian Categorisation definitionof Category B is as follows:

Drugswhichhave been taken by only alimited number of pregnantwomen and women of

childbearingage, without an increase inthe frequency of malformation or other direct or

indirect harmful effects on the humanfoetus having been observed.

Studies in animals are inadequate ormay be lacking, but availabledata show noevidence of

an increased occurrence of foetal damage.

Use in Lactation

Since many drugs are excreted in humanmilk, caution should be exercised if ALBALON

RELIEF™ eye drops are administeredto a breastfeeding woman.

ADVERSEREACTIONS

Pupillary dilation may occur in someindividuals. Prolonged use may result in increased

redness of the eye. Some patients mayalsoexperience epithelialxerosis fromprolonged

topical instillation of local decongestants, which mayexacerbate the symptoms.

OVERDOSAGE

No information on overdosage is available inhumans. Should accidental overdosagein the

eye(s) occur,flush eye(s) with water ornormal saline. Contact thePoison’s Information

Centre if there is concernover possibleaccidental ingestion.

PHARMACEUTICAL PRECAUTIONS

Store below25 o

C.Opensingle-use containerimmediately before applying eye drops. Use

once only and then discard.

MEDICINECLASSIFICATION

General Medicine.

PACKAGEQUANTITIES

Eye Drops, 0.4 mL sterile unitdosecontainers in packs of 5s.

NAME AND ADDRESS

AllerganNew Zealand Limited

Cornerof Manu TapuDrive and

JosephHammond Palce

Auckland International Airport

Mangere

AUCKLAND

Toll free telephone: 0800 659 912

DATE OF PREPARATION

4 September, 2008

Trademark of Allergan Inc.

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Summary of opinion: Sprycel,dasatinib,  13/12/2018,  Positive

Summary of opinion: Sprycel,dasatinib, 13/12/2018, Positive

Summary of opinion: Sprycel,dasatinib, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rizmoic,naldemedine,  13/12/2018,  Positive

Summary of opinion: Rizmoic,naldemedine, 13/12/2018, Positive

Summary of opinion: Rizmoic,naldemedine, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rubraca,rucaparib,  13/12/2018,  Positive

Summary of opinion: Rubraca,rucaparib, 13/12/2018, Positive

Summary of opinion: Rubraca,rucaparib, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Zirabev,bevacizumab,  13/12/2018,  Positive

Summary of opinion: Zirabev,bevacizumab, 13/12/2018, Positive

Summary of opinion: Zirabev,bevacizumab, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

12-12-2018

Oncaspar (Les Laboratoires Servier)

Oncaspar (Les Laboratoires Servier)

Oncaspar (Active substance: pegaspargase) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8757 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3789/T/21

Europe -DG Health and Food Safety

12-12-2018

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Active substance: daclatasvir) - Centralised - Yearly update - Commission Decision (2018)8758 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Active substance: atazanavir / cobicistat) - Centralised - Yearly update - Commission Decision (2018)8679 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Active substance: efmoroctocog alfa) - Centralised - Variation - Commission Decision (2018)8678 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3964/X/21

Europe -DG Health and Food Safety

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

7-12-2018


Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004,  06/12/2018,  Positive

Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004, 06/12/2018, Positive

Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004, 06/12/2018, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Summary of opinion: Kriptazen,halofuginone,  06/12/2018,  Positive

Summary of opinion: Kriptazen,halofuginone, 06/12/2018, Positive

Summary of opinion: Kriptazen,halofuginone, 06/12/2018, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated),  06/12/2018,  Positive

Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated), 06/12/2018, Positive

Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated), 06/12/2018, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Europe - EMA - European Medicines Agency